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Ukrainian diabetes care, insulin access ‘severely disrupted’
with shortages resulting more from distribution problems than supply itself, according to multiple sources.
In 2021, there were about 2.3 million people with diabetes in Ukraine, roughly 7% of the total population. Of those, about 120,000 have type 1 diabetes and depend on insulin to live, while a similar number have insulin-treated type 2 diabetes.
Donations of insulin, other medications, and supplies have been pouring in since late February from sources including the Ukrainian diaspora, nongovernmental organizations, other European governments, universities, and product manufacturers. “The main problem now is logistic,” Boris Mankovsky, MD, president of the Ukrainian Diabetology Association, said in an interview.
Insulin manufacturer Novo Nordisk’s warehouse continues to operate, although deliveries have been curtailed because of shortages in delivery staff. The company is working to get medications to patients either through pharmacies or humanitarian organizations and has funded refugee support efforts, they said in a March 8 statement.
But even if the supplies reach the pharmacies, they may not reach patients for a variety of logistical reasons, noted Dr. Mankovsky, who is head of the department of diabetology at the P.L. Shupyk National Medical Academy for Postgraduate Education in Kyiv. “So, there are a lot of problems. I don’t know exactly where the main bottleneck is, but there are shortages, definitely.”
Insulin supplies have also been distributed very unequally by region and type, with various shipments containing long-acting, short-acting, analog, or human insulins. “We’re very grateful for all of it. But it’s not centrally coordinated, which of course is understandable, but it means that a lot of donations go to one place and no supply goes to another,” Dr. Mankovsky said.
Most of the donated supplies have been going to western Ukraine, where the capital Kyiv is located. “But the main problem now is the eastern part of Ukraine. It’s difficult and dangerous to deliver any supplies there, especially [with] the terrible situation in Mariupol. Eastern Ukraine now suffers the most, at least at this minute,” he said.
Diabetes specialists continue to work, at least for now
Ivan Smirnov, MD, PhD, head of the endocrinology department at Kharkiv Regional Hospital, in the northeastern part of the country, said in an email to this news organization: “I continue to stay in Kharkiv, in spite of the situation. A lot of people are killed, many people are wounded. My hospital is full of wounded civilians ... a lot of buildings are destroyed partly and some completely.”
Dr. Smirnov said that he and his colleagues “find the way to overcome the fear ... in constant work. Part of the work is online consulting assistance for routine patients. ... But the main time now is dedicated to providing the diabetes patients with insulin. This is a heavy job to do indeed.”
Dr. Mankovsky, who practices adult diabetology and endocrinology in Kyiv, continues to manage patients, but mostly remotely. “Practice is severely disrupted. I’m willing to see patients but it’s extremely difficult and dangerous for them and probably not possible to travel to see me. So that’s why all our communications now is distant, through phone or internet. ... We can communicate and I’m able to provide some recommendations for changes in treatment or some corrections in insulin therapy.”
Despite the Russians closing in on Kyiv, Dr. Mankovsky said, “I’ve decided to stay as long as possible. Then, nobody knows of course but I think I have to. ... We hear explosions every day. ... I’m in the center of the city and the streets are empty. It’s heartbreaking.”
Supplies are reaching refugees
Dr. Mankovsky said: “Now we have huge movement of refugees. Among them are a lot of people with diabetes who moved out of their place and nobody knows where they are. It’s really a huge disruption.”
According to the type 1 diabetes advocacy organization JDRF, many men with diabetes aged 18-60 are remaining in Ukraine to fight, despite the increased risk with the disease. But an estimated 15,000 children with type 1 diabetes and their families are attempting to escape the conflict by moving to the western regions of the country or over the borders.
“Those who make it to Hungary, Moldova, Poland, or Romania are being received with wonderful generosity. We have heard stories ranging from governments making it possible to pick up insulin free without a script to individuals emptying their cupboards of insulin for those whose need is urgent,” JDRF said in a statement on March 2.
For its part, Novo Nordisk has donated 55 million Danish kroner (about 7.3 million Euros, or $8.2 million U.S. dollars) to support international relief organizations in assisting refugees.
Ivan Tkac, MD, PhD, professor of medicine at Safárik University in Kosice, Slovakia, is assisting refugees, including those with diabetes. Slovakia is predominantly a transit country for refugees from Ukraine, he said in an interview.
“However, in solidarity with Ukraine, we are providing emergency medical care for both Ukrainians and refugees from third countries leaving Ukraine,” he said, noting that those individuals are primarily foreign students who had been studying there.
“Asylum seekers receive full medical insurance paid by the government of the Slovak Republic. As part of this care, the refugees are provided with the necessary amount of insulin and other antidiabetic drugs, as well as medical devices needed for the treatment of diabetes. The European Commission has pledged to supply Slovakia with the necessary quantities of medicines for the treatment of diabetes in the coming weeks as part of its assistance to the countries bordering Ukraine. In addition, some humanitarian organizations are organizing supplies of insulin and other medicines for soldiers fighting in the Ukrainian army,” Dr. Tkac said.
How you can help
A number of organizations are providing assistance specifically to people with diabetes, as well as broader medical assistance to people remaining in Ukraine and to refugees.
A collaboration between the Ministry of Health of Ukraine, the humanitarian agency Direct Relief, and the International Diabetes Federation is working to determine where supplies are short, to secure donations within Europe, and to open up “green corridors” within Ukraine to deliver them quickly to where they’re needed. They have asked those who wish to help to donate to Direct Relief and direct donations to the “Ukraine crisis.”
Another effort organized by IDF Europe is Connect Solidarity, a program that “aims to facilitate support from IDF Europe member associations across Europe wishing to help other national diabetes associations in Ukraine’s neighboring countries, provide advice, medicines, and supplies to Ukrainian refugees.”
IDF President Andrew Boulton, MD, told this news organization that he has been in almost daily contact with senior colleagues working in diabetes in Ukraine, and that he is working with the organization’s affiliated charity Life for a Child in addition to the other charitable agencies. “We will continue to do our utmost best to help those with diabetes living in Ukraine. However, this is, of course, very challenging, and we hope that we are doing the best we can in such a difficult situation. We all hope and pray that this situation is soon resolved.”
The European Association for the Study of Diabetes is taking a somewhat different approach, by encouraging its members to “support people with ill health, including diabetes, with donations through established [nongovernmental organizations] that have the capacity to help on site, such as United Nations High Commissioner for Refugees or International Committee of the Red Cross.”
Dr. Mankovsky told this news organization that he is very grateful for all the support from around the world: “Just thanks. I’ve got so much support, so many phone calls, so many letters ... not just me, all of us. People wise and friendship wise we feel support. It’s really important, emotionally and with insulin supply and other medications. Without that, it would be much more difficult.”
Pandemic-prompted changes enable wartime diabetes care
Dramatic changes in diabetes care delivery in Ukraine necessitated by the COVID-19 pandemic have proved indispensable during the Russian invasion.
In a piece published May 29, 2020, in the Journal of Diabetes Science and Technology, Dr. Mankovsky described how the pandemic hit just as Ukraine’s health system was pivoting from government controlled to insurance based.
Prior to the pandemic, patients with both type 1 and type 2 diabetes were regularly admitted to hospital for routine checkups, insulin dose management, and other treatments, a “remnant of the Soviet-era medical practice, which emphasized heavily on hospital admissions,” Dr. Mankovsky said in an interview.
This was the case, he wrote in the article, “despite the common understanding that such a system was a waste of resources ... this policy was changing much slower than we wanted.”
But the COVID-19 pandemic changed that practice “abruptly and dramatically,” so that all hospitalizations for patients with diabetes were stopped unless there was a real metabolic emergency.
Subsequently, Dr. Mankovsky wrote, “almost every health professional recognizes the particular importance of the new ways of communications with patients and with other colleagues.”
Indeed, in his email to this news organization, Dr. Smirnov mentioned that the routine diabetes management work he is still able to do remotely despite the extreme disruption in his region “is easy because of long-term COVID-period experience.”
Also because of the pandemic, insulin prescriptions were switched from traditional paper to electronic transfer, so that patients could easily pick them up at the pharmacy. “This new ... system proved to be not just very convenient for all parties involved, but in the current situation, it allowed us to prevent so many medically unnecessary visits to the clinics, which otherwise would have presented the real threat to the patients’ health and risk to get them infected,” Dr. Mankovsky wrote in 2020.
Now with the new danger, he said, “the inability to see patients is probably the least of our problems.”
A version of this article first appeared on Medscape.com.
with shortages resulting more from distribution problems than supply itself, according to multiple sources.
In 2021, there were about 2.3 million people with diabetes in Ukraine, roughly 7% of the total population. Of those, about 120,000 have type 1 diabetes and depend on insulin to live, while a similar number have insulin-treated type 2 diabetes.
Donations of insulin, other medications, and supplies have been pouring in since late February from sources including the Ukrainian diaspora, nongovernmental organizations, other European governments, universities, and product manufacturers. “The main problem now is logistic,” Boris Mankovsky, MD, president of the Ukrainian Diabetology Association, said in an interview.
Insulin manufacturer Novo Nordisk’s warehouse continues to operate, although deliveries have been curtailed because of shortages in delivery staff. The company is working to get medications to patients either through pharmacies or humanitarian organizations and has funded refugee support efforts, they said in a March 8 statement.
But even if the supplies reach the pharmacies, they may not reach patients for a variety of logistical reasons, noted Dr. Mankovsky, who is head of the department of diabetology at the P.L. Shupyk National Medical Academy for Postgraduate Education in Kyiv. “So, there are a lot of problems. I don’t know exactly where the main bottleneck is, but there are shortages, definitely.”
Insulin supplies have also been distributed very unequally by region and type, with various shipments containing long-acting, short-acting, analog, or human insulins. “We’re very grateful for all of it. But it’s not centrally coordinated, which of course is understandable, but it means that a lot of donations go to one place and no supply goes to another,” Dr. Mankovsky said.
Most of the donated supplies have been going to western Ukraine, where the capital Kyiv is located. “But the main problem now is the eastern part of Ukraine. It’s difficult and dangerous to deliver any supplies there, especially [with] the terrible situation in Mariupol. Eastern Ukraine now suffers the most, at least at this minute,” he said.
Diabetes specialists continue to work, at least for now
Ivan Smirnov, MD, PhD, head of the endocrinology department at Kharkiv Regional Hospital, in the northeastern part of the country, said in an email to this news organization: “I continue to stay in Kharkiv, in spite of the situation. A lot of people are killed, many people are wounded. My hospital is full of wounded civilians ... a lot of buildings are destroyed partly and some completely.”
Dr. Smirnov said that he and his colleagues “find the way to overcome the fear ... in constant work. Part of the work is online consulting assistance for routine patients. ... But the main time now is dedicated to providing the diabetes patients with insulin. This is a heavy job to do indeed.”
Dr. Mankovsky, who practices adult diabetology and endocrinology in Kyiv, continues to manage patients, but mostly remotely. “Practice is severely disrupted. I’m willing to see patients but it’s extremely difficult and dangerous for them and probably not possible to travel to see me. So that’s why all our communications now is distant, through phone or internet. ... We can communicate and I’m able to provide some recommendations for changes in treatment or some corrections in insulin therapy.”
Despite the Russians closing in on Kyiv, Dr. Mankovsky said, “I’ve decided to stay as long as possible. Then, nobody knows of course but I think I have to. ... We hear explosions every day. ... I’m in the center of the city and the streets are empty. It’s heartbreaking.”
Supplies are reaching refugees
Dr. Mankovsky said: “Now we have huge movement of refugees. Among them are a lot of people with diabetes who moved out of their place and nobody knows where they are. It’s really a huge disruption.”
According to the type 1 diabetes advocacy organization JDRF, many men with diabetes aged 18-60 are remaining in Ukraine to fight, despite the increased risk with the disease. But an estimated 15,000 children with type 1 diabetes and their families are attempting to escape the conflict by moving to the western regions of the country or over the borders.
“Those who make it to Hungary, Moldova, Poland, or Romania are being received with wonderful generosity. We have heard stories ranging from governments making it possible to pick up insulin free without a script to individuals emptying their cupboards of insulin for those whose need is urgent,” JDRF said in a statement on March 2.
For its part, Novo Nordisk has donated 55 million Danish kroner (about 7.3 million Euros, or $8.2 million U.S. dollars) to support international relief organizations in assisting refugees.
Ivan Tkac, MD, PhD, professor of medicine at Safárik University in Kosice, Slovakia, is assisting refugees, including those with diabetes. Slovakia is predominantly a transit country for refugees from Ukraine, he said in an interview.
“However, in solidarity with Ukraine, we are providing emergency medical care for both Ukrainians and refugees from third countries leaving Ukraine,” he said, noting that those individuals are primarily foreign students who had been studying there.
“Asylum seekers receive full medical insurance paid by the government of the Slovak Republic. As part of this care, the refugees are provided with the necessary amount of insulin and other antidiabetic drugs, as well as medical devices needed for the treatment of diabetes. The European Commission has pledged to supply Slovakia with the necessary quantities of medicines for the treatment of diabetes in the coming weeks as part of its assistance to the countries bordering Ukraine. In addition, some humanitarian organizations are organizing supplies of insulin and other medicines for soldiers fighting in the Ukrainian army,” Dr. Tkac said.
How you can help
A number of organizations are providing assistance specifically to people with diabetes, as well as broader medical assistance to people remaining in Ukraine and to refugees.
A collaboration between the Ministry of Health of Ukraine, the humanitarian agency Direct Relief, and the International Diabetes Federation is working to determine where supplies are short, to secure donations within Europe, and to open up “green corridors” within Ukraine to deliver them quickly to where they’re needed. They have asked those who wish to help to donate to Direct Relief and direct donations to the “Ukraine crisis.”
Another effort organized by IDF Europe is Connect Solidarity, a program that “aims to facilitate support from IDF Europe member associations across Europe wishing to help other national diabetes associations in Ukraine’s neighboring countries, provide advice, medicines, and supplies to Ukrainian refugees.”
IDF President Andrew Boulton, MD, told this news organization that he has been in almost daily contact with senior colleagues working in diabetes in Ukraine, and that he is working with the organization’s affiliated charity Life for a Child in addition to the other charitable agencies. “We will continue to do our utmost best to help those with diabetes living in Ukraine. However, this is, of course, very challenging, and we hope that we are doing the best we can in such a difficult situation. We all hope and pray that this situation is soon resolved.”
The European Association for the Study of Diabetes is taking a somewhat different approach, by encouraging its members to “support people with ill health, including diabetes, with donations through established [nongovernmental organizations] that have the capacity to help on site, such as United Nations High Commissioner for Refugees or International Committee of the Red Cross.”
Dr. Mankovsky told this news organization that he is very grateful for all the support from around the world: “Just thanks. I’ve got so much support, so many phone calls, so many letters ... not just me, all of us. People wise and friendship wise we feel support. It’s really important, emotionally and with insulin supply and other medications. Without that, it would be much more difficult.”
Pandemic-prompted changes enable wartime diabetes care
Dramatic changes in diabetes care delivery in Ukraine necessitated by the COVID-19 pandemic have proved indispensable during the Russian invasion.
In a piece published May 29, 2020, in the Journal of Diabetes Science and Technology, Dr. Mankovsky described how the pandemic hit just as Ukraine’s health system was pivoting from government controlled to insurance based.
Prior to the pandemic, patients with both type 1 and type 2 diabetes were regularly admitted to hospital for routine checkups, insulin dose management, and other treatments, a “remnant of the Soviet-era medical practice, which emphasized heavily on hospital admissions,” Dr. Mankovsky said in an interview.
This was the case, he wrote in the article, “despite the common understanding that such a system was a waste of resources ... this policy was changing much slower than we wanted.”
But the COVID-19 pandemic changed that practice “abruptly and dramatically,” so that all hospitalizations for patients with diabetes were stopped unless there was a real metabolic emergency.
Subsequently, Dr. Mankovsky wrote, “almost every health professional recognizes the particular importance of the new ways of communications with patients and with other colleagues.”
Indeed, in his email to this news organization, Dr. Smirnov mentioned that the routine diabetes management work he is still able to do remotely despite the extreme disruption in his region “is easy because of long-term COVID-period experience.”
Also because of the pandemic, insulin prescriptions were switched from traditional paper to electronic transfer, so that patients could easily pick them up at the pharmacy. “This new ... system proved to be not just very convenient for all parties involved, but in the current situation, it allowed us to prevent so many medically unnecessary visits to the clinics, which otherwise would have presented the real threat to the patients’ health and risk to get them infected,” Dr. Mankovsky wrote in 2020.
Now with the new danger, he said, “the inability to see patients is probably the least of our problems.”
A version of this article first appeared on Medscape.com.
with shortages resulting more from distribution problems than supply itself, according to multiple sources.
In 2021, there were about 2.3 million people with diabetes in Ukraine, roughly 7% of the total population. Of those, about 120,000 have type 1 diabetes and depend on insulin to live, while a similar number have insulin-treated type 2 diabetes.
Donations of insulin, other medications, and supplies have been pouring in since late February from sources including the Ukrainian diaspora, nongovernmental organizations, other European governments, universities, and product manufacturers. “The main problem now is logistic,” Boris Mankovsky, MD, president of the Ukrainian Diabetology Association, said in an interview.
Insulin manufacturer Novo Nordisk’s warehouse continues to operate, although deliveries have been curtailed because of shortages in delivery staff. The company is working to get medications to patients either through pharmacies or humanitarian organizations and has funded refugee support efforts, they said in a March 8 statement.
But even if the supplies reach the pharmacies, they may not reach patients for a variety of logistical reasons, noted Dr. Mankovsky, who is head of the department of diabetology at the P.L. Shupyk National Medical Academy for Postgraduate Education in Kyiv. “So, there are a lot of problems. I don’t know exactly where the main bottleneck is, but there are shortages, definitely.”
Insulin supplies have also been distributed very unequally by region and type, with various shipments containing long-acting, short-acting, analog, or human insulins. “We’re very grateful for all of it. But it’s not centrally coordinated, which of course is understandable, but it means that a lot of donations go to one place and no supply goes to another,” Dr. Mankovsky said.
Most of the donated supplies have been going to western Ukraine, where the capital Kyiv is located. “But the main problem now is the eastern part of Ukraine. It’s difficult and dangerous to deliver any supplies there, especially [with] the terrible situation in Mariupol. Eastern Ukraine now suffers the most, at least at this minute,” he said.
Diabetes specialists continue to work, at least for now
Ivan Smirnov, MD, PhD, head of the endocrinology department at Kharkiv Regional Hospital, in the northeastern part of the country, said in an email to this news organization: “I continue to stay in Kharkiv, in spite of the situation. A lot of people are killed, many people are wounded. My hospital is full of wounded civilians ... a lot of buildings are destroyed partly and some completely.”
Dr. Smirnov said that he and his colleagues “find the way to overcome the fear ... in constant work. Part of the work is online consulting assistance for routine patients. ... But the main time now is dedicated to providing the diabetes patients with insulin. This is a heavy job to do indeed.”
Dr. Mankovsky, who practices adult diabetology and endocrinology in Kyiv, continues to manage patients, but mostly remotely. “Practice is severely disrupted. I’m willing to see patients but it’s extremely difficult and dangerous for them and probably not possible to travel to see me. So that’s why all our communications now is distant, through phone or internet. ... We can communicate and I’m able to provide some recommendations for changes in treatment or some corrections in insulin therapy.”
Despite the Russians closing in on Kyiv, Dr. Mankovsky said, “I’ve decided to stay as long as possible. Then, nobody knows of course but I think I have to. ... We hear explosions every day. ... I’m in the center of the city and the streets are empty. It’s heartbreaking.”
Supplies are reaching refugees
Dr. Mankovsky said: “Now we have huge movement of refugees. Among them are a lot of people with diabetes who moved out of their place and nobody knows where they are. It’s really a huge disruption.”
According to the type 1 diabetes advocacy organization JDRF, many men with diabetes aged 18-60 are remaining in Ukraine to fight, despite the increased risk with the disease. But an estimated 15,000 children with type 1 diabetes and their families are attempting to escape the conflict by moving to the western regions of the country or over the borders.
“Those who make it to Hungary, Moldova, Poland, or Romania are being received with wonderful generosity. We have heard stories ranging from governments making it possible to pick up insulin free without a script to individuals emptying their cupboards of insulin for those whose need is urgent,” JDRF said in a statement on March 2.
For its part, Novo Nordisk has donated 55 million Danish kroner (about 7.3 million Euros, or $8.2 million U.S. dollars) to support international relief organizations in assisting refugees.
Ivan Tkac, MD, PhD, professor of medicine at Safárik University in Kosice, Slovakia, is assisting refugees, including those with diabetes. Slovakia is predominantly a transit country for refugees from Ukraine, he said in an interview.
“However, in solidarity with Ukraine, we are providing emergency medical care for both Ukrainians and refugees from third countries leaving Ukraine,” he said, noting that those individuals are primarily foreign students who had been studying there.
“Asylum seekers receive full medical insurance paid by the government of the Slovak Republic. As part of this care, the refugees are provided with the necessary amount of insulin and other antidiabetic drugs, as well as medical devices needed for the treatment of diabetes. The European Commission has pledged to supply Slovakia with the necessary quantities of medicines for the treatment of diabetes in the coming weeks as part of its assistance to the countries bordering Ukraine. In addition, some humanitarian organizations are organizing supplies of insulin and other medicines for soldiers fighting in the Ukrainian army,” Dr. Tkac said.
How you can help
A number of organizations are providing assistance specifically to people with diabetes, as well as broader medical assistance to people remaining in Ukraine and to refugees.
A collaboration between the Ministry of Health of Ukraine, the humanitarian agency Direct Relief, and the International Diabetes Federation is working to determine where supplies are short, to secure donations within Europe, and to open up “green corridors” within Ukraine to deliver them quickly to where they’re needed. They have asked those who wish to help to donate to Direct Relief and direct donations to the “Ukraine crisis.”
Another effort organized by IDF Europe is Connect Solidarity, a program that “aims to facilitate support from IDF Europe member associations across Europe wishing to help other national diabetes associations in Ukraine’s neighboring countries, provide advice, medicines, and supplies to Ukrainian refugees.”
IDF President Andrew Boulton, MD, told this news organization that he has been in almost daily contact with senior colleagues working in diabetes in Ukraine, and that he is working with the organization’s affiliated charity Life for a Child in addition to the other charitable agencies. “We will continue to do our utmost best to help those with diabetes living in Ukraine. However, this is, of course, very challenging, and we hope that we are doing the best we can in such a difficult situation. We all hope and pray that this situation is soon resolved.”
The European Association for the Study of Diabetes is taking a somewhat different approach, by encouraging its members to “support people with ill health, including diabetes, with donations through established [nongovernmental organizations] that have the capacity to help on site, such as United Nations High Commissioner for Refugees or International Committee of the Red Cross.”
Dr. Mankovsky told this news organization that he is very grateful for all the support from around the world: “Just thanks. I’ve got so much support, so many phone calls, so many letters ... not just me, all of us. People wise and friendship wise we feel support. It’s really important, emotionally and with insulin supply and other medications. Without that, it would be much more difficult.”
Pandemic-prompted changes enable wartime diabetes care
Dramatic changes in diabetes care delivery in Ukraine necessitated by the COVID-19 pandemic have proved indispensable during the Russian invasion.
In a piece published May 29, 2020, in the Journal of Diabetes Science and Technology, Dr. Mankovsky described how the pandemic hit just as Ukraine’s health system was pivoting from government controlled to insurance based.
Prior to the pandemic, patients with both type 1 and type 2 diabetes were regularly admitted to hospital for routine checkups, insulin dose management, and other treatments, a “remnant of the Soviet-era medical practice, which emphasized heavily on hospital admissions,” Dr. Mankovsky said in an interview.
This was the case, he wrote in the article, “despite the common understanding that such a system was a waste of resources ... this policy was changing much slower than we wanted.”
But the COVID-19 pandemic changed that practice “abruptly and dramatically,” so that all hospitalizations for patients with diabetes were stopped unless there was a real metabolic emergency.
Subsequently, Dr. Mankovsky wrote, “almost every health professional recognizes the particular importance of the new ways of communications with patients and with other colleagues.”
Indeed, in his email to this news organization, Dr. Smirnov mentioned that the routine diabetes management work he is still able to do remotely despite the extreme disruption in his region “is easy because of long-term COVID-period experience.”
Also because of the pandemic, insulin prescriptions were switched from traditional paper to electronic transfer, so that patients could easily pick them up at the pharmacy. “This new ... system proved to be not just very convenient for all parties involved, but in the current situation, it allowed us to prevent so many medically unnecessary visits to the clinics, which otherwise would have presented the real threat to the patients’ health and risk to get them infected,” Dr. Mankovsky wrote in 2020.
Now with the new danger, he said, “the inability to see patients is probably the least of our problems.”
A version of this article first appeared on Medscape.com.
Can a tool help overcome barriers to diabetes medication cost?
The resource, “Having Healthcare Cost Conversations to Improve Patient Outcomes: A Practical Guide,” was jointly developed by the Association of Diabetes Care & Education Specialists and Beyond Type 1, the nonprofit patient advocacy organization.
Indeed, the guide appeared as President Biden discussed his proposal to cap insulin costs at $35 per insulin vial during the State of the Union address, during which he introduced a young boy with type 1 diabetes in the guest box, as reported by this news organization. On March 3, Civica, a nonprofit coalition of health systems and philanthropies, announced it plans to manufacture generic insulin at a deeply discounted price, as reported by this news organization.
“Just to see diabetes front and center at the State of the Union followed by these announcements is certainly reflective of our own advocacy effort to make sure that people have affordable options for insulin, diabetes medications, services,” Kate Thomas, ADCES chief advocacy and external affairs officer, said in an interview. She added that ADCES has also pushed for legislation in Congress that would expand access to diabetes self-management training under the Medicare program.
The guide includes advice about overcoming barriers to discussing treatment costs with patients, suggested questions to ask patients about specific costs, and determinants of health and conversational approaches. Links are provided to resources for obtaining affordable insulin, other diabetes medications, and continuous glucose monitoring and insulin pump equipment.
“We know that, especially during primary care visits, there is limited time along with numbers of issues to talk about, so I think our challenge is how do we prioritize these conversations with something that can lead to action, not just saying you should do this but how do you actually do it,” Ms. Thomas said.
The introduction summarizes results from a 2021 Beyond Type 1 survey confirming prior findings reported by this news organization that cost is a frequent barrier for many individuals living with diabetes. “Especially right now where we are in terms of the impact of the pandemic and with peoples’ job statuses changing, I think it’s worthwhile to raise this in patient encounters,” Ms. Thomas said.
Overcoming conversational barriers
The first of three tables in the guide provides a list of “barriers to having a cost conversation” in the first column and “suggested solutions” in the second. For example, for the barrier, “You have insufficient time and/or knowledge about cost,” the suggestion is, “request and share available faculty and resources, including benefits coordinators, social workers, and community-based organizations. Work with the pharmacists and other members of the diabetes care team to identify resources that lower cost of medications.”
And for another barrier, “patients are often embarrassed or ashamed to initiate discussions of affordability,” the suggested solution is: “Normalize the issue of cost of care barriers for patients.”
A second table offers specific questions to ask patients about costs of medications and care, determinants of health, and financial barriers. These include: “What are some challenges you’ve had to accessing your medications or taking them as prescribed? What are some out-of-pocket health care costs you need help with? What challenges do you have accessing healthy food for you and your family?”
A link to a screening tool for social determinants of health is also included.
Language suggestions include talking about “cost of care” rather than “money,” asking patients if they’ve understood everything correctly by repeating back what they’ve said, and asking for confirmation and discussing follow-up.
Overall, the tool is designed to be a “broad conversation starter,” and not just about medications, Ms. Thomas said. “This is for all audiences and it’s meant to be something that the provider can tailor depending on who they’re speaking to. ... It’s about medications, but also the entire cost of care, including services and devices, transportation to appointments, access to food. ... Diabetes care isn’t just taking medication. It’s so many more factors.”
Ms. Thomas reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The resource, “Having Healthcare Cost Conversations to Improve Patient Outcomes: A Practical Guide,” was jointly developed by the Association of Diabetes Care & Education Specialists and Beyond Type 1, the nonprofit patient advocacy organization.
Indeed, the guide appeared as President Biden discussed his proposal to cap insulin costs at $35 per insulin vial during the State of the Union address, during which he introduced a young boy with type 1 diabetes in the guest box, as reported by this news organization. On March 3, Civica, a nonprofit coalition of health systems and philanthropies, announced it plans to manufacture generic insulin at a deeply discounted price, as reported by this news organization.
“Just to see diabetes front and center at the State of the Union followed by these announcements is certainly reflective of our own advocacy effort to make sure that people have affordable options for insulin, diabetes medications, services,” Kate Thomas, ADCES chief advocacy and external affairs officer, said in an interview. She added that ADCES has also pushed for legislation in Congress that would expand access to diabetes self-management training under the Medicare program.
The guide includes advice about overcoming barriers to discussing treatment costs with patients, suggested questions to ask patients about specific costs, and determinants of health and conversational approaches. Links are provided to resources for obtaining affordable insulin, other diabetes medications, and continuous glucose monitoring and insulin pump equipment.
“We know that, especially during primary care visits, there is limited time along with numbers of issues to talk about, so I think our challenge is how do we prioritize these conversations with something that can lead to action, not just saying you should do this but how do you actually do it,” Ms. Thomas said.
The introduction summarizes results from a 2021 Beyond Type 1 survey confirming prior findings reported by this news organization that cost is a frequent barrier for many individuals living with diabetes. “Especially right now where we are in terms of the impact of the pandemic and with peoples’ job statuses changing, I think it’s worthwhile to raise this in patient encounters,” Ms. Thomas said.
Overcoming conversational barriers
The first of three tables in the guide provides a list of “barriers to having a cost conversation” in the first column and “suggested solutions” in the second. For example, for the barrier, “You have insufficient time and/or knowledge about cost,” the suggestion is, “request and share available faculty and resources, including benefits coordinators, social workers, and community-based organizations. Work with the pharmacists and other members of the diabetes care team to identify resources that lower cost of medications.”
And for another barrier, “patients are often embarrassed or ashamed to initiate discussions of affordability,” the suggested solution is: “Normalize the issue of cost of care barriers for patients.”
A second table offers specific questions to ask patients about costs of medications and care, determinants of health, and financial barriers. These include: “What are some challenges you’ve had to accessing your medications or taking them as prescribed? What are some out-of-pocket health care costs you need help with? What challenges do you have accessing healthy food for you and your family?”
A link to a screening tool for social determinants of health is also included.
Language suggestions include talking about “cost of care” rather than “money,” asking patients if they’ve understood everything correctly by repeating back what they’ve said, and asking for confirmation and discussing follow-up.
Overall, the tool is designed to be a “broad conversation starter,” and not just about medications, Ms. Thomas said. “This is for all audiences and it’s meant to be something that the provider can tailor depending on who they’re speaking to. ... It’s about medications, but also the entire cost of care, including services and devices, transportation to appointments, access to food. ... Diabetes care isn’t just taking medication. It’s so many more factors.”
Ms. Thomas reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The resource, “Having Healthcare Cost Conversations to Improve Patient Outcomes: A Practical Guide,” was jointly developed by the Association of Diabetes Care & Education Specialists and Beyond Type 1, the nonprofit patient advocacy organization.
Indeed, the guide appeared as President Biden discussed his proposal to cap insulin costs at $35 per insulin vial during the State of the Union address, during which he introduced a young boy with type 1 diabetes in the guest box, as reported by this news organization. On March 3, Civica, a nonprofit coalition of health systems and philanthropies, announced it plans to manufacture generic insulin at a deeply discounted price, as reported by this news organization.
“Just to see diabetes front and center at the State of the Union followed by these announcements is certainly reflective of our own advocacy effort to make sure that people have affordable options for insulin, diabetes medications, services,” Kate Thomas, ADCES chief advocacy and external affairs officer, said in an interview. She added that ADCES has also pushed for legislation in Congress that would expand access to diabetes self-management training under the Medicare program.
The guide includes advice about overcoming barriers to discussing treatment costs with patients, suggested questions to ask patients about specific costs, and determinants of health and conversational approaches. Links are provided to resources for obtaining affordable insulin, other diabetes medications, and continuous glucose monitoring and insulin pump equipment.
“We know that, especially during primary care visits, there is limited time along with numbers of issues to talk about, so I think our challenge is how do we prioritize these conversations with something that can lead to action, not just saying you should do this but how do you actually do it,” Ms. Thomas said.
The introduction summarizes results from a 2021 Beyond Type 1 survey confirming prior findings reported by this news organization that cost is a frequent barrier for many individuals living with diabetes. “Especially right now where we are in terms of the impact of the pandemic and with peoples’ job statuses changing, I think it’s worthwhile to raise this in patient encounters,” Ms. Thomas said.
Overcoming conversational barriers
The first of three tables in the guide provides a list of “barriers to having a cost conversation” in the first column and “suggested solutions” in the second. For example, for the barrier, “You have insufficient time and/or knowledge about cost,” the suggestion is, “request and share available faculty and resources, including benefits coordinators, social workers, and community-based organizations. Work with the pharmacists and other members of the diabetes care team to identify resources that lower cost of medications.”
And for another barrier, “patients are often embarrassed or ashamed to initiate discussions of affordability,” the suggested solution is: “Normalize the issue of cost of care barriers for patients.”
A second table offers specific questions to ask patients about costs of medications and care, determinants of health, and financial barriers. These include: “What are some challenges you’ve had to accessing your medications or taking them as prescribed? What are some out-of-pocket health care costs you need help with? What challenges do you have accessing healthy food for you and your family?”
A link to a screening tool for social determinants of health is also included.
Language suggestions include talking about “cost of care” rather than “money,” asking patients if they’ve understood everything correctly by repeating back what they’ve said, and asking for confirmation and discussing follow-up.
Overall, the tool is designed to be a “broad conversation starter,” and not just about medications, Ms. Thomas said. “This is for all audiences and it’s meant to be something that the provider can tailor depending on who they’re speaking to. ... It’s about medications, but also the entire cost of care, including services and devices, transportation to appointments, access to food. ... Diabetes care isn’t just taking medication. It’s so many more factors.”
Ms. Thomas reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Is a blood test for type 1 diabetes in kids worth the cost?
Universal screening for presymptomatic type 1 diabetes among schoolchildren would cost approximately 22 euros (about $25) per child screened, and about 7,000 euros (about $7,900) per child diagnosed, a new analysis of data from a German program finds.
The data come from the Fr1da study, in which a blood test for type 1 diabetes–associated islet autoantibodies is offered to all children aged 21 months to 6 years old in Bavaria.
Families of those who test positive are offered participation in a program of diabetes education, metabolic staging, psychological evaluation for stress, and prospective follow-up.
The researchers explain that, worldwide, 4 in 1,000 people under the age of 20 years have type 1 diabetes. It is the most common metabolic disease in children and adolescents. Only about 1 in 10 of those affected has a close relative with the disease. This means that type 1 diabetes can affect any child.
However, in many cases, the disease does not become known until a severe to life-threatening metabolic derailment known as diabetic ketoacidosis (DKA) occurs. This often leads to intensive medical treatment, a longer hospitalization, and poorer blood glucose control, which can result in an increased risk of secondary diseases and very high costs for the health care system.
“We want to protect as many children as possible from serious metabolic derailments. This is only possible with type 1 diabetes screenings. Therefore, we strongly support to include early detection tests in standard medical care,” Peter Achenbach, DrMed, senior author of the study, said in a statement from his institution, Helmholtz Zentrum München in Neuherberg, Germany.
The new findings were published in Diabetes Care by Florian M. Karl, also of Helmholtz Zentrum München, and colleagues.
In 2020, the Fr1da investigators reported that, of 90,632 children who participated from February 2015 to May 2019, 0.31% (280) were diagnosed with presymptomatic type 1 diabetes through the presence of two or more islet autoantibodies.
This news organization asked Brett McQueen, PhD, who led a similar study examining cost and cost-effectiveness in the Autoimmunity Screening for Kids (ASK) program, in which Denver-area children aged 2-17 years are offered autoantibody screening for both type 1 diabetes and celiac disease, for comment.
“If we have a chance to change a child’s life from when they’re 2 or 3 years old and there’s even a small chance that this thing potentially improves health outcomes for a decent price, what are we waiting for?” said Dr. McQueen, who is assistant professor in the department of clinical pharmacy at the University of Colorado, Aurora.
Is DKA prevention enough to justify universal screening?
Although identifying type 1 diabetes before symptoms arise could help avoid DKA, currently no therapeutic interventions are available to prevent or delay the trajectory from presymptomatic to clinical type 1 diabetes.
A possible future intervention – the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio) – had a setback in July 2021 when the Food and Drug Administration declined to approve it for the delay of type 1 diabetes in at-risk individuals.
However, on Feb. 22 Provention Bio announced that it has resubmitted the Biologics License Application for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals. The FDA now has 30 days to review the resubmission, determine whether it is complete and acceptable for review, and provide a review goal date, according to a company statement.
But even without the ability to forestall the development of type 1 diabetes, screening proponents point to the potential benefit from educating families about early signs of diabetes onset and thereby preventing progression to DKA and both its short-term and possible long-term sequelae.
Prevention of DKA at diagnosis has been linked to improved long-term glycemic control and other potential health benefits.
And the frequency of DKA at the onset of type 1 diabetes has increased in recent years, to more than 20% in Germany and over 45% in the United States.
But, prior data have suggested that universal screening for presymptomatic type 1 diabetes is unlikely to be cost effective if only the health and economic benefits of prevention of DKA at type 1 diabetes onset is considered, unless the screening costs are exceedingly low.
What will it take to implement universal screening?
“What this paper does is contribute really to our understanding of more around resource utilization,” noted Dr. McQueen. “As they correctly identify, it’s really hard to compare country prices. It’s easier to compare utilization.”
In Dr. McQueen’s ASK program, the cost per child screened and per case detected in that program were similar to those found in the German study, even though the cost of the antibody testing itself was considerably lower in Germany than in the United States.
Fr1da included more components of screening and monitoring than did ASK, Dr. McQueen told this news organization.
The conclusions of the ASK study were that “presymptomatic type 1 diabetes screening may be cost effective in areas with a high prevalence of DKA and an infrastructure facilitating screening and monitoring if the benefits of avoiding DKA events and improved [hemoglobin] A1c persist over long-run time horizons.”
Nonetheless, Dr. McQueen thinks it’s unlikely that universal screening will be recommended by professional societies or covered by payers in the United States until a pharmacologic intervention to forestall disease progression is available.“Teplizumab approval could move this along. ... We’re just trying to take one factor, the economics of it, to create the most efficient scenario so that if it were to be adopted we would catch the most cases, prevent the most complications, benefit children the most in terms of their lifetime health outcomes – all at the minimum cost possible.”
‘A benchmark for the expected implementation cost of screening’
Mr. Karl and colleagues simulated the cost of implementation of this screening as standard care in Germany – assuming the same 0.31% prevalence found in Fr1da – the average cost per child was estimated at 21.73 euros, including 9.34 euros for laboratory costs, 12.25 euros for pediatrician costs, and 0.14 euros for local diabetes clinics to perform metabolic staging and education for children diagnosed with presymptomatic type 1 diabetes.
The model included 50% of the costs incurred in Fr1da for obtaining informed consent. Negative autoantibody results from the initial screening were not communicated to families, and all children with presymptomatic type 1 diabetes received staging and education. The estimated average cost per diagnosed child was 7,035 euros.
“Although our analyses are subject to some level of uncertainty, they provide a benchmark for the expected implementation cost of screening,” said coauthor Michael Laxy, MSc, PhD, also at Helmholtz Zentrum München.
“Next, we aim to evaluate the long-term ratio of screening costs, potential cost savings through the prevention of metabolic derailment and its consequences, and potentially increased quality of life with a type 1 diabetes screening compared to the costs and quality of life without a screening.”
Dr. McQueen is working along similar lines in Colorado, attempting to create a model that incorporates all the different possibilities including DKA monitoring, teplizumab availability, screening children at different ages, and the effect of including blood glucose monitoring in children identified with presymptomatic type 1 diabetes.
“There are so many different potential answers and avenues and no one has really put it all together,” he observed.
But he believes that economics shouldn’t be the only factor used in deciding whether to institute widespread screening.
This study was supported by grants from the German Federal Ministry of Education and Research to the German Center for Diabetes Research (DZD). The Fr1da study was supported by grants from the LifeScience-Stiftung, JDRF International, the Bavarian State Ministry of Health and Care, the Leona M. and Harry B. Helmsley Charitable Trust, Deutsche Diabetes-Stiftung, Landesverband Bayern der Betriebskrankenkassen, B. Braun-Stiftung, Deutsche Diabetes Hilfe, and the German Federal Ministry of Education and Research to the DZD. The authors disclosed no relevant financial relationships. The ASK study was funded by JDRF International, the Leona M. and Harry B. Helmsley Charitable Trust, and Janssen Research and Development. Dr. McQueen has received institutional funding for value assessment applications from the Institute for Clinical and Economic Review, the PhRMA Foundation, and PhRMA.
A version of this article first appeared on Medscape.com.
Universal screening for presymptomatic type 1 diabetes among schoolchildren would cost approximately 22 euros (about $25) per child screened, and about 7,000 euros (about $7,900) per child diagnosed, a new analysis of data from a German program finds.
The data come from the Fr1da study, in which a blood test for type 1 diabetes–associated islet autoantibodies is offered to all children aged 21 months to 6 years old in Bavaria.
Families of those who test positive are offered participation in a program of diabetes education, metabolic staging, psychological evaluation for stress, and prospective follow-up.
The researchers explain that, worldwide, 4 in 1,000 people under the age of 20 years have type 1 diabetes. It is the most common metabolic disease in children and adolescents. Only about 1 in 10 of those affected has a close relative with the disease. This means that type 1 diabetes can affect any child.
However, in many cases, the disease does not become known until a severe to life-threatening metabolic derailment known as diabetic ketoacidosis (DKA) occurs. This often leads to intensive medical treatment, a longer hospitalization, and poorer blood glucose control, which can result in an increased risk of secondary diseases and very high costs for the health care system.
“We want to protect as many children as possible from serious metabolic derailments. This is only possible with type 1 diabetes screenings. Therefore, we strongly support to include early detection tests in standard medical care,” Peter Achenbach, DrMed, senior author of the study, said in a statement from his institution, Helmholtz Zentrum München in Neuherberg, Germany.
The new findings were published in Diabetes Care by Florian M. Karl, also of Helmholtz Zentrum München, and colleagues.
In 2020, the Fr1da investigators reported that, of 90,632 children who participated from February 2015 to May 2019, 0.31% (280) were diagnosed with presymptomatic type 1 diabetes through the presence of two or more islet autoantibodies.
This news organization asked Brett McQueen, PhD, who led a similar study examining cost and cost-effectiveness in the Autoimmunity Screening for Kids (ASK) program, in which Denver-area children aged 2-17 years are offered autoantibody screening for both type 1 diabetes and celiac disease, for comment.
“If we have a chance to change a child’s life from when they’re 2 or 3 years old and there’s even a small chance that this thing potentially improves health outcomes for a decent price, what are we waiting for?” said Dr. McQueen, who is assistant professor in the department of clinical pharmacy at the University of Colorado, Aurora.
Is DKA prevention enough to justify universal screening?
Although identifying type 1 diabetes before symptoms arise could help avoid DKA, currently no therapeutic interventions are available to prevent or delay the trajectory from presymptomatic to clinical type 1 diabetes.
A possible future intervention – the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio) – had a setback in July 2021 when the Food and Drug Administration declined to approve it for the delay of type 1 diabetes in at-risk individuals.
However, on Feb. 22 Provention Bio announced that it has resubmitted the Biologics License Application for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals. The FDA now has 30 days to review the resubmission, determine whether it is complete and acceptable for review, and provide a review goal date, according to a company statement.
But even without the ability to forestall the development of type 1 diabetes, screening proponents point to the potential benefit from educating families about early signs of diabetes onset and thereby preventing progression to DKA and both its short-term and possible long-term sequelae.
Prevention of DKA at diagnosis has been linked to improved long-term glycemic control and other potential health benefits.
And the frequency of DKA at the onset of type 1 diabetes has increased in recent years, to more than 20% in Germany and over 45% in the United States.
But, prior data have suggested that universal screening for presymptomatic type 1 diabetes is unlikely to be cost effective if only the health and economic benefits of prevention of DKA at type 1 diabetes onset is considered, unless the screening costs are exceedingly low.
What will it take to implement universal screening?
“What this paper does is contribute really to our understanding of more around resource utilization,” noted Dr. McQueen. “As they correctly identify, it’s really hard to compare country prices. It’s easier to compare utilization.”
In Dr. McQueen’s ASK program, the cost per child screened and per case detected in that program were similar to those found in the German study, even though the cost of the antibody testing itself was considerably lower in Germany than in the United States.
Fr1da included more components of screening and monitoring than did ASK, Dr. McQueen told this news organization.
The conclusions of the ASK study were that “presymptomatic type 1 diabetes screening may be cost effective in areas with a high prevalence of DKA and an infrastructure facilitating screening and monitoring if the benefits of avoiding DKA events and improved [hemoglobin] A1c persist over long-run time horizons.”
Nonetheless, Dr. McQueen thinks it’s unlikely that universal screening will be recommended by professional societies or covered by payers in the United States until a pharmacologic intervention to forestall disease progression is available.“Teplizumab approval could move this along. ... We’re just trying to take one factor, the economics of it, to create the most efficient scenario so that if it were to be adopted we would catch the most cases, prevent the most complications, benefit children the most in terms of their lifetime health outcomes – all at the minimum cost possible.”
‘A benchmark for the expected implementation cost of screening’
Mr. Karl and colleagues simulated the cost of implementation of this screening as standard care in Germany – assuming the same 0.31% prevalence found in Fr1da – the average cost per child was estimated at 21.73 euros, including 9.34 euros for laboratory costs, 12.25 euros for pediatrician costs, and 0.14 euros for local diabetes clinics to perform metabolic staging and education for children diagnosed with presymptomatic type 1 diabetes.
The model included 50% of the costs incurred in Fr1da for obtaining informed consent. Negative autoantibody results from the initial screening were not communicated to families, and all children with presymptomatic type 1 diabetes received staging and education. The estimated average cost per diagnosed child was 7,035 euros.
“Although our analyses are subject to some level of uncertainty, they provide a benchmark for the expected implementation cost of screening,” said coauthor Michael Laxy, MSc, PhD, also at Helmholtz Zentrum München.
“Next, we aim to evaluate the long-term ratio of screening costs, potential cost savings through the prevention of metabolic derailment and its consequences, and potentially increased quality of life with a type 1 diabetes screening compared to the costs and quality of life without a screening.”
Dr. McQueen is working along similar lines in Colorado, attempting to create a model that incorporates all the different possibilities including DKA monitoring, teplizumab availability, screening children at different ages, and the effect of including blood glucose monitoring in children identified with presymptomatic type 1 diabetes.
“There are so many different potential answers and avenues and no one has really put it all together,” he observed.
But he believes that economics shouldn’t be the only factor used in deciding whether to institute widespread screening.
This study was supported by grants from the German Federal Ministry of Education and Research to the German Center for Diabetes Research (DZD). The Fr1da study was supported by grants from the LifeScience-Stiftung, JDRF International, the Bavarian State Ministry of Health and Care, the Leona M. and Harry B. Helmsley Charitable Trust, Deutsche Diabetes-Stiftung, Landesverband Bayern der Betriebskrankenkassen, B. Braun-Stiftung, Deutsche Diabetes Hilfe, and the German Federal Ministry of Education and Research to the DZD. The authors disclosed no relevant financial relationships. The ASK study was funded by JDRF International, the Leona M. and Harry B. Helmsley Charitable Trust, and Janssen Research and Development. Dr. McQueen has received institutional funding for value assessment applications from the Institute for Clinical and Economic Review, the PhRMA Foundation, and PhRMA.
A version of this article first appeared on Medscape.com.
Universal screening for presymptomatic type 1 diabetes among schoolchildren would cost approximately 22 euros (about $25) per child screened, and about 7,000 euros (about $7,900) per child diagnosed, a new analysis of data from a German program finds.
The data come from the Fr1da study, in which a blood test for type 1 diabetes–associated islet autoantibodies is offered to all children aged 21 months to 6 years old in Bavaria.
Families of those who test positive are offered participation in a program of diabetes education, metabolic staging, psychological evaluation for stress, and prospective follow-up.
The researchers explain that, worldwide, 4 in 1,000 people under the age of 20 years have type 1 diabetes. It is the most common metabolic disease in children and adolescents. Only about 1 in 10 of those affected has a close relative with the disease. This means that type 1 diabetes can affect any child.
However, in many cases, the disease does not become known until a severe to life-threatening metabolic derailment known as diabetic ketoacidosis (DKA) occurs. This often leads to intensive medical treatment, a longer hospitalization, and poorer blood glucose control, which can result in an increased risk of secondary diseases and very high costs for the health care system.
“We want to protect as many children as possible from serious metabolic derailments. This is only possible with type 1 diabetes screenings. Therefore, we strongly support to include early detection tests in standard medical care,” Peter Achenbach, DrMed, senior author of the study, said in a statement from his institution, Helmholtz Zentrum München in Neuherberg, Germany.
The new findings were published in Diabetes Care by Florian M. Karl, also of Helmholtz Zentrum München, and colleagues.
In 2020, the Fr1da investigators reported that, of 90,632 children who participated from February 2015 to May 2019, 0.31% (280) were diagnosed with presymptomatic type 1 diabetes through the presence of two or more islet autoantibodies.
This news organization asked Brett McQueen, PhD, who led a similar study examining cost and cost-effectiveness in the Autoimmunity Screening for Kids (ASK) program, in which Denver-area children aged 2-17 years are offered autoantibody screening for both type 1 diabetes and celiac disease, for comment.
“If we have a chance to change a child’s life from when they’re 2 or 3 years old and there’s even a small chance that this thing potentially improves health outcomes for a decent price, what are we waiting for?” said Dr. McQueen, who is assistant professor in the department of clinical pharmacy at the University of Colorado, Aurora.
Is DKA prevention enough to justify universal screening?
Although identifying type 1 diabetes before symptoms arise could help avoid DKA, currently no therapeutic interventions are available to prevent or delay the trajectory from presymptomatic to clinical type 1 diabetes.
A possible future intervention – the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio) – had a setback in July 2021 when the Food and Drug Administration declined to approve it for the delay of type 1 diabetes in at-risk individuals.
However, on Feb. 22 Provention Bio announced that it has resubmitted the Biologics License Application for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals. The FDA now has 30 days to review the resubmission, determine whether it is complete and acceptable for review, and provide a review goal date, according to a company statement.
But even without the ability to forestall the development of type 1 diabetes, screening proponents point to the potential benefit from educating families about early signs of diabetes onset and thereby preventing progression to DKA and both its short-term and possible long-term sequelae.
Prevention of DKA at diagnosis has been linked to improved long-term glycemic control and other potential health benefits.
And the frequency of DKA at the onset of type 1 diabetes has increased in recent years, to more than 20% in Germany and over 45% in the United States.
But, prior data have suggested that universal screening for presymptomatic type 1 diabetes is unlikely to be cost effective if only the health and economic benefits of prevention of DKA at type 1 diabetes onset is considered, unless the screening costs are exceedingly low.
What will it take to implement universal screening?
“What this paper does is contribute really to our understanding of more around resource utilization,” noted Dr. McQueen. “As they correctly identify, it’s really hard to compare country prices. It’s easier to compare utilization.”
In Dr. McQueen’s ASK program, the cost per child screened and per case detected in that program were similar to those found in the German study, even though the cost of the antibody testing itself was considerably lower in Germany than in the United States.
Fr1da included more components of screening and monitoring than did ASK, Dr. McQueen told this news organization.
The conclusions of the ASK study were that “presymptomatic type 1 diabetes screening may be cost effective in areas with a high prevalence of DKA and an infrastructure facilitating screening and monitoring if the benefits of avoiding DKA events and improved [hemoglobin] A1c persist over long-run time horizons.”
Nonetheless, Dr. McQueen thinks it’s unlikely that universal screening will be recommended by professional societies or covered by payers in the United States until a pharmacologic intervention to forestall disease progression is available.“Teplizumab approval could move this along. ... We’re just trying to take one factor, the economics of it, to create the most efficient scenario so that if it were to be adopted we would catch the most cases, prevent the most complications, benefit children the most in terms of their lifetime health outcomes – all at the minimum cost possible.”
‘A benchmark for the expected implementation cost of screening’
Mr. Karl and colleagues simulated the cost of implementation of this screening as standard care in Germany – assuming the same 0.31% prevalence found in Fr1da – the average cost per child was estimated at 21.73 euros, including 9.34 euros for laboratory costs, 12.25 euros for pediatrician costs, and 0.14 euros for local diabetes clinics to perform metabolic staging and education for children diagnosed with presymptomatic type 1 diabetes.
The model included 50% of the costs incurred in Fr1da for obtaining informed consent. Negative autoantibody results from the initial screening were not communicated to families, and all children with presymptomatic type 1 diabetes received staging and education. The estimated average cost per diagnosed child was 7,035 euros.
“Although our analyses are subject to some level of uncertainty, they provide a benchmark for the expected implementation cost of screening,” said coauthor Michael Laxy, MSc, PhD, also at Helmholtz Zentrum München.
“Next, we aim to evaluate the long-term ratio of screening costs, potential cost savings through the prevention of metabolic derailment and its consequences, and potentially increased quality of life with a type 1 diabetes screening compared to the costs and quality of life without a screening.”
Dr. McQueen is working along similar lines in Colorado, attempting to create a model that incorporates all the different possibilities including DKA monitoring, teplizumab availability, screening children at different ages, and the effect of including blood glucose monitoring in children identified with presymptomatic type 1 diabetes.
“There are so many different potential answers and avenues and no one has really put it all together,” he observed.
But he believes that economics shouldn’t be the only factor used in deciding whether to institute widespread screening.
This study was supported by grants from the German Federal Ministry of Education and Research to the German Center for Diabetes Research (DZD). The Fr1da study was supported by grants from the LifeScience-Stiftung, JDRF International, the Bavarian State Ministry of Health and Care, the Leona M. and Harry B. Helmsley Charitable Trust, Deutsche Diabetes-Stiftung, Landesverband Bayern der Betriebskrankenkassen, B. Braun-Stiftung, Deutsche Diabetes Hilfe, and the German Federal Ministry of Education and Research to the DZD. The authors disclosed no relevant financial relationships. The ASK study was funded by JDRF International, the Leona M. and Harry B. Helmsley Charitable Trust, and Janssen Research and Development. Dr. McQueen has received institutional funding for value assessment applications from the Institute for Clinical and Economic Review, the PhRMA Foundation, and PhRMA.
A version of this article first appeared on Medscape.com.
FROM DIABETES CARE
Next-generation Dexcom CGM, G7, accurate and easier to use
The Dexcom G7 continuous glucose monitor (CGM) is as accurate or better than other currently marketed CGM devices for measuring glucose in those with diabetes, new data from a pivotal study suggest.
Currently under review by the U.S. Food and Drug Administration, the G7 is expected to be an improvement over the Dexcom G6 version in several ways.
The on-body size will be 60% smaller, “roughly the size of three stacked quarters,” according to the authors, and will incorporate the sensor with a single-use transmitter, as opposed to the current separate 3-month transmitter used with the G6 sensor. This will eliminate the need for using a transmitter across multiple sensor sessions (as is the case for G6).
The warm-up period after insertion is reduced from 2 hours to 27 minutes, and users are given an extra 12-hour “grace period” after the 10-day wear period to change the device before it stops displaying glucose data. Up to 24 hours of missed data can also be recaptured.
“The enhanced features of G7 may increase clinical adoption, encourage sustained use, and reduce the burden of diabetes management,” write Satish K. Garg, MD, of the University of Colorado, Aurora, and colleagues, in their article, published online Feb. 14 in Diabetes Technology & Therapeutics.
Several features of the G6 remain unchanged, including factory calibration, but also the capacity for optional user calibrations, use of Bluetooth to transmit data up to 20 feet (approximately 6 meters), and data displays on either a dedicated receiver or a variety of iOS and Android smart devices.
It will also allow for user-customized settings and alerts, as well as the option for real-time remote “share” monitoring with caregivers or providers. The G7 will also not be susceptible to interference by acetaminophen (paracetamol) or ascorbic acid.
And, like the G6, the G7 was submitted for approval to the FDA as an “integrated CGM,” meaning that it will be interoperable with other compatible devices, including insulin pumps, glucose meters, or other electronic devices used for diabetes management.
Accuracy shown on abdomen, arm
The prospective, multicenter, single-arm study reported by Dr. Garg and colleagues was conducted at 12 U.S. sites between February and June 2021.
In-clinic visits were conducted on days 1 or 2, 4 or 7, and one additional day for comparisons with a reference glucose measure (YSI 2300 Stat Plus glucose analyzer). Participants wore blinded G7 sensors concurrently on the upper arm and abdomen while continuing to use their own personal glucose monitoring method (CGM or fingerstick) at home.
A total of 316 insulin-using adults with type 1 or type 2 diabetes contributed data from 308 arm- and 311 abdomen-placed blinded devices, which generated 77,774 matched pairs of data within the blood glucose reportable range of 40-400 mg/dL.
The overall mean absolute relative difference (MARD) of each CGM-YSI pair (a standard metric for CGM analysis) was 8.2%, with 9.1% for the abdomen and 8.2% for the arm.
Accuracy remained high in both arm- and abdomen-placed sensors across the 10-day wear period through the 12-hour grace period and across glucose ranges. There were no significant differences between G7 accuracy by diabetes type, insulin regimen, or body mass index.
The highest agreement rates and lowest MARDs occurred when CGM readings were increasing or decreasing by no more than 1 mg/dL per minute. However, even at the highest rates of glucose concentration change, MARD values below 10% were found for arm-placed sensors and below 10.5% for abdomen-placed sensors, Dr. Garg and colleagues report.
When the hypoglycemia threshold alert was set to 55 mg/dL, true alert rates for detection of hypoglycemia below 70 mg/dL by sensors worn on the arm and abdomen were 91.3% and 85.2%, respectively. With hyperglycemia threshold alerts set to 300 mg/dL, the true alert rates for detection of hyperglycemia greater than 250 mg/dL by sensors worn on the arm and abdomen were 99.9% and 99.8% respectively.
The overall mean time lag for the sensors was 3.5 minutes, 3.6 minutes for the arm, and 3.4 minutes for the abdomen. There were no serious adverse events during the study.
The study excluded children and adolescents; data from these populations will be reported separately, the authors note.
Accuracy at least as good as prior Dexcom versions, competitors
The MARD values of 8.2% on the arm and 9.1% on the abdomen were similar to or better than accuracy measurements of other commercially available CGM systems, note Dr. Garg and colleagues, although they acknowledge that few head-to-head studies at different anatomic locations have been conducted.
A study of an older Dexcom version (G4 Platinum) found MARD estimates of 12.0% on the arm and 12.3% on the abdomen, the authors note.
The newly FDA-approved implantable Eversense E3 (Senseonics) CGM, worn on the upper arm, has a MARD of 9.1%, while the arm-placed Abbott FreeStyle Libre 2, approved in the U.S. in June 2020, has an overall MARD of 9.3%.
Lag-time differences between the reference and G7 were also similar to or better than time delays in prior-generation Dexcom CGMs, Dr. Garg and colleagues say.
Participants also completed a survey. “The redesigned applicator allows for sensor deployment with one hand, and most participants found G7 easier to insert than their prior CGM system,” the researchers say.
Finally, “unlike G6, G7 allows for temporary silencing of all audible alerts, including Urgent Low. Taken together, these attributes are anticipated to provide for a better end-user experience with G7 and help reduce diabetes burden,” they conclude.
The study was supported by a grant from Dexcom. Dr. Garg has reported receiving consultant fees from Medtronic, Novo Nordisk, Zealand, LifeScan, Roche, and Lilly, as well as research grants through the University of Colorado from Lilly, Novo Nordisk, Medtronic, Dexcom, T1D Exchange, Helmsley Trust, NIDDK, and JDRF.
A version of this article first appeared on Medscape.com.
The Dexcom G7 continuous glucose monitor (CGM) is as accurate or better than other currently marketed CGM devices for measuring glucose in those with diabetes, new data from a pivotal study suggest.
Currently under review by the U.S. Food and Drug Administration, the G7 is expected to be an improvement over the Dexcom G6 version in several ways.
The on-body size will be 60% smaller, “roughly the size of three stacked quarters,” according to the authors, and will incorporate the sensor with a single-use transmitter, as opposed to the current separate 3-month transmitter used with the G6 sensor. This will eliminate the need for using a transmitter across multiple sensor sessions (as is the case for G6).
The warm-up period after insertion is reduced from 2 hours to 27 minutes, and users are given an extra 12-hour “grace period” after the 10-day wear period to change the device before it stops displaying glucose data. Up to 24 hours of missed data can also be recaptured.
“The enhanced features of G7 may increase clinical adoption, encourage sustained use, and reduce the burden of diabetes management,” write Satish K. Garg, MD, of the University of Colorado, Aurora, and colleagues, in their article, published online Feb. 14 in Diabetes Technology & Therapeutics.
Several features of the G6 remain unchanged, including factory calibration, but also the capacity for optional user calibrations, use of Bluetooth to transmit data up to 20 feet (approximately 6 meters), and data displays on either a dedicated receiver or a variety of iOS and Android smart devices.
It will also allow for user-customized settings and alerts, as well as the option for real-time remote “share” monitoring with caregivers or providers. The G7 will also not be susceptible to interference by acetaminophen (paracetamol) or ascorbic acid.
And, like the G6, the G7 was submitted for approval to the FDA as an “integrated CGM,” meaning that it will be interoperable with other compatible devices, including insulin pumps, glucose meters, or other electronic devices used for diabetes management.
Accuracy shown on abdomen, arm
The prospective, multicenter, single-arm study reported by Dr. Garg and colleagues was conducted at 12 U.S. sites between February and June 2021.
In-clinic visits were conducted on days 1 or 2, 4 or 7, and one additional day for comparisons with a reference glucose measure (YSI 2300 Stat Plus glucose analyzer). Participants wore blinded G7 sensors concurrently on the upper arm and abdomen while continuing to use their own personal glucose monitoring method (CGM or fingerstick) at home.
A total of 316 insulin-using adults with type 1 or type 2 diabetes contributed data from 308 arm- and 311 abdomen-placed blinded devices, which generated 77,774 matched pairs of data within the blood glucose reportable range of 40-400 mg/dL.
The overall mean absolute relative difference (MARD) of each CGM-YSI pair (a standard metric for CGM analysis) was 8.2%, with 9.1% for the abdomen and 8.2% for the arm.
Accuracy remained high in both arm- and abdomen-placed sensors across the 10-day wear period through the 12-hour grace period and across glucose ranges. There were no significant differences between G7 accuracy by diabetes type, insulin regimen, or body mass index.
The highest agreement rates and lowest MARDs occurred when CGM readings were increasing or decreasing by no more than 1 mg/dL per minute. However, even at the highest rates of glucose concentration change, MARD values below 10% were found for arm-placed sensors and below 10.5% for abdomen-placed sensors, Dr. Garg and colleagues report.
When the hypoglycemia threshold alert was set to 55 mg/dL, true alert rates for detection of hypoglycemia below 70 mg/dL by sensors worn on the arm and abdomen were 91.3% and 85.2%, respectively. With hyperglycemia threshold alerts set to 300 mg/dL, the true alert rates for detection of hyperglycemia greater than 250 mg/dL by sensors worn on the arm and abdomen were 99.9% and 99.8% respectively.
The overall mean time lag for the sensors was 3.5 minutes, 3.6 minutes for the arm, and 3.4 minutes for the abdomen. There were no serious adverse events during the study.
The study excluded children and adolescents; data from these populations will be reported separately, the authors note.
Accuracy at least as good as prior Dexcom versions, competitors
The MARD values of 8.2% on the arm and 9.1% on the abdomen were similar to or better than accuracy measurements of other commercially available CGM systems, note Dr. Garg and colleagues, although they acknowledge that few head-to-head studies at different anatomic locations have been conducted.
A study of an older Dexcom version (G4 Platinum) found MARD estimates of 12.0% on the arm and 12.3% on the abdomen, the authors note.
The newly FDA-approved implantable Eversense E3 (Senseonics) CGM, worn on the upper arm, has a MARD of 9.1%, while the arm-placed Abbott FreeStyle Libre 2, approved in the U.S. in June 2020, has an overall MARD of 9.3%.
Lag-time differences between the reference and G7 were also similar to or better than time delays in prior-generation Dexcom CGMs, Dr. Garg and colleagues say.
Participants also completed a survey. “The redesigned applicator allows for sensor deployment with one hand, and most participants found G7 easier to insert than their prior CGM system,” the researchers say.
Finally, “unlike G6, G7 allows for temporary silencing of all audible alerts, including Urgent Low. Taken together, these attributes are anticipated to provide for a better end-user experience with G7 and help reduce diabetes burden,” they conclude.
The study was supported by a grant from Dexcom. Dr. Garg has reported receiving consultant fees from Medtronic, Novo Nordisk, Zealand, LifeScan, Roche, and Lilly, as well as research grants through the University of Colorado from Lilly, Novo Nordisk, Medtronic, Dexcom, T1D Exchange, Helmsley Trust, NIDDK, and JDRF.
A version of this article first appeared on Medscape.com.
The Dexcom G7 continuous glucose monitor (CGM) is as accurate or better than other currently marketed CGM devices for measuring glucose in those with diabetes, new data from a pivotal study suggest.
Currently under review by the U.S. Food and Drug Administration, the G7 is expected to be an improvement over the Dexcom G6 version in several ways.
The on-body size will be 60% smaller, “roughly the size of three stacked quarters,” according to the authors, and will incorporate the sensor with a single-use transmitter, as opposed to the current separate 3-month transmitter used with the G6 sensor. This will eliminate the need for using a transmitter across multiple sensor sessions (as is the case for G6).
The warm-up period after insertion is reduced from 2 hours to 27 minutes, and users are given an extra 12-hour “grace period” after the 10-day wear period to change the device before it stops displaying glucose data. Up to 24 hours of missed data can also be recaptured.
“The enhanced features of G7 may increase clinical adoption, encourage sustained use, and reduce the burden of diabetes management,” write Satish K. Garg, MD, of the University of Colorado, Aurora, and colleagues, in their article, published online Feb. 14 in Diabetes Technology & Therapeutics.
Several features of the G6 remain unchanged, including factory calibration, but also the capacity for optional user calibrations, use of Bluetooth to transmit data up to 20 feet (approximately 6 meters), and data displays on either a dedicated receiver or a variety of iOS and Android smart devices.
It will also allow for user-customized settings and alerts, as well as the option for real-time remote “share” monitoring with caregivers or providers. The G7 will also not be susceptible to interference by acetaminophen (paracetamol) or ascorbic acid.
And, like the G6, the G7 was submitted for approval to the FDA as an “integrated CGM,” meaning that it will be interoperable with other compatible devices, including insulin pumps, glucose meters, or other electronic devices used for diabetes management.
Accuracy shown on abdomen, arm
The prospective, multicenter, single-arm study reported by Dr. Garg and colleagues was conducted at 12 U.S. sites between February and June 2021.
In-clinic visits were conducted on days 1 or 2, 4 or 7, and one additional day for comparisons with a reference glucose measure (YSI 2300 Stat Plus glucose analyzer). Participants wore blinded G7 sensors concurrently on the upper arm and abdomen while continuing to use their own personal glucose monitoring method (CGM or fingerstick) at home.
A total of 316 insulin-using adults with type 1 or type 2 diabetes contributed data from 308 arm- and 311 abdomen-placed blinded devices, which generated 77,774 matched pairs of data within the blood glucose reportable range of 40-400 mg/dL.
The overall mean absolute relative difference (MARD) of each CGM-YSI pair (a standard metric for CGM analysis) was 8.2%, with 9.1% for the abdomen and 8.2% for the arm.
Accuracy remained high in both arm- and abdomen-placed sensors across the 10-day wear period through the 12-hour grace period and across glucose ranges. There were no significant differences between G7 accuracy by diabetes type, insulin regimen, or body mass index.
The highest agreement rates and lowest MARDs occurred when CGM readings were increasing or decreasing by no more than 1 mg/dL per minute. However, even at the highest rates of glucose concentration change, MARD values below 10% were found for arm-placed sensors and below 10.5% for abdomen-placed sensors, Dr. Garg and colleagues report.
When the hypoglycemia threshold alert was set to 55 mg/dL, true alert rates for detection of hypoglycemia below 70 mg/dL by sensors worn on the arm and abdomen were 91.3% and 85.2%, respectively. With hyperglycemia threshold alerts set to 300 mg/dL, the true alert rates for detection of hyperglycemia greater than 250 mg/dL by sensors worn on the arm and abdomen were 99.9% and 99.8% respectively.
The overall mean time lag for the sensors was 3.5 minutes, 3.6 minutes for the arm, and 3.4 minutes for the abdomen. There were no serious adverse events during the study.
The study excluded children and adolescents; data from these populations will be reported separately, the authors note.
Accuracy at least as good as prior Dexcom versions, competitors
The MARD values of 8.2% on the arm and 9.1% on the abdomen were similar to or better than accuracy measurements of other commercially available CGM systems, note Dr. Garg and colleagues, although they acknowledge that few head-to-head studies at different anatomic locations have been conducted.
A study of an older Dexcom version (G4 Platinum) found MARD estimates of 12.0% on the arm and 12.3% on the abdomen, the authors note.
The newly FDA-approved implantable Eversense E3 (Senseonics) CGM, worn on the upper arm, has a MARD of 9.1%, while the arm-placed Abbott FreeStyle Libre 2, approved in the U.S. in June 2020, has an overall MARD of 9.3%.
Lag-time differences between the reference and G7 were also similar to or better than time delays in prior-generation Dexcom CGMs, Dr. Garg and colleagues say.
Participants also completed a survey. “The redesigned applicator allows for sensor deployment with one hand, and most participants found G7 easier to insert than their prior CGM system,” the researchers say.
Finally, “unlike G6, G7 allows for temporary silencing of all audible alerts, including Urgent Low. Taken together, these attributes are anticipated to provide for a better end-user experience with G7 and help reduce diabetes burden,” they conclude.
The study was supported by a grant from Dexcom. Dr. Garg has reported receiving consultant fees from Medtronic, Novo Nordisk, Zealand, LifeScan, Roche, and Lilly, as well as research grants through the University of Colorado from Lilly, Novo Nordisk, Medtronic, Dexcom, T1D Exchange, Helmsley Trust, NIDDK, and JDRF.
A version of this article first appeared on Medscape.com.
Estrogen supplementation may reduce COVID-19 death risk
Estrogen supplementation is associated with a reduced risk of death from COVID-19 among postmenopausal women, new research suggests.
The findings, from a nationwide study using data from Sweden, were published online Feb. 14 in BMJ Open by Malin Sund, MD, PhD, of Umeå (Sweden) University Faculty of Medicine and colleagues.
Among postmenopausal women aged 50-80 years with verified COVID-19, those receiving estrogen as part of hormone replacement therapy for menopausal symptoms were less than half as likely to die from it as those not receiving estrogen, even after adjustment for confounders.
“This study shows an association between estrogen levels and COVID-19 death. Consequently, drugs increasing estrogen levels may have a role in therapeutic efforts to alleviate COVID-19 severity in postmenopausal women and could be studied in randomized control trials,” the investigators write.
However, coauthor Anne-Marie Fors Connolly, MD, PhD, a resident in clinical microbiology at Umeå University, cautioned: “This is an observational study. Further clinical studies are needed to verify these results before recommending clinicians to consider estrogen supplementation.”
Stephen Evans, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, agrees.
He told the U.K. Science and Media Centre: “This is an observational study comparing three groups of women based on whether they used hormonal therapy to boost estrogen levels or who had, as a result of treatment for breast cancer ... reduced estrogen levels or neither. The findings are apparently dramatic.”
“At the very least, great caution should be exercised in thinking that menopausal hormone therapy will have substantial, or even any, benefits in dealing with COVID-19,” he warned.
Do women die less frequently from COVID-19 than men?
Studies conducted early in the pandemic suggest women may be protected from poor outcomes of SARS-CoV-2 infection, compared with men, even after adjustment for confounders.
According to more recent data from the Swedish Public Health Agency, of the 16,501 people who have died from COVID-19 since the start of the pandemic, about 45% are women and 55% are men. About 70% who have received intensive care because of COVID-19 are men, although cumulative data suggest that women are nearly as likely to die from COVID-19 as men, Dr. Connolly told this news organization.
For the current study, a total of 14,685 women aged 50-80 years were included, of whom 17.3% (2,535) had received estrogen supplementation, 81.2% (11,923) had native estrogen levels with no breast cancer or estrogen supplementation (controls), and 1.5% (227) had decreased estrogen levels because of breast cancer and antiestrogen treatment.
The group with decreased estrogen levels had a more than twofold risk of dying from COVID-19 compared with controls (odds ratio, 2.35), but this difference was no longer significant after adjustments for potential confounders including age, income, and educational level, and weighted Charlson Comorbidity Index (wCCI).
However, the group with augmented estrogen levels had a decreased risk of dying from COVID-19 before (odds ratio, 0.45) and after (OR, 0.47) adjustment.
The percentages of patients who died of COVID-19 were 4.6% of controls, 10.1% of those with decreased estrogen, and 2.1% with increased estrogen.
Not surprisingly, the risk of dying from COVID-19 also increased with age (OR of 1.15 for every year increase in age) and comorbidities (OR, 1.13 per increase in wCCI). Low income and having only a primary level education also increased the odds of dying from COVID-19.
Data on obesity, a known risk factor for COVID-19 death, weren’t reported.
“Obesity would have been a very relevant variable to include. Unfortunately, this information is not present in the nationwide registry data that we used for our study,” Dr. Connolly told this news organization.
While the data are observational and can’t be used to inform treatment, Dr. Connolly pointed to a U.S. randomized clinical trial currently recruiting patients that will investigate the effect of estradiol and progesterone therapy in 120 adults hospitalized with COVID-19.
In the meantime, she warned doctors and patients: “Please do not consider ending antiestrogen treatment following breast cancer – this is a necessary treatment for the cancer.”
Dr. Evans noted, “There are short-term benefits of menopausal hormone therapy but women should not, based on this or other observational studies, be advised to take HRT [hormone replacement therapy] for a supposed benefit on death from COVID-19.”
The study had several nonpharmaceutical industry funders, including Umeå University and the Knut and Alice Wallenberg Foundation. The authors and Dr. Evans have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Estrogen supplementation is associated with a reduced risk of death from COVID-19 among postmenopausal women, new research suggests.
The findings, from a nationwide study using data from Sweden, were published online Feb. 14 in BMJ Open by Malin Sund, MD, PhD, of Umeå (Sweden) University Faculty of Medicine and colleagues.
Among postmenopausal women aged 50-80 years with verified COVID-19, those receiving estrogen as part of hormone replacement therapy for menopausal symptoms were less than half as likely to die from it as those not receiving estrogen, even after adjustment for confounders.
“This study shows an association between estrogen levels and COVID-19 death. Consequently, drugs increasing estrogen levels may have a role in therapeutic efforts to alleviate COVID-19 severity in postmenopausal women and could be studied in randomized control trials,” the investigators write.
However, coauthor Anne-Marie Fors Connolly, MD, PhD, a resident in clinical microbiology at Umeå University, cautioned: “This is an observational study. Further clinical studies are needed to verify these results before recommending clinicians to consider estrogen supplementation.”
Stephen Evans, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, agrees.
He told the U.K. Science and Media Centre: “This is an observational study comparing three groups of women based on whether they used hormonal therapy to boost estrogen levels or who had, as a result of treatment for breast cancer ... reduced estrogen levels or neither. The findings are apparently dramatic.”
“At the very least, great caution should be exercised in thinking that menopausal hormone therapy will have substantial, or even any, benefits in dealing with COVID-19,” he warned.
Do women die less frequently from COVID-19 than men?
Studies conducted early in the pandemic suggest women may be protected from poor outcomes of SARS-CoV-2 infection, compared with men, even after adjustment for confounders.
According to more recent data from the Swedish Public Health Agency, of the 16,501 people who have died from COVID-19 since the start of the pandemic, about 45% are women and 55% are men. About 70% who have received intensive care because of COVID-19 are men, although cumulative data suggest that women are nearly as likely to die from COVID-19 as men, Dr. Connolly told this news organization.
For the current study, a total of 14,685 women aged 50-80 years were included, of whom 17.3% (2,535) had received estrogen supplementation, 81.2% (11,923) had native estrogen levels with no breast cancer or estrogen supplementation (controls), and 1.5% (227) had decreased estrogen levels because of breast cancer and antiestrogen treatment.
The group with decreased estrogen levels had a more than twofold risk of dying from COVID-19 compared with controls (odds ratio, 2.35), but this difference was no longer significant after adjustments for potential confounders including age, income, and educational level, and weighted Charlson Comorbidity Index (wCCI).
However, the group with augmented estrogen levels had a decreased risk of dying from COVID-19 before (odds ratio, 0.45) and after (OR, 0.47) adjustment.
The percentages of patients who died of COVID-19 were 4.6% of controls, 10.1% of those with decreased estrogen, and 2.1% with increased estrogen.
Not surprisingly, the risk of dying from COVID-19 also increased with age (OR of 1.15 for every year increase in age) and comorbidities (OR, 1.13 per increase in wCCI). Low income and having only a primary level education also increased the odds of dying from COVID-19.
Data on obesity, a known risk factor for COVID-19 death, weren’t reported.
“Obesity would have been a very relevant variable to include. Unfortunately, this information is not present in the nationwide registry data that we used for our study,” Dr. Connolly told this news organization.
While the data are observational and can’t be used to inform treatment, Dr. Connolly pointed to a U.S. randomized clinical trial currently recruiting patients that will investigate the effect of estradiol and progesterone therapy in 120 adults hospitalized with COVID-19.
In the meantime, she warned doctors and patients: “Please do not consider ending antiestrogen treatment following breast cancer – this is a necessary treatment for the cancer.”
Dr. Evans noted, “There are short-term benefits of menopausal hormone therapy but women should not, based on this or other observational studies, be advised to take HRT [hormone replacement therapy] for a supposed benefit on death from COVID-19.”
The study had several nonpharmaceutical industry funders, including Umeå University and the Knut and Alice Wallenberg Foundation. The authors and Dr. Evans have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Estrogen supplementation is associated with a reduced risk of death from COVID-19 among postmenopausal women, new research suggests.
The findings, from a nationwide study using data from Sweden, were published online Feb. 14 in BMJ Open by Malin Sund, MD, PhD, of Umeå (Sweden) University Faculty of Medicine and colleagues.
Among postmenopausal women aged 50-80 years with verified COVID-19, those receiving estrogen as part of hormone replacement therapy for menopausal symptoms were less than half as likely to die from it as those not receiving estrogen, even after adjustment for confounders.
“This study shows an association between estrogen levels and COVID-19 death. Consequently, drugs increasing estrogen levels may have a role in therapeutic efforts to alleviate COVID-19 severity in postmenopausal women and could be studied in randomized control trials,” the investigators write.
However, coauthor Anne-Marie Fors Connolly, MD, PhD, a resident in clinical microbiology at Umeå University, cautioned: “This is an observational study. Further clinical studies are needed to verify these results before recommending clinicians to consider estrogen supplementation.”
Stephen Evans, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, agrees.
He told the U.K. Science and Media Centre: “This is an observational study comparing three groups of women based on whether they used hormonal therapy to boost estrogen levels or who had, as a result of treatment for breast cancer ... reduced estrogen levels or neither. The findings are apparently dramatic.”
“At the very least, great caution should be exercised in thinking that menopausal hormone therapy will have substantial, or even any, benefits in dealing with COVID-19,” he warned.
Do women die less frequently from COVID-19 than men?
Studies conducted early in the pandemic suggest women may be protected from poor outcomes of SARS-CoV-2 infection, compared with men, even after adjustment for confounders.
According to more recent data from the Swedish Public Health Agency, of the 16,501 people who have died from COVID-19 since the start of the pandemic, about 45% are women and 55% are men. About 70% who have received intensive care because of COVID-19 are men, although cumulative data suggest that women are nearly as likely to die from COVID-19 as men, Dr. Connolly told this news organization.
For the current study, a total of 14,685 women aged 50-80 years were included, of whom 17.3% (2,535) had received estrogen supplementation, 81.2% (11,923) had native estrogen levels with no breast cancer or estrogen supplementation (controls), and 1.5% (227) had decreased estrogen levels because of breast cancer and antiestrogen treatment.
The group with decreased estrogen levels had a more than twofold risk of dying from COVID-19 compared with controls (odds ratio, 2.35), but this difference was no longer significant after adjustments for potential confounders including age, income, and educational level, and weighted Charlson Comorbidity Index (wCCI).
However, the group with augmented estrogen levels had a decreased risk of dying from COVID-19 before (odds ratio, 0.45) and after (OR, 0.47) adjustment.
The percentages of patients who died of COVID-19 were 4.6% of controls, 10.1% of those with decreased estrogen, and 2.1% with increased estrogen.
Not surprisingly, the risk of dying from COVID-19 also increased with age (OR of 1.15 for every year increase in age) and comorbidities (OR, 1.13 per increase in wCCI). Low income and having only a primary level education also increased the odds of dying from COVID-19.
Data on obesity, a known risk factor for COVID-19 death, weren’t reported.
“Obesity would have been a very relevant variable to include. Unfortunately, this information is not present in the nationwide registry data that we used for our study,” Dr. Connolly told this news organization.
While the data are observational and can’t be used to inform treatment, Dr. Connolly pointed to a U.S. randomized clinical trial currently recruiting patients that will investigate the effect of estradiol and progesterone therapy in 120 adults hospitalized with COVID-19.
In the meantime, she warned doctors and patients: “Please do not consider ending antiestrogen treatment following breast cancer – this is a necessary treatment for the cancer.”
Dr. Evans noted, “There are short-term benefits of menopausal hormone therapy but women should not, based on this or other observational studies, be advised to take HRT [hormone replacement therapy] for a supposed benefit on death from COVID-19.”
The study had several nonpharmaceutical industry funders, including Umeå University and the Knut and Alice Wallenberg Foundation. The authors and Dr. Evans have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM BMJ OPEN
FDA okays 6-month implanted Eversense CGM for diabetes
The U.S. Food and Drug Administration has approved a new second-generation version of the implanted continuous glucose monitoring (CGM) system Eversense (Senseonics) that lasts for 6 months.
The Eversense E3 CGM system doubles the wear time from 3 months with the previous Eversense device approved in the United States in 2018. As before, the new system is approved for adults with diabetes aged 18 years and older.
This means that it will be the longest lasting CGM system available in the United States, with essentially two sensor insertion and removal procedures per year, the company said.
Data from the pivotal PROMISE trial of the 6-month version were presented at the American Diabetes Association Scientific Sessions in 2021, as reported by this news organization.
An older 6-month wear time version (Eversense XL) has been available in Europe since 2017. The new second-generation 6-month system is currently under regulatory review there.
The PROMISE trial included 181 participants with diabetes, about two-thirds with type 1 and one-third with type 2 diabetes, at eight clinical research sites.
“We repeatedly hear from our patients with diabetes that what they desire is a long-lasting sensor that is also highly accurate ... The next generation Eversense E3 System delivers on both,” said PROMISE study principal investigator Satish Garg, MD, professor of medicine and director of the adult diabetes program at the Barbara Davis Center, University of Colorado, Aurora, in a company press release.
The Eversense E3 consists of a fluorescence-based sensor, a transmitter, and a smartphone app that displays glucose values, trends, and alerts. The sensor is inserted subcutaneously into the upper arm by a certified health care professional in a brief office procedure. The transmitter is placed on the skin on top of the sensor. Glucose data are sent to the app automatically every 5 minutes.
The system includes an on-body vibratory alert as well as alerts on the app for high and low blood glucose values. Eversense readings may be used for treatment decisions, but users still must perform fingerstick glucose checks for calibration.
The regulatory review for the Eversense E3 was delayed for a year due to the COVID-19 pandemic. It will be distributed in the United States through a partnership with Ascensia Diabetes Care beginning in the second quarter of 2022, according to a Senseonics statement.
In addition, “the company expects the majority of its expenses for 2022 to be for research and development for ongoing feasibility and pivotal clinical trials for additional products in its product pipeline, including the start of its 365-day pivotal trial.”
Health care providers who want to offer the Eversense CGM System to their patients can sign up here or call 844-SENSE4U (844-736-7348).
Patients interested in getting started on Eversense can sign up here and will be among the first to know when Eversense E3 is commercially available.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved a new second-generation version of the implanted continuous glucose monitoring (CGM) system Eversense (Senseonics) that lasts for 6 months.
The Eversense E3 CGM system doubles the wear time from 3 months with the previous Eversense device approved in the United States in 2018. As before, the new system is approved for adults with diabetes aged 18 years and older.
This means that it will be the longest lasting CGM system available in the United States, with essentially two sensor insertion and removal procedures per year, the company said.
Data from the pivotal PROMISE trial of the 6-month version were presented at the American Diabetes Association Scientific Sessions in 2021, as reported by this news organization.
An older 6-month wear time version (Eversense XL) has been available in Europe since 2017. The new second-generation 6-month system is currently under regulatory review there.
The PROMISE trial included 181 participants with diabetes, about two-thirds with type 1 and one-third with type 2 diabetes, at eight clinical research sites.
“We repeatedly hear from our patients with diabetes that what they desire is a long-lasting sensor that is also highly accurate ... The next generation Eversense E3 System delivers on both,” said PROMISE study principal investigator Satish Garg, MD, professor of medicine and director of the adult diabetes program at the Barbara Davis Center, University of Colorado, Aurora, in a company press release.
The Eversense E3 consists of a fluorescence-based sensor, a transmitter, and a smartphone app that displays glucose values, trends, and alerts. The sensor is inserted subcutaneously into the upper arm by a certified health care professional in a brief office procedure. The transmitter is placed on the skin on top of the sensor. Glucose data are sent to the app automatically every 5 minutes.
The system includes an on-body vibratory alert as well as alerts on the app for high and low blood glucose values. Eversense readings may be used for treatment decisions, but users still must perform fingerstick glucose checks for calibration.
The regulatory review for the Eversense E3 was delayed for a year due to the COVID-19 pandemic. It will be distributed in the United States through a partnership with Ascensia Diabetes Care beginning in the second quarter of 2022, according to a Senseonics statement.
In addition, “the company expects the majority of its expenses for 2022 to be for research and development for ongoing feasibility and pivotal clinical trials for additional products in its product pipeline, including the start of its 365-day pivotal trial.”
Health care providers who want to offer the Eversense CGM System to their patients can sign up here or call 844-SENSE4U (844-736-7348).
Patients interested in getting started on Eversense can sign up here and will be among the first to know when Eversense E3 is commercially available.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved a new second-generation version of the implanted continuous glucose monitoring (CGM) system Eversense (Senseonics) that lasts for 6 months.
The Eversense E3 CGM system doubles the wear time from 3 months with the previous Eversense device approved in the United States in 2018. As before, the new system is approved for adults with diabetes aged 18 years and older.
This means that it will be the longest lasting CGM system available in the United States, with essentially two sensor insertion and removal procedures per year, the company said.
Data from the pivotal PROMISE trial of the 6-month version were presented at the American Diabetes Association Scientific Sessions in 2021, as reported by this news organization.
An older 6-month wear time version (Eversense XL) has been available in Europe since 2017. The new second-generation 6-month system is currently under regulatory review there.
The PROMISE trial included 181 participants with diabetes, about two-thirds with type 1 and one-third with type 2 diabetes, at eight clinical research sites.
“We repeatedly hear from our patients with diabetes that what they desire is a long-lasting sensor that is also highly accurate ... The next generation Eversense E3 System delivers on both,” said PROMISE study principal investigator Satish Garg, MD, professor of medicine and director of the adult diabetes program at the Barbara Davis Center, University of Colorado, Aurora, in a company press release.
The Eversense E3 consists of a fluorescence-based sensor, a transmitter, and a smartphone app that displays glucose values, trends, and alerts. The sensor is inserted subcutaneously into the upper arm by a certified health care professional in a brief office procedure. The transmitter is placed on the skin on top of the sensor. Glucose data are sent to the app automatically every 5 minutes.
The system includes an on-body vibratory alert as well as alerts on the app for high and low blood glucose values. Eversense readings may be used for treatment decisions, but users still must perform fingerstick glucose checks for calibration.
The regulatory review for the Eversense E3 was delayed for a year due to the COVID-19 pandemic. It will be distributed in the United States through a partnership with Ascensia Diabetes Care beginning in the second quarter of 2022, according to a Senseonics statement.
In addition, “the company expects the majority of its expenses for 2022 to be for research and development for ongoing feasibility and pivotal clinical trials for additional products in its product pipeline, including the start of its 365-day pivotal trial.”
Health care providers who want to offer the Eversense CGM System to their patients can sign up here or call 844-SENSE4U (844-736-7348).
Patients interested in getting started on Eversense can sign up here and will be among the first to know when Eversense E3 is commercially available.
A version of this article first appeared on Medscape.com.
Do latest SURPASS findings with twincretin in diabetes impress?
, new research shows.
The novel once-weekly injectable agent is nicknamed a twincretin because it combines two different gut-hormone activities. It works both as a glucagonlike peptide-1 (GLP-1) receptor agonist and as an agent that mimics the glucose-dependent insulinotropic polypeptide (GIP).
Findings from the randomized phase 3 SURPASS-5 clinical trial were published online Feb. 8 in JAMA.
This is the latest in a series of SURPASS trials of tirzepatide in individuals with type 2 diabetes for which results have been presented at various conferences, announced by the company, and/or published since late 2020.
SURPASS-5 specifically investigated the effect on glycemic control of adding three different doses of once-weekly subcutaneous tirzepatide compared with placebo in 475 adults who hadn’t achieved target A1c levels using insulin glargine with or without metformin. Statistically significant reductions in A1c were found at 40 weeks for all three doses.
Moreover, authors Dominik Dahl, MD, group practice for internal medicine and diabetology, Hamburg, Germany, and colleagues note that the improvements in the tirzepatide groups “were associated with significantly lower insulin glargine use and significant bodyweight reduction compared with placebo.”
“Despite the differences in glycemic control between the tirzepatide and placebo groups, the rate of clinically significant or severe hypoglycemia was below one event per patient-year in all treatment groups,” they add.
However, concerns about the study protocol and generalizability were raised in an accompanying editorial by Stuart R. Chipkin, MD, of the School of Public Health & Health Sciences, University of Massachusetts Amherst.
“Importantly, the study did not compare tirzepatide with other treatments that could have been used to target the postprandial glycemic pattern of the study population,” he writes.
And ultimately, he says: “Even though the results of this investigation are important for demonstrating the potential clinical benefit of [tirzepatide], and may help to advance the goal of achieving U.S. Food and Drug Administration approval, the study may leave clinicians uncertain about when and how to best use tirzepatide to improve clinical outcomes for patients with type 2 diabetes.”
Significant A1c, weight reductions when added to insulin glargine
The randomized, phase 3 SURPASS-5 trial was conducted at 45 centers in eight countries between August 2019 and January 2021. The 475 adult participants had type 2 diabetes inadequately controlled (baseline A1c, 7.0%-10.5%) with once-daily insulin glargine, with or without metformin. They were randomized to receive once-weekly subcutaneous injections of tirzepatide in doses of 5 mg, 10 mg, or 15 mg, or volume-matched placebo injections over 40 weeks.
The mean changes from baseline in A1c at week 40, the primary study endpoint, were –2.11, –2.40, and –2.34 percentage points for the 5 mg, 10 mg, and 15 mg doses of tirzepatide, respectively (P < .001), versus a nonsignificant change of –0.86 percentage points with placebo. The differences from placebo at week 40 were also significant for the 10-mg and 15-mg doses (both P < .001).
Significantly higher proportions of patients receiving 5 mg, 10 mg, and 15 mg tirzepatide met the A1c target of less than 7% at week 40, compared with placebo (85%-90% vs. 34%; P < .001). Significantly higher proportions of patients in the 10-mg and 15-mg dose groups also achieved A1c less than 5.7% (42% and 50%, respectively, vs. 3%).
Mean fasting glucose was also reduced significantly with all doses of tirzepatide by 58.2 mg/dL, 64.0 mg/dL, and 62.6 mg/dL, respectively, versus 39.2 mg/dL with placebo (all P <0.001 vs. placebo).
At week 40, mean body weight reductions from baseline were 5.4 kg (11.9 lbs), 7.5 kg, and 8.8 kg versus just 1.6 kg with placebo (all P <0.001 vs. placebo).
All three tirzepatide doses were also associated with significant improvements from baseline in total cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, and triglycerides.
Gastrointestinal adverse events, hypoglycemia seen in minority
The most common treatment-emergent adverse events in the tirzepatide groups versus placebo were gastrointestinal, including diarrhea (12%-21% vs. 10%), nausea (13%-18% vs. 2.5%), vomiting (7%-13% vs. 2.5%), and decreased appetite (7%-14% vs. 1.7%). Most of these adverse events were mild to moderate in intensity and decreased over time in the tirzepatide groups.
There were no deaths in the study. Serious adverse events were reported by 8%-11% in the tirzepatide groups, compared with 8% in the placebo group. Drug discontinuation due to adverse events occurred in 6.0%, 8.4%, and 10.8% of the 5-mg, 10-mg, and 15-mg dose groups, respectively, versus 2.5% in the placebo group.
Rates of hypoglycemia (less than or equal to 70 mg/dL) ranged from 14.2% to 19.3% with tirzepatide versus 12.5% with placebo. There were three episodes of severe hypoglycemia (less than 54 mg/dL), two with 10 mg tirzepatide and one with 15 mg tirzepatide.
Editorial raises questions
In his editorial, Dr. Chipkin writes that the study “demonstrated that use of tirzepatide was associated with significant reductions in A1c and weight in a fairly homogeneous cohort of patients with type 2 diabetes who were receiving insulin glargine with or without metformin.”
“The protocol answered questions about efficacy but left open questions about generalizability and effectiveness in different populations, especially patients with certain complications or comorbid chronic diseases.” He also notes that younger adults and Black patients were not well-represented.
And the study didn’t allow for dividing up the glargine dose or for adding short-acting insulin before meals or any other pre-meal medications and “thus may represent a departure from usual care” in the setting of rising glucose levels.
The authors themselves acknowledge that “the postprandial glucose excursions observed in the placebo group suggest an additional prandial intervention was likely needed in some patients, despite the strict inclusion criteria and the treat-to-target-approach used in the study.”
Dr. Chipkin concludes that “although patients are likely to embrace a medication with weight loss outcomes, the protocol also leaves unanswered questions about reducing insulin and evaluating the comparative risk of adverse effects.”
The study was sponsored by Eli Lilly. Dr. Dahl has reported receiving personal fees from Eli Lilly during the conduct of the study and personal fees from Afimmune, Novo Nordisk, and Novartis outside the submitted work. Dr. Chipkin has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research shows.
The novel once-weekly injectable agent is nicknamed a twincretin because it combines two different gut-hormone activities. It works both as a glucagonlike peptide-1 (GLP-1) receptor agonist and as an agent that mimics the glucose-dependent insulinotropic polypeptide (GIP).
Findings from the randomized phase 3 SURPASS-5 clinical trial were published online Feb. 8 in JAMA.
This is the latest in a series of SURPASS trials of tirzepatide in individuals with type 2 diabetes for which results have been presented at various conferences, announced by the company, and/or published since late 2020.
SURPASS-5 specifically investigated the effect on glycemic control of adding three different doses of once-weekly subcutaneous tirzepatide compared with placebo in 475 adults who hadn’t achieved target A1c levels using insulin glargine with or without metformin. Statistically significant reductions in A1c were found at 40 weeks for all three doses.
Moreover, authors Dominik Dahl, MD, group practice for internal medicine and diabetology, Hamburg, Germany, and colleagues note that the improvements in the tirzepatide groups “were associated with significantly lower insulin glargine use and significant bodyweight reduction compared with placebo.”
“Despite the differences in glycemic control between the tirzepatide and placebo groups, the rate of clinically significant or severe hypoglycemia was below one event per patient-year in all treatment groups,” they add.
However, concerns about the study protocol and generalizability were raised in an accompanying editorial by Stuart R. Chipkin, MD, of the School of Public Health & Health Sciences, University of Massachusetts Amherst.
“Importantly, the study did not compare tirzepatide with other treatments that could have been used to target the postprandial glycemic pattern of the study population,” he writes.
And ultimately, he says: “Even though the results of this investigation are important for demonstrating the potential clinical benefit of [tirzepatide], and may help to advance the goal of achieving U.S. Food and Drug Administration approval, the study may leave clinicians uncertain about when and how to best use tirzepatide to improve clinical outcomes for patients with type 2 diabetes.”
Significant A1c, weight reductions when added to insulin glargine
The randomized, phase 3 SURPASS-5 trial was conducted at 45 centers in eight countries between August 2019 and January 2021. The 475 adult participants had type 2 diabetes inadequately controlled (baseline A1c, 7.0%-10.5%) with once-daily insulin glargine, with or without metformin. They were randomized to receive once-weekly subcutaneous injections of tirzepatide in doses of 5 mg, 10 mg, or 15 mg, or volume-matched placebo injections over 40 weeks.
The mean changes from baseline in A1c at week 40, the primary study endpoint, were –2.11, –2.40, and –2.34 percentage points for the 5 mg, 10 mg, and 15 mg doses of tirzepatide, respectively (P < .001), versus a nonsignificant change of –0.86 percentage points with placebo. The differences from placebo at week 40 were also significant for the 10-mg and 15-mg doses (both P < .001).
Significantly higher proportions of patients receiving 5 mg, 10 mg, and 15 mg tirzepatide met the A1c target of less than 7% at week 40, compared with placebo (85%-90% vs. 34%; P < .001). Significantly higher proportions of patients in the 10-mg and 15-mg dose groups also achieved A1c less than 5.7% (42% and 50%, respectively, vs. 3%).
Mean fasting glucose was also reduced significantly with all doses of tirzepatide by 58.2 mg/dL, 64.0 mg/dL, and 62.6 mg/dL, respectively, versus 39.2 mg/dL with placebo (all P <0.001 vs. placebo).
At week 40, mean body weight reductions from baseline were 5.4 kg (11.9 lbs), 7.5 kg, and 8.8 kg versus just 1.6 kg with placebo (all P <0.001 vs. placebo).
All three tirzepatide doses were also associated with significant improvements from baseline in total cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, and triglycerides.
Gastrointestinal adverse events, hypoglycemia seen in minority
The most common treatment-emergent adverse events in the tirzepatide groups versus placebo were gastrointestinal, including diarrhea (12%-21% vs. 10%), nausea (13%-18% vs. 2.5%), vomiting (7%-13% vs. 2.5%), and decreased appetite (7%-14% vs. 1.7%). Most of these adverse events were mild to moderate in intensity and decreased over time in the tirzepatide groups.
There were no deaths in the study. Serious adverse events were reported by 8%-11% in the tirzepatide groups, compared with 8% in the placebo group. Drug discontinuation due to adverse events occurred in 6.0%, 8.4%, and 10.8% of the 5-mg, 10-mg, and 15-mg dose groups, respectively, versus 2.5% in the placebo group.
Rates of hypoglycemia (less than or equal to 70 mg/dL) ranged from 14.2% to 19.3% with tirzepatide versus 12.5% with placebo. There were three episodes of severe hypoglycemia (less than 54 mg/dL), two with 10 mg tirzepatide and one with 15 mg tirzepatide.
Editorial raises questions
In his editorial, Dr. Chipkin writes that the study “demonstrated that use of tirzepatide was associated with significant reductions in A1c and weight in a fairly homogeneous cohort of patients with type 2 diabetes who were receiving insulin glargine with or without metformin.”
“The protocol answered questions about efficacy but left open questions about generalizability and effectiveness in different populations, especially patients with certain complications or comorbid chronic diseases.” He also notes that younger adults and Black patients were not well-represented.
And the study didn’t allow for dividing up the glargine dose or for adding short-acting insulin before meals or any other pre-meal medications and “thus may represent a departure from usual care” in the setting of rising glucose levels.
The authors themselves acknowledge that “the postprandial glucose excursions observed in the placebo group suggest an additional prandial intervention was likely needed in some patients, despite the strict inclusion criteria and the treat-to-target-approach used in the study.”
Dr. Chipkin concludes that “although patients are likely to embrace a medication with weight loss outcomes, the protocol also leaves unanswered questions about reducing insulin and evaluating the comparative risk of adverse effects.”
The study was sponsored by Eli Lilly. Dr. Dahl has reported receiving personal fees from Eli Lilly during the conduct of the study and personal fees from Afimmune, Novo Nordisk, and Novartis outside the submitted work. Dr. Chipkin has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research shows.
The novel once-weekly injectable agent is nicknamed a twincretin because it combines two different gut-hormone activities. It works both as a glucagonlike peptide-1 (GLP-1) receptor agonist and as an agent that mimics the glucose-dependent insulinotropic polypeptide (GIP).
Findings from the randomized phase 3 SURPASS-5 clinical trial were published online Feb. 8 in JAMA.
This is the latest in a series of SURPASS trials of tirzepatide in individuals with type 2 diabetes for which results have been presented at various conferences, announced by the company, and/or published since late 2020.
SURPASS-5 specifically investigated the effect on glycemic control of adding three different doses of once-weekly subcutaneous tirzepatide compared with placebo in 475 adults who hadn’t achieved target A1c levels using insulin glargine with or without metformin. Statistically significant reductions in A1c were found at 40 weeks for all three doses.
Moreover, authors Dominik Dahl, MD, group practice for internal medicine and diabetology, Hamburg, Germany, and colleagues note that the improvements in the tirzepatide groups “were associated with significantly lower insulin glargine use and significant bodyweight reduction compared with placebo.”
“Despite the differences in glycemic control between the tirzepatide and placebo groups, the rate of clinically significant or severe hypoglycemia was below one event per patient-year in all treatment groups,” they add.
However, concerns about the study protocol and generalizability were raised in an accompanying editorial by Stuart R. Chipkin, MD, of the School of Public Health & Health Sciences, University of Massachusetts Amherst.
“Importantly, the study did not compare tirzepatide with other treatments that could have been used to target the postprandial glycemic pattern of the study population,” he writes.
And ultimately, he says: “Even though the results of this investigation are important for demonstrating the potential clinical benefit of [tirzepatide], and may help to advance the goal of achieving U.S. Food and Drug Administration approval, the study may leave clinicians uncertain about when and how to best use tirzepatide to improve clinical outcomes for patients with type 2 diabetes.”
Significant A1c, weight reductions when added to insulin glargine
The randomized, phase 3 SURPASS-5 trial was conducted at 45 centers in eight countries between August 2019 and January 2021. The 475 adult participants had type 2 diabetes inadequately controlled (baseline A1c, 7.0%-10.5%) with once-daily insulin glargine, with or without metformin. They were randomized to receive once-weekly subcutaneous injections of tirzepatide in doses of 5 mg, 10 mg, or 15 mg, or volume-matched placebo injections over 40 weeks.
The mean changes from baseline in A1c at week 40, the primary study endpoint, were –2.11, –2.40, and –2.34 percentage points for the 5 mg, 10 mg, and 15 mg doses of tirzepatide, respectively (P < .001), versus a nonsignificant change of –0.86 percentage points with placebo. The differences from placebo at week 40 were also significant for the 10-mg and 15-mg doses (both P < .001).
Significantly higher proportions of patients receiving 5 mg, 10 mg, and 15 mg tirzepatide met the A1c target of less than 7% at week 40, compared with placebo (85%-90% vs. 34%; P < .001). Significantly higher proportions of patients in the 10-mg and 15-mg dose groups also achieved A1c less than 5.7% (42% and 50%, respectively, vs. 3%).
Mean fasting glucose was also reduced significantly with all doses of tirzepatide by 58.2 mg/dL, 64.0 mg/dL, and 62.6 mg/dL, respectively, versus 39.2 mg/dL with placebo (all P <0.001 vs. placebo).
At week 40, mean body weight reductions from baseline were 5.4 kg (11.9 lbs), 7.5 kg, and 8.8 kg versus just 1.6 kg with placebo (all P <0.001 vs. placebo).
All three tirzepatide doses were also associated with significant improvements from baseline in total cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, and triglycerides.
Gastrointestinal adverse events, hypoglycemia seen in minority
The most common treatment-emergent adverse events in the tirzepatide groups versus placebo were gastrointestinal, including diarrhea (12%-21% vs. 10%), nausea (13%-18% vs. 2.5%), vomiting (7%-13% vs. 2.5%), and decreased appetite (7%-14% vs. 1.7%). Most of these adverse events were mild to moderate in intensity and decreased over time in the tirzepatide groups.
There were no deaths in the study. Serious adverse events were reported by 8%-11% in the tirzepatide groups, compared with 8% in the placebo group. Drug discontinuation due to adverse events occurred in 6.0%, 8.4%, and 10.8% of the 5-mg, 10-mg, and 15-mg dose groups, respectively, versus 2.5% in the placebo group.
Rates of hypoglycemia (less than or equal to 70 mg/dL) ranged from 14.2% to 19.3% with tirzepatide versus 12.5% with placebo. There were three episodes of severe hypoglycemia (less than 54 mg/dL), two with 10 mg tirzepatide and one with 15 mg tirzepatide.
Editorial raises questions
In his editorial, Dr. Chipkin writes that the study “demonstrated that use of tirzepatide was associated with significant reductions in A1c and weight in a fairly homogeneous cohort of patients with type 2 diabetes who were receiving insulin glargine with or without metformin.”
“The protocol answered questions about efficacy but left open questions about generalizability and effectiveness in different populations, especially patients with certain complications or comorbid chronic diseases.” He also notes that younger adults and Black patients were not well-represented.
And the study didn’t allow for dividing up the glargine dose or for adding short-acting insulin before meals or any other pre-meal medications and “thus may represent a departure from usual care” in the setting of rising glucose levels.
The authors themselves acknowledge that “the postprandial glucose excursions observed in the placebo group suggest an additional prandial intervention was likely needed in some patients, despite the strict inclusion criteria and the treat-to-target-approach used in the study.”
Dr. Chipkin concludes that “although patients are likely to embrace a medication with weight loss outcomes, the protocol also leaves unanswered questions about reducing insulin and evaluating the comparative risk of adverse effects.”
The study was sponsored by Eli Lilly. Dr. Dahl has reported receiving personal fees from Eli Lilly during the conduct of the study and personal fees from Afimmune, Novo Nordisk, and Novartis outside the submitted work. Dr. Chipkin has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Switching to a healthy diet can add 10 years to life
Just a few changes to your diet could add years to your life, but the sooner you start the better.
Maintaining a healthy diet is important, but most people find this difficult to do daily. In a new study, researchers examined the effects of individual healthful and nonhealthful types of foods and estimated the impact by age and sex of swapping some for others.
say the Norwegian scientists who conducted the study, published in PLOS Medicine on Feb. 8.
They developed an online tool that anyone can use to get an idea of how individual food choices can affect life expectancy.
The biggest overall impact comes from eating more plant-based foods (legumes), whole grains and nuts, and less red and processed meat. Fruits and vegetables also have a positive health impact, but on average people who eat a typical Western diet are already consuming those in relatively high amounts. Fish is included on the healthful list, whereas sugar-sweetened beverages (sodas) and foods based on refined [white] grains, such as white bread, are among those to be avoided.
The study found that although it’s never too late to start, young adults can expect to see more years gained by adopting healthful eating than would older adults.
“Our results indicate that for individuals with a typical Western diet, sustained dietary changes at any age may give substantial health benefits, although the gains are the largest if changes start early in life,” said the researchers.
Depending on how many healthy dietary “switches” are made and maintained and the amounts consumed, a 20-year-old man in the United States could extend his life up to 13 years, and a 20-year old woman by 11 years.
That number drops with age but changing from a typical diet to the optimized diet at age 60 years could still increase life expectancy by 8 years for women and 9 years for men, and even an 80-year-old female could gain more than 3 years with healthier food choices.
Until now, research in this area has shown health benefits associated with separate food groups or specific diet patterns, while focusing less on the health impact of other dietary changes. The statistical ‘modeling’ approach used in this study bridges that gap, the researchers said.
“Understanding the relative health potential of different food groups could enable people to make feasible and significant health gains,” they concluded.
A version of this article was first published on WebMD.com.
Just a few changes to your diet could add years to your life, but the sooner you start the better.
Maintaining a healthy diet is important, but most people find this difficult to do daily. In a new study, researchers examined the effects of individual healthful and nonhealthful types of foods and estimated the impact by age and sex of swapping some for others.
say the Norwegian scientists who conducted the study, published in PLOS Medicine on Feb. 8.
They developed an online tool that anyone can use to get an idea of how individual food choices can affect life expectancy.
The biggest overall impact comes from eating more plant-based foods (legumes), whole grains and nuts, and less red and processed meat. Fruits and vegetables also have a positive health impact, but on average people who eat a typical Western diet are already consuming those in relatively high amounts. Fish is included on the healthful list, whereas sugar-sweetened beverages (sodas) and foods based on refined [white] grains, such as white bread, are among those to be avoided.
The study found that although it’s never too late to start, young adults can expect to see more years gained by adopting healthful eating than would older adults.
“Our results indicate that for individuals with a typical Western diet, sustained dietary changes at any age may give substantial health benefits, although the gains are the largest if changes start early in life,” said the researchers.
Depending on how many healthy dietary “switches” are made and maintained and the amounts consumed, a 20-year-old man in the United States could extend his life up to 13 years, and a 20-year old woman by 11 years.
That number drops with age but changing from a typical diet to the optimized diet at age 60 years could still increase life expectancy by 8 years for women and 9 years for men, and even an 80-year-old female could gain more than 3 years with healthier food choices.
Until now, research in this area has shown health benefits associated with separate food groups or specific diet patterns, while focusing less on the health impact of other dietary changes. The statistical ‘modeling’ approach used in this study bridges that gap, the researchers said.
“Understanding the relative health potential of different food groups could enable people to make feasible and significant health gains,” they concluded.
A version of this article was first published on WebMD.com.
Just a few changes to your diet could add years to your life, but the sooner you start the better.
Maintaining a healthy diet is important, but most people find this difficult to do daily. In a new study, researchers examined the effects of individual healthful and nonhealthful types of foods and estimated the impact by age and sex of swapping some for others.
say the Norwegian scientists who conducted the study, published in PLOS Medicine on Feb. 8.
They developed an online tool that anyone can use to get an idea of how individual food choices can affect life expectancy.
The biggest overall impact comes from eating more plant-based foods (legumes), whole grains and nuts, and less red and processed meat. Fruits and vegetables also have a positive health impact, but on average people who eat a typical Western diet are already consuming those in relatively high amounts. Fish is included on the healthful list, whereas sugar-sweetened beverages (sodas) and foods based on refined [white] grains, such as white bread, are among those to be avoided.
The study found that although it’s never too late to start, young adults can expect to see more years gained by adopting healthful eating than would older adults.
“Our results indicate that for individuals with a typical Western diet, sustained dietary changes at any age may give substantial health benefits, although the gains are the largest if changes start early in life,” said the researchers.
Depending on how many healthy dietary “switches” are made and maintained and the amounts consumed, a 20-year-old man in the United States could extend his life up to 13 years, and a 20-year old woman by 11 years.
That number drops with age but changing from a typical diet to the optimized diet at age 60 years could still increase life expectancy by 8 years for women and 9 years for men, and even an 80-year-old female could gain more than 3 years with healthier food choices.
Until now, research in this area has shown health benefits associated with separate food groups or specific diet patterns, while focusing less on the health impact of other dietary changes. The statistical ‘modeling’ approach used in this study bridges that gap, the researchers said.
“Understanding the relative health potential of different food groups could enable people to make feasible and significant health gains,” they concluded.
A version of this article was first published on WebMD.com.
FROM PLOS MEDICINE
Endocrine Society and others to FDA: Restrict BPA
The chemical is used to make plastics in items such as food containers, pitchers, and inner linings of metal products. Small amounts of BPA can leak into food and beverages.
The petition points to a December 2021 report by the European Food Safety Authority titled: “Re-evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs,” which summarizes evidence gathered since 2013.
It concludes that “there is a health concern from BPA exposure for all age groups.” Specific concerns include harm to the immune system and male and female reproductive systems.
Average American exposed to 5,000 times the safe level of BPA
The EFSA established a new “tolerable daily intake” of BPA of 0.04 ng/kg of body weight per day. By contrast, in 2014 the FDA estimated that the mean BPA intake for the U.S. population older than 2 years was 200 ng/kg bw/day and that the 90th percentile for BPA intake was 500 ng/kg of body weight per day.
“Using FDA’s own exposure estimates, the average American is exposed to more than 5000 times the safe level of 0.04 ng BPA/kg [body weight per day] set by the EFSA expert panel. Without a doubt, these values constitute a high health risk and support the conclusion that uses of BPA are not safe ... Given the magnitude of the overexposure, we request an expedited review by FDA,” the petition reads.
In addition to the Endocrine Society, which has long warned about the dangers of endocrine-disrupting chemicals, other signatories to the petition include the Environmental Defense Fund, Breast Cancer Prevention Partners, Clean Water Action/Clean Water Fund, Consumer Reports, Environmental Working Group, Healthy Babies Bright Futures, and the former director of the National Institute of Environmental Health Sciences and National Toxicology Program.
In a statement, Endocrine Society BPA expert Heather Patisaul, PhD, of North Carolina University, Raleigh, said the report’s findings “are extremely concerning and prove the point that even very low levels of BPA exposure can be harmful and lead to issues with reproductive health, breast cancer risk, behavior, and metabolism.”
“The FDA needs to acknowledge the science behind endocrine-disrupting chemicals and act accordingly to protect public health,” she urged.
The FDA is expected to decide within the next few days whether to open a docket to accept comments.
A final decision could take 6 months or longer, an Endocrine Society spokesperson told this news organization.
A version of this article first appeared on Medscape.com.
The chemical is used to make plastics in items such as food containers, pitchers, and inner linings of metal products. Small amounts of BPA can leak into food and beverages.
The petition points to a December 2021 report by the European Food Safety Authority titled: “Re-evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs,” which summarizes evidence gathered since 2013.
It concludes that “there is a health concern from BPA exposure for all age groups.” Specific concerns include harm to the immune system and male and female reproductive systems.
Average American exposed to 5,000 times the safe level of BPA
The EFSA established a new “tolerable daily intake” of BPA of 0.04 ng/kg of body weight per day. By contrast, in 2014 the FDA estimated that the mean BPA intake for the U.S. population older than 2 years was 200 ng/kg bw/day and that the 90th percentile for BPA intake was 500 ng/kg of body weight per day.
“Using FDA’s own exposure estimates, the average American is exposed to more than 5000 times the safe level of 0.04 ng BPA/kg [body weight per day] set by the EFSA expert panel. Without a doubt, these values constitute a high health risk and support the conclusion that uses of BPA are not safe ... Given the magnitude of the overexposure, we request an expedited review by FDA,” the petition reads.
In addition to the Endocrine Society, which has long warned about the dangers of endocrine-disrupting chemicals, other signatories to the petition include the Environmental Defense Fund, Breast Cancer Prevention Partners, Clean Water Action/Clean Water Fund, Consumer Reports, Environmental Working Group, Healthy Babies Bright Futures, and the former director of the National Institute of Environmental Health Sciences and National Toxicology Program.
In a statement, Endocrine Society BPA expert Heather Patisaul, PhD, of North Carolina University, Raleigh, said the report’s findings “are extremely concerning and prove the point that even very low levels of BPA exposure can be harmful and lead to issues with reproductive health, breast cancer risk, behavior, and metabolism.”
“The FDA needs to acknowledge the science behind endocrine-disrupting chemicals and act accordingly to protect public health,” she urged.
The FDA is expected to decide within the next few days whether to open a docket to accept comments.
A final decision could take 6 months or longer, an Endocrine Society spokesperson told this news organization.
A version of this article first appeared on Medscape.com.
The chemical is used to make plastics in items such as food containers, pitchers, and inner linings of metal products. Small amounts of BPA can leak into food and beverages.
The petition points to a December 2021 report by the European Food Safety Authority titled: “Re-evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs,” which summarizes evidence gathered since 2013.
It concludes that “there is a health concern from BPA exposure for all age groups.” Specific concerns include harm to the immune system and male and female reproductive systems.
Average American exposed to 5,000 times the safe level of BPA
The EFSA established a new “tolerable daily intake” of BPA of 0.04 ng/kg of body weight per day. By contrast, in 2014 the FDA estimated that the mean BPA intake for the U.S. population older than 2 years was 200 ng/kg bw/day and that the 90th percentile for BPA intake was 500 ng/kg of body weight per day.
“Using FDA’s own exposure estimates, the average American is exposed to more than 5000 times the safe level of 0.04 ng BPA/kg [body weight per day] set by the EFSA expert panel. Without a doubt, these values constitute a high health risk and support the conclusion that uses of BPA are not safe ... Given the magnitude of the overexposure, we request an expedited review by FDA,” the petition reads.
In addition to the Endocrine Society, which has long warned about the dangers of endocrine-disrupting chemicals, other signatories to the petition include the Environmental Defense Fund, Breast Cancer Prevention Partners, Clean Water Action/Clean Water Fund, Consumer Reports, Environmental Working Group, Healthy Babies Bright Futures, and the former director of the National Institute of Environmental Health Sciences and National Toxicology Program.
In a statement, Endocrine Society BPA expert Heather Patisaul, PhD, of North Carolina University, Raleigh, said the report’s findings “are extremely concerning and prove the point that even very low levels of BPA exposure can be harmful and lead to issues with reproductive health, breast cancer risk, behavior, and metabolism.”
“The FDA needs to acknowledge the science behind endocrine-disrupting chemicals and act accordingly to protect public health,” she urged.
The FDA is expected to decide within the next few days whether to open a docket to accept comments.
A final decision could take 6 months or longer, an Endocrine Society spokesperson told this news organization.
A version of this article first appeared on Medscape.com.
Does using A1c to diagnose diabetes miss some patients?
The introduction of hemoglobin A1c as an option for diagnosing type 2 diabetes over a decade ago may have resulted in underdiagnosis, new research indicates.
In 2011, the World Health Organization advised that A1c measurement, with a cutoff value of 6.5%, could be used to diagnose diabetes. The American Diabetes Association had issued similar guidance in 2010.
Prior to that time, the less-convenient 2-hour oral glucose tolerance test (OGTT) and fasting blood glucose (FBG) were the only recommended tests. While WHO made no recommendations for interpreting values below 6.5%, the ADA designated 5.7%-6.4% as prediabetes.
The new study, published online in The Lancet Regional Health–Europe, showed that the incidence of type 2 diabetes in Denmark had been increasing prior to the 2012 adoption of A1c as a diagnostic option but declined thereafter. And all-cause mortality among people with type 2 diabetes, which had been dropping, began to increase after that time.
“Our findings suggest that fewer patients have been diagnosed with [type 2 diabetes] since A1c testing was introduced as a convenient diagnostic option. We may thus be missing a group with borderline increased A1c values that is still at high metabolic and cardiovascular risk,” Jakob S. Knudsen, MD, of the department of clinical epidemiology, Aarhus (Denmark) University Hospital, and colleagues wrote.
Therefore, Dr. Knudsen said in an interview, clinicians should “consider testing with FBG or OGTT when presented with borderline A1c values.”
The reason for the increase in mortality after incident type 2 diabetes diagnosis, he said, “is that the patients who would have reduced the average mortality are no longer diagnosed...This does not reflect that we are treating already diagnosed patients any worse, rather some patients are not diagnosed.”
But M. Sue Kirkman, MD, emeritus professor of medicine at the University of North Carolina at Chapel Hill, who was part of the writing group for the 2010 ADA guidelines, isn’t convinced.
“This is an interesting paper, but it is a bit hard to believe that a change in WHO recommendations would have such a large and almost immediate impact on incidence and mortality. It seems likely that ... factors [other] than just the changes in recommendations for the diagnostic test account for these findings,” she said.
Dr. Kirkman pointed to new data just out from the Centers for Disease Control and Prevention on Jan. 26 that don›t show evidence of a higher proportion of people in the United States who have undiagnosed diabetes, “which would be expected if more cases were being ‘missed’ by A1c.”
She added that the CDC incidence data “show a continuing steady rate of decline in incidence that began in 2008, before any organizations recommended using A1c to screen for or diagnose diabetes.” Moreover, “there is evidence that type 2 diabetes incidence has fallen or plateaued in many countries since 2006, well before the WHO recommendation, with most of the studies from developed countries.”
But Dr. Knudsen also cited other data, including a study that showed a drop or stabilization in diagnosed diabetes incidence in high-income countries since 2010.
“That study concluded that the reasons for the declines in the incidence of diagnosed diabetes warrant further investigation with appropriate data sources, which was a main objective of our study,” wrote Dr. Knudsen and coauthors.
Dr. Knudsen said in an interview: “We are not the first to make the point that this sudden change is related to A1c introduction...but we are the first to have the data to clearly show that is the case.”
Diabetes incidence dropped but mortality rose after 2010
The population-based longitudinal study used four Danish medical databases and included 415,553 patients treated for type 2 diabetes for the first time from 1995-2018 and 2,060,279 matched comparators not treated for diabetes.
From 1995 until the 2012 introduction of A1c as a diagnostic option, the annual standardized incidence rates of type 2 diabetes more than doubled, from 193 per 100,000 population to 396 per 100,000 population, at a rate of 4.1% per year.
But from 2011 to 2018, the annual standardized incidence rate declined by 36%, to 253 per 100,000 population, a 5.7% annualized decrease.
The increase prior to 2011 occurred in both men and women and in all age groups, while the subsequent decline was seen primarily in the older age groups. The all-cause mortality risk within the first year after diabetes diagnosis was higher than subsequent 1-year mortality risks and not different between men and women.
From the periods 1995-1997 to 2010-2012, the adjusted mortality rate among those with type 2 diabetes decreased by 44%, from 72 deaths per 1000 person-years to 40 deaths per 1000 person-years (adjusted mortality rate ratio, 0.55). After that low level in 2010-2012, mortality increased by 27% to 48 per 1000 person-years (adjusted mortality rate ratio 0.69, compared with 1995-1997).
The reversed mortality trend after 2010-2012 was caused almost entirely by the increase in the first year after diabetes diagnosis, Dr. Knudsen and colleagues noted.
According to Dr. Kirkman, “A1c is strongly predictive of complications and mortality. That plus its ease of use and the fact that more people may be screened mean it’s still a good option. But for any of these tests, people who are slightly below the cut-point should not be considered normal or low risk.”
Indeed, Dr. Knudsen and colleagues said, “these findings may have implications for clinical practice and suggest that a more multifactorial view of metabolic risk is needed.”
Dr. Knudsen and Dr. Kirkman have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The introduction of hemoglobin A1c as an option for diagnosing type 2 diabetes over a decade ago may have resulted in underdiagnosis, new research indicates.
In 2011, the World Health Organization advised that A1c measurement, with a cutoff value of 6.5%, could be used to diagnose diabetes. The American Diabetes Association had issued similar guidance in 2010.
Prior to that time, the less-convenient 2-hour oral glucose tolerance test (OGTT) and fasting blood glucose (FBG) were the only recommended tests. While WHO made no recommendations for interpreting values below 6.5%, the ADA designated 5.7%-6.4% as prediabetes.
The new study, published online in The Lancet Regional Health–Europe, showed that the incidence of type 2 diabetes in Denmark had been increasing prior to the 2012 adoption of A1c as a diagnostic option but declined thereafter. And all-cause mortality among people with type 2 diabetes, which had been dropping, began to increase after that time.
“Our findings suggest that fewer patients have been diagnosed with [type 2 diabetes] since A1c testing was introduced as a convenient diagnostic option. We may thus be missing a group with borderline increased A1c values that is still at high metabolic and cardiovascular risk,” Jakob S. Knudsen, MD, of the department of clinical epidemiology, Aarhus (Denmark) University Hospital, and colleagues wrote.
Therefore, Dr. Knudsen said in an interview, clinicians should “consider testing with FBG or OGTT when presented with borderline A1c values.”
The reason for the increase in mortality after incident type 2 diabetes diagnosis, he said, “is that the patients who would have reduced the average mortality are no longer diagnosed...This does not reflect that we are treating already diagnosed patients any worse, rather some patients are not diagnosed.”
But M. Sue Kirkman, MD, emeritus professor of medicine at the University of North Carolina at Chapel Hill, who was part of the writing group for the 2010 ADA guidelines, isn’t convinced.
“This is an interesting paper, but it is a bit hard to believe that a change in WHO recommendations would have such a large and almost immediate impact on incidence and mortality. It seems likely that ... factors [other] than just the changes in recommendations for the diagnostic test account for these findings,” she said.
Dr. Kirkman pointed to new data just out from the Centers for Disease Control and Prevention on Jan. 26 that don›t show evidence of a higher proportion of people in the United States who have undiagnosed diabetes, “which would be expected if more cases were being ‘missed’ by A1c.”
She added that the CDC incidence data “show a continuing steady rate of decline in incidence that began in 2008, before any organizations recommended using A1c to screen for or diagnose diabetes.” Moreover, “there is evidence that type 2 diabetes incidence has fallen or plateaued in many countries since 2006, well before the WHO recommendation, with most of the studies from developed countries.”
But Dr. Knudsen also cited other data, including a study that showed a drop or stabilization in diagnosed diabetes incidence in high-income countries since 2010.
“That study concluded that the reasons for the declines in the incidence of diagnosed diabetes warrant further investigation with appropriate data sources, which was a main objective of our study,” wrote Dr. Knudsen and coauthors.
Dr. Knudsen said in an interview: “We are not the first to make the point that this sudden change is related to A1c introduction...but we are the first to have the data to clearly show that is the case.”
Diabetes incidence dropped but mortality rose after 2010
The population-based longitudinal study used four Danish medical databases and included 415,553 patients treated for type 2 diabetes for the first time from 1995-2018 and 2,060,279 matched comparators not treated for diabetes.
From 1995 until the 2012 introduction of A1c as a diagnostic option, the annual standardized incidence rates of type 2 diabetes more than doubled, from 193 per 100,000 population to 396 per 100,000 population, at a rate of 4.1% per year.
But from 2011 to 2018, the annual standardized incidence rate declined by 36%, to 253 per 100,000 population, a 5.7% annualized decrease.
The increase prior to 2011 occurred in both men and women and in all age groups, while the subsequent decline was seen primarily in the older age groups. The all-cause mortality risk within the first year after diabetes diagnosis was higher than subsequent 1-year mortality risks and not different between men and women.
From the periods 1995-1997 to 2010-2012, the adjusted mortality rate among those with type 2 diabetes decreased by 44%, from 72 deaths per 1000 person-years to 40 deaths per 1000 person-years (adjusted mortality rate ratio, 0.55). After that low level in 2010-2012, mortality increased by 27% to 48 per 1000 person-years (adjusted mortality rate ratio 0.69, compared with 1995-1997).
The reversed mortality trend after 2010-2012 was caused almost entirely by the increase in the first year after diabetes diagnosis, Dr. Knudsen and colleagues noted.
According to Dr. Kirkman, “A1c is strongly predictive of complications and mortality. That plus its ease of use and the fact that more people may be screened mean it’s still a good option. But for any of these tests, people who are slightly below the cut-point should not be considered normal or low risk.”
Indeed, Dr. Knudsen and colleagues said, “these findings may have implications for clinical practice and suggest that a more multifactorial view of metabolic risk is needed.”
Dr. Knudsen and Dr. Kirkman have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The introduction of hemoglobin A1c as an option for diagnosing type 2 diabetes over a decade ago may have resulted in underdiagnosis, new research indicates.
In 2011, the World Health Organization advised that A1c measurement, with a cutoff value of 6.5%, could be used to diagnose diabetes. The American Diabetes Association had issued similar guidance in 2010.
Prior to that time, the less-convenient 2-hour oral glucose tolerance test (OGTT) and fasting blood glucose (FBG) were the only recommended tests. While WHO made no recommendations for interpreting values below 6.5%, the ADA designated 5.7%-6.4% as prediabetes.
The new study, published online in The Lancet Regional Health–Europe, showed that the incidence of type 2 diabetes in Denmark had been increasing prior to the 2012 adoption of A1c as a diagnostic option but declined thereafter. And all-cause mortality among people with type 2 diabetes, which had been dropping, began to increase after that time.
“Our findings suggest that fewer patients have been diagnosed with [type 2 diabetes] since A1c testing was introduced as a convenient diagnostic option. We may thus be missing a group with borderline increased A1c values that is still at high metabolic and cardiovascular risk,” Jakob S. Knudsen, MD, of the department of clinical epidemiology, Aarhus (Denmark) University Hospital, and colleagues wrote.
Therefore, Dr. Knudsen said in an interview, clinicians should “consider testing with FBG or OGTT when presented with borderline A1c values.”
The reason for the increase in mortality after incident type 2 diabetes diagnosis, he said, “is that the patients who would have reduced the average mortality are no longer diagnosed...This does not reflect that we are treating already diagnosed patients any worse, rather some patients are not diagnosed.”
But M. Sue Kirkman, MD, emeritus professor of medicine at the University of North Carolina at Chapel Hill, who was part of the writing group for the 2010 ADA guidelines, isn’t convinced.
“This is an interesting paper, but it is a bit hard to believe that a change in WHO recommendations would have such a large and almost immediate impact on incidence and mortality. It seems likely that ... factors [other] than just the changes in recommendations for the diagnostic test account for these findings,” she said.
Dr. Kirkman pointed to new data just out from the Centers for Disease Control and Prevention on Jan. 26 that don›t show evidence of a higher proportion of people in the United States who have undiagnosed diabetes, “which would be expected if more cases were being ‘missed’ by A1c.”
She added that the CDC incidence data “show a continuing steady rate of decline in incidence that began in 2008, before any organizations recommended using A1c to screen for or diagnose diabetes.” Moreover, “there is evidence that type 2 diabetes incidence has fallen or plateaued in many countries since 2006, well before the WHO recommendation, with most of the studies from developed countries.”
But Dr. Knudsen also cited other data, including a study that showed a drop or stabilization in diagnosed diabetes incidence in high-income countries since 2010.
“That study concluded that the reasons for the declines in the incidence of diagnosed diabetes warrant further investigation with appropriate data sources, which was a main objective of our study,” wrote Dr. Knudsen and coauthors.
Dr. Knudsen said in an interview: “We are not the first to make the point that this sudden change is related to A1c introduction...but we are the first to have the data to clearly show that is the case.”
Diabetes incidence dropped but mortality rose after 2010
The population-based longitudinal study used four Danish medical databases and included 415,553 patients treated for type 2 diabetes for the first time from 1995-2018 and 2,060,279 matched comparators not treated for diabetes.
From 1995 until the 2012 introduction of A1c as a diagnostic option, the annual standardized incidence rates of type 2 diabetes more than doubled, from 193 per 100,000 population to 396 per 100,000 population, at a rate of 4.1% per year.
But from 2011 to 2018, the annual standardized incidence rate declined by 36%, to 253 per 100,000 population, a 5.7% annualized decrease.
The increase prior to 2011 occurred in both men and women and in all age groups, while the subsequent decline was seen primarily in the older age groups. The all-cause mortality risk within the first year after diabetes diagnosis was higher than subsequent 1-year mortality risks and not different between men and women.
From the periods 1995-1997 to 2010-2012, the adjusted mortality rate among those with type 2 diabetes decreased by 44%, from 72 deaths per 1000 person-years to 40 deaths per 1000 person-years (adjusted mortality rate ratio, 0.55). After that low level in 2010-2012, mortality increased by 27% to 48 per 1000 person-years (adjusted mortality rate ratio 0.69, compared with 1995-1997).
The reversed mortality trend after 2010-2012 was caused almost entirely by the increase in the first year after diabetes diagnosis, Dr. Knudsen and colleagues noted.
According to Dr. Kirkman, “A1c is strongly predictive of complications and mortality. That plus its ease of use and the fact that more people may be screened mean it’s still a good option. But for any of these tests, people who are slightly below the cut-point should not be considered normal or low risk.”
Indeed, Dr. Knudsen and colleagues said, “these findings may have implications for clinical practice and suggest that a more multifactorial view of metabolic risk is needed.”
Dr. Knudsen and Dr. Kirkman have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE LANCET REGIONAL HEALTH–EUROPE