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Predischarge preparation for diabetes management lowers recidivism
ORLANDO – Older hospitalized patients with diabetes who felt unprepared for discharge or who had coping difficulties after discharge had a significantly increased risk of readmission within 30 days in a prospective mixed-methods study.
The findings have important implications for diabetes educators, according to Jacqueline LaManna, Ph.D., of the University of Central Florida, Orlando.
Of 96 patients with a mean age of 75 years who were included in the qualitative and quantitative study, 30 experienced an event of recidivism, defined as an unplanned provider or emergency department visit, and 16 of those were readmitted within 30 days, Dr. LaManna reported at the annual meeting of the American Association of Diabetes Educators.
Perceived readiness for discharge was lower in those who experienced an event of 30-day recidivism. Other factors associated with 30-day recidivism included difficulty managing medications, difficulty controlling or managing diabetes, and difficulty managing other chronic health problems. All these associations were statistically significant and were interrelated, Dr. LaManna said.
Difficulty managing medications after discharge was also associated with lower perceptions of transition quality.
Scores on the 15-item Care Transition Measure (CTM-15) – a measure of perceived transition quality – were positively correlated, with high statistical significance, with readiness for discharge, quality of discharge content provided, and skill of the nurse in delivering discharge content. Greater reported difficulty in the early transition period was associated with lower CTM-15 scores.
Scores on the Post-Discharge Coping Difficulties Scale (PDCDS) were higher in subjects who reported unmet information needs, those who experienced 30-day recidivism, and those who experienced problems managing medications, controlling diabetes, and managing other chronic illness during the early and intermediate transition periods.
A model including three factors that were significant predictors of recidivism – 7-day PDCDS score, 30-day PDCDS score, and difficulty managing chronic illness – correctly classified 78% of cases of event recidivism within 30 days, Dr. LaManna said.
Factors that were not associated with recidivism – either in the early (within 7 days) or intermediate (within 30 days) stage after discharge – included age and sex, chronic disease dyad pattern, diabetes-related health status variables, use of hospitalist services, length of stay, quality of discharge teaching, availability of an in-home family care provider, and use of home health services.
Several major themes, with implications for diabetes educators, emerged from the following findings, Dr. LaManna said:
• The daily stuff is difficult. Study participants commonly reported having difficulty with personal care and household tasks, walking and mobility, transportation, and obtaining supplies and medicine.
• Engineering care at home is complex. Many participants reported feeling that they "come last," because they are the caretakers for grandchildren, elderly spouses, and/or elderly parents. Managing things on their own is also difficult, and while they were diligent in mobilizing resources for support in an effort to remain independent, support systems are very fragile. Also, the hospital-to-home transition is difficult on families and this increases patient stress.
• Life is stressful. Many subjects complained about having to deal with too many outside influences with respect to their care and decisions, and many struggled with grief and depression and/or anxiety and frustration.
• Managing numerous complex health problems is onerous. Maintaining diabetes control was difficult for many patients, as was managing other chronic health problems. Trying to keep track of multiple medications was a particular challenge, and many subjects said they needed more information to help them with self-management.
Of note, many of these factors were at least as much of an issue at 30 days as they were at 7 days. For example, personal care remained an issue over time, with an equal proportion (56%) of patients reporting have such difficulties at 7 and 30 days, respectively. Further, the overall percentage of patients reporting difficulty managing multiple health problems increased from 52% to 78%, and the percentage having difficulty controlling their diabetes, in particular, increased from 18% to 29%.
This latter finding is particularly concerning given that the cut-off for most case management programs is 30 days.
"They are setting up for the next [recidivism] event," Dr. La Manna said.
The findings show that the home recovery transition is dynamic, and that the needs of older adults and family caregivers change.
Adults with cognitive impairment were not included in this study, so the findings represent somewhat of a "best-case scenario."
Thus, the findings suggest that even in "ideal" cases, the transition may be difficult, Dr. LaManna said, noting that the obstacles patients face are numerous.
"We need to be considering, as diabetes educators, what’s going on – not just with diabetes, but with other chronic health conditions. Multimorbidity is a really important thing," Dr. LaManna said.
The findings also suggest a need for inclusion of discharge readiness assessment into transitional care practices to improve predischarge identification of patients at risk for recidivism, and a need for sequential postdischarge follow-up for a longer period of time.
In the ambulatory setting, it would be useful to include PDCDS assessment, which includes only 10 simple questions.
"It might help you to identify somebody who’s struggling at home who could benefit from referral right then and there – at least warranting some follow-up. That could absolutely very easily be done in ambulatory setting," she said, noting that inclusion of a family stress assessment into transition planning is also important.
The findings suggest that diabetes educators have the potential to positively affect the transition experiences of hospitalized older adults and their family caregivers (the hospital from which patients for this study were recruited had no diabetes educators on staff).
Dr. LaManna reported having no disclosures.
ORLANDO – Older hospitalized patients with diabetes who felt unprepared for discharge or who had coping difficulties after discharge had a significantly increased risk of readmission within 30 days in a prospective mixed-methods study.
The findings have important implications for diabetes educators, according to Jacqueline LaManna, Ph.D., of the University of Central Florida, Orlando.
Of 96 patients with a mean age of 75 years who were included in the qualitative and quantitative study, 30 experienced an event of recidivism, defined as an unplanned provider or emergency department visit, and 16 of those were readmitted within 30 days, Dr. LaManna reported at the annual meeting of the American Association of Diabetes Educators.
Perceived readiness for discharge was lower in those who experienced an event of 30-day recidivism. Other factors associated with 30-day recidivism included difficulty managing medications, difficulty controlling or managing diabetes, and difficulty managing other chronic health problems. All these associations were statistically significant and were interrelated, Dr. LaManna said.
Difficulty managing medications after discharge was also associated with lower perceptions of transition quality.
Scores on the 15-item Care Transition Measure (CTM-15) – a measure of perceived transition quality – were positively correlated, with high statistical significance, with readiness for discharge, quality of discharge content provided, and skill of the nurse in delivering discharge content. Greater reported difficulty in the early transition period was associated with lower CTM-15 scores.
Scores on the Post-Discharge Coping Difficulties Scale (PDCDS) were higher in subjects who reported unmet information needs, those who experienced 30-day recidivism, and those who experienced problems managing medications, controlling diabetes, and managing other chronic illness during the early and intermediate transition periods.
A model including three factors that were significant predictors of recidivism – 7-day PDCDS score, 30-day PDCDS score, and difficulty managing chronic illness – correctly classified 78% of cases of event recidivism within 30 days, Dr. LaManna said.
Factors that were not associated with recidivism – either in the early (within 7 days) or intermediate (within 30 days) stage after discharge – included age and sex, chronic disease dyad pattern, diabetes-related health status variables, use of hospitalist services, length of stay, quality of discharge teaching, availability of an in-home family care provider, and use of home health services.
Several major themes, with implications for diabetes educators, emerged from the following findings, Dr. LaManna said:
• The daily stuff is difficult. Study participants commonly reported having difficulty with personal care and household tasks, walking and mobility, transportation, and obtaining supplies and medicine.
• Engineering care at home is complex. Many participants reported feeling that they "come last," because they are the caretakers for grandchildren, elderly spouses, and/or elderly parents. Managing things on their own is also difficult, and while they were diligent in mobilizing resources for support in an effort to remain independent, support systems are very fragile. Also, the hospital-to-home transition is difficult on families and this increases patient stress.
• Life is stressful. Many subjects complained about having to deal with too many outside influences with respect to their care and decisions, and many struggled with grief and depression and/or anxiety and frustration.
• Managing numerous complex health problems is onerous. Maintaining diabetes control was difficult for many patients, as was managing other chronic health problems. Trying to keep track of multiple medications was a particular challenge, and many subjects said they needed more information to help them with self-management.
Of note, many of these factors were at least as much of an issue at 30 days as they were at 7 days. For example, personal care remained an issue over time, with an equal proportion (56%) of patients reporting have such difficulties at 7 and 30 days, respectively. Further, the overall percentage of patients reporting difficulty managing multiple health problems increased from 52% to 78%, and the percentage having difficulty controlling their diabetes, in particular, increased from 18% to 29%.
This latter finding is particularly concerning given that the cut-off for most case management programs is 30 days.
"They are setting up for the next [recidivism] event," Dr. La Manna said.
The findings show that the home recovery transition is dynamic, and that the needs of older adults and family caregivers change.
Adults with cognitive impairment were not included in this study, so the findings represent somewhat of a "best-case scenario."
Thus, the findings suggest that even in "ideal" cases, the transition may be difficult, Dr. LaManna said, noting that the obstacles patients face are numerous.
"We need to be considering, as diabetes educators, what’s going on – not just with diabetes, but with other chronic health conditions. Multimorbidity is a really important thing," Dr. LaManna said.
The findings also suggest a need for inclusion of discharge readiness assessment into transitional care practices to improve predischarge identification of patients at risk for recidivism, and a need for sequential postdischarge follow-up for a longer period of time.
In the ambulatory setting, it would be useful to include PDCDS assessment, which includes only 10 simple questions.
"It might help you to identify somebody who’s struggling at home who could benefit from referral right then and there – at least warranting some follow-up. That could absolutely very easily be done in ambulatory setting," she said, noting that inclusion of a family stress assessment into transition planning is also important.
The findings suggest that diabetes educators have the potential to positively affect the transition experiences of hospitalized older adults and their family caregivers (the hospital from which patients for this study were recruited had no diabetes educators on staff).
Dr. LaManna reported having no disclosures.
ORLANDO – Older hospitalized patients with diabetes who felt unprepared for discharge or who had coping difficulties after discharge had a significantly increased risk of readmission within 30 days in a prospective mixed-methods study.
The findings have important implications for diabetes educators, according to Jacqueline LaManna, Ph.D., of the University of Central Florida, Orlando.
Of 96 patients with a mean age of 75 years who were included in the qualitative and quantitative study, 30 experienced an event of recidivism, defined as an unplanned provider or emergency department visit, and 16 of those were readmitted within 30 days, Dr. LaManna reported at the annual meeting of the American Association of Diabetes Educators.
Perceived readiness for discharge was lower in those who experienced an event of 30-day recidivism. Other factors associated with 30-day recidivism included difficulty managing medications, difficulty controlling or managing diabetes, and difficulty managing other chronic health problems. All these associations were statistically significant and were interrelated, Dr. LaManna said.
Difficulty managing medications after discharge was also associated with lower perceptions of transition quality.
Scores on the 15-item Care Transition Measure (CTM-15) – a measure of perceived transition quality – were positively correlated, with high statistical significance, with readiness for discharge, quality of discharge content provided, and skill of the nurse in delivering discharge content. Greater reported difficulty in the early transition period was associated with lower CTM-15 scores.
Scores on the Post-Discharge Coping Difficulties Scale (PDCDS) were higher in subjects who reported unmet information needs, those who experienced 30-day recidivism, and those who experienced problems managing medications, controlling diabetes, and managing other chronic illness during the early and intermediate transition periods.
A model including three factors that were significant predictors of recidivism – 7-day PDCDS score, 30-day PDCDS score, and difficulty managing chronic illness – correctly classified 78% of cases of event recidivism within 30 days, Dr. LaManna said.
Factors that were not associated with recidivism – either in the early (within 7 days) or intermediate (within 30 days) stage after discharge – included age and sex, chronic disease dyad pattern, diabetes-related health status variables, use of hospitalist services, length of stay, quality of discharge teaching, availability of an in-home family care provider, and use of home health services.
Several major themes, with implications for diabetes educators, emerged from the following findings, Dr. LaManna said:
• The daily stuff is difficult. Study participants commonly reported having difficulty with personal care and household tasks, walking and mobility, transportation, and obtaining supplies and medicine.
• Engineering care at home is complex. Many participants reported feeling that they "come last," because they are the caretakers for grandchildren, elderly spouses, and/or elderly parents. Managing things on their own is also difficult, and while they were diligent in mobilizing resources for support in an effort to remain independent, support systems are very fragile. Also, the hospital-to-home transition is difficult on families and this increases patient stress.
• Life is stressful. Many subjects complained about having to deal with too many outside influences with respect to their care and decisions, and many struggled with grief and depression and/or anxiety and frustration.
• Managing numerous complex health problems is onerous. Maintaining diabetes control was difficult for many patients, as was managing other chronic health problems. Trying to keep track of multiple medications was a particular challenge, and many subjects said they needed more information to help them with self-management.
Of note, many of these factors were at least as much of an issue at 30 days as they were at 7 days. For example, personal care remained an issue over time, with an equal proportion (56%) of patients reporting have such difficulties at 7 and 30 days, respectively. Further, the overall percentage of patients reporting difficulty managing multiple health problems increased from 52% to 78%, and the percentage having difficulty controlling their diabetes, in particular, increased from 18% to 29%.
This latter finding is particularly concerning given that the cut-off for most case management programs is 30 days.
"They are setting up for the next [recidivism] event," Dr. La Manna said.
The findings show that the home recovery transition is dynamic, and that the needs of older adults and family caregivers change.
Adults with cognitive impairment were not included in this study, so the findings represent somewhat of a "best-case scenario."
Thus, the findings suggest that even in "ideal" cases, the transition may be difficult, Dr. LaManna said, noting that the obstacles patients face are numerous.
"We need to be considering, as diabetes educators, what’s going on – not just with diabetes, but with other chronic health conditions. Multimorbidity is a really important thing," Dr. LaManna said.
The findings also suggest a need for inclusion of discharge readiness assessment into transitional care practices to improve predischarge identification of patients at risk for recidivism, and a need for sequential postdischarge follow-up for a longer period of time.
In the ambulatory setting, it would be useful to include PDCDS assessment, which includes only 10 simple questions.
"It might help you to identify somebody who’s struggling at home who could benefit from referral right then and there – at least warranting some follow-up. That could absolutely very easily be done in ambulatory setting," she said, noting that inclusion of a family stress assessment into transition planning is also important.
The findings suggest that diabetes educators have the potential to positively affect the transition experiences of hospitalized older adults and their family caregivers (the hospital from which patients for this study were recruited had no diabetes educators on staff).
Dr. LaManna reported having no disclosures.
AT AADE 14
Key clinical point: Diabetes patients who leave the hospital feeling prepared to manage the disease have fewer unplanned visits.
Major finding: Thirty of 96 patients experienced recidivism; 16 of those were readmitted.
Data source: A prospective, mixed-methods study of diabetes patients discharged from a hospital without any diabetes educators on staff.
Disclosures: Dr. LaManna reported having no disclosures.
New protocol improves diabetic acidosis management in ED
ORLANDO – A new protocol for managing mild diabetic ketoacidosis in the emergency department led to a substantially improved discharge rate at a large teaching hospital.
Prior to development of the Emergency Valuable Approach and Diabetes Education (EVADE) protocol, almost all patients who presented with diabetic ketoacidosis (DKA) were admitted to the hospital, and most of those were admitted to the intensive care unit. However, in the most recent month for which outcomes data for the EVADE protocol are available, 24 of 106 patients (23%) managed according to the protocol were discharged from the ED and 82 were admitted, Marianne Chojnicki, a registered nurse and certified diabetes educator at the Joslin Diabetes Center, Boston, reported at the annual meeting of the American Association of Diabetes Educators.
The average length of stay in the ED for those who were discharged was 20 hours. The average length of stay in the hospital for 23 patients with a non-ICU admission was 136 hours, and the average length of stay in the ICU for 59 patients with an ICU admission was 33 hours, followed by 77 hours in the hospital after ICU discharge.
The findings have important implications for the care of patients presenting with DKA, which is documented in up to 9% of all hospital discharge summaries among patients with diabetes, and which is associated with mortality of up to 2%, Ms. Chojnicki noted.
"That’s a significant number of lives that are lost each year from a preventable event," she said.
In an effort to improve the discharge rate to at least 10%, Joslin Diabetes Center physicians, nurses, and diabetes educators worked together with Beth Israel Deaconess Medical Center in Boston to develop the EVADE protocol, which stemmed from a clinical approach used to manage DKA, and which is initiated in the ED based on clinical triggers.
They thought that a significant number of admissions were avoidable in a well-managed, coordinated system. The goal was to provide optimal cost-effective management for DKA, Ms. Chojnicki said.
From the outset, diabetes education was recognized as a key component of this protocol, she noted.
The education is individualized and covers multiple topics, such as identification of the circumstances leading up to DKA, a review of insulin action and technique of administration, and a review of ways to prevent DKA recurrence.
Evaluating the EVADE protocol
To evaluate the effectiveness of the protocol, a system was put in place to identify all patients who presented to the ED with blood glucose higher than 300 mg/dL and bicarbonate of 20 mEq/L or less. The patients were flagged for enrollment to be managed according to the EVADE protocol if their status was determined to be caused by DKA, and if they consented.
This process began in September 2013, and the first several months were spent refining management and defining quality indicators.
Month 8 results suggest that the protocol is effective for increasing discharge rates and reducing ICU admissions.
"Our initial goal was to discharge 10%, so we are above goal," Ms. Chojnicki said.
Overall, patients with mild to moderate DKA are going home from the ED, she said.
Typically, those with moderate DKA are admitted if they have a secondary diagnosis, and those patients are going to non-ICU beds.
"Only the sickest of the sick – basically those who are acidotic – are the patients going to the ICU," she said.
Preliminary data from an ongoing review of the results by a health economist show that despite the fact that the sickest patients are going to the ICU, the number of ICU days is decreasing in the wake of the EVADE protocol implementation.
This seems counterintuitive, but the latest data show that before EVADE, the average time spent in the ICU was 47.8 hours, and after EVADE the average time spent in the ICU was 31.6 hours.
"We shaved off 16.2 hours in one of the highest-cost areas of the hospital," Ms. Chojnicki said.
Notably, only one patient who was treated according to the EVADE protocol returned to the ED within 30 days, and that was a patient with issues related to alcohol abuse, she noted.
The findings suggest that mild DKA can be optimally managed in the setting of identification of the triggering factor, stabilization of glucose and electrolyte imbalances, patient education, and close follow-up, and that such management allows for more patients to be discharged from the ED, she said.
Ms. Chojnicki reported having no disclosures.
The EVADE protocol, step by step
The EVADE protocol for eligible patients begins with initiation of intravenous fluids but withholding insulin until initial labs are available. Once lab results confirm diabetic ketoacidosis, the staff initiates IV insulin.
A team including an attending endocrinologist, two nurse practitioners, and a certified diabetes educator are alerted when a patient is enrolled into the protocol.
Patients with all forms of DKA, including mild DKA without an anion gap, are managed on insulin drip with an endpoint goal of reaching a bicarbonate level of 21 mEq/L.
"The decision [to keep the patient in the ED for further observation and treatment or admit to the ICU] is based on the severity of the DKA and/or existing concurrent medical illness. If admitted to the ICU, the patient remains in the ICU arm of the DKA protocol, which involves frequent monitoring of glucose, electrolytes, venous blood gas, and urine output. Treatment is aimed at correcting the DKA and associated electrolyte disturbances," explained Maria Koen, a nurse practitioner and certified diabetes educator at Joslin Diabetes Center.
Regardless of whether the patient is admitted or remains in the ED, treatment involves the same IV insulin algorithm, which calls for no initial bolus; the starting rate is based on the initial finger stick, Ms. Koen noted.
Other features of the protocol include hourly finger sticks with adjustment of the dose with a goal of a target blood glucose of 100-180 mg/dL. Every 3 hours, someone on the team assesses venous blood gas and electrolytes.
IV fluid is run concurrently with IV insulin. Once the glucose drops to less than 250 mg/dL, fluid is changed to 5% dextrose in normal saline (D5NS). Once glucose increases again to 250 mg/dL, the protocol calls for discontinuation of D5NS with continuation of IV insulin infusion until the acidosis resolves.
If severe hypoglycemia occurs, D50 (50% dextrose) can be given as a bolus to reach the target of 100-180 mg/dL. The insulin drip is then resumed at 50% of the rate prior to the hypoglycemic event.
"Generally, we use normal saline or lactated Ringer’s as a first choice for IV fluid, at a rate of approximately 1 liter an hour for the first 4 hours, and this may be adjusted for patients who are at risk for volume overload, such as elders or patients with chronic kidney disease or congestive heart failure," she said.
After the first 4 hours, the IV solution may be changed to half of the normal saline, or half of the D5, if blood glucose drops below 250 mg/dL, at a rate of 125-250 cc per hour.
IV fluids may also be discontinued at this point if the patient is able to tolerate oral fluids.
The protocol also calls for electrolyte repletion as needed. Potassium may be added to each liter of IV fluid if the serum potassium reaches less than 5 mEq/L and the patient is voiding. The amount added is at the discretion of the attending physician, Ms. Koen said.
"Keep in mind that as the acidosis resolves, serum potassium will decrease. In such events, if severe hypokalemia occurs, it may be necessary to either decrease the insulin rate or temporarily hold the IV insulin drip," she said, noting that oral potassium and IV or oral phosphate can also be given once a patient can tolerate oral intake.
Insulin pumps should be removed to avoid overlap with the IV insulin, and the team should assess pump function and self-management.
Urine output and ability to tolerate oral intake should be assessed throughout the protocol, and patients should eat as soon as they are able to tolerate oral intake. The team should assess clinical status every 4 hours.
The patients’ care can move beyond the strictures of the protocol once they are either admitted to the ICU or stabilized in the ED. Those not admitted to the ICU can be discharged to home once their anion gap closes, their bicarbonate reaches more than 20 mEq/L, they can tolerate oral intake, and they successfully transition to a subcutaneous insulin regimen.
The transition to subcutaneous insulin requires that the basal dose be determined based on the patient’s home long-acting insulin dose or adjusted based on the nurse practitioner’s or doctor’s recommendations. Dosing for patients who are newly diagnosed or insulin naïve is calculated based on body weight in kilograms x 0.2.
When the patient is able to tolerate oral intake, prandial subcutaneous insulin based on the home prandial insulin dose should be initiated. Dosing in those who are insulin naïve should be based on body weight in kilograms x 0.2 and divided by 3 (but only with team recommendation).
"When transitioning from the IV insulin drip to subcutaneous insulin, if only basal insulin is given we recommend an overlap of the IV insulin drip for 2 hours. If both basal and prandial insulin are given at the same time, the recommendation is to overlap the insulin drip for at least 1 hour, and then the drip may be turned off," Ms. Koen said.
Insulin pumps may be restarted under the guidance of the certified diabetes educator. Electrolytes and glucose should be reassessed 2 hours after the insulin drip is stopped to ensure there is no return of the DKA.
Any patients with pH below 7.3, bicarbonate below 21 mEq/L, or an inability to tolerate oral intake will remain in the ED for continued observation and management. The patient is ready for discharge once pH is greater than 7.3, the anion gap closes, glucose reaches 250 mg/dL, and the patient can tolerate oral intake and has transitioned to subcutaneous insulin.
Following discharge, someone on the team should phone the patient, ideally within 24 hours, to ensure compliance with the postdischarge plan and schedule a follow-up clinic visit.
Ms. Koen reported having no disclosures.
ORLANDO – A new protocol for managing mild diabetic ketoacidosis in the emergency department led to a substantially improved discharge rate at a large teaching hospital.
Prior to development of the Emergency Valuable Approach and Diabetes Education (EVADE) protocol, almost all patients who presented with diabetic ketoacidosis (DKA) were admitted to the hospital, and most of those were admitted to the intensive care unit. However, in the most recent month for which outcomes data for the EVADE protocol are available, 24 of 106 patients (23%) managed according to the protocol were discharged from the ED and 82 were admitted, Marianne Chojnicki, a registered nurse and certified diabetes educator at the Joslin Diabetes Center, Boston, reported at the annual meeting of the American Association of Diabetes Educators.
The average length of stay in the ED for those who were discharged was 20 hours. The average length of stay in the hospital for 23 patients with a non-ICU admission was 136 hours, and the average length of stay in the ICU for 59 patients with an ICU admission was 33 hours, followed by 77 hours in the hospital after ICU discharge.
The findings have important implications for the care of patients presenting with DKA, which is documented in up to 9% of all hospital discharge summaries among patients with diabetes, and which is associated with mortality of up to 2%, Ms. Chojnicki noted.
"That’s a significant number of lives that are lost each year from a preventable event," she said.
In an effort to improve the discharge rate to at least 10%, Joslin Diabetes Center physicians, nurses, and diabetes educators worked together with Beth Israel Deaconess Medical Center in Boston to develop the EVADE protocol, which stemmed from a clinical approach used to manage DKA, and which is initiated in the ED based on clinical triggers.
They thought that a significant number of admissions were avoidable in a well-managed, coordinated system. The goal was to provide optimal cost-effective management for DKA, Ms. Chojnicki said.
From the outset, diabetes education was recognized as a key component of this protocol, she noted.
The education is individualized and covers multiple topics, such as identification of the circumstances leading up to DKA, a review of insulin action and technique of administration, and a review of ways to prevent DKA recurrence.
Evaluating the EVADE protocol
To evaluate the effectiveness of the protocol, a system was put in place to identify all patients who presented to the ED with blood glucose higher than 300 mg/dL and bicarbonate of 20 mEq/L or less. The patients were flagged for enrollment to be managed according to the EVADE protocol if their status was determined to be caused by DKA, and if they consented.
This process began in September 2013, and the first several months were spent refining management and defining quality indicators.
Month 8 results suggest that the protocol is effective for increasing discharge rates and reducing ICU admissions.
"Our initial goal was to discharge 10%, so we are above goal," Ms. Chojnicki said.
Overall, patients with mild to moderate DKA are going home from the ED, she said.
Typically, those with moderate DKA are admitted if they have a secondary diagnosis, and those patients are going to non-ICU beds.
"Only the sickest of the sick – basically those who are acidotic – are the patients going to the ICU," she said.
Preliminary data from an ongoing review of the results by a health economist show that despite the fact that the sickest patients are going to the ICU, the number of ICU days is decreasing in the wake of the EVADE protocol implementation.
This seems counterintuitive, but the latest data show that before EVADE, the average time spent in the ICU was 47.8 hours, and after EVADE the average time spent in the ICU was 31.6 hours.
"We shaved off 16.2 hours in one of the highest-cost areas of the hospital," Ms. Chojnicki said.
Notably, only one patient who was treated according to the EVADE protocol returned to the ED within 30 days, and that was a patient with issues related to alcohol abuse, she noted.
The findings suggest that mild DKA can be optimally managed in the setting of identification of the triggering factor, stabilization of glucose and electrolyte imbalances, patient education, and close follow-up, and that such management allows for more patients to be discharged from the ED, she said.
Ms. Chojnicki reported having no disclosures.
The EVADE protocol, step by step
The EVADE protocol for eligible patients begins with initiation of intravenous fluids but withholding insulin until initial labs are available. Once lab results confirm diabetic ketoacidosis, the staff initiates IV insulin.
A team including an attending endocrinologist, two nurse practitioners, and a certified diabetes educator are alerted when a patient is enrolled into the protocol.
Patients with all forms of DKA, including mild DKA without an anion gap, are managed on insulin drip with an endpoint goal of reaching a bicarbonate level of 21 mEq/L.
"The decision [to keep the patient in the ED for further observation and treatment or admit to the ICU] is based on the severity of the DKA and/or existing concurrent medical illness. If admitted to the ICU, the patient remains in the ICU arm of the DKA protocol, which involves frequent monitoring of glucose, electrolytes, venous blood gas, and urine output. Treatment is aimed at correcting the DKA and associated electrolyte disturbances," explained Maria Koen, a nurse practitioner and certified diabetes educator at Joslin Diabetes Center.
Regardless of whether the patient is admitted or remains in the ED, treatment involves the same IV insulin algorithm, which calls for no initial bolus; the starting rate is based on the initial finger stick, Ms. Koen noted.
Other features of the protocol include hourly finger sticks with adjustment of the dose with a goal of a target blood glucose of 100-180 mg/dL. Every 3 hours, someone on the team assesses venous blood gas and electrolytes.
IV fluid is run concurrently with IV insulin. Once the glucose drops to less than 250 mg/dL, fluid is changed to 5% dextrose in normal saline (D5NS). Once glucose increases again to 250 mg/dL, the protocol calls for discontinuation of D5NS with continuation of IV insulin infusion until the acidosis resolves.
If severe hypoglycemia occurs, D50 (50% dextrose) can be given as a bolus to reach the target of 100-180 mg/dL. The insulin drip is then resumed at 50% of the rate prior to the hypoglycemic event.
"Generally, we use normal saline or lactated Ringer’s as a first choice for IV fluid, at a rate of approximately 1 liter an hour for the first 4 hours, and this may be adjusted for patients who are at risk for volume overload, such as elders or patients with chronic kidney disease or congestive heart failure," she said.
After the first 4 hours, the IV solution may be changed to half of the normal saline, or half of the D5, if blood glucose drops below 250 mg/dL, at a rate of 125-250 cc per hour.
IV fluids may also be discontinued at this point if the patient is able to tolerate oral fluids.
The protocol also calls for electrolyte repletion as needed. Potassium may be added to each liter of IV fluid if the serum potassium reaches less than 5 mEq/L and the patient is voiding. The amount added is at the discretion of the attending physician, Ms. Koen said.
"Keep in mind that as the acidosis resolves, serum potassium will decrease. In such events, if severe hypokalemia occurs, it may be necessary to either decrease the insulin rate or temporarily hold the IV insulin drip," she said, noting that oral potassium and IV or oral phosphate can also be given once a patient can tolerate oral intake.
Insulin pumps should be removed to avoid overlap with the IV insulin, and the team should assess pump function and self-management.
Urine output and ability to tolerate oral intake should be assessed throughout the protocol, and patients should eat as soon as they are able to tolerate oral intake. The team should assess clinical status every 4 hours.
The patients’ care can move beyond the strictures of the protocol once they are either admitted to the ICU or stabilized in the ED. Those not admitted to the ICU can be discharged to home once their anion gap closes, their bicarbonate reaches more than 20 mEq/L, they can tolerate oral intake, and they successfully transition to a subcutaneous insulin regimen.
The transition to subcutaneous insulin requires that the basal dose be determined based on the patient’s home long-acting insulin dose or adjusted based on the nurse practitioner’s or doctor’s recommendations. Dosing for patients who are newly diagnosed or insulin naïve is calculated based on body weight in kilograms x 0.2.
When the patient is able to tolerate oral intake, prandial subcutaneous insulin based on the home prandial insulin dose should be initiated. Dosing in those who are insulin naïve should be based on body weight in kilograms x 0.2 and divided by 3 (but only with team recommendation).
"When transitioning from the IV insulin drip to subcutaneous insulin, if only basal insulin is given we recommend an overlap of the IV insulin drip for 2 hours. If both basal and prandial insulin are given at the same time, the recommendation is to overlap the insulin drip for at least 1 hour, and then the drip may be turned off," Ms. Koen said.
Insulin pumps may be restarted under the guidance of the certified diabetes educator. Electrolytes and glucose should be reassessed 2 hours after the insulin drip is stopped to ensure there is no return of the DKA.
Any patients with pH below 7.3, bicarbonate below 21 mEq/L, or an inability to tolerate oral intake will remain in the ED for continued observation and management. The patient is ready for discharge once pH is greater than 7.3, the anion gap closes, glucose reaches 250 mg/dL, and the patient can tolerate oral intake and has transitioned to subcutaneous insulin.
Following discharge, someone on the team should phone the patient, ideally within 24 hours, to ensure compliance with the postdischarge plan and schedule a follow-up clinic visit.
Ms. Koen reported having no disclosures.
ORLANDO – A new protocol for managing mild diabetic ketoacidosis in the emergency department led to a substantially improved discharge rate at a large teaching hospital.
Prior to development of the Emergency Valuable Approach and Diabetes Education (EVADE) protocol, almost all patients who presented with diabetic ketoacidosis (DKA) were admitted to the hospital, and most of those were admitted to the intensive care unit. However, in the most recent month for which outcomes data for the EVADE protocol are available, 24 of 106 patients (23%) managed according to the protocol were discharged from the ED and 82 were admitted, Marianne Chojnicki, a registered nurse and certified diabetes educator at the Joslin Diabetes Center, Boston, reported at the annual meeting of the American Association of Diabetes Educators.
The average length of stay in the ED for those who were discharged was 20 hours. The average length of stay in the hospital for 23 patients with a non-ICU admission was 136 hours, and the average length of stay in the ICU for 59 patients with an ICU admission was 33 hours, followed by 77 hours in the hospital after ICU discharge.
The findings have important implications for the care of patients presenting with DKA, which is documented in up to 9% of all hospital discharge summaries among patients with diabetes, and which is associated with mortality of up to 2%, Ms. Chojnicki noted.
"That’s a significant number of lives that are lost each year from a preventable event," she said.
In an effort to improve the discharge rate to at least 10%, Joslin Diabetes Center physicians, nurses, and diabetes educators worked together with Beth Israel Deaconess Medical Center in Boston to develop the EVADE protocol, which stemmed from a clinical approach used to manage DKA, and which is initiated in the ED based on clinical triggers.
They thought that a significant number of admissions were avoidable in a well-managed, coordinated system. The goal was to provide optimal cost-effective management for DKA, Ms. Chojnicki said.
From the outset, diabetes education was recognized as a key component of this protocol, she noted.
The education is individualized and covers multiple topics, such as identification of the circumstances leading up to DKA, a review of insulin action and technique of administration, and a review of ways to prevent DKA recurrence.
Evaluating the EVADE protocol
To evaluate the effectiveness of the protocol, a system was put in place to identify all patients who presented to the ED with blood glucose higher than 300 mg/dL and bicarbonate of 20 mEq/L or less. The patients were flagged for enrollment to be managed according to the EVADE protocol if their status was determined to be caused by DKA, and if they consented.
This process began in September 2013, and the first several months were spent refining management and defining quality indicators.
Month 8 results suggest that the protocol is effective for increasing discharge rates and reducing ICU admissions.
"Our initial goal was to discharge 10%, so we are above goal," Ms. Chojnicki said.
Overall, patients with mild to moderate DKA are going home from the ED, she said.
Typically, those with moderate DKA are admitted if they have a secondary diagnosis, and those patients are going to non-ICU beds.
"Only the sickest of the sick – basically those who are acidotic – are the patients going to the ICU," she said.
Preliminary data from an ongoing review of the results by a health economist show that despite the fact that the sickest patients are going to the ICU, the number of ICU days is decreasing in the wake of the EVADE protocol implementation.
This seems counterintuitive, but the latest data show that before EVADE, the average time spent in the ICU was 47.8 hours, and after EVADE the average time spent in the ICU was 31.6 hours.
"We shaved off 16.2 hours in one of the highest-cost areas of the hospital," Ms. Chojnicki said.
Notably, only one patient who was treated according to the EVADE protocol returned to the ED within 30 days, and that was a patient with issues related to alcohol abuse, she noted.
The findings suggest that mild DKA can be optimally managed in the setting of identification of the triggering factor, stabilization of glucose and electrolyte imbalances, patient education, and close follow-up, and that such management allows for more patients to be discharged from the ED, she said.
Ms. Chojnicki reported having no disclosures.
The EVADE protocol, step by step
The EVADE protocol for eligible patients begins with initiation of intravenous fluids but withholding insulin until initial labs are available. Once lab results confirm diabetic ketoacidosis, the staff initiates IV insulin.
A team including an attending endocrinologist, two nurse practitioners, and a certified diabetes educator are alerted when a patient is enrolled into the protocol.
Patients with all forms of DKA, including mild DKA without an anion gap, are managed on insulin drip with an endpoint goal of reaching a bicarbonate level of 21 mEq/L.
"The decision [to keep the patient in the ED for further observation and treatment or admit to the ICU] is based on the severity of the DKA and/or existing concurrent medical illness. If admitted to the ICU, the patient remains in the ICU arm of the DKA protocol, which involves frequent monitoring of glucose, electrolytes, venous blood gas, and urine output. Treatment is aimed at correcting the DKA and associated electrolyte disturbances," explained Maria Koen, a nurse practitioner and certified diabetes educator at Joslin Diabetes Center.
Regardless of whether the patient is admitted or remains in the ED, treatment involves the same IV insulin algorithm, which calls for no initial bolus; the starting rate is based on the initial finger stick, Ms. Koen noted.
Other features of the protocol include hourly finger sticks with adjustment of the dose with a goal of a target blood glucose of 100-180 mg/dL. Every 3 hours, someone on the team assesses venous blood gas and electrolytes.
IV fluid is run concurrently with IV insulin. Once the glucose drops to less than 250 mg/dL, fluid is changed to 5% dextrose in normal saline (D5NS). Once glucose increases again to 250 mg/dL, the protocol calls for discontinuation of D5NS with continuation of IV insulin infusion until the acidosis resolves.
If severe hypoglycemia occurs, D50 (50% dextrose) can be given as a bolus to reach the target of 100-180 mg/dL. The insulin drip is then resumed at 50% of the rate prior to the hypoglycemic event.
"Generally, we use normal saline or lactated Ringer’s as a first choice for IV fluid, at a rate of approximately 1 liter an hour for the first 4 hours, and this may be adjusted for patients who are at risk for volume overload, such as elders or patients with chronic kidney disease or congestive heart failure," she said.
After the first 4 hours, the IV solution may be changed to half of the normal saline, or half of the D5, if blood glucose drops below 250 mg/dL, at a rate of 125-250 cc per hour.
IV fluids may also be discontinued at this point if the patient is able to tolerate oral fluids.
The protocol also calls for electrolyte repletion as needed. Potassium may be added to each liter of IV fluid if the serum potassium reaches less than 5 mEq/L and the patient is voiding. The amount added is at the discretion of the attending physician, Ms. Koen said.
"Keep in mind that as the acidosis resolves, serum potassium will decrease. In such events, if severe hypokalemia occurs, it may be necessary to either decrease the insulin rate or temporarily hold the IV insulin drip," she said, noting that oral potassium and IV or oral phosphate can also be given once a patient can tolerate oral intake.
Insulin pumps should be removed to avoid overlap with the IV insulin, and the team should assess pump function and self-management.
Urine output and ability to tolerate oral intake should be assessed throughout the protocol, and patients should eat as soon as they are able to tolerate oral intake. The team should assess clinical status every 4 hours.
The patients’ care can move beyond the strictures of the protocol once they are either admitted to the ICU or stabilized in the ED. Those not admitted to the ICU can be discharged to home once their anion gap closes, their bicarbonate reaches more than 20 mEq/L, they can tolerate oral intake, and they successfully transition to a subcutaneous insulin regimen.
The transition to subcutaneous insulin requires that the basal dose be determined based on the patient’s home long-acting insulin dose or adjusted based on the nurse practitioner’s or doctor’s recommendations. Dosing for patients who are newly diagnosed or insulin naïve is calculated based on body weight in kilograms x 0.2.
When the patient is able to tolerate oral intake, prandial subcutaneous insulin based on the home prandial insulin dose should be initiated. Dosing in those who are insulin naïve should be based on body weight in kilograms x 0.2 and divided by 3 (but only with team recommendation).
"When transitioning from the IV insulin drip to subcutaneous insulin, if only basal insulin is given we recommend an overlap of the IV insulin drip for 2 hours. If both basal and prandial insulin are given at the same time, the recommendation is to overlap the insulin drip for at least 1 hour, and then the drip may be turned off," Ms. Koen said.
Insulin pumps may be restarted under the guidance of the certified diabetes educator. Electrolytes and glucose should be reassessed 2 hours after the insulin drip is stopped to ensure there is no return of the DKA.
Any patients with pH below 7.3, bicarbonate below 21 mEq/L, or an inability to tolerate oral intake will remain in the ED for continued observation and management. The patient is ready for discharge once pH is greater than 7.3, the anion gap closes, glucose reaches 250 mg/dL, and the patient can tolerate oral intake and has transitioned to subcutaneous insulin.
Following discharge, someone on the team should phone the patient, ideally within 24 hours, to ensure compliance with the postdischarge plan and schedule a follow-up clinic visit.
Ms. Koen reported having no disclosures.
AT AADE 14
Key clinical point: Use of the protocol increases the discharge rate of patients presenting with mild to moderate diabetic ketoacidosis.
Major finding: A total of 23% of patients were discharged from the ED.
Data source: A review of outcomes in 106 patients following protocol implementation.
Disclosures: Ms. Chojnicki reported having no disclosures.
Sodium controversy: More fuel for the fire
Three large international studies addressing sodium intake’s effect on blood pressure and on cardiovascular and mortality outcomes are not likely to quell the controversy surrounding this issue. Rather, since the findings of one study directly oppose those of the other two, the results promise to fan the flames a bit higher.
All three studies were reported online August 14 in the New England Journal of Medicine.
Sodium and blood pressure: PURE
The first report concerned a substudy of data from the Prospective Urban Rural Epidemiology (PURE) study involving 102,216 adults aged 35-70 years residing in 667 communities in 18 low-, middle-, and high-income countries worldwide. Urinary sodium and potassium levels were used as surrogates for dietary intake of these elements, and these excretion levels were correlated with the participants’ blood pressure levels, said Andrew Mente, Ph.D., of the Population Health Research Institute, Hamilton (Ont.) Health Services, McMaster University, and his associates.
Current guidelines recommend a maximum sodium intake of 1.5-2.4 g/day, depending on the country. Only 0.6% of the study population achieved the lowest level of 1.5 g/day, the level recommended in the United States, and only 10% achieved less than 3 g/day. The largest segment of the study population, 46%, had a sodium excretion of 3-5 g/day, and the next largest segment, 44%, had a sodium excretion of more than 5 g/day.
"This suggests that, at present, human consumption of extremely low amounts of sodium for prolonged periods is rare," the investigators noted.
The investigators found, after multivariate adjustment, that for each 1-g increment in sodium excretion, there was an increment of 2.11 mm Hg in systolic blood pressure and 0.78 mm Hg in diastolic blood pressure (P less than .001 for both) for all areas of the globe.
However, this correlation was nonlinear. The association between sodium and blood pressure was weak in the largest subset of participants who had an excretion of 3-5 g/day, and was nonsignificant in those who had an excretion of less than 3 g/day.
The association between sodium intake and blood pressure was stronger in people who had an excretion of more than 5 g/day and in those who already had hypertension at baseline. It also increased with increasing patient age.
Taken together, these findings indicate that sodium’s effect on blood pressure is nonuniform and depends on the background diet of the population as well as the individual’s age and hypertension status, Dr. Mente and his associates said (N. Engl. J. Med. 2014 Aug. 14;371:601-11 [doi:10.1056/NEJMoa1311989]).
Sodium and cardiovascular mortality: PURE
The second report also was a substudy of the PURE study, this time headed by Dr. Martin O’Donnell of the Population Health Institute and McMaster University. The researchers performed a prospective cohort study involving 101,945 PURE participants to assess the association between baseline urinary sodium and potassium excretion, again as a surrogate for intake, with mortality and incident cardiovascular (CV) events during 3.7 years of follow-up.
The primary composite outcome of death or a major CV event occurred in 3,317 participants (3.3%). The mean 24-hour sodium excretion was 4.9 g.
Surprisingly, the lowest risk of death and CV events was seen not in people with the recommended levels of sodium excretion but in those whose sodium excretion was much higher, at 3-6 g/day. Risks actually increased at levels of sodium excretion that were lower than 3 g/day, as is recommended, as well as at levels that were higher than 6 g/day. Moreover, the association between high sodium excretion and high CV and mortality risk was significant only among adults who already had hypertension at baseline.
"The projected benefits of low sodium intake ... are derived from models ... that assume a linear relationship between sodium intake and blood pressure and between blood pressure and cardiovascular events. Implicit in these guidelines is the assumption that there is no unsafe lower limit of sodium intake," Dr. O’Donnell and his associates wrote (N. Engl. J. Med. 2014 Aug. 14;371:612-23 [doi:10.1056/NEJMoa131889]).
The findings from both of these PURE studies call those assumptions into question.
Sodium and cardiovascular mortality: NUTRICODE
The third report was a review of the literature regarding sodium intake’s effect on CV mortality worldwide; the gathered data then served as the basis for a complex statistical model that estimated how many deaths could be attributed to sodium consumption in excess of a reference level of 2.0 g/day. This study was performed by the Global Burden of Diseases, Nutrition, and Chronic Diseases Expert Group (NUTRICODE) and was headed by Dr. Dariush Mozaffarian, a cardiologist and epidemiologist with Tufts University and the Harvard School of Public Health, both in Boston.
These investigators quantified sodium intake in 66 countries (accounting for 74% of adults throughout the world) by age, sex, and country of residence, and correlated these data first with findings from their meta-analysis of 107 randomized trials of interventions to curb sodium intake and then with the results of two large international trials linking the effects of various blood pressure levels on CV mortality.
They estimated that the mean level of sodium intake worldwide is 3.95 g/day and that those mean levels varied by geographic region from a low of 2.18 g to a high of 5.51 g. "Overall, 181 of 187 countries – 99.2% of the adult population of the world – had estimated mean levels of sodium intake exceeding the World Health Organization recommendation of 2.0 g/day," Dr. Mozaffarian and his associates said.
Contrary to the findings of the two PURE analyses, these data showed "strong evidence of a linear dose-response relationship" between sodium intake and blood pressure, such that each reduction of 2.30 g/day of sodium was significantly linked with a reduction of 3.82 mm Hg in systolic blood pressure, as well as a direct correlation between increasing blood pressure and increasing CV mortality.
Extrapolating from these data, "we found that 1.65 million deaths from CV causes worldwide in 2010 were attributable to sodium consumption above the reference level" of 2 g/day. "Globally, 40.4% of these deaths occurred prematurely, i.e. in persons younger than 70 years of age," Dr. Mozaffarian and his associates said (N. Engl. J. Med. 2014 Aug. 14;371:624-34 [doi:10.1056/NEJMoa1304127]).
"In sum, approximately 1 of every 10 deaths from CV causes worldwide and nearly 1 of every 5 premature deaths from CV causes were attributed to sodium consumption above the reference level," they said.
In an editorial accompanying this report, Dr. Suzanne Oparil said, "The NUTRICODE investigators should be applauded for a herculean effort in synthesizing a large body of data regarding the potential harm of excess salt consumption" (N. Engl. J. Med. 2014 Aug. 14;371:677-9 [doi:10.1056/NEJMe1407695]).
"However, given the numerous assumptions necessitated by the lack of high-quality data [in the literature], caution should be taken in interpreting the findings of this study," said Dr. Oparil of the vascular biology and hypertension program, University of Alabama at Birmingham.
The PURE studies were supported by the Heart and Stroke Foundation of Ontario, the Population Health Research Institute, the Canadian Institutes of Health Research, several pharmaceutical companies, and various national or local organizations in 18 participating countries. These funders played no role in the design or conduct of the studies, in collection or analysis of data, or in preparing the manuscript. Dr. O’Donnell reported ties to Boehringer Ingelheim, Bayer, Bristol-Myers Squibb, and Pfizer, and his associates reported ties to Sanofi-Aventis, AstraZeneca, and Cadila. The NUTRICODE study was funded by the Bill and Melinda Gates Foundation.
The provocative findings from both groups of PURE investigators call into question "the feasibility and usefulness of reducing dietary sodium as a population-based strategy for reducing blood pressure," said Dr. Suzanne Oparil.
The authors’ suggested alternative approach of recommending high-quality diets rich in potassium "might achieve greater health benefits, including blood pressure reduction, than aggressive sodium reduction alone," she noted.
Dr. Suzanne Oparil is in the vascular biology and hypertension program at the University of Alabama at Birmingham. These remarks were taken from her editorial accompanying the three reports on sodium consumption (N. Engl. J. Med. 2014 Aug. 14;371:677-9 [doi:10.1056/NEJMe1407695]).
The provocative findings from both groups of PURE investigators call into question "the feasibility and usefulness of reducing dietary sodium as a population-based strategy for reducing blood pressure," said Dr. Suzanne Oparil.
The authors’ suggested alternative approach of recommending high-quality diets rich in potassium "might achieve greater health benefits, including blood pressure reduction, than aggressive sodium reduction alone," she noted.
Dr. Suzanne Oparil is in the vascular biology and hypertension program at the University of Alabama at Birmingham. These remarks were taken from her editorial accompanying the three reports on sodium consumption (N. Engl. J. Med. 2014 Aug. 14;371:677-9 [doi:10.1056/NEJMe1407695]).
The provocative findings from both groups of PURE investigators call into question "the feasibility and usefulness of reducing dietary sodium as a population-based strategy for reducing blood pressure," said Dr. Suzanne Oparil.
The authors’ suggested alternative approach of recommending high-quality diets rich in potassium "might achieve greater health benefits, including blood pressure reduction, than aggressive sodium reduction alone," she noted.
Dr. Suzanne Oparil is in the vascular biology and hypertension program at the University of Alabama at Birmingham. These remarks were taken from her editorial accompanying the three reports on sodium consumption (N. Engl. J. Med. 2014 Aug. 14;371:677-9 [doi:10.1056/NEJMe1407695]).
Three large international studies addressing sodium intake’s effect on blood pressure and on cardiovascular and mortality outcomes are not likely to quell the controversy surrounding this issue. Rather, since the findings of one study directly oppose those of the other two, the results promise to fan the flames a bit higher.
All three studies were reported online August 14 in the New England Journal of Medicine.
Sodium and blood pressure: PURE
The first report concerned a substudy of data from the Prospective Urban Rural Epidemiology (PURE) study involving 102,216 adults aged 35-70 years residing in 667 communities in 18 low-, middle-, and high-income countries worldwide. Urinary sodium and potassium levels were used as surrogates for dietary intake of these elements, and these excretion levels were correlated with the participants’ blood pressure levels, said Andrew Mente, Ph.D., of the Population Health Research Institute, Hamilton (Ont.) Health Services, McMaster University, and his associates.
Current guidelines recommend a maximum sodium intake of 1.5-2.4 g/day, depending on the country. Only 0.6% of the study population achieved the lowest level of 1.5 g/day, the level recommended in the United States, and only 10% achieved less than 3 g/day. The largest segment of the study population, 46%, had a sodium excretion of 3-5 g/day, and the next largest segment, 44%, had a sodium excretion of more than 5 g/day.
"This suggests that, at present, human consumption of extremely low amounts of sodium for prolonged periods is rare," the investigators noted.
The investigators found, after multivariate adjustment, that for each 1-g increment in sodium excretion, there was an increment of 2.11 mm Hg in systolic blood pressure and 0.78 mm Hg in diastolic blood pressure (P less than .001 for both) for all areas of the globe.
However, this correlation was nonlinear. The association between sodium and blood pressure was weak in the largest subset of participants who had an excretion of 3-5 g/day, and was nonsignificant in those who had an excretion of less than 3 g/day.
The association between sodium intake and blood pressure was stronger in people who had an excretion of more than 5 g/day and in those who already had hypertension at baseline. It also increased with increasing patient age.
Taken together, these findings indicate that sodium’s effect on blood pressure is nonuniform and depends on the background diet of the population as well as the individual’s age and hypertension status, Dr. Mente and his associates said (N. Engl. J. Med. 2014 Aug. 14;371:601-11 [doi:10.1056/NEJMoa1311989]).
Sodium and cardiovascular mortality: PURE
The second report also was a substudy of the PURE study, this time headed by Dr. Martin O’Donnell of the Population Health Institute and McMaster University. The researchers performed a prospective cohort study involving 101,945 PURE participants to assess the association between baseline urinary sodium and potassium excretion, again as a surrogate for intake, with mortality and incident cardiovascular (CV) events during 3.7 years of follow-up.
The primary composite outcome of death or a major CV event occurred in 3,317 participants (3.3%). The mean 24-hour sodium excretion was 4.9 g.
Surprisingly, the lowest risk of death and CV events was seen not in people with the recommended levels of sodium excretion but in those whose sodium excretion was much higher, at 3-6 g/day. Risks actually increased at levels of sodium excretion that were lower than 3 g/day, as is recommended, as well as at levels that were higher than 6 g/day. Moreover, the association between high sodium excretion and high CV and mortality risk was significant only among adults who already had hypertension at baseline.
"The projected benefits of low sodium intake ... are derived from models ... that assume a linear relationship between sodium intake and blood pressure and between blood pressure and cardiovascular events. Implicit in these guidelines is the assumption that there is no unsafe lower limit of sodium intake," Dr. O’Donnell and his associates wrote (N. Engl. J. Med. 2014 Aug. 14;371:612-23 [doi:10.1056/NEJMoa131889]).
The findings from both of these PURE studies call those assumptions into question.
Sodium and cardiovascular mortality: NUTRICODE
The third report was a review of the literature regarding sodium intake’s effect on CV mortality worldwide; the gathered data then served as the basis for a complex statistical model that estimated how many deaths could be attributed to sodium consumption in excess of a reference level of 2.0 g/day. This study was performed by the Global Burden of Diseases, Nutrition, and Chronic Diseases Expert Group (NUTRICODE) and was headed by Dr. Dariush Mozaffarian, a cardiologist and epidemiologist with Tufts University and the Harvard School of Public Health, both in Boston.
These investigators quantified sodium intake in 66 countries (accounting for 74% of adults throughout the world) by age, sex, and country of residence, and correlated these data first with findings from their meta-analysis of 107 randomized trials of interventions to curb sodium intake and then with the results of two large international trials linking the effects of various blood pressure levels on CV mortality.
They estimated that the mean level of sodium intake worldwide is 3.95 g/day and that those mean levels varied by geographic region from a low of 2.18 g to a high of 5.51 g. "Overall, 181 of 187 countries – 99.2% of the adult population of the world – had estimated mean levels of sodium intake exceeding the World Health Organization recommendation of 2.0 g/day," Dr. Mozaffarian and his associates said.
Contrary to the findings of the two PURE analyses, these data showed "strong evidence of a linear dose-response relationship" between sodium intake and blood pressure, such that each reduction of 2.30 g/day of sodium was significantly linked with a reduction of 3.82 mm Hg in systolic blood pressure, as well as a direct correlation between increasing blood pressure and increasing CV mortality.
Extrapolating from these data, "we found that 1.65 million deaths from CV causes worldwide in 2010 were attributable to sodium consumption above the reference level" of 2 g/day. "Globally, 40.4% of these deaths occurred prematurely, i.e. in persons younger than 70 years of age," Dr. Mozaffarian and his associates said (N. Engl. J. Med. 2014 Aug. 14;371:624-34 [doi:10.1056/NEJMoa1304127]).
"In sum, approximately 1 of every 10 deaths from CV causes worldwide and nearly 1 of every 5 premature deaths from CV causes were attributed to sodium consumption above the reference level," they said.
In an editorial accompanying this report, Dr. Suzanne Oparil said, "The NUTRICODE investigators should be applauded for a herculean effort in synthesizing a large body of data regarding the potential harm of excess salt consumption" (N. Engl. J. Med. 2014 Aug. 14;371:677-9 [doi:10.1056/NEJMe1407695]).
"However, given the numerous assumptions necessitated by the lack of high-quality data [in the literature], caution should be taken in interpreting the findings of this study," said Dr. Oparil of the vascular biology and hypertension program, University of Alabama at Birmingham.
The PURE studies were supported by the Heart and Stroke Foundation of Ontario, the Population Health Research Institute, the Canadian Institutes of Health Research, several pharmaceutical companies, and various national or local organizations in 18 participating countries. These funders played no role in the design or conduct of the studies, in collection or analysis of data, or in preparing the manuscript. Dr. O’Donnell reported ties to Boehringer Ingelheim, Bayer, Bristol-Myers Squibb, and Pfizer, and his associates reported ties to Sanofi-Aventis, AstraZeneca, and Cadila. The NUTRICODE study was funded by the Bill and Melinda Gates Foundation.
Three large international studies addressing sodium intake’s effect on blood pressure and on cardiovascular and mortality outcomes are not likely to quell the controversy surrounding this issue. Rather, since the findings of one study directly oppose those of the other two, the results promise to fan the flames a bit higher.
All three studies were reported online August 14 in the New England Journal of Medicine.
Sodium and blood pressure: PURE
The first report concerned a substudy of data from the Prospective Urban Rural Epidemiology (PURE) study involving 102,216 adults aged 35-70 years residing in 667 communities in 18 low-, middle-, and high-income countries worldwide. Urinary sodium and potassium levels were used as surrogates for dietary intake of these elements, and these excretion levels were correlated with the participants’ blood pressure levels, said Andrew Mente, Ph.D., of the Population Health Research Institute, Hamilton (Ont.) Health Services, McMaster University, and his associates.
Current guidelines recommend a maximum sodium intake of 1.5-2.4 g/day, depending on the country. Only 0.6% of the study population achieved the lowest level of 1.5 g/day, the level recommended in the United States, and only 10% achieved less than 3 g/day. The largest segment of the study population, 46%, had a sodium excretion of 3-5 g/day, and the next largest segment, 44%, had a sodium excretion of more than 5 g/day.
"This suggests that, at present, human consumption of extremely low amounts of sodium for prolonged periods is rare," the investigators noted.
The investigators found, after multivariate adjustment, that for each 1-g increment in sodium excretion, there was an increment of 2.11 mm Hg in systolic blood pressure and 0.78 mm Hg in diastolic blood pressure (P less than .001 for both) for all areas of the globe.
However, this correlation was nonlinear. The association between sodium and blood pressure was weak in the largest subset of participants who had an excretion of 3-5 g/day, and was nonsignificant in those who had an excretion of less than 3 g/day.
The association between sodium intake and blood pressure was stronger in people who had an excretion of more than 5 g/day and in those who already had hypertension at baseline. It also increased with increasing patient age.
Taken together, these findings indicate that sodium’s effect on blood pressure is nonuniform and depends on the background diet of the population as well as the individual’s age and hypertension status, Dr. Mente and his associates said (N. Engl. J. Med. 2014 Aug. 14;371:601-11 [doi:10.1056/NEJMoa1311989]).
Sodium and cardiovascular mortality: PURE
The second report also was a substudy of the PURE study, this time headed by Dr. Martin O’Donnell of the Population Health Institute and McMaster University. The researchers performed a prospective cohort study involving 101,945 PURE participants to assess the association between baseline urinary sodium and potassium excretion, again as a surrogate for intake, with mortality and incident cardiovascular (CV) events during 3.7 years of follow-up.
The primary composite outcome of death or a major CV event occurred in 3,317 participants (3.3%). The mean 24-hour sodium excretion was 4.9 g.
Surprisingly, the lowest risk of death and CV events was seen not in people with the recommended levels of sodium excretion but in those whose sodium excretion was much higher, at 3-6 g/day. Risks actually increased at levels of sodium excretion that were lower than 3 g/day, as is recommended, as well as at levels that were higher than 6 g/day. Moreover, the association between high sodium excretion and high CV and mortality risk was significant only among adults who already had hypertension at baseline.
"The projected benefits of low sodium intake ... are derived from models ... that assume a linear relationship between sodium intake and blood pressure and between blood pressure and cardiovascular events. Implicit in these guidelines is the assumption that there is no unsafe lower limit of sodium intake," Dr. O’Donnell and his associates wrote (N. Engl. J. Med. 2014 Aug. 14;371:612-23 [doi:10.1056/NEJMoa131889]).
The findings from both of these PURE studies call those assumptions into question.
Sodium and cardiovascular mortality: NUTRICODE
The third report was a review of the literature regarding sodium intake’s effect on CV mortality worldwide; the gathered data then served as the basis for a complex statistical model that estimated how many deaths could be attributed to sodium consumption in excess of a reference level of 2.0 g/day. This study was performed by the Global Burden of Diseases, Nutrition, and Chronic Diseases Expert Group (NUTRICODE) and was headed by Dr. Dariush Mozaffarian, a cardiologist and epidemiologist with Tufts University and the Harvard School of Public Health, both in Boston.
These investigators quantified sodium intake in 66 countries (accounting for 74% of adults throughout the world) by age, sex, and country of residence, and correlated these data first with findings from their meta-analysis of 107 randomized trials of interventions to curb sodium intake and then with the results of two large international trials linking the effects of various blood pressure levels on CV mortality.
They estimated that the mean level of sodium intake worldwide is 3.95 g/day and that those mean levels varied by geographic region from a low of 2.18 g to a high of 5.51 g. "Overall, 181 of 187 countries – 99.2% of the adult population of the world – had estimated mean levels of sodium intake exceeding the World Health Organization recommendation of 2.0 g/day," Dr. Mozaffarian and his associates said.
Contrary to the findings of the two PURE analyses, these data showed "strong evidence of a linear dose-response relationship" between sodium intake and blood pressure, such that each reduction of 2.30 g/day of sodium was significantly linked with a reduction of 3.82 mm Hg in systolic blood pressure, as well as a direct correlation between increasing blood pressure and increasing CV mortality.
Extrapolating from these data, "we found that 1.65 million deaths from CV causes worldwide in 2010 were attributable to sodium consumption above the reference level" of 2 g/day. "Globally, 40.4% of these deaths occurred prematurely, i.e. in persons younger than 70 years of age," Dr. Mozaffarian and his associates said (N. Engl. J. Med. 2014 Aug. 14;371:624-34 [doi:10.1056/NEJMoa1304127]).
"In sum, approximately 1 of every 10 deaths from CV causes worldwide and nearly 1 of every 5 premature deaths from CV causes were attributed to sodium consumption above the reference level," they said.
In an editorial accompanying this report, Dr. Suzanne Oparil said, "The NUTRICODE investigators should be applauded for a herculean effort in synthesizing a large body of data regarding the potential harm of excess salt consumption" (N. Engl. J. Med. 2014 Aug. 14;371:677-9 [doi:10.1056/NEJMe1407695]).
"However, given the numerous assumptions necessitated by the lack of high-quality data [in the literature], caution should be taken in interpreting the findings of this study," said Dr. Oparil of the vascular biology and hypertension program, University of Alabama at Birmingham.
The PURE studies were supported by the Heart and Stroke Foundation of Ontario, the Population Health Research Institute, the Canadian Institutes of Health Research, several pharmaceutical companies, and various national or local organizations in 18 participating countries. These funders played no role in the design or conduct of the studies, in collection or analysis of data, or in preparing the manuscript. Dr. O’Donnell reported ties to Boehringer Ingelheim, Bayer, Bristol-Myers Squibb, and Pfizer, and his associates reported ties to Sanofi-Aventis, AstraZeneca, and Cadila. The NUTRICODE study was funded by the Bill and Melinda Gates Foundation.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: The results from two of three large studies on the sodium intake/blood pressure/cardiovascular death triad contradict each other.
Major finding: Sodium excretion, as an indicator of intake, positively correlated with systolic and diastolic blood pressure across all geographic regions of the globe, but this correlation was nonlinear and was weakest in the largest subset of participants, who had an intake of 3-5 g/day. The lowest risk of death and CV events was seen not in people with the recommended levels of sodium excretion but in those whose sodium excretion was much higher, at 3-6 g/day; risks actually increased at levels of sodium excretion that were lower than 3 g/day, as is recommended. 1.65 million deaths from CV causes worldwide in 2010 were attributable to sodium consumption above the WHO recommended maximum of 2 g/day.
Data source: PURE, a prospective international epidemiologic study of the link between sodium excretion and blood pressure in 102,216 adults, and NUTRICODE, a review of the literature plus statistical modeling of CV deaths tied to sodium consumption worldwide.
Disclosures: The PURE studies were supported by the Heart and Stroke Foundation of Ontario, the Population Health Research Institute, the Canadian Institutes of Health Research, several pharmaceutical companies, and various national or local organizations in 18 participating countries. Dr. O’Donnell reported ties to Boehringer Ingelheim, Bayer, Bristol-Myers Squibb, and Pfizer, and his associates reported ties to Sanofi-Aventis, AstraZeneca, and Cadila. The NUTRICODE study was funded by the Bill and Melinda Gates Foundation.
Diabetes, hypertension drive higher CVD risk in blacks and women
Risk factors for cardiovascular disease have disproportionately affected women and blacks, and while the gender gap has narrowed over time, black-white disparities have widened, reported authors of a large 10-year cohort study published Aug. 11 in the journal Circulation.
The study showed that factors such as high cholesterol and smoking account for less cardiovascular disease (CVD) risk than in the past, said Dr. Susan Cheng of Harvard Medical School in Boston and her associates. "However, the combined contribution of all traditional risk factors has remained substantially higher in women, compared with men, and in blacks, compared with whites," the investigators said. "These sex- and race-based differences continue to be especially pronounced for hypertension and diabetes mellitus."
The researchers calculated the population-attributable risks (PARs) of five major modifiable risk factors – smoking, hypercholesterolemia, hypertension, diabetes, and obesity – for the 10-year incidence of CVD among 13,541 participants in the Atherosclerosis Risk in Communities (ARIC) study. The cohort was 56% female, 26% black, and aged 52-66 years when examined during the time periods 1987-1989, 1990-1992, or 1996-1998, the investigators said (Circulation 2014 Aug. 11 [doi:10.1161/circulationaha.113.008506]).
The contribution of smoking and high cholesterol to CVD risk fell, (from 0.15 to 0.13 and from 0.18 to 0.09, respectively) during the study period, and the contribution of obesity stayed the same at 0.06, the researchers reported.
But by 1996-1998, diabetes mellitus accounted for significantly more CVD risk in blacks than whites (0.28 vs. 0.13), and the same was true for hypertension (0.36 vs. 0.21; P = .08) and all risk factors combined (0.67 vs. 0.48; P = .002), the researchers said. Similarly, PARs for women surpassed those for men for diabetes (0.21 vs. 0.14; P less than .0001) and hypertension (0.32 vs. 0.19; P = .02), they reported.
The racial differences suggest that prevention efforts based on traditional risk factors have benefited whites more than blacks, the researchers added. However, most blacks in the study were from the ARIC study center located in Jackson, Miss., so the race-based findings might be specific to that area, they noted.
"The reasons for persistent sex differences in attributable CVD risks over time are not yet clear," said Dr. Cheng and associates. They added that sex-based differences could stem from clustering; underrecognition or undertreatment of risk factors in women; biological differences that are not yet understood; or nontraditional risk factors in men.
The National Heart, Lung, and Blood Institute funded the study. Dr. Cheng also received funding from the Ellison Foundation. The authors reported no conflicts of interest.
Risk factors for cardiovascular disease have disproportionately affected women and blacks, and while the gender gap has narrowed over time, black-white disparities have widened, reported authors of a large 10-year cohort study published Aug. 11 in the journal Circulation.
The study showed that factors such as high cholesterol and smoking account for less cardiovascular disease (CVD) risk than in the past, said Dr. Susan Cheng of Harvard Medical School in Boston and her associates. "However, the combined contribution of all traditional risk factors has remained substantially higher in women, compared with men, and in blacks, compared with whites," the investigators said. "These sex- and race-based differences continue to be especially pronounced for hypertension and diabetes mellitus."
The researchers calculated the population-attributable risks (PARs) of five major modifiable risk factors – smoking, hypercholesterolemia, hypertension, diabetes, and obesity – for the 10-year incidence of CVD among 13,541 participants in the Atherosclerosis Risk in Communities (ARIC) study. The cohort was 56% female, 26% black, and aged 52-66 years when examined during the time periods 1987-1989, 1990-1992, or 1996-1998, the investigators said (Circulation 2014 Aug. 11 [doi:10.1161/circulationaha.113.008506]).
The contribution of smoking and high cholesterol to CVD risk fell, (from 0.15 to 0.13 and from 0.18 to 0.09, respectively) during the study period, and the contribution of obesity stayed the same at 0.06, the researchers reported.
But by 1996-1998, diabetes mellitus accounted for significantly more CVD risk in blacks than whites (0.28 vs. 0.13), and the same was true for hypertension (0.36 vs. 0.21; P = .08) and all risk factors combined (0.67 vs. 0.48; P = .002), the researchers said. Similarly, PARs for women surpassed those for men for diabetes (0.21 vs. 0.14; P less than .0001) and hypertension (0.32 vs. 0.19; P = .02), they reported.
The racial differences suggest that prevention efforts based on traditional risk factors have benefited whites more than blacks, the researchers added. However, most blacks in the study were from the ARIC study center located in Jackson, Miss., so the race-based findings might be specific to that area, they noted.
"The reasons for persistent sex differences in attributable CVD risks over time are not yet clear," said Dr. Cheng and associates. They added that sex-based differences could stem from clustering; underrecognition or undertreatment of risk factors in women; biological differences that are not yet understood; or nontraditional risk factors in men.
The National Heart, Lung, and Blood Institute funded the study. Dr. Cheng also received funding from the Ellison Foundation. The authors reported no conflicts of interest.
Risk factors for cardiovascular disease have disproportionately affected women and blacks, and while the gender gap has narrowed over time, black-white disparities have widened, reported authors of a large 10-year cohort study published Aug. 11 in the journal Circulation.
The study showed that factors such as high cholesterol and smoking account for less cardiovascular disease (CVD) risk than in the past, said Dr. Susan Cheng of Harvard Medical School in Boston and her associates. "However, the combined contribution of all traditional risk factors has remained substantially higher in women, compared with men, and in blacks, compared with whites," the investigators said. "These sex- and race-based differences continue to be especially pronounced for hypertension and diabetes mellitus."
The researchers calculated the population-attributable risks (PARs) of five major modifiable risk factors – smoking, hypercholesterolemia, hypertension, diabetes, and obesity – for the 10-year incidence of CVD among 13,541 participants in the Atherosclerosis Risk in Communities (ARIC) study. The cohort was 56% female, 26% black, and aged 52-66 years when examined during the time periods 1987-1989, 1990-1992, or 1996-1998, the investigators said (Circulation 2014 Aug. 11 [doi:10.1161/circulationaha.113.008506]).
The contribution of smoking and high cholesterol to CVD risk fell, (from 0.15 to 0.13 and from 0.18 to 0.09, respectively) during the study period, and the contribution of obesity stayed the same at 0.06, the researchers reported.
But by 1996-1998, diabetes mellitus accounted for significantly more CVD risk in blacks than whites (0.28 vs. 0.13), and the same was true for hypertension (0.36 vs. 0.21; P = .08) and all risk factors combined (0.67 vs. 0.48; P = .002), the researchers said. Similarly, PARs for women surpassed those for men for diabetes (0.21 vs. 0.14; P less than .0001) and hypertension (0.32 vs. 0.19; P = .02), they reported.
The racial differences suggest that prevention efforts based on traditional risk factors have benefited whites more than blacks, the researchers added. However, most blacks in the study were from the ARIC study center located in Jackson, Miss., so the race-based findings might be specific to that area, they noted.
"The reasons for persistent sex differences in attributable CVD risks over time are not yet clear," said Dr. Cheng and associates. They added that sex-based differences could stem from clustering; underrecognition or undertreatment of risk factors in women; biological differences that are not yet understood; or nontraditional risk factors in men.
The National Heart, Lung, and Blood Institute funded the study. Dr. Cheng also received funding from the Ellison Foundation. The authors reported no conflicts of interest.
FROM CIRCULATION
Key clinical point: Cardiovascular risk factors disproportionately affect blacks and women; and while the gender gap has narrowed, the disparity between blacks and whites has increased.
Major finding: By 1996-1998, population attributable risks (PARs) for blacks exceeded those for whites for diabetes (P less than .0001), hypertension (P = .08), and all risk factors combined (P = .002). Among women, PARs surpassed those of men for diabetes (P less than .0001) and hypertension (P = .02).
Data source: Cohort analysis of 13,541 participants in the Atherosclerosis Risk in Communities Study. Participants were 52-66 years old, 56% female, 26% black, and had no cardiovascular disease when examined during 1987-1989, 1990-1992, or 1996-1998.
Disclosures: The study was funded by the National Heart, Lung, and Blood Institute. Dr. Cheng received additional funding from the Ellison Foundation. The authors reported no conflicts of interest.
VIDEO: Future direction for AADE and diabetes education
ORLANDO – The field of diabetes education is evolving, especially as health reform is slowly changing the country’s health care landscape.
Deborah Greenwood, Ph.D., the 2014 president-elect for American Association of Diabetes Educators, talked with us during the AADE annual meeting about how the organization is assessing the changes and what it has planned.
On Twitter @naseemmiller
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ORLANDO – The field of diabetes education is evolving, especially as health reform is slowly changing the country’s health care landscape.
Deborah Greenwood, Ph.D., the 2014 president-elect for American Association of Diabetes Educators, talked with us during the AADE annual meeting about how the organization is assessing the changes and what it has planned.
On Twitter @naseemmiller
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ORLANDO – The field of diabetes education is evolving, especially as health reform is slowly changing the country’s health care landscape.
Deborah Greenwood, Ph.D., the 2014 president-elect for American Association of Diabetes Educators, talked with us during the AADE annual meeting about how the organization is assessing the changes and what it has planned.
On Twitter @naseemmiller
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT AADE 2014
FDA approves canagliflozin/metformin combination
The Food and Drug Administration has approved Invokamet, a fixed-dose combination of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, and metformin, for type 2 diabetes.
Janssen Pharmaceuticals, which will market Invokamet in the United States, says that it’s the first such combination approved by the FDA. Specifically, the indication is "as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled by treatment that includes either canagliflozin or metformin, or who are already being treated with both canagliflozin and metformin as separate medications."
The drug will be available in four dosage combinations containing canagliflozin 50 mg or 150 mg and metformin 500 mg or 1000 mg. The recommended dose is twice daily.
Canagliflozin was originally approved by the FDA in March 2013. During three phase III trials of canagliflozin plus metformin, the combination "lowered blood sugar and, in pre-specified secondary endpoints, was associated with significant reductions in body weight and systolic blood pressure," according to the statement. The most common adverse events were female genital mycotic infections, urinary tract infections, and increased urination. The most common adverse reactions with metformin were diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. Canagliflozin can increase the risk of hypoglycemia when combined with insulin or a sulfonylurea. The company says that lower doses of those therapies may be required to minimize the risk of hypoglycemia when used in combination with Invokamet.
There is also a boxed warning on the potential for lactic acidosis.
On Twitter @aliciaault
The Food and Drug Administration has approved Invokamet, a fixed-dose combination of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, and metformin, for type 2 diabetes.
Janssen Pharmaceuticals, which will market Invokamet in the United States, says that it’s the first such combination approved by the FDA. Specifically, the indication is "as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled by treatment that includes either canagliflozin or metformin, or who are already being treated with both canagliflozin and metformin as separate medications."
The drug will be available in four dosage combinations containing canagliflozin 50 mg or 150 mg and metformin 500 mg or 1000 mg. The recommended dose is twice daily.
Canagliflozin was originally approved by the FDA in March 2013. During three phase III trials of canagliflozin plus metformin, the combination "lowered blood sugar and, in pre-specified secondary endpoints, was associated with significant reductions in body weight and systolic blood pressure," according to the statement. The most common adverse events were female genital mycotic infections, urinary tract infections, and increased urination. The most common adverse reactions with metformin were diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. Canagliflozin can increase the risk of hypoglycemia when combined with insulin or a sulfonylurea. The company says that lower doses of those therapies may be required to minimize the risk of hypoglycemia when used in combination with Invokamet.
There is also a boxed warning on the potential for lactic acidosis.
On Twitter @aliciaault
The Food and Drug Administration has approved Invokamet, a fixed-dose combination of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, and metformin, for type 2 diabetes.
Janssen Pharmaceuticals, which will market Invokamet in the United States, says that it’s the first such combination approved by the FDA. Specifically, the indication is "as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled by treatment that includes either canagliflozin or metformin, or who are already being treated with both canagliflozin and metformin as separate medications."
The drug will be available in four dosage combinations containing canagliflozin 50 mg or 150 mg and metformin 500 mg or 1000 mg. The recommended dose is twice daily.
Canagliflozin was originally approved by the FDA in March 2013. During three phase III trials of canagliflozin plus metformin, the combination "lowered blood sugar and, in pre-specified secondary endpoints, was associated with significant reductions in body weight and systolic blood pressure," according to the statement. The most common adverse events were female genital mycotic infections, urinary tract infections, and increased urination. The most common adverse reactions with metformin were diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. Canagliflozin can increase the risk of hypoglycemia when combined with insulin or a sulfonylurea. The company says that lower doses of those therapies may be required to minimize the risk of hypoglycemia when used in combination with Invokamet.
There is also a boxed warning on the potential for lactic acidosis.
On Twitter @aliciaault
Diabetes education should seek to improve health care literacy
ORLANDO – Formal inpatient diabetes education can reduce hospital readmissions, a review of the literature suggested.
The education is most effective when it comes to helping patients understand discharge instructions and transition care, and when it involves an effort to improve health care literacy, Aiqun Liu, a registered nurse and certified diabetes educator at Barnes-Jewish Hospital at Washington University, St. Louis, reported at the annual meeting of the American Association of Diabetes Educators.
In 2008, about one in five hospitalizations was diabetes related, 20% of patients were readmitted within 30 days of discharge, and 26% were readmitted within 90 days, Ms. Liu found.
Most readmissions (87% in this review) are unplanned, and about 20% of the unplanned readmissions are potentially avoidable, she said.
Furthermore, these hospitalizations are a significant contributor to total health expenditures, accounting for nearly half of diabetes-related medical costs.
Health literacy is essential for successful self-care, but 15%-40% of patients with diabetes were found to have low health literacy, which is associated with less knowledge and skill with respect to self-management, more emergency department visits and hospital admissions, and poorer health outcomes, she said in an interview.
Based on 10 articles published between 2007 and 2013 that met prespecified search criteria, a number of educational strategies appear useful for improving health literacy and reducing readmissions, she said.
Focusing on discharge-related topics is particularly important. Such topics include blood glucose monitoring, medications, diet/nutrition, physical activity, warning signs that should prompt a call to the patient’s doctor, and lifestyle change related to illness.
Pharmacist-based interventions also were shown to be helpful and empowering. These included medication reconciliation, inpatient counseling, provision of simple adherence aids, and telephone follow-up after discharge, Ms. Liu noted.
Effective strategies for improving health literacy, self-care, and self-efficacy included pictograph-based discharge instructions, provision of health literacy– and numeracy-sensitive materials, clear communication between patients and providers, and use of the teach-back method to improve understanding and information retention.
The review also underscored the importance of transition care, providing patients with discharge instructions, appropriate prescriptions for diabetes medications and supplies, and making follow-up appointments proved most useful.
Individualized telephone follow-up after discharge is also important, Ms. Liu said.
In one study, formal inpatient diabetes education was associated with significantly reduced 30-day and 180-day readmission rates (P = .001 and .04, respectively).
The findings support the implementation of clinical protocols and interventions to support and improve health literacy; the use of literacy-sensitive materials and approaches to improve understanding of instructions and to enhance diabetes self-management; and training of health professionals regarding health literacy, numeracy, and clear communication techniques, she said, noting that additional research is needed to identify practical tools for improving health literacy in the inpatient setting.
Ms. Liu reported having no disclosures.
ORLANDO – Formal inpatient diabetes education can reduce hospital readmissions, a review of the literature suggested.
The education is most effective when it comes to helping patients understand discharge instructions and transition care, and when it involves an effort to improve health care literacy, Aiqun Liu, a registered nurse and certified diabetes educator at Barnes-Jewish Hospital at Washington University, St. Louis, reported at the annual meeting of the American Association of Diabetes Educators.
In 2008, about one in five hospitalizations was diabetes related, 20% of patients were readmitted within 30 days of discharge, and 26% were readmitted within 90 days, Ms. Liu found.
Most readmissions (87% in this review) are unplanned, and about 20% of the unplanned readmissions are potentially avoidable, she said.
Furthermore, these hospitalizations are a significant contributor to total health expenditures, accounting for nearly half of diabetes-related medical costs.
Health literacy is essential for successful self-care, but 15%-40% of patients with diabetes were found to have low health literacy, which is associated with less knowledge and skill with respect to self-management, more emergency department visits and hospital admissions, and poorer health outcomes, she said in an interview.
Based on 10 articles published between 2007 and 2013 that met prespecified search criteria, a number of educational strategies appear useful for improving health literacy and reducing readmissions, she said.
Focusing on discharge-related topics is particularly important. Such topics include blood glucose monitoring, medications, diet/nutrition, physical activity, warning signs that should prompt a call to the patient’s doctor, and lifestyle change related to illness.
Pharmacist-based interventions also were shown to be helpful and empowering. These included medication reconciliation, inpatient counseling, provision of simple adherence aids, and telephone follow-up after discharge, Ms. Liu noted.
Effective strategies for improving health literacy, self-care, and self-efficacy included pictograph-based discharge instructions, provision of health literacy– and numeracy-sensitive materials, clear communication between patients and providers, and use of the teach-back method to improve understanding and information retention.
The review also underscored the importance of transition care, providing patients with discharge instructions, appropriate prescriptions for diabetes medications and supplies, and making follow-up appointments proved most useful.
Individualized telephone follow-up after discharge is also important, Ms. Liu said.
In one study, formal inpatient diabetes education was associated with significantly reduced 30-day and 180-day readmission rates (P = .001 and .04, respectively).
The findings support the implementation of clinical protocols and interventions to support and improve health literacy; the use of literacy-sensitive materials and approaches to improve understanding of instructions and to enhance diabetes self-management; and training of health professionals regarding health literacy, numeracy, and clear communication techniques, she said, noting that additional research is needed to identify practical tools for improving health literacy in the inpatient setting.
Ms. Liu reported having no disclosures.
ORLANDO – Formal inpatient diabetes education can reduce hospital readmissions, a review of the literature suggested.
The education is most effective when it comes to helping patients understand discharge instructions and transition care, and when it involves an effort to improve health care literacy, Aiqun Liu, a registered nurse and certified diabetes educator at Barnes-Jewish Hospital at Washington University, St. Louis, reported at the annual meeting of the American Association of Diabetes Educators.
In 2008, about one in five hospitalizations was diabetes related, 20% of patients were readmitted within 30 days of discharge, and 26% were readmitted within 90 days, Ms. Liu found.
Most readmissions (87% in this review) are unplanned, and about 20% of the unplanned readmissions are potentially avoidable, she said.
Furthermore, these hospitalizations are a significant contributor to total health expenditures, accounting for nearly half of diabetes-related medical costs.
Health literacy is essential for successful self-care, but 15%-40% of patients with diabetes were found to have low health literacy, which is associated with less knowledge and skill with respect to self-management, more emergency department visits and hospital admissions, and poorer health outcomes, she said in an interview.
Based on 10 articles published between 2007 and 2013 that met prespecified search criteria, a number of educational strategies appear useful for improving health literacy and reducing readmissions, she said.
Focusing on discharge-related topics is particularly important. Such topics include blood glucose monitoring, medications, diet/nutrition, physical activity, warning signs that should prompt a call to the patient’s doctor, and lifestyle change related to illness.
Pharmacist-based interventions also were shown to be helpful and empowering. These included medication reconciliation, inpatient counseling, provision of simple adherence aids, and telephone follow-up after discharge, Ms. Liu noted.
Effective strategies for improving health literacy, self-care, and self-efficacy included pictograph-based discharge instructions, provision of health literacy– and numeracy-sensitive materials, clear communication between patients and providers, and use of the teach-back method to improve understanding and information retention.
The review also underscored the importance of transition care, providing patients with discharge instructions, appropriate prescriptions for diabetes medications and supplies, and making follow-up appointments proved most useful.
Individualized telephone follow-up after discharge is also important, Ms. Liu said.
In one study, formal inpatient diabetes education was associated with significantly reduced 30-day and 180-day readmission rates (P = .001 and .04, respectively).
The findings support the implementation of clinical protocols and interventions to support and improve health literacy; the use of literacy-sensitive materials and approaches to improve understanding of instructions and to enhance diabetes self-management; and training of health professionals regarding health literacy, numeracy, and clear communication techniques, she said, noting that additional research is needed to identify practical tools for improving health literacy in the inpatient setting.
Ms. Liu reported having no disclosures.
AT AADE 14
Key clinical point: Inpatient diabetes education can help prevent rehospitalizations.
Major finding: Up to 40% of diabetes patient have low health care literacy.
Data source: A review of 10 articles from the literature.
Disclosures: Ms. Liu reported having no disclosures.
VIDEO: DAWN2 shows need for patient-centered care in diabetes
ORLANDO – Nearly a decade after the results of the Diabetes Attitudes Wishes and Needs (DAWN) trial showed that the emotional health of patients with diabetes was not being adequately addressed, findings from the DAWN2 trial show that not much has changed in that regard.
Almost half of the more than 8,500 patients with diabetes who participated in the multinational DAWN2 trial reported experiencing emotional distress as a result of their diabetes, and 14% had likely clinical depression. The results also show that most patients with diabetes want to improve self-management, and that having a large social support network is associated with better psychosocial outcomes.
At the annual meeting of the American Association of Diabetes Educators, Martha Funnell, a certified diabetes educator, associate research scientist at the University of Michigan, Ann Arbor, and a member of the advisory committee for the Novo Nordisk–sponsored DAWN trials, discussed the findings and their clinical implications.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ORLANDO – Nearly a decade after the results of the Diabetes Attitudes Wishes and Needs (DAWN) trial showed that the emotional health of patients with diabetes was not being adequately addressed, findings from the DAWN2 trial show that not much has changed in that regard.
Almost half of the more than 8,500 patients with diabetes who participated in the multinational DAWN2 trial reported experiencing emotional distress as a result of their diabetes, and 14% had likely clinical depression. The results also show that most patients with diabetes want to improve self-management, and that having a large social support network is associated with better psychosocial outcomes.
At the annual meeting of the American Association of Diabetes Educators, Martha Funnell, a certified diabetes educator, associate research scientist at the University of Michigan, Ann Arbor, and a member of the advisory committee for the Novo Nordisk–sponsored DAWN trials, discussed the findings and their clinical implications.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ORLANDO – Nearly a decade after the results of the Diabetes Attitudes Wishes and Needs (DAWN) trial showed that the emotional health of patients with diabetes was not being adequately addressed, findings from the DAWN2 trial show that not much has changed in that regard.
Almost half of the more than 8,500 patients with diabetes who participated in the multinational DAWN2 trial reported experiencing emotional distress as a result of their diabetes, and 14% had likely clinical depression. The results also show that most patients with diabetes want to improve self-management, and that having a large social support network is associated with better psychosocial outcomes.
At the annual meeting of the American Association of Diabetes Educators, Martha Funnell, a certified diabetes educator, associate research scientist at the University of Michigan, Ann Arbor, and a member of the advisory committee for the Novo Nordisk–sponsored DAWN trials, discussed the findings and their clinical implications.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT AADE 14
DAWN2: Addressing emotional distress may improve diabetes self management
ORLANDO – Emotional distress associated with a diabetes diagnosis explains many patients’ difficulties with self-management, based on results from the DAWN2 study presented at the annual meeting of the American Association of Diabetes Educators.
The Novo Nordisk–sponsored DAWN2 (Diabetes Attitudes Wishes and Needs 2) study included 15,438 adults from 17 countries: 8,596 were people with diabetes (1,368 with type 1 and 7,228 with type 2), 2,057 were family members of people with diabetes, and 4,785 were health care providers. The researchers set out primarily to determine the factors that prevent and facilitate active and successful diabetes management.
"The ultimate goal for all of us and for this study is to enable all people with diabetes to live full, healthy, and productive lives, and to be engaged in their own care, preserving their health, and improving their quality of life," said Martha Funnell, a certified diabetes educator, associate research scientist at the University of Michigan, Ann Arbor, and a member of an advisory panel for the DAWN studies.
The first results from DAWN, published in 2005 and 2006, indicated that the psychosocial needs of patients with diabetes were not being met. The findings were based on the results of a survey that covered a broad range of topics, such as health and quality of life, attitudes and beliefs about diabetes, diabetes training, care and support, active self-management, and diabetes education and information. The first global benchmarking results were published in three articles in Diabetic Medicine (Diabet. Med. 2013;30:767-98).
Although a number of themes emerged from the DAWN findings, those with respect to emotional health stand out. In response to those results, emotional well-being has been incorporated into standards of care, Ms. Funnell said. In DAWN2, slightly more patients reported experiencing ongoing emotional distress as a result of diabetes (45% vs. 43%); 14% likely had clinical depression as a result of their diagnosis.
The findings are concerning as emotional distress – feelings of anger, fear, frustration, sadness, and guilt – are among the biggest influencers of self-management. Further, diabetes-related distress has an adverse impact on outcomes, including hemoglobin A1c levels, dietary and exercise behaviors, quality of life, and depression, Ms. Funnell said.
Diabetes also affects other aspects of life: 44% of people with diabetes in DAWN2 said their finances were affected, 38% said leisure activities were affected, 35% said that work and studies were affected, and 21% reported problems with family and peer relationships.
"We have to address diabetes-related distress if we want our patients to make changes and improve their outcomes," she said.
Notably, 52% of health care providers in DAWN2 reported asking patients how their life was affected by diabetes, yet only 24% of patients said their health care provider asked them that question.
"If I was going to do a one-question educational assessment, that would be the question [I would ask] because that tells pretty much all I need to know to work with that person," Ms. Funnell said.
Other findings from DAWN2 included the following:
• Family members of diabetes patients are burdened by the disease as well; 39% said they wanted to be more involved and 37% said they didn’t know how to be more involved.
• Most people with diabetes said that they want to be actively engaged and to participate in their care, but most aren’t.
• Half of the respondents with diabetes had never participated in a diabetes education program.
• Health care providers report a desire for more training in many aspects of diabetes care.
• Discrimination because of diabetes was reported by 19% of patients, implying a lack of awareness about diabetes.
An analysis of U.S.-only data from DAWN2 also shed light on important issues related to diabetes care and self-management.
The more than 500 U.S. respondents with diabetes in the DAWN2 study reported following a healthy eating plan for a mean of 4.7 days per week. They participated in at least 30 minutes of physical activity on a mean of 2.7 days per week and 65% expressed a desire to improve on this measure. Patients tested their blood sugar levels as recommended by their health care provider a mean of 4.5 days per week and took all medication as prescribed on a mean of 6.4 days per week. They checked their feet on a mean of 4.7 days per week (Curr. Med. Res. Opin. 2014 July 31:1-39).
Adherence varied considerably by ethnic group. For example, non-Hispanic white patients had the lowest scores for physical activity, Chinese Americans had the lowest scores for testing their blood sugar as recommended, and African Americans and Hispanics had the best scores for checking their feet.
Psychological outcomes also differed by ethnicity. African Americans had the best scores and non-Hispanic whites had the worst scores for well-being, quality of life, diabetes empowerment, and diabetes impact. Hispanics had the worst scores for quality of life and diabetes distress.
The DAWN2 data for U.S. survey respondents also indicated a substantial level of distress among people with diabetes and their family members. Having a large social support network for diabetes was related to better psychosocial outcomes, but few people with diabetes let others know how they can best provide support.
Also, U.S. respondents were pleased with the level of involvement of their family in diabetes care, and they feel that family members help a great deal by listening to them when they talk about difficulties associated with living with diabetes.
Diabetes is a burden from a management and psychological perspective. Patients need to be encouraged to ask for support when it is needed, and clinicians need to recognize that family members are untapped resources for patient support as well as a group in need of support as they deal with the burdens of caring for a family member with diabetes, Ms. Funnell added.
"Finally, we absolutely have to involve the person with diabetes and their family members as equal partners when developing care solutions," she said. Family members need to be taught how to help, and patients need to be asked how diabetes is affecting their life to identify problems and set appropriate goals for solving them.
"We need to truly focus on patient-centered care. ... We really need to surround the patient with their family and their friends, their health care, their communities, their workplaces, and the larger society if they are going to be successful in their self-management. It takes a village to manage diabetes, and every one of us has a role to play to make person-centered diabetes care and patient-centered diabetes education and ongoing support the reality that it needs to be," she said.
Ms. Funnell reported serving as a board or advisory panel member for Novo Nordisk, the sponsor of DAWN2, as well as several other drug companies involved in diabetes care, and receiving grant funding from BMS Foundation.
ORLANDO – Emotional distress associated with a diabetes diagnosis explains many patients’ difficulties with self-management, based on results from the DAWN2 study presented at the annual meeting of the American Association of Diabetes Educators.
The Novo Nordisk–sponsored DAWN2 (Diabetes Attitudes Wishes and Needs 2) study included 15,438 adults from 17 countries: 8,596 were people with diabetes (1,368 with type 1 and 7,228 with type 2), 2,057 were family members of people with diabetes, and 4,785 were health care providers. The researchers set out primarily to determine the factors that prevent and facilitate active and successful diabetes management.
"The ultimate goal for all of us and for this study is to enable all people with diabetes to live full, healthy, and productive lives, and to be engaged in their own care, preserving their health, and improving their quality of life," said Martha Funnell, a certified diabetes educator, associate research scientist at the University of Michigan, Ann Arbor, and a member of an advisory panel for the DAWN studies.
The first results from DAWN, published in 2005 and 2006, indicated that the psychosocial needs of patients with diabetes were not being met. The findings were based on the results of a survey that covered a broad range of topics, such as health and quality of life, attitudes and beliefs about diabetes, diabetes training, care and support, active self-management, and diabetes education and information. The first global benchmarking results were published in three articles in Diabetic Medicine (Diabet. Med. 2013;30:767-98).
Although a number of themes emerged from the DAWN findings, those with respect to emotional health stand out. In response to those results, emotional well-being has been incorporated into standards of care, Ms. Funnell said. In DAWN2, slightly more patients reported experiencing ongoing emotional distress as a result of diabetes (45% vs. 43%); 14% likely had clinical depression as a result of their diagnosis.
The findings are concerning as emotional distress – feelings of anger, fear, frustration, sadness, and guilt – are among the biggest influencers of self-management. Further, diabetes-related distress has an adverse impact on outcomes, including hemoglobin A1c levels, dietary and exercise behaviors, quality of life, and depression, Ms. Funnell said.
Diabetes also affects other aspects of life: 44% of people with diabetes in DAWN2 said their finances were affected, 38% said leisure activities were affected, 35% said that work and studies were affected, and 21% reported problems with family and peer relationships.
"We have to address diabetes-related distress if we want our patients to make changes and improve their outcomes," she said.
Notably, 52% of health care providers in DAWN2 reported asking patients how their life was affected by diabetes, yet only 24% of patients said their health care provider asked them that question.
"If I was going to do a one-question educational assessment, that would be the question [I would ask] because that tells pretty much all I need to know to work with that person," Ms. Funnell said.
Other findings from DAWN2 included the following:
• Family members of diabetes patients are burdened by the disease as well; 39% said they wanted to be more involved and 37% said they didn’t know how to be more involved.
• Most people with diabetes said that they want to be actively engaged and to participate in their care, but most aren’t.
• Half of the respondents with diabetes had never participated in a diabetes education program.
• Health care providers report a desire for more training in many aspects of diabetes care.
• Discrimination because of diabetes was reported by 19% of patients, implying a lack of awareness about diabetes.
An analysis of U.S.-only data from DAWN2 also shed light on important issues related to diabetes care and self-management.
The more than 500 U.S. respondents with diabetes in the DAWN2 study reported following a healthy eating plan for a mean of 4.7 days per week. They participated in at least 30 minutes of physical activity on a mean of 2.7 days per week and 65% expressed a desire to improve on this measure. Patients tested their blood sugar levels as recommended by their health care provider a mean of 4.5 days per week and took all medication as prescribed on a mean of 6.4 days per week. They checked their feet on a mean of 4.7 days per week (Curr. Med. Res. Opin. 2014 July 31:1-39).
Adherence varied considerably by ethnic group. For example, non-Hispanic white patients had the lowest scores for physical activity, Chinese Americans had the lowest scores for testing their blood sugar as recommended, and African Americans and Hispanics had the best scores for checking their feet.
Psychological outcomes also differed by ethnicity. African Americans had the best scores and non-Hispanic whites had the worst scores for well-being, quality of life, diabetes empowerment, and diabetes impact. Hispanics had the worst scores for quality of life and diabetes distress.
The DAWN2 data for U.S. survey respondents also indicated a substantial level of distress among people with diabetes and their family members. Having a large social support network for diabetes was related to better psychosocial outcomes, but few people with diabetes let others know how they can best provide support.
Also, U.S. respondents were pleased with the level of involvement of their family in diabetes care, and they feel that family members help a great deal by listening to them when they talk about difficulties associated with living with diabetes.
Diabetes is a burden from a management and psychological perspective. Patients need to be encouraged to ask for support when it is needed, and clinicians need to recognize that family members are untapped resources for patient support as well as a group in need of support as they deal with the burdens of caring for a family member with diabetes, Ms. Funnell added.
"Finally, we absolutely have to involve the person with diabetes and their family members as equal partners when developing care solutions," she said. Family members need to be taught how to help, and patients need to be asked how diabetes is affecting their life to identify problems and set appropriate goals for solving them.
"We need to truly focus on patient-centered care. ... We really need to surround the patient with their family and their friends, their health care, their communities, their workplaces, and the larger society if they are going to be successful in their self-management. It takes a village to manage diabetes, and every one of us has a role to play to make person-centered diabetes care and patient-centered diabetes education and ongoing support the reality that it needs to be," she said.
Ms. Funnell reported serving as a board or advisory panel member for Novo Nordisk, the sponsor of DAWN2, as well as several other drug companies involved in diabetes care, and receiving grant funding from BMS Foundation.
ORLANDO – Emotional distress associated with a diabetes diagnosis explains many patients’ difficulties with self-management, based on results from the DAWN2 study presented at the annual meeting of the American Association of Diabetes Educators.
The Novo Nordisk–sponsored DAWN2 (Diabetes Attitudes Wishes and Needs 2) study included 15,438 adults from 17 countries: 8,596 were people with diabetes (1,368 with type 1 and 7,228 with type 2), 2,057 were family members of people with diabetes, and 4,785 were health care providers. The researchers set out primarily to determine the factors that prevent and facilitate active and successful diabetes management.
"The ultimate goal for all of us and for this study is to enable all people with diabetes to live full, healthy, and productive lives, and to be engaged in their own care, preserving their health, and improving their quality of life," said Martha Funnell, a certified diabetes educator, associate research scientist at the University of Michigan, Ann Arbor, and a member of an advisory panel for the DAWN studies.
The first results from DAWN, published in 2005 and 2006, indicated that the psychosocial needs of patients with diabetes were not being met. The findings were based on the results of a survey that covered a broad range of topics, such as health and quality of life, attitudes and beliefs about diabetes, diabetes training, care and support, active self-management, and diabetes education and information. The first global benchmarking results were published in three articles in Diabetic Medicine (Diabet. Med. 2013;30:767-98).
Although a number of themes emerged from the DAWN findings, those with respect to emotional health stand out. In response to those results, emotional well-being has been incorporated into standards of care, Ms. Funnell said. In DAWN2, slightly more patients reported experiencing ongoing emotional distress as a result of diabetes (45% vs. 43%); 14% likely had clinical depression as a result of their diagnosis.
The findings are concerning as emotional distress – feelings of anger, fear, frustration, sadness, and guilt – are among the biggest influencers of self-management. Further, diabetes-related distress has an adverse impact on outcomes, including hemoglobin A1c levels, dietary and exercise behaviors, quality of life, and depression, Ms. Funnell said.
Diabetes also affects other aspects of life: 44% of people with diabetes in DAWN2 said their finances were affected, 38% said leisure activities were affected, 35% said that work and studies were affected, and 21% reported problems with family and peer relationships.
"We have to address diabetes-related distress if we want our patients to make changes and improve their outcomes," she said.
Notably, 52% of health care providers in DAWN2 reported asking patients how their life was affected by diabetes, yet only 24% of patients said their health care provider asked them that question.
"If I was going to do a one-question educational assessment, that would be the question [I would ask] because that tells pretty much all I need to know to work with that person," Ms. Funnell said.
Other findings from DAWN2 included the following:
• Family members of diabetes patients are burdened by the disease as well; 39% said they wanted to be more involved and 37% said they didn’t know how to be more involved.
• Most people with diabetes said that they want to be actively engaged and to participate in their care, but most aren’t.
• Half of the respondents with diabetes had never participated in a diabetes education program.
• Health care providers report a desire for more training in many aspects of diabetes care.
• Discrimination because of diabetes was reported by 19% of patients, implying a lack of awareness about diabetes.
An analysis of U.S.-only data from DAWN2 also shed light on important issues related to diabetes care and self-management.
The more than 500 U.S. respondents with diabetes in the DAWN2 study reported following a healthy eating plan for a mean of 4.7 days per week. They participated in at least 30 minutes of physical activity on a mean of 2.7 days per week and 65% expressed a desire to improve on this measure. Patients tested their blood sugar levels as recommended by their health care provider a mean of 4.5 days per week and took all medication as prescribed on a mean of 6.4 days per week. They checked their feet on a mean of 4.7 days per week (Curr. Med. Res. Opin. 2014 July 31:1-39).
Adherence varied considerably by ethnic group. For example, non-Hispanic white patients had the lowest scores for physical activity, Chinese Americans had the lowest scores for testing their blood sugar as recommended, and African Americans and Hispanics had the best scores for checking their feet.
Psychological outcomes also differed by ethnicity. African Americans had the best scores and non-Hispanic whites had the worst scores for well-being, quality of life, diabetes empowerment, and diabetes impact. Hispanics had the worst scores for quality of life and diabetes distress.
The DAWN2 data for U.S. survey respondents also indicated a substantial level of distress among people with diabetes and their family members. Having a large social support network for diabetes was related to better psychosocial outcomes, but few people with diabetes let others know how they can best provide support.
Also, U.S. respondents were pleased with the level of involvement of their family in diabetes care, and they feel that family members help a great deal by listening to them when they talk about difficulties associated with living with diabetes.
Diabetes is a burden from a management and psychological perspective. Patients need to be encouraged to ask for support when it is needed, and clinicians need to recognize that family members are untapped resources for patient support as well as a group in need of support as they deal with the burdens of caring for a family member with diabetes, Ms. Funnell added.
"Finally, we absolutely have to involve the person with diabetes and their family members as equal partners when developing care solutions," she said. Family members need to be taught how to help, and patients need to be asked how diabetes is affecting their life to identify problems and set appropriate goals for solving them.
"We need to truly focus on patient-centered care. ... We really need to surround the patient with their family and their friends, their health care, their communities, their workplaces, and the larger society if they are going to be successful in their self-management. It takes a village to manage diabetes, and every one of us has a role to play to make person-centered diabetes care and patient-centered diabetes education and ongoing support the reality that it needs to be," she said.
Ms. Funnell reported serving as a board or advisory panel member for Novo Nordisk, the sponsor of DAWN2, as well as several other drug companies involved in diabetes care, and receiving grant funding from BMS Foundation.
AT AADE 14
Key clinical point: Asking patients how their life is affected by diabetes may address emotional distress and improve self-management.
Major finding: Emotional distress was reported by 45% of diabetes patients surveyed.
Data source: The DAWN2 study, which analyzed survey responses of 15,438 adults.
Disclosures: Ms. Funnell reported serving as a board or advisory panel member for Novo Nordisk, the sponsor of DAWN2, as well as several other drug companies involved in diabetes care.
VIDEO: Tips from AADE’s Diabetes Educator of the Year
ORLANDO – Susan Weiner has been on the diabetes education front line for nearly 25 years, and she was just elected as Educator of the Year for her "special contributions to the field through dedication, innovation, and sensitivity in patient care" at the annual meeting of the American Association of Diabetes Educators.
Ms. Weiner, who is in private practice in Long Island, New York, also recently wrote a book, "The Complete Diabetes Organizer," to help patients organize various aspects of their lives so that they can successfully manage their diabetes.
In a video interview, Ms. Weiner shares some of her advice with physicians.
On Twitter @naseemmiller
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ORLANDO – Susan Weiner has been on the diabetes education front line for nearly 25 years, and she was just elected as Educator of the Year for her "special contributions to the field through dedication, innovation, and sensitivity in patient care" at the annual meeting of the American Association of Diabetes Educators.
Ms. Weiner, who is in private practice in Long Island, New York, also recently wrote a book, "The Complete Diabetes Organizer," to help patients organize various aspects of their lives so that they can successfully manage their diabetes.
In a video interview, Ms. Weiner shares some of her advice with physicians.
On Twitter @naseemmiller
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ORLANDO – Susan Weiner has been on the diabetes education front line for nearly 25 years, and she was just elected as Educator of the Year for her "special contributions to the field through dedication, innovation, and sensitivity in patient care" at the annual meeting of the American Association of Diabetes Educators.
Ms. Weiner, who is in private practice in Long Island, New York, also recently wrote a book, "The Complete Diabetes Organizer," to help patients organize various aspects of their lives so that they can successfully manage their diabetes.
In a video interview, Ms. Weiner shares some of her advice with physicians.
On Twitter @naseemmiller
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT AADE 2014
