American Association of Diabetes Educators (AADE): Annual Meeting

LAS VEGAS – Shared medical appointments can be a financially viable way to implement effective diabetes education to a large number of patients in primary care settings, the experience of one practice in south Texas demonstrated.

The premise of the shared medical appointment (SMA), first described in 1974 as a model for well-child consultations, is to provide the educational part of a medical appointment once with a large group of patients rather than repeating the same material over and over again on a one-on-one basis.

"Shared medical appointments are a health care delivery model that provide an opportunity to manage chronic illness, and improve quality and patient self-efficacy and self-management," certified diabetes educator Iris Sanchez of the Weslaco (Tex.) Medical Clinic said at the annual meeting of the American Association of Diabetes Educators.

Weslaco is just to the north of the Mexico border. As such, the population is nearly 100% Hispanic and the diabetes rates are high: In the town’s county of Hidalgo, 13.3% of the population have diabetes, compared with 10.3% for the state of Texas and 8.3% for the entire United States. Patients often travel long distances to get to the clinic for medical visits. Based on evidence from a large body of literature, shared medical appointments were seen as a potential way for the clinic to maximize efficiency of delivery of diabetes education while also delivering quality medical care, said Dr. Sanchez, whose report was published online earlier this year (The Diabetes Educator 2011 March 31 [doi:10.1177/0145721711401667).

The program was developed within the context of the chronic care model, a proposed framework for organizing care for patients with chronic conditions that incorporates the elements of community resources and policies, health systems, self-management support, delivery systems design, decision support, and clinical information systems (Milbank Q. 1996;74:511-44).

The clinic employs one physician and two nurse practitioners. The team invited to speak to the group about self-management included a dietician, podiatrist, social worker, exercise physiologist, and others. Flyers were posted in exam rooms and in the lobby to advertise the "Diabetes Days," and ads were placed in the local newspaper in English and Spanish.

The shared medical appointment, including the educational component plus the medical visit, lasted a total of 90 minutes. Patients were called out during the group education session to see the physician or nurse practitioner for their medical visits, and would then return to the room. To maintain confidentiality, individual cases were not discussed during the educational sessions, Dr. Sanchez noted.

Progress notes were kept, and outcomes tracked using an electronic medical record system. Initially scheduled once a week with 12 people in the group, the SMAs have recently been expanded to twice weekly. It’s important to tell patients that the SMAs are not a choice, but are to be kept just as they would a medical appointment. Participation initially varied from 30% to 100%, but now hovers around 90%.

Of 70 patients seen between September and November 2009, 65 had a second visit and 49 a third. Prior to initiation of the program, 75% had not had a urine albumin measurement in the previous 12 months, 34% had not had an eye exam, and 55% were not on daily aspirin. All of these standards of care were implemented as part of the SMA, which resulted in increased revenue from services such as eye exams and urine screens, Dr. Sanchez pointed out.

Average hemoglobin A_1c at initiation was 7.95%. That dropped to 7.48% on second measurement, and rose slightly to 7.51% at a third measurement. For those with a second HbA_1c value, 25 (42%) had an increase and 34 (58%) had a decrease. The differences were not statistically significant, but they were clinically significant, she said.

"Shared medical appointments were appropriate for patients who were motivated and willing to learn. Patients who were not motivated to self manage their disease tended to have higher A_1c levels and did not return to subsequent SMA," Dr. Sanchez noted.

There are billing codes for group diabetes self-management education, G0109 and G0271. However, to use these, a clinic needs to receive certification from the American Diabetes Association, the American Association of Diabetes Educators, or the Indian Health Service. Weslaco is working on receiving that certification, but has not done so yet. However, the practice was able to bill for SMA using evaluation and management codes 99201-99215, which cover the medical appointment part of the visit.

Dr. Sanchez reported having no financial disclosures.

LAS VEGAS – Shared medical appointments can be a financially viable way to implement effective diabetes education to a large number of patients in primary care settings, the experience of one practice in south Texas demonstrated.

The premise of the shared medical appointment (SMA), first described in 1974 as a model for well-child consultations, is to provide the educational part of a medical appointment once with a large group of patients rather than repeating the same material over and over again on a one-on-one basis.

"Shared medical appointments are a health care delivery model that provide an opportunity to manage chronic illness, and improve quality and patient self-efficacy and self-management," certified diabetes educator Iris Sanchez of the Weslaco (Tex.) Medical Clinic said at the annual meeting of the American Association of Diabetes Educators.

Weslaco is just to the north of the Mexico border. As such, the population is nearly 100% Hispanic and the diabetes rates are high: In the town’s county of Hidalgo, 13.3% of the population have diabetes, compared with 10.3% for the state of Texas and 8.3% for the entire United States. Patients often travel long distances to get to the clinic for medical visits. Based on evidence from a large body of literature, shared medical appointments were seen as a potential way for the clinic to maximize efficiency of delivery of diabetes education while also delivering quality medical care, said Dr. Sanchez, whose report was published online earlier this year (The Diabetes Educator 2011 March 31 [doi:10.1177/0145721711401667).

The program was developed within the context of the chronic care model, a proposed framework for organizing care for patients with chronic conditions that incorporates the elements of community resources and policies, health systems, self-management support, delivery systems design, decision support, and clinical information systems (Milbank Q. 1996;74:511-44).

The clinic employs one physician and two nurse practitioners. The team invited to speak to the group about self-management included a dietician, podiatrist, social worker, exercise physiologist, and others. Flyers were posted in exam rooms and in the lobby to advertise the "Diabetes Days," and ads were placed in the local newspaper in English and Spanish.

The shared medical appointment, including the educational component plus the medical visit, lasted a total of 90 minutes. Patients were called out during the group education session to see the physician or nurse practitioner for their medical visits, and would then return to the room. To maintain confidentiality, individual cases were not discussed during the educational sessions, Dr. Sanchez noted.

Progress notes were kept, and outcomes tracked using an electronic medical record system. Initially scheduled once a week with 12 people in the group, the SMAs have recently been expanded to twice weekly. It’s important to tell patients that the SMAs are not a choice, but are to be kept just as they would a medical appointment. Participation initially varied from 30% to 100%, but now hovers around 90%.

Of 70 patients seen between September and November 2009, 65 had a second visit and 49 a third. Prior to initiation of the program, 75% had not had a urine albumin measurement in the previous 12 months, 34% had not had an eye exam, and 55% were not on daily aspirin. All of these standards of care were implemented as part of the SMA, which resulted in increased revenue from services such as eye exams and urine screens, Dr. Sanchez pointed out.

Average hemoglobin A_1c at initiation was 7.95%. That dropped to 7.48% on second measurement, and rose slightly to 7.51% at a third measurement. For those with a second HbA_1c value, 25 (42%) had an increase and 34 (58%) had a decrease. The differences were not statistically significant, but they were clinically significant, she said.

"Shared medical appointments were appropriate for patients who were motivated and willing to learn. Patients who were not motivated to self manage their disease tended to have higher A_1c levels and did not return to subsequent SMA," Dr. Sanchez noted.

There are billing codes for group diabetes self-management education, G0109 and G0271. However, to use these, a clinic needs to receive certification from the American Diabetes Association, the American Association of Diabetes Educators, or the Indian Health Service. Weslaco is working on receiving that certification, but has not done so yet. However, the practice was able to bill for SMA using evaluation and management codes 99201-99215, which cover the medical appointment part of the visit.

Dr. Sanchez reported having no financial disclosures.

LAS VEGAS – Shared medical appointments can be a financially viable way to implement effective diabetes education to a large number of patients in primary care settings, the experience of one practice in south Texas demonstrated.

The premise of the shared medical appointment (SMA), first described in 1974 as a model for well-child consultations, is to provide the educational part of a medical appointment once with a large group of patients rather than repeating the same material over and over again on a one-on-one basis.

"Shared medical appointments are a health care delivery model that provide an opportunity to manage chronic illness, and improve quality and patient self-efficacy and self-management," certified diabetes educator Iris Sanchez of the Weslaco (Tex.) Medical Clinic said at the annual meeting of the American Association of Diabetes Educators.

Weslaco is just to the north of the Mexico border. As such, the population is nearly 100% Hispanic and the diabetes rates are high: In the town’s county of Hidalgo, 13.3% of the population have diabetes, compared with 10.3% for the state of Texas and 8.3% for the entire United States. Patients often travel long distances to get to the clinic for medical visits. Based on evidence from a large body of literature, shared medical appointments were seen as a potential way for the clinic to maximize efficiency of delivery of diabetes education while also delivering quality medical care, said Dr. Sanchez, whose report was published online earlier this year (The Diabetes Educator 2011 March 31 [doi:10.1177/0145721711401667).

The program was developed within the context of the chronic care model, a proposed framework for organizing care for patients with chronic conditions that incorporates the elements of community resources and policies, health systems, self-management support, delivery systems design, decision support, and clinical information systems (Milbank Q. 1996;74:511-44).

The clinic employs one physician and two nurse practitioners. The team invited to speak to the group about self-management included a dietician, podiatrist, social worker, exercise physiologist, and others. Flyers were posted in exam rooms and in the lobby to advertise the "Diabetes Days," and ads were placed in the local newspaper in English and Spanish.

The shared medical appointment, including the educational component plus the medical visit, lasted a total of 90 minutes. Patients were called out during the group education session to see the physician or nurse practitioner for their medical visits, and would then return to the room. To maintain confidentiality, individual cases were not discussed during the educational sessions, Dr. Sanchez noted.

Progress notes were kept, and outcomes tracked using an electronic medical record system. Initially scheduled once a week with 12 people in the group, the SMAs have recently been expanded to twice weekly. It’s important to tell patients that the SMAs are not a choice, but are to be kept just as they would a medical appointment. Participation initially varied from 30% to 100%, but now hovers around 90%.

Of 70 patients seen between September and November 2009, 65 had a second visit and 49 a third. Prior to initiation of the program, 75% had not had a urine albumin measurement in the previous 12 months, 34% had not had an eye exam, and 55% were not on daily aspirin. All of these standards of care were implemented as part of the SMA, which resulted in increased revenue from services such as eye exams and urine screens, Dr. Sanchez pointed out.

Average hemoglobin A_1c at initiation was 7.95%. That dropped to 7.48% on second measurement, and rose slightly to 7.51% at a third measurement. For those with a second HbA_1c value, 25 (42%) had an increase and 34 (58%) had a decrease. The differences were not statistically significant, but they were clinically significant, she said.

"Shared medical appointments were appropriate for patients who were motivated and willing to learn. Patients who were not motivated to self manage their disease tended to have higher A_1c levels and did not return to subsequent SMA," Dr. Sanchez noted.

There are billing codes for group diabetes self-management education, G0109 and G0271. However, to use these, a clinic needs to receive certification from the American Diabetes Association, the American Association of Diabetes Educators, or the Indian Health Service. Weslaco is working on receiving that certification, but has not done so yet. However, the practice was able to bill for SMA using evaluation and management codes 99201-99215, which cover the medical appointment part of the visit.

Dr. Sanchez reported having no financial disclosures.

LAS VEGAS – Insulin pump therapy may be cost saving, compared with multiple daily injections for patients with type 2 diabetes who have high insulin dose requirements, according to the results of a small study.

Among high insulin users – those using more than 150 units daily – pump delivery saved more than $12,000 over 4 years because basal rates dropped dramatically owing to better insulin absorption, said certified diabetes educator Phyllis Wolff-McDonagh, DNP, at the annual meeting of the American Association of Diabetes Educators.

Although insulin pump therapy has been well studied and is widely used among patients with type 1 diabetes, evidence backing its use in type 2 diabetes is limited. However, in the few studies that have been done, insulin pumps have been found at least as effective as multiple daily injections at improving hemoglobin A_1c levels, and in some cases they did a better job. None of those studies looked at cost.

In this retrospective feasibility study, Dr. Wolff-McDonagh and her associates analyzed the medical records of 15 adults aged 40-64 years. All 15 patients had started insulin pump therapy within the previous 7 years after failing to achieve HbA_1c levels below 8% despite multiple daily injection (MDI) therapy for at least 1 year (Diabetes Educ. 2010;36:657-65).

At baseline, the mean HbA _1c level was 9.4%. There was a significant 10% decline in HbA _1c level at 3 months, which was maintained at 6 months, but the HbA _1c level was no longer significantly different from baseline at 1 year (9.8%). However, with the removal of a single outlier patient whose HbA _1c had actually increased by 22%, the 1-year 8.2% drop in HbA _1c was significant, compared with baseline, reported Dr. Wolff-McDonagh of the Diabetes and Endocrinology Center of Suffolk, Patchogue, N.Y.

As is often observed in both type 1 and type 2 diabetes patients, the improved glycemic control was associated with a significant increase in body mass index, from 38.6 kg/m² at baseline to 40.0 kg/m² at 1 year, with a leveling off at 6 months. This weight gain is believed to result from a reduction in glycosuria with improved glycemic control, she noted.

There was no significant change from baseline in bolus insulin doses at 3, 6, or 12 months, but basal insulin use was significantly lower than baseline at all three time points. The delivery of continual small amounts of basal insulin – as opposed to a single injection of long-acting basal insulin with MDI – appears to reduce insulin resistance and improve absorption, resulting in a substantial decrease in basal insulin use, she noted.

For the cost analysis, patients were divided into three groups according to the level of basal insulin use prior to pump initiation: a low-dose group (less than 100 units/day), a moderate-dose group (100-150 units/day), and a heavy-use group (more than 150 units/day). Cost calculations included both supplies (syringes or pen needles, pump plus pump supplies) and the insulin.

The cost of MDI, assuming four injections per day, totaled $525/year or $2,100 for 4 years, the length of an insulin pump warranty. Costs of pump therapy were a one-time $5,250 charge for the pump, plus $1,500 per year for supplies, totaling $11,250 for 4 years. For the low-dose patients, MDI was less expensive than pump delivery over the 4 years: $9,172 vs. $14,994. For the moderate-use group, the costs were about equal: $22,380 for MDI and $23,002 for pump therapy.

However, for the heavy-use group, MDI was significantly more expensive than pump therapy: $41,100 vs. $28,826. With the potential cost savings from improved glycemic control factored in, insulin pumps could also prove cost savings even for the moderate-use group, Dr. Wolff-McDonagh pointed out.

Moreover, for patients taking extremely large doses of insulin, using U-500 insulin in the pump – currently an off-label use – offers further potential cost savings: A 20-mL vial of U-500 insulin is about $337, and a 10-mL vial of insulin analogue is about $120. Because U-500 insulin is five times as concentrated, the cost is approximately one-quarter that of U-100 insulin per unit, she noted.

The lack of reimbursement for insulin pump use in patients with type 2 diabetes is a major obstacle to its wider use. Medicare uses C-peptide level to determine pump eligibility, a policy that is not evidence based. "Medicare needs to re-look at this, but before that can happen, large randomized controlled studies need to be done to see what happens over long periods of time," Dr. Wolff-McDonagh said.

Dr. Wolff-McDonagh stated that she had no financial disclosures.

LAS VEGAS – Insulin pump therapy may be cost saving, compared with multiple daily injections for patients with type 2 diabetes who have high insulin dose requirements, according to the results of a small study.

Among high insulin users – those using more than 150 units daily – pump delivery saved more than $12,000 over 4 years because basal rates dropped dramatically owing to better insulin absorption, said certified diabetes educator Phyllis Wolff-McDonagh, DNP, at the annual meeting of the American Association of Diabetes Educators.

Although insulin pump therapy has been well studied and is widely used among patients with type 1 diabetes, evidence backing its use in type 2 diabetes is limited. However, in the few studies that have been done, insulin pumps have been found at least as effective as multiple daily injections at improving hemoglobin A_1c levels, and in some cases they did a better job. None of those studies looked at cost.

In this retrospective feasibility study, Dr. Wolff-McDonagh and her associates analyzed the medical records of 15 adults aged 40-64 years. All 15 patients had started insulin pump therapy within the previous 7 years after failing to achieve HbA_1c levels below 8% despite multiple daily injection (MDI) therapy for at least 1 year (Diabetes Educ. 2010;36:657-65).

At baseline, the mean HbA _1c level was 9.4%. There was a significant 10% decline in HbA _1c level at 3 months, which was maintained at 6 months, but the HbA _1c level was no longer significantly different from baseline at 1 year (9.8%). However, with the removal of a single outlier patient whose HbA _1c had actually increased by 22%, the 1-year 8.2% drop in HbA _1c was significant, compared with baseline, reported Dr. Wolff-McDonagh of the Diabetes and Endocrinology Center of Suffolk, Patchogue, N.Y.

As is often observed in both type 1 and type 2 diabetes patients, the improved glycemic control was associated with a significant increase in body mass index, from 38.6 kg/m² at baseline to 40.0 kg/m² at 1 year, with a leveling off at 6 months. This weight gain is believed to result from a reduction in glycosuria with improved glycemic control, she noted.

There was no significant change from baseline in bolus insulin doses at 3, 6, or 12 months, but basal insulin use was significantly lower than baseline at all three time points. The delivery of continual small amounts of basal insulin – as opposed to a single injection of long-acting basal insulin with MDI – appears to reduce insulin resistance and improve absorption, resulting in a substantial decrease in basal insulin use, she noted.

For the cost analysis, patients were divided into three groups according to the level of basal insulin use prior to pump initiation: a low-dose group (less than 100 units/day), a moderate-dose group (100-150 units/day), and a heavy-use group (more than 150 units/day). Cost calculations included both supplies (syringes or pen needles, pump plus pump supplies) and the insulin.

The cost of MDI, assuming four injections per day, totaled $525/year or $2,100 for 4 years, the length of an insulin pump warranty. Costs of pump therapy were a one-time $5,250 charge for the pump, plus $1,500 per year for supplies, totaling $11,250 for 4 years. For the low-dose patients, MDI was less expensive than pump delivery over the 4 years: $9,172 vs. $14,994. For the moderate-use group, the costs were about equal: $22,380 for MDI and $23,002 for pump therapy.

However, for the heavy-use group, MDI was significantly more expensive than pump therapy: $41,100 vs. $28,826. With the potential cost savings from improved glycemic control factored in, insulin pumps could also prove cost savings even for the moderate-use group, Dr. Wolff-McDonagh pointed out.

Moreover, for patients taking extremely large doses of insulin, using U-500 insulin in the pump – currently an off-label use – offers further potential cost savings: A 20-mL vial of U-500 insulin is about $337, and a 10-mL vial of insulin analogue is about $120. Because U-500 insulin is five times as concentrated, the cost is approximately one-quarter that of U-100 insulin per unit, she noted.

The lack of reimbursement for insulin pump use in patients with type 2 diabetes is a major obstacle to its wider use. Medicare uses C-peptide level to determine pump eligibility, a policy that is not evidence based. "Medicare needs to re-look at this, but before that can happen, large randomized controlled studies need to be done to see what happens over long periods of time," Dr. Wolff-McDonagh said.

Dr. Wolff-McDonagh stated that she had no financial disclosures.

LAS VEGAS – Insulin pump therapy may be cost saving, compared with multiple daily injections for patients with type 2 diabetes who have high insulin dose requirements, according to the results of a small study.

Among high insulin users – those using more than 150 units daily – pump delivery saved more than $12,000 over 4 years because basal rates dropped dramatically owing to better insulin absorption, said certified diabetes educator Phyllis Wolff-McDonagh, DNP, at the annual meeting of the American Association of Diabetes Educators.

Although insulin pump therapy has been well studied and is widely used among patients with type 1 diabetes, evidence backing its use in type 2 diabetes is limited. However, in the few studies that have been done, insulin pumps have been found at least as effective as multiple daily injections at improving hemoglobin A_1c levels, and in some cases they did a better job. None of those studies looked at cost.

In this retrospective feasibility study, Dr. Wolff-McDonagh and her associates analyzed the medical records of 15 adults aged 40-64 years. All 15 patients had started insulin pump therapy within the previous 7 years after failing to achieve HbA_1c levels below 8% despite multiple daily injection (MDI) therapy for at least 1 year (Diabetes Educ. 2010;36:657-65).

At baseline, the mean HbA _1c level was 9.4%. There was a significant 10% decline in HbA _1c level at 3 months, which was maintained at 6 months, but the HbA _1c level was no longer significantly different from baseline at 1 year (9.8%). However, with the removal of a single outlier patient whose HbA _1c had actually increased by 22%, the 1-year 8.2% drop in HbA _1c was significant, compared with baseline, reported Dr. Wolff-McDonagh of the Diabetes and Endocrinology Center of Suffolk, Patchogue, N.Y.

As is often observed in both type 1 and type 2 diabetes patients, the improved glycemic control was associated with a significant increase in body mass index, from 38.6 kg/m² at baseline to 40.0 kg/m² at 1 year, with a leveling off at 6 months. This weight gain is believed to result from a reduction in glycosuria with improved glycemic control, she noted.

There was no significant change from baseline in bolus insulin doses at 3, 6, or 12 months, but basal insulin use was significantly lower than baseline at all three time points. The delivery of continual small amounts of basal insulin – as opposed to a single injection of long-acting basal insulin with MDI – appears to reduce insulin resistance and improve absorption, resulting in a substantial decrease in basal insulin use, she noted.

For the cost analysis, patients were divided into three groups according to the level of basal insulin use prior to pump initiation: a low-dose group (less than 100 units/day), a moderate-dose group (100-150 units/day), and a heavy-use group (more than 150 units/day). Cost calculations included both supplies (syringes or pen needles, pump plus pump supplies) and the insulin.

The cost of MDI, assuming four injections per day, totaled $525/year or $2,100 for 4 years, the length of an insulin pump warranty. Costs of pump therapy were a one-time $5,250 charge for the pump, plus $1,500 per year for supplies, totaling $11,250 for 4 years. For the low-dose patients, MDI was less expensive than pump delivery over the 4 years: $9,172 vs. $14,994. For the moderate-use group, the costs were about equal: $22,380 for MDI and $23,002 for pump therapy.

However, for the heavy-use group, MDI was significantly more expensive than pump therapy: $41,100 vs. $28,826. With the potential cost savings from improved glycemic control factored in, insulin pumps could also prove cost savings even for the moderate-use group, Dr. Wolff-McDonagh pointed out.

Moreover, for patients taking extremely large doses of insulin, using U-500 insulin in the pump – currently an off-label use – offers further potential cost savings: A 20-mL vial of U-500 insulin is about $337, and a 10-mL vial of insulin analogue is about $120. Because U-500 insulin is five times as concentrated, the cost is approximately one-quarter that of U-100 insulin per unit, she noted.

The lack of reimbursement for insulin pump use in patients with type 2 diabetes is a major obstacle to its wider use. Medicare uses C-peptide level to determine pump eligibility, a policy that is not evidence based. "Medicare needs to re-look at this, but before that can happen, large randomized controlled studies need to be done to see what happens over long periods of time," Dr. Wolff-McDonagh said.

Dr. Wolff-McDonagh stated that she had no financial disclosures.

LAS VEGAS – The investigational, controlled-release phentermine/topiramate combination produced significant weight loss that was associated with significantly improved quality of life in two studies of overweight and obese individuals.

Vivus Inc., which sponsored the studies, is developing the once-daily oral, controlled-release formulation of low-dose phentermine plus topiramate under the name Qnexa. Designed to decrease appetite and increase satiety, the combination treatment has completed phase III clinical trials for the treatment of obesity and is currently under evaluation by the U.S. Food and Drug Administration for that indication. It also is in phase II trials for the treatment of type 2 diabetes and obstructive sleep apnea, according to a company statement.

Ronette L. Kolotkin, Ph.D., summarized the 56-week weight loss data for Qnexa at the annual meeting of the American Association of Diabetes Educators, and presented new findings on quality of life from two phase III, double-blind, placebo-controlled trials. One study (EQUIP) enrolled 1,267 subjects with body mass indexes of 35 kg/m² or greater. The other (CONQUER) enrolled 2,487 patients who had BMIs of 27-45 plus two or more comorbidities, such as diabetes, dyslipidemia, or hypertension.

In the EQUIP trial, subjects were randomized to 3.75-mg phentermine/23-mg topiramate, 15-mg phentermine/92-mg topiramate, or placebo. They were mostly women (83%), with a mean age of 43 years and mean BMI of 42. Among those who completed 56 weeks of treatment, the percentage of weight loss was 3% for placebo, 7% for the lower dose, and 15% for the higher dose. In the intent-to-treat (ITT) analysis with the last observation carried forward (LOCF), the weight loss percentages were 2%, 5%, and 11%, respectively, said Dr. Kolotkin, a clinical psychologist, researcher, and consultant with Obesity and Quality of Life Consulting, Durham, N.C.

In the CONQUER trial, two-thirds of the patients were women, with a mean age of 51 years and a mean BMI of 37. They were randomized to 7.5-mg phentermine/46-mg topiramate, 15-mg phentermine/92-mg topiramate, or placebo. At 56 weeks, the completers had lost 2% of their body weight with placebo, 11% with the lower dose, and 13% with the higher dose. In the ITT/LOCF analysis, the weight loss percentages were 1%, 8%, and 10%, respectively. In both studies, weight loss was statistically significant for both drug doses but not for placebo, Dr. Kolotkin said.

Two measures were used to assess health-related quality of life (HRQOL). One, the Impact of Weight on Quality of Life–Lite (IWQOL-Lite), is a 31-item survey, each beginning with the phrase "Because of my weight...," with five possible responses ranging from "Never true" to "Always true." Domains include physical function ("...I have trouble tying my shoe"), self-esteem ("I’m afraid of being rejected"), sexual life ("I do not enjoy sexual activity"), public distress ("I experience ridicule, teasing, etc."), and work ("I am less productive than I could be"). Scoring is on a 0-100 scale, with a higher score signifying better HRQOL.

The other measure, the Study Short Form–36 (SF-36), assesses general HRQOL with a 36-item survey pertaining to physical and mental/psychosocial health, each with four health domains. Scoring is also on a 0-100 scale, with higher being better

Results of the Quality of Life Studies

At 56 weeks in the ITT-LOCF analysis, IWQOL score changes were significantly better for both treatment groups than for placebo. With the higher dose, score increases ranged from 7 for work to 16 for self-esteem in EQUIP and from 8 for public distress to 16 for self-esteem in CONQUER.

On the SF-36, in CONQUER there were statistically significant increases from baseline to 56 weeks in the areas of physical functioning, physical role functioning, bodily pain, general health, vitality, and the overall physical component summary score. However, changes in the overall mental component, social functioning, emotional role functioning, and mental health were not significant, Dr. Kolotkin reported.

Further evaluation assessed the degree to which the changes were meaningful, with the definition of "meaningful" on the IWQOL-Lite total score as an increase of 8-12 points, depending on score severity at baseline (J. Clin. Epidemiol. 2004;57:1153-60).

In EQUIP, the proportions of patients achieving a meaningful change in weight-related quality of life were 30% with placebo, 37% with the lower phentermine/topiramate dose, and 49% with the higher dose.

In CONQUER, meaningful improvement on IWQOL-Lite occurred in 36% of the placebo patients, compared with 52% of each of the two doses of phentermine/topiramate. Similar results in CONQUER were seen with the SF-36, for which meaningful improvement was defined as an increase of 2.5 or more points. Those percentages were 36% for placebo, 55% for the lower dose, and 53% for the higher dose, she reported.

Not surprisingly, improvement in quality of life was directly related to amount of weight lost. In EQUIP, those losing less than 5% of their body weight had a mean change of 5 points on the IWQOL-Lite at 56 weeks, compared with 17 points for those who lost 10% or more of their body weight. Similar results were seen on the IWQOL-Lite in CONQUER (from 6 vs. 18 points, respectively), and on the SF-36 in CONQUER (2 vs. 6 points).

"Quality of life is an important health outcome in its own right, representing the ultimate goal of all health interventions," Dr. Kolotkin said, quoting Dr. Richard Rubin (Diabetes Metab. Res. Rev. 1999;15:205-18). And, she added, "Improved HRQOL has been shown to improve diabetes self-management, which is likely, in turn, to slow disease progression."

Separately, Miriam M. Rueger, R.N., a certified diabetes educator at the University of Alabama at Birmingham, and her associates presented data showing sustained weight loss among the CONQUER patients in a 52-week extension trial (SEQUEL).

In the double-blind, placebo-controlled extension study of subjects who completed 56 weeks of treatment in CONQUER and enrolled in SEQUEL, the original randomization was maintained in a total of 675 patients for an additional 52 weeks, with 227 continuing to receive placebo, 153 the lower phentermine/topiramate dose, and 295 the higher dose. In the ITT-LOCF analysis at 108 weeks, significantly greater weight loss was achieved with both the lower and higher drug doses, compared with placebo (9% and 11%, respectively, compared with 2%). The proportions of those achieving a body weight loss of 10% or more were 54% and 50% for the higher and lower doses, respectively, vs. just 12% with placebo, said Ms. Rueger.

The proportion of patients who discontinued the study because of adverse events was low and did not differ between groups, ranging from 3% with placebo to 5% with the lower drug dose, they said.

All studies were funded by Vivus. Dr. Kolotkin and Ms. Rueger reported having no further disclosures.

LAS VEGAS – The investigational, controlled-release phentermine/topiramate combination produced significant weight loss that was associated with significantly improved quality of life in two studies of overweight and obese individuals.

Vivus Inc., which sponsored the studies, is developing the once-daily oral, controlled-release formulation of low-dose phentermine plus topiramate under the name Qnexa. Designed to decrease appetite and increase satiety, the combination treatment has completed phase III clinical trials for the treatment of obesity and is currently under evaluation by the U.S. Food and Drug Administration for that indication. It also is in phase II trials for the treatment of type 2 diabetes and obstructive sleep apnea, according to a company statement.

Ronette L. Kolotkin, Ph.D., summarized the 56-week weight loss data for Qnexa at the annual meeting of the American Association of Diabetes Educators, and presented new findings on quality of life from two phase III, double-blind, placebo-controlled trials. One study (EQUIP) enrolled 1,267 subjects with body mass indexes of 35 kg/m² or greater. The other (CONQUER) enrolled 2,487 patients who had BMIs of 27-45 plus two or more comorbidities, such as diabetes, dyslipidemia, or hypertension.

In the EQUIP trial, subjects were randomized to 3.75-mg phentermine/23-mg topiramate, 15-mg phentermine/92-mg topiramate, or placebo. They were mostly women (83%), with a mean age of 43 years and mean BMI of 42. Among those who completed 56 weeks of treatment, the percentage of weight loss was 3% for placebo, 7% for the lower dose, and 15% for the higher dose. In the intent-to-treat (ITT) analysis with the last observation carried forward (LOCF), the weight loss percentages were 2%, 5%, and 11%, respectively, said Dr. Kolotkin, a clinical psychologist, researcher, and consultant with Obesity and Quality of Life Consulting, Durham, N.C.

In the CONQUER trial, two-thirds of the patients were women, with a mean age of 51 years and a mean BMI of 37. They were randomized to 7.5-mg phentermine/46-mg topiramate, 15-mg phentermine/92-mg topiramate, or placebo. At 56 weeks, the completers had lost 2% of their body weight with placebo, 11% with the lower dose, and 13% with the higher dose. In the ITT/LOCF analysis, the weight loss percentages were 1%, 8%, and 10%, respectively. In both studies, weight loss was statistically significant for both drug doses but not for placebo, Dr. Kolotkin said.

Two measures were used to assess health-related quality of life (HRQOL). One, the Impact of Weight on Quality of Life–Lite (IWQOL-Lite), is a 31-item survey, each beginning with the phrase "Because of my weight...," with five possible responses ranging from "Never true" to "Always true." Domains include physical function ("...I have trouble tying my shoe"), self-esteem ("I’m afraid of being rejected"), sexual life ("I do not enjoy sexual activity"), public distress ("I experience ridicule, teasing, etc."), and work ("I am less productive than I could be"). Scoring is on a 0-100 scale, with a higher score signifying better HRQOL.

The other measure, the Study Short Form–36 (SF-36), assesses general HRQOL with a 36-item survey pertaining to physical and mental/psychosocial health, each with four health domains. Scoring is also on a 0-100 scale, with higher being better

Results of the Quality of Life Studies

At 56 weeks in the ITT-LOCF analysis, IWQOL score changes were significantly better for both treatment groups than for placebo. With the higher dose, score increases ranged from 7 for work to 16 for self-esteem in EQUIP and from 8 for public distress to 16 for self-esteem in CONQUER.

On the SF-36, in CONQUER there were statistically significant increases from baseline to 56 weeks in the areas of physical functioning, physical role functioning, bodily pain, general health, vitality, and the overall physical component summary score. However, changes in the overall mental component, social functioning, emotional role functioning, and mental health were not significant, Dr. Kolotkin reported.

Further evaluation assessed the degree to which the changes were meaningful, with the definition of "meaningful" on the IWQOL-Lite total score as an increase of 8-12 points, depending on score severity at baseline (J. Clin. Epidemiol. 2004;57:1153-60).

In EQUIP, the proportions of patients achieving a meaningful change in weight-related quality of life were 30% with placebo, 37% with the lower phentermine/topiramate dose, and 49% with the higher dose.

In CONQUER, meaningful improvement on IWQOL-Lite occurred in 36% of the placebo patients, compared with 52% of each of the two doses of phentermine/topiramate. Similar results in CONQUER were seen with the SF-36, for which meaningful improvement was defined as an increase of 2.5 or more points. Those percentages were 36% for placebo, 55% for the lower dose, and 53% for the higher dose, she reported.

Not surprisingly, improvement in quality of life was directly related to amount of weight lost. In EQUIP, those losing less than 5% of their body weight had a mean change of 5 points on the IWQOL-Lite at 56 weeks, compared with 17 points for those who lost 10% or more of their body weight. Similar results were seen on the IWQOL-Lite in CONQUER (from 6 vs. 18 points, respectively), and on the SF-36 in CONQUER (2 vs. 6 points).

"Quality of life is an important health outcome in its own right, representing the ultimate goal of all health interventions," Dr. Kolotkin said, quoting Dr. Richard Rubin (Diabetes Metab. Res. Rev. 1999;15:205-18). And, she added, "Improved HRQOL has been shown to improve diabetes self-management, which is likely, in turn, to slow disease progression."

Separately, Miriam M. Rueger, R.N., a certified diabetes educator at the University of Alabama at Birmingham, and her associates presented data showing sustained weight loss among the CONQUER patients in a 52-week extension trial (SEQUEL).

In the double-blind, placebo-controlled extension study of subjects who completed 56 weeks of treatment in CONQUER and enrolled in SEQUEL, the original randomization was maintained in a total of 675 patients for an additional 52 weeks, with 227 continuing to receive placebo, 153 the lower phentermine/topiramate dose, and 295 the higher dose. In the ITT-LOCF analysis at 108 weeks, significantly greater weight loss was achieved with both the lower and higher drug doses, compared with placebo (9% and 11%, respectively, compared with 2%). The proportions of those achieving a body weight loss of 10% or more were 54% and 50% for the higher and lower doses, respectively, vs. just 12% with placebo, said Ms. Rueger.

The proportion of patients who discontinued the study because of adverse events was low and did not differ between groups, ranging from 3% with placebo to 5% with the lower drug dose, they said.

All studies were funded by Vivus. Dr. Kolotkin and Ms. Rueger reported having no further disclosures.

LAS VEGAS – The investigational, controlled-release phentermine/topiramate combination produced significant weight loss that was associated with significantly improved quality of life in two studies of overweight and obese individuals.

Vivus Inc., which sponsored the studies, is developing the once-daily oral, controlled-release formulation of low-dose phentermine plus topiramate under the name Qnexa. Designed to decrease appetite and increase satiety, the combination treatment has completed phase III clinical trials for the treatment of obesity and is currently under evaluation by the U.S. Food and Drug Administration for that indication. It also is in phase II trials for the treatment of type 2 diabetes and obstructive sleep apnea, according to a company statement.

Ronette L. Kolotkin, Ph.D., summarized the 56-week weight loss data for Qnexa at the annual meeting of the American Association of Diabetes Educators, and presented new findings on quality of life from two phase III, double-blind, placebo-controlled trials. One study (EQUIP) enrolled 1,267 subjects with body mass indexes of 35 kg/m² or greater. The other (CONQUER) enrolled 2,487 patients who had BMIs of 27-45 plus two or more comorbidities, such as diabetes, dyslipidemia, or hypertension.

In the EQUIP trial, subjects were randomized to 3.75-mg phentermine/23-mg topiramate, 15-mg phentermine/92-mg topiramate, or placebo. They were mostly women (83%), with a mean age of 43 years and mean BMI of 42. Among those who completed 56 weeks of treatment, the percentage of weight loss was 3% for placebo, 7% for the lower dose, and 15% for the higher dose. In the intent-to-treat (ITT) analysis with the last observation carried forward (LOCF), the weight loss percentages were 2%, 5%, and 11%, respectively, said Dr. Kolotkin, a clinical psychologist, researcher, and consultant with Obesity and Quality of Life Consulting, Durham, N.C.

In the CONQUER trial, two-thirds of the patients were women, with a mean age of 51 years and a mean BMI of 37. They were randomized to 7.5-mg phentermine/46-mg topiramate, 15-mg phentermine/92-mg topiramate, or placebo. At 56 weeks, the completers had lost 2% of their body weight with placebo, 11% with the lower dose, and 13% with the higher dose. In the ITT/LOCF analysis, the weight loss percentages were 1%, 8%, and 10%, respectively. In both studies, weight loss was statistically significant for both drug doses but not for placebo, Dr. Kolotkin said.

Two measures were used to assess health-related quality of life (HRQOL). One, the Impact of Weight on Quality of Life–Lite (IWQOL-Lite), is a 31-item survey, each beginning with the phrase "Because of my weight...," with five possible responses ranging from "Never true" to "Always true." Domains include physical function ("...I have trouble tying my shoe"), self-esteem ("I’m afraid of being rejected"), sexual life ("I do not enjoy sexual activity"), public distress ("I experience ridicule, teasing, etc."), and work ("I am less productive than I could be"). Scoring is on a 0-100 scale, with a higher score signifying better HRQOL.

The other measure, the Study Short Form–36 (SF-36), assesses general HRQOL with a 36-item survey pertaining to physical and mental/psychosocial health, each with four health domains. Scoring is also on a 0-100 scale, with higher being better

Results of the Quality of Life Studies

At 56 weeks in the ITT-LOCF analysis, IWQOL score changes were significantly better for both treatment groups than for placebo. With the higher dose, score increases ranged from 7 for work to 16 for self-esteem in EQUIP and from 8 for public distress to 16 for self-esteem in CONQUER.

On the SF-36, in CONQUER there were statistically significant increases from baseline to 56 weeks in the areas of physical functioning, physical role functioning, bodily pain, general health, vitality, and the overall physical component summary score. However, changes in the overall mental component, social functioning, emotional role functioning, and mental health were not significant, Dr. Kolotkin reported.

Further evaluation assessed the degree to which the changes were meaningful, with the definition of "meaningful" on the IWQOL-Lite total score as an increase of 8-12 points, depending on score severity at baseline (J. Clin. Epidemiol. 2004;57:1153-60).

In EQUIP, the proportions of patients achieving a meaningful change in weight-related quality of life were 30% with placebo, 37% with the lower phentermine/topiramate dose, and 49% with the higher dose.

In CONQUER, meaningful improvement on IWQOL-Lite occurred in 36% of the placebo patients, compared with 52% of each of the two doses of phentermine/topiramate. Similar results in CONQUER were seen with the SF-36, for which meaningful improvement was defined as an increase of 2.5 or more points. Those percentages were 36% for placebo, 55% for the lower dose, and 53% for the higher dose, she reported.

Not surprisingly, improvement in quality of life was directly related to amount of weight lost. In EQUIP, those losing less than 5% of their body weight had a mean change of 5 points on the IWQOL-Lite at 56 weeks, compared with 17 points for those who lost 10% or more of their body weight. Similar results were seen on the IWQOL-Lite in CONQUER (from 6 vs. 18 points, respectively), and on the SF-36 in CONQUER (2 vs. 6 points).

"Quality of life is an important health outcome in its own right, representing the ultimate goal of all health interventions," Dr. Kolotkin said, quoting Dr. Richard Rubin (Diabetes Metab. Res. Rev. 1999;15:205-18). And, she added, "Improved HRQOL has been shown to improve diabetes self-management, which is likely, in turn, to slow disease progression."

Separately, Miriam M. Rueger, R.N., a certified diabetes educator at the University of Alabama at Birmingham, and her associates presented data showing sustained weight loss among the CONQUER patients in a 52-week extension trial (SEQUEL).

In the double-blind, placebo-controlled extension study of subjects who completed 56 weeks of treatment in CONQUER and enrolled in SEQUEL, the original randomization was maintained in a total of 675 patients for an additional 52 weeks, with 227 continuing to receive placebo, 153 the lower phentermine/topiramate dose, and 295 the higher dose. In the ITT-LOCF analysis at 108 weeks, significantly greater weight loss was achieved with both the lower and higher drug doses, compared with placebo (9% and 11%, respectively, compared with 2%). The proportions of those achieving a body weight loss of 10% or more were 54% and 50% for the higher and lower doses, respectively, vs. just 12% with placebo, said Ms. Rueger.

The proportion of patients who discontinued the study because of adverse events was low and did not differ between groups, ranging from 3% with placebo to 5% with the lower drug dose, they said.

All studies were funded by Vivus. Dr. Kolotkin and Ms. Rueger reported having no further disclosures.

LAS VEGAS – An outpatient protocol allowed for successful management of acute hyperglycemia in 20 of 27 patients who presented in a primary care setting with blood sugar levels 400 mg/dL or higher.

Inpatient protocols for managing diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar syndrome (HHS) are well defined, with a strong evidence base, yet no such protocols exist for managing acute hyperglycemia in outpatient settings. Some data suggest that type 1 diabetes patients with mild DKA can be managed with subcutaneous rapid-acting insulin analogs in an outpatient setting (Diabetes Care 2004;27:1873-8), but it is currently unknown if symptomatic, mild hyperglycemia in type 2 diabetes patients can be managed adequately in such settings, said certified diabetes educator Becky Armor, PharmD., of the University of Oklahoma, Oklahoma City.

The study enrolled patients who were identified by the physician or nurse as having a fingerstick blood glucose level of 400 mg/dL or above, but who did not have an acute illness, moderate to large ketones, a venous glucose level of 700 mg/dL or higher, or new-onset diabetes. The setting was a freestanding academic family medicine practice that included a full-time diabetes clinic that serves more than 2,500 patients (Diabetes Ther. 2011;2:67-80).

The objective of the study was to determine if the protocol could push blood glucose levels below 300 mg/dL within a 4-hour window, Dr. Armor said.

The hyperglycemia protocol called for patients to be given 0.15 U/kg of rapid-acting insulin, injected subcutaneously into the abdomen (where absorption is fastest). Fingerstick blood glucose testing was done hourly. Lab work included a basic metabolic panel, urinalysis, and blood ketones. Hydration of 1,000 mL or more was given orally or intravenously. Diabetes drug therapy was reestablished. Sick-day management guidelines were reviewed with patients, many of whom had been unaware of them. Patients also were referred for more intensive diabetes management and were given instructions and told to return for follow-up within 72 hours.

Initial fingerstick glucose values could not be assessed in 4 of the 27 patients because the monitor used did not read above 600 mg/dL and simply read as "high." In the other 23 patients, average initial blood glucose was 484 mg/dL. For all 27, the final value achieved was 274 mg/dL, with an average time to achieving less than 300 mg/dL of 2.35 hours.

The protocol was successful in 20 of the 27 patients enrolled (74%). The reasons for lack of success in the other seven patients were not related to clinical issues but rather included transportation and/or communication problems, such as the patient having to leave to catch the last bus and then being unreachable by phone. One patient developed large blood ketones and was referred to the emergency department, Dr. Armor noted.

Predictors of protocol failure, assessed by logistic regression, included age greater than 65 years (both such patients failed the protocol), and "personal stress," such as loss of a job or serious illness of another family member. Indeed, the protocol succeeded in 85% of those without stress, while only 43% of those with personal stress were protocol successes. This is to be expected because the "stress hormones" cortisol and norepinephrine counter the effectiveness of insulin, she said.

Initial venous glucose also predicted success, with a mean of 351 mg/dL in the success group versus 406 mg/dL in the failure group, although the difference was not statistically significant.

"Primary care clinics need improved chronic care models, because keeping patients with diabetes in a system of care allows for resolution of issues leading up to acute hyperglycemic episodes. Managing acute hyperglycemia in the outpatient setting could potentially decrease the frequency of hyperglycemia and diabetes emergencies, and DKA- and HHS-related hospital admissions," Dr. Armor concluded.

The study was funded by the University of Oklahoma College of Pharmacy, Tulsa. Dr. Armor stated that she had no conflicts of interest.

LAS VEGAS – An outpatient protocol allowed for successful management of acute hyperglycemia in 20 of 27 patients who presented in a primary care setting with blood sugar levels 400 mg/dL or higher.

Inpatient protocols for managing diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar syndrome (HHS) are well defined, with a strong evidence base, yet no such protocols exist for managing acute hyperglycemia in outpatient settings. Some data suggest that type 1 diabetes patients with mild DKA can be managed with subcutaneous rapid-acting insulin analogs in an outpatient setting (Diabetes Care 2004;27:1873-8), but it is currently unknown if symptomatic, mild hyperglycemia in type 2 diabetes patients can be managed adequately in such settings, said certified diabetes educator Becky Armor, PharmD., of the University of Oklahoma, Oklahoma City.

The study enrolled patients who were identified by the physician or nurse as having a fingerstick blood glucose level of 400 mg/dL or above, but who did not have an acute illness, moderate to large ketones, a venous glucose level of 700 mg/dL or higher, or new-onset diabetes. The setting was a freestanding academic family medicine practice that included a full-time diabetes clinic that serves more than 2,500 patients (Diabetes Ther. 2011;2:67-80).

The objective of the study was to determine if the protocol could push blood glucose levels below 300 mg/dL within a 4-hour window, Dr. Armor said.

The hyperglycemia protocol called for patients to be given 0.15 U/kg of rapid-acting insulin, injected subcutaneously into the abdomen (where absorption is fastest). Fingerstick blood glucose testing was done hourly. Lab work included a basic metabolic panel, urinalysis, and blood ketones. Hydration of 1,000 mL or more was given orally or intravenously. Diabetes drug therapy was reestablished. Sick-day management guidelines were reviewed with patients, many of whom had been unaware of them. Patients also were referred for more intensive diabetes management and were given instructions and told to return for follow-up within 72 hours.

Initial fingerstick glucose values could not be assessed in 4 of the 27 patients because the monitor used did not read above 600 mg/dL and simply read as "high." In the other 23 patients, average initial blood glucose was 484 mg/dL. For all 27, the final value achieved was 274 mg/dL, with an average time to achieving less than 300 mg/dL of 2.35 hours.

The protocol was successful in 20 of the 27 patients enrolled (74%). The reasons for lack of success in the other seven patients were not related to clinical issues but rather included transportation and/or communication problems, such as the patient having to leave to catch the last bus and then being unreachable by phone. One patient developed large blood ketones and was referred to the emergency department, Dr. Armor noted.

Predictors of protocol failure, assessed by logistic regression, included age greater than 65 years (both such patients failed the protocol), and "personal stress," such as loss of a job or serious illness of another family member. Indeed, the protocol succeeded in 85% of those without stress, while only 43% of those with personal stress were protocol successes. This is to be expected because the "stress hormones" cortisol and norepinephrine counter the effectiveness of insulin, she said.

Initial venous glucose also predicted success, with a mean of 351 mg/dL in the success group versus 406 mg/dL in the failure group, although the difference was not statistically significant.

"Primary care clinics need improved chronic care models, because keeping patients with diabetes in a system of care allows for resolution of issues leading up to acute hyperglycemic episodes. Managing acute hyperglycemia in the outpatient setting could potentially decrease the frequency of hyperglycemia and diabetes emergencies, and DKA- and HHS-related hospital admissions," Dr. Armor concluded.

The study was funded by the University of Oklahoma College of Pharmacy, Tulsa. Dr. Armor stated that she had no conflicts of interest.

LAS VEGAS – An outpatient protocol allowed for successful management of acute hyperglycemia in 20 of 27 patients who presented in a primary care setting with blood sugar levels 400 mg/dL or higher.

Inpatient protocols for managing diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar syndrome (HHS) are well defined, with a strong evidence base, yet no such protocols exist for managing acute hyperglycemia in outpatient settings. Some data suggest that type 1 diabetes patients with mild DKA can be managed with subcutaneous rapid-acting insulin analogs in an outpatient setting (Diabetes Care 2004;27:1873-8), but it is currently unknown if symptomatic, mild hyperglycemia in type 2 diabetes patients can be managed adequately in such settings, said certified diabetes educator Becky Armor, PharmD., of the University of Oklahoma, Oklahoma City.

The study enrolled patients who were identified by the physician or nurse as having a fingerstick blood glucose level of 400 mg/dL or above, but who did not have an acute illness, moderate to large ketones, a venous glucose level of 700 mg/dL or higher, or new-onset diabetes. The setting was a freestanding academic family medicine practice that included a full-time diabetes clinic that serves more than 2,500 patients (Diabetes Ther. 2011;2:67-80).

The objective of the study was to determine if the protocol could push blood glucose levels below 300 mg/dL within a 4-hour window, Dr. Armor said.

The hyperglycemia protocol called for patients to be given 0.15 U/kg of rapid-acting insulin, injected subcutaneously into the abdomen (where absorption is fastest). Fingerstick blood glucose testing was done hourly. Lab work included a basic metabolic panel, urinalysis, and blood ketones. Hydration of 1,000 mL or more was given orally or intravenously. Diabetes drug therapy was reestablished. Sick-day management guidelines were reviewed with patients, many of whom had been unaware of them. Patients also were referred for more intensive diabetes management and were given instructions and told to return for follow-up within 72 hours.

Initial fingerstick glucose values could not be assessed in 4 of the 27 patients because the monitor used did not read above 600 mg/dL and simply read as "high." In the other 23 patients, average initial blood glucose was 484 mg/dL. For all 27, the final value achieved was 274 mg/dL, with an average time to achieving less than 300 mg/dL of 2.35 hours.

The protocol was successful in 20 of the 27 patients enrolled (74%). The reasons for lack of success in the other seven patients were not related to clinical issues but rather included transportation and/or communication problems, such as the patient having to leave to catch the last bus and then being unreachable by phone. One patient developed large blood ketones and was referred to the emergency department, Dr. Armor noted.

Predictors of protocol failure, assessed by logistic regression, included age greater than 65 years (both such patients failed the protocol), and "personal stress," such as loss of a job or serious illness of another family member. Indeed, the protocol succeeded in 85% of those without stress, while only 43% of those with personal stress were protocol successes. This is to be expected because the "stress hormones" cortisol and norepinephrine counter the effectiveness of insulin, she said.

Initial venous glucose also predicted success, with a mean of 351 mg/dL in the success group versus 406 mg/dL in the failure group, although the difference was not statistically significant.

"Primary care clinics need improved chronic care models, because keeping patients with diabetes in a system of care allows for resolution of issues leading up to acute hyperglycemic episodes. Managing acute hyperglycemia in the outpatient setting could potentially decrease the frequency of hyperglycemia and diabetes emergencies, and DKA- and HHS-related hospital admissions," Dr. Armor concluded.

The study was funded by the University of Oklahoma College of Pharmacy, Tulsa. Dr. Armor stated that she had no conflicts of interest.