Hypoglycemia Common Among Diabetic Children Under 7 Years of Age

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STOCKHOLM – Hypoglycemia occurred an average of nearly five times a week among 14 children with type 1 diabetes aged younger than 7 years who were evaluated in a prospective study.

“We need to identify age-specific strategies to improve insulin treatment for preschool children,” said Dr. Frida Sundberg of Queen Silvia Children’s Hospital, Gothenburg, Sweden.

The study included 14 children seen at the hospital who met the inclusion criteria of less than 7 years of age, a type 1 diabetes duration of more than 3 months, and the ability of the parents to upload at least 300 days’ worth of glucose values from the child’s glucose meter. Data were collected prospectively from autumn 2008 until autumn 2009. The eight boys and six girls had a mean age of 4.8 years and diabetes duration of 2.4 years.

Eleven were on pump therapy and three were on multiple injections at the start of the study, and one shifted to a pump during the year. They had a mean hemoglobin A1c value of 7.8%, with seven of the children achieving the target of less than 7.5% recommended by the International Society for Pediatric and Adolescent Diabetes, Dr. Sundberg reported.

They averaged 7.8 self blood glucose measurements per day, including a mean of 1.2 readings during the night (10:00 p.m.-6:00 a.m.). Hypoglycemia, defined as a value less than 4 mmol/L (72 mg/dL), occurred an average of 0.66 times per day/4.6 times per week. The mean number of nights with detected hypoglycemia was 21 (4-42) per patient year, or 6% of all nights. Severe hypoglycemia, defined as seizures or unconsciousness, was reported twice by one child and once by another, for a rate of 21 events per 100 patient years.

“Further data on how to balance nutrition, insulin, and physical activity in order to achieve good glycemic control, and thereby preserve health and quality of life in the short and long perspective are needed,” she concluded.

This study was supported by Barndiabetesfonden. Dr. Sundberg stated that she had no further disclosures.

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STOCKHOLM – Hypoglycemia occurred an average of nearly five times a week among 14 children with type 1 diabetes aged younger than 7 years who were evaluated in a prospective study.

“We need to identify age-specific strategies to improve insulin treatment for preschool children,” said Dr. Frida Sundberg of Queen Silvia Children’s Hospital, Gothenburg, Sweden.

The study included 14 children seen at the hospital who met the inclusion criteria of less than 7 years of age, a type 1 diabetes duration of more than 3 months, and the ability of the parents to upload at least 300 days’ worth of glucose values from the child’s glucose meter. Data were collected prospectively from autumn 2008 until autumn 2009. The eight boys and six girls had a mean age of 4.8 years and diabetes duration of 2.4 years.

Eleven were on pump therapy and three were on multiple injections at the start of the study, and one shifted to a pump during the year. They had a mean hemoglobin A1c value of 7.8%, with seven of the children achieving the target of less than 7.5% recommended by the International Society for Pediatric and Adolescent Diabetes, Dr. Sundberg reported.

They averaged 7.8 self blood glucose measurements per day, including a mean of 1.2 readings during the night (10:00 p.m.-6:00 a.m.). Hypoglycemia, defined as a value less than 4 mmol/L (72 mg/dL), occurred an average of 0.66 times per day/4.6 times per week. The mean number of nights with detected hypoglycemia was 21 (4-42) per patient year, or 6% of all nights. Severe hypoglycemia, defined as seizures or unconsciousness, was reported twice by one child and once by another, for a rate of 21 events per 100 patient years.

“Further data on how to balance nutrition, insulin, and physical activity in order to achieve good glycemic control, and thereby preserve health and quality of life in the short and long perspective are needed,” she concluded.

This study was supported by Barndiabetesfonden. Dr. Sundberg stated that she had no further disclosures.

STOCKHOLM – Hypoglycemia occurred an average of nearly five times a week among 14 children with type 1 diabetes aged younger than 7 years who were evaluated in a prospective study.

“We need to identify age-specific strategies to improve insulin treatment for preschool children,” said Dr. Frida Sundberg of Queen Silvia Children’s Hospital, Gothenburg, Sweden.

The study included 14 children seen at the hospital who met the inclusion criteria of less than 7 years of age, a type 1 diabetes duration of more than 3 months, and the ability of the parents to upload at least 300 days’ worth of glucose values from the child’s glucose meter. Data were collected prospectively from autumn 2008 until autumn 2009. The eight boys and six girls had a mean age of 4.8 years and diabetes duration of 2.4 years.

Eleven were on pump therapy and three were on multiple injections at the start of the study, and one shifted to a pump during the year. They had a mean hemoglobin A1c value of 7.8%, with seven of the children achieving the target of less than 7.5% recommended by the International Society for Pediatric and Adolescent Diabetes, Dr. Sundberg reported.

They averaged 7.8 self blood glucose measurements per day, including a mean of 1.2 readings during the night (10:00 p.m.-6:00 a.m.). Hypoglycemia, defined as a value less than 4 mmol/L (72 mg/dL), occurred an average of 0.66 times per day/4.6 times per week. The mean number of nights with detected hypoglycemia was 21 (4-42) per patient year, or 6% of all nights. Severe hypoglycemia, defined as seizures or unconsciousness, was reported twice by one child and once by another, for a rate of 21 events per 100 patient years.

“Further data on how to balance nutrition, insulin, and physical activity in order to achieve good glycemic control, and thereby preserve health and quality of life in the short and long perspective are needed,” she concluded.

This study was supported by Barndiabetesfonden. Dr. Sundberg stated that she had no further disclosures.

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FROM THE ANNUAL MEETING OF THE EUROPEAN ASSOCIATION FOR THE STUDY OF DIABETES

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Major Finding: Hypoglycemia occurred an average of nearly five times a week among 14 children with type 1 diabetes aged younger than 7 years.

Data Source: Prospective study using self blood glucose monitoring data.

Disclosures: Study was supported by Barndiabetesfonden. Dr. Sundberg stated that she had no further disclosures.

Metformin's Anticancer Potential Is Generating a Buzz

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STOCKHOLM – Excitement is rising in the diabetes and oncology worlds regarding the potential anticancer effects of metformin.

“An off-patent, old drug, famous for its role in type 2 diabetes, is now a hot topic in cancer research,” Dr. Michael Pollak said at a press briefing at the meeting.

Epidemiologic data have shown that rates of colon, lung, breast, and prostate cancer among diabetes patients treated with metformin are lower than those of the general population (BMJ 2005;330:1304-5 and Diabetes Care 2010;33:1304-8).

“We don't mean 2% lower or 10% lower: It was roughly half the expected cancer rate. Cancer epidemiologists pay a lot of attention when we see that kind of a finding to try and prove that it's an artifact or some kind of mistake, because a reduction of cancer mortality of 50% is something we've never seen before as a consequence of any prevention strategy,” said Dr. Pollak, professor of medicine and oncology at McGill University, Montreal.

Since all the epidemiologic data are retrospective, researchers initially were skeptical. But laboratory studies supported the epidemiology, showing that metformin appears to reduce tumor aggressiveness in a variety of cancer models (Cancer Res. 2007;67:10804-12 and 2006;66:10269-73).

There are several theories about the mechanism. Metformin acts primarily in the liver, where it reduces glucose secretion. The drug also reduces insulin levels, which could inhibit tumors whose growth is stimulated by insulin.

Research is aimed at determining precisely which molecular subtypes are likely to respond. “We don't believe it will work uniformly in all tumors in all people,” said Dr. Pollak, who is also director of the Cancer Prevention Centre at SMBD–Jewish General Hospital, Montreal.

Research is “administratively unusual,” because the drug is off patent, so there is limited private sector interest. But academic research is taking off in many countries, with many proposed and some initiated epidemiologic studies, laboratory investigations, and even clinical trials of nondiabetic patients with cancer.

“We're not here to announce the final conclusions. We're here to share the excitement that something unexpected and interesting has happened, and it's now under investigation,” Dr. Pollak said.

It's too early to suggest that cancer patients begin taking metformin. Even so, “If you have cancer and diabetes that can be controlled by metformin, metformin becomes a pretty rational choice at this point. Not because we're sure it will help, but because there's a chance.”

Dr. Pollak has ties to or has consulted for Novo-Nordisk, Eli Lilly & Co., Pfizer Inc., Sanofi-Aventis, and Boehringer Ingelheim GmbH.

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STOCKHOLM – Excitement is rising in the diabetes and oncology worlds regarding the potential anticancer effects of metformin.

“An off-patent, old drug, famous for its role in type 2 diabetes, is now a hot topic in cancer research,” Dr. Michael Pollak said at a press briefing at the meeting.

Epidemiologic data have shown that rates of colon, lung, breast, and prostate cancer among diabetes patients treated with metformin are lower than those of the general population (BMJ 2005;330:1304-5 and Diabetes Care 2010;33:1304-8).

“We don't mean 2% lower or 10% lower: It was roughly half the expected cancer rate. Cancer epidemiologists pay a lot of attention when we see that kind of a finding to try and prove that it's an artifact or some kind of mistake, because a reduction of cancer mortality of 50% is something we've never seen before as a consequence of any prevention strategy,” said Dr. Pollak, professor of medicine and oncology at McGill University, Montreal.

Since all the epidemiologic data are retrospective, researchers initially were skeptical. But laboratory studies supported the epidemiology, showing that metformin appears to reduce tumor aggressiveness in a variety of cancer models (Cancer Res. 2007;67:10804-12 and 2006;66:10269-73).

There are several theories about the mechanism. Metformin acts primarily in the liver, where it reduces glucose secretion. The drug also reduces insulin levels, which could inhibit tumors whose growth is stimulated by insulin.

Research is aimed at determining precisely which molecular subtypes are likely to respond. “We don't believe it will work uniformly in all tumors in all people,” said Dr. Pollak, who is also director of the Cancer Prevention Centre at SMBD–Jewish General Hospital, Montreal.

Research is “administratively unusual,” because the drug is off patent, so there is limited private sector interest. But academic research is taking off in many countries, with many proposed and some initiated epidemiologic studies, laboratory investigations, and even clinical trials of nondiabetic patients with cancer.

“We're not here to announce the final conclusions. We're here to share the excitement that something unexpected and interesting has happened, and it's now under investigation,” Dr. Pollak said.

It's too early to suggest that cancer patients begin taking metformin. Even so, “If you have cancer and diabetes that can be controlled by metformin, metformin becomes a pretty rational choice at this point. Not because we're sure it will help, but because there's a chance.”

Dr. Pollak has ties to or has consulted for Novo-Nordisk, Eli Lilly & Co., Pfizer Inc., Sanofi-Aventis, and Boehringer Ingelheim GmbH.

STOCKHOLM – Excitement is rising in the diabetes and oncology worlds regarding the potential anticancer effects of metformin.

“An off-patent, old drug, famous for its role in type 2 diabetes, is now a hot topic in cancer research,” Dr. Michael Pollak said at a press briefing at the meeting.

Epidemiologic data have shown that rates of colon, lung, breast, and prostate cancer among diabetes patients treated with metformin are lower than those of the general population (BMJ 2005;330:1304-5 and Diabetes Care 2010;33:1304-8).

“We don't mean 2% lower or 10% lower: It was roughly half the expected cancer rate. Cancer epidemiologists pay a lot of attention when we see that kind of a finding to try and prove that it's an artifact or some kind of mistake, because a reduction of cancer mortality of 50% is something we've never seen before as a consequence of any prevention strategy,” said Dr. Pollak, professor of medicine and oncology at McGill University, Montreal.

Since all the epidemiologic data are retrospective, researchers initially were skeptical. But laboratory studies supported the epidemiology, showing that metformin appears to reduce tumor aggressiveness in a variety of cancer models (Cancer Res. 2007;67:10804-12 and 2006;66:10269-73).

There are several theories about the mechanism. Metformin acts primarily in the liver, where it reduces glucose secretion. The drug also reduces insulin levels, which could inhibit tumors whose growth is stimulated by insulin.

Research is aimed at determining precisely which molecular subtypes are likely to respond. “We don't believe it will work uniformly in all tumors in all people,” said Dr. Pollak, who is also director of the Cancer Prevention Centre at SMBD–Jewish General Hospital, Montreal.

Research is “administratively unusual,” because the drug is off patent, so there is limited private sector interest. But academic research is taking off in many countries, with many proposed and some initiated epidemiologic studies, laboratory investigations, and even clinical trials of nondiabetic patients with cancer.

“We're not here to announce the final conclusions. We're here to share the excitement that something unexpected and interesting has happened, and it's now under investigation,” Dr. Pollak said.

It's too early to suggest that cancer patients begin taking metformin. Even so, “If you have cancer and diabetes that can be controlled by metformin, metformin becomes a pretty rational choice at this point. Not because we're sure it will help, but because there's a chance.”

Dr. Pollak has ties to or has consulted for Novo-Nordisk, Eli Lilly & Co., Pfizer Inc., Sanofi-Aventis, and Boehringer Ingelheim GmbH.

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Diabetes Screening May Lower CV Event Risk

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STOCKHOLM – Screening for prevalent type 2 diabetes in primary care identified people at high modifiable cardiovascular risk, but subsequent intensive multifactorial treatment improved cardiovascular outcomes by only an insignificant 17% over routine care in a large 5-year randomized study.

Nevertheless, “when compared to no screening and no diabetes treatment, screening and either early routine diabetes care or intensive multifactorial treatment are likely to reduce cardiovascular morbidity and mortality by nearly half,” Dr. William H. Herman, who was not involved in the research, commented at the annual meeting of the European Association for the Study of Diabetes.

Indeed, the difference between the intensive intervention and routine treatment groups is not the main point of the ADDITION study, said Dr. Herman, professor of medicine at the University of Michigan, Ann Arbor, who served as the independent commentator on the study.

Photo credit: Miriam E. Tucker

Dr. William H. Herman (left) and Dr. Simon Griffin discussed the treatment-phase results of the European ADDITION study.

“The reality is that once people were labeled with diabetes they achieved much better risk factor control. … During the time this community-based study was being conducted, there were major national and international initiatives to improve diabetes care, and they clearly had an impact on blood pressure, cholesterol, smoking, and glycemia,” Dr. Herman said in an interview. “It's the combination of screening, diagnosis, and treatment that seemed to have an impact.”

As part of the Anglo-Danish-Dutch Study of Intensive Treatment in People With Screen Detected Diabetes in Primary Care (ADDITION), 76,308 people aged 40-69 years without known diabetes were screened in Denmark, Great Britain, and the Netherlands.

The screening results showed that individuals with screening-detected type 2 diabetes and included in the ADDITION study had an elevated and possibly modifiable risk of coronary heart disease (CHD). Specifically, the median estimated 10-year risk of CHD was 11% in women and 21% in men (Diabetologia 2008;51:1127-34).

Dr. Simon Griffin of the Institute of Metabolic Science, Addenbrooke's Hospital, Cambridge, England, presented the 5-year ADDITION outcome results for 1,379 randomized to routine care and 1,678 who received intensive multifactorial intervention. At baseline, patients were aged 60 years and had a mean body mass index of 32 kg/m

The intensive intervention included lifestyle education (dietary modification, increased physical activity, and smoking cessation) and intensive treatment of blood glucose, blood pressure and lipids, and prophylactic aspirin with or without motivational interviewing.

Over the 5-year study period, treatment with antihypertensive medication, statins, and aspirin increased dramatically in both groups, although to a slightly greater degree in the intensive treatment group. At 5 years, statin use was 68% for the routine care group and 78% for intensive treatment, daily aspirin was used by 40% and 69%, and glucose-lowering medication by 54% and 64%, respectively, Dr. Griffin reported.

The proportion of patients achieving targets for blood pressure, cholesterol, and glycemia – targets that changed over the study period based on national guidelines – increased in both groups but was slightly greater with intensive treatment.

The primary outcome composite of cardiovascular mortality, nonfatal MI, nonfatal stroke, revascularization as a first event, and amputation did not differ significantly between the routine and intensive treatment groups at 8.5% vs. 7.2%, with a hazard ratio of 0.83.

All-cause mortality, a secondary outcome, also did not differ significantly, with a hazard ratio of 0.91, Dr. Griffin said.

Dr. Griffin noted that mortality in both groups was low, and even in the routine care group it was lower than that of the general diabetes population in Denmark and only slightly higher than the age-matched Danish general population.

The ADDITION study was funded by unrestricted grants from Novo Nordisk A/S (main industry sponsor), ASTRA Denmark, Pfizer Danmark, GlaxoSmithKline, Pharma Denmark, SERVIER Danmark,(A/S HemoCue Danmark, and A/S Novo Nordisk Scandinavia AB. Research funds also were contributed by the Danish Council for Strategic Research, Danish Research Foundation for General Practice, Danish Centre for Evaluation and Health Technology Assessment, the Aarhus University Research Foundation, Novo Nordisk Foundation, the National Board of Health, the Danish Medical Research Council, the Danish Diabetes Association, the A.P. Møller Foundation for the Advancement of Medical Science, the Bernhard and Marie Kleins Trust, the Centre for Innovation in Nursing Education, the County of Aarhus, and the Danish Council of Nursing.

Dr. Griffin said he has received lecture fees from GSK, Unilever, Eli Lilly, and MSD. Dr. Herman stated that he had nothing to disclose.

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STOCKHOLM – Screening for prevalent type 2 diabetes in primary care identified people at high modifiable cardiovascular risk, but subsequent intensive multifactorial treatment improved cardiovascular outcomes by only an insignificant 17% over routine care in a large 5-year randomized study.

Nevertheless, “when compared to no screening and no diabetes treatment, screening and either early routine diabetes care or intensive multifactorial treatment are likely to reduce cardiovascular morbidity and mortality by nearly half,” Dr. William H. Herman, who was not involved in the research, commented at the annual meeting of the European Association for the Study of Diabetes.

Indeed, the difference between the intensive intervention and routine treatment groups is not the main point of the ADDITION study, said Dr. Herman, professor of medicine at the University of Michigan, Ann Arbor, who served as the independent commentator on the study.

Photo credit: Miriam E. Tucker

Dr. William H. Herman (left) and Dr. Simon Griffin discussed the treatment-phase results of the European ADDITION study.

“The reality is that once people were labeled with diabetes they achieved much better risk factor control. … During the time this community-based study was being conducted, there were major national and international initiatives to improve diabetes care, and they clearly had an impact on blood pressure, cholesterol, smoking, and glycemia,” Dr. Herman said in an interview. “It's the combination of screening, diagnosis, and treatment that seemed to have an impact.”

As part of the Anglo-Danish-Dutch Study of Intensive Treatment in People With Screen Detected Diabetes in Primary Care (ADDITION), 76,308 people aged 40-69 years without known diabetes were screened in Denmark, Great Britain, and the Netherlands.

The screening results showed that individuals with screening-detected type 2 diabetes and included in the ADDITION study had an elevated and possibly modifiable risk of coronary heart disease (CHD). Specifically, the median estimated 10-year risk of CHD was 11% in women and 21% in men (Diabetologia 2008;51:1127-34).

Dr. Simon Griffin of the Institute of Metabolic Science, Addenbrooke's Hospital, Cambridge, England, presented the 5-year ADDITION outcome results for 1,379 randomized to routine care and 1,678 who received intensive multifactorial intervention. At baseline, patients were aged 60 years and had a mean body mass index of 32 kg/m

The intensive intervention included lifestyle education (dietary modification, increased physical activity, and smoking cessation) and intensive treatment of blood glucose, blood pressure and lipids, and prophylactic aspirin with or without motivational interviewing.

Over the 5-year study period, treatment with antihypertensive medication, statins, and aspirin increased dramatically in both groups, although to a slightly greater degree in the intensive treatment group. At 5 years, statin use was 68% for the routine care group and 78% for intensive treatment, daily aspirin was used by 40% and 69%, and glucose-lowering medication by 54% and 64%, respectively, Dr. Griffin reported.

The proportion of patients achieving targets for blood pressure, cholesterol, and glycemia – targets that changed over the study period based on national guidelines – increased in both groups but was slightly greater with intensive treatment.

The primary outcome composite of cardiovascular mortality, nonfatal MI, nonfatal stroke, revascularization as a first event, and amputation did not differ significantly between the routine and intensive treatment groups at 8.5% vs. 7.2%, with a hazard ratio of 0.83.

All-cause mortality, a secondary outcome, also did not differ significantly, with a hazard ratio of 0.91, Dr. Griffin said.

Dr. Griffin noted that mortality in both groups was low, and even in the routine care group it was lower than that of the general diabetes population in Denmark and only slightly higher than the age-matched Danish general population.

The ADDITION study was funded by unrestricted grants from Novo Nordisk A/S (main industry sponsor), ASTRA Denmark, Pfizer Danmark, GlaxoSmithKline, Pharma Denmark, SERVIER Danmark,(A/S HemoCue Danmark, and A/S Novo Nordisk Scandinavia AB. Research funds also were contributed by the Danish Council for Strategic Research, Danish Research Foundation for General Practice, Danish Centre for Evaluation and Health Technology Assessment, the Aarhus University Research Foundation, Novo Nordisk Foundation, the National Board of Health, the Danish Medical Research Council, the Danish Diabetes Association, the A.P. Møller Foundation for the Advancement of Medical Science, the Bernhard and Marie Kleins Trust, the Centre for Innovation in Nursing Education, the County of Aarhus, and the Danish Council of Nursing.

Dr. Griffin said he has received lecture fees from GSK, Unilever, Eli Lilly, and MSD. Dr. Herman stated that he had nothing to disclose.

STOCKHOLM – Screening for prevalent type 2 diabetes in primary care identified people at high modifiable cardiovascular risk, but subsequent intensive multifactorial treatment improved cardiovascular outcomes by only an insignificant 17% over routine care in a large 5-year randomized study.

Nevertheless, “when compared to no screening and no diabetes treatment, screening and either early routine diabetes care or intensive multifactorial treatment are likely to reduce cardiovascular morbidity and mortality by nearly half,” Dr. William H. Herman, who was not involved in the research, commented at the annual meeting of the European Association for the Study of Diabetes.

Indeed, the difference between the intensive intervention and routine treatment groups is not the main point of the ADDITION study, said Dr. Herman, professor of medicine at the University of Michigan, Ann Arbor, who served as the independent commentator on the study.

Photo credit: Miriam E. Tucker

Dr. William H. Herman (left) and Dr. Simon Griffin discussed the treatment-phase results of the European ADDITION study.

“The reality is that once people were labeled with diabetes they achieved much better risk factor control. … During the time this community-based study was being conducted, there were major national and international initiatives to improve diabetes care, and they clearly had an impact on blood pressure, cholesterol, smoking, and glycemia,” Dr. Herman said in an interview. “It's the combination of screening, diagnosis, and treatment that seemed to have an impact.”

As part of the Anglo-Danish-Dutch Study of Intensive Treatment in People With Screen Detected Diabetes in Primary Care (ADDITION), 76,308 people aged 40-69 years without known diabetes were screened in Denmark, Great Britain, and the Netherlands.

The screening results showed that individuals with screening-detected type 2 diabetes and included in the ADDITION study had an elevated and possibly modifiable risk of coronary heart disease (CHD). Specifically, the median estimated 10-year risk of CHD was 11% in women and 21% in men (Diabetologia 2008;51:1127-34).

Dr. Simon Griffin of the Institute of Metabolic Science, Addenbrooke's Hospital, Cambridge, England, presented the 5-year ADDITION outcome results for 1,379 randomized to routine care and 1,678 who received intensive multifactorial intervention. At baseline, patients were aged 60 years and had a mean body mass index of 32 kg/m

The intensive intervention included lifestyle education (dietary modification, increased physical activity, and smoking cessation) and intensive treatment of blood glucose, blood pressure and lipids, and prophylactic aspirin with or without motivational interviewing.

Over the 5-year study period, treatment with antihypertensive medication, statins, and aspirin increased dramatically in both groups, although to a slightly greater degree in the intensive treatment group. At 5 years, statin use was 68% for the routine care group and 78% for intensive treatment, daily aspirin was used by 40% and 69%, and glucose-lowering medication by 54% and 64%, respectively, Dr. Griffin reported.

The proportion of patients achieving targets for blood pressure, cholesterol, and glycemia – targets that changed over the study period based on national guidelines – increased in both groups but was slightly greater with intensive treatment.

The primary outcome composite of cardiovascular mortality, nonfatal MI, nonfatal stroke, revascularization as a first event, and amputation did not differ significantly between the routine and intensive treatment groups at 8.5% vs. 7.2%, with a hazard ratio of 0.83.

All-cause mortality, a secondary outcome, also did not differ significantly, with a hazard ratio of 0.91, Dr. Griffin said.

Dr. Griffin noted that mortality in both groups was low, and even in the routine care group it was lower than that of the general diabetes population in Denmark and only slightly higher than the age-matched Danish general population.

The ADDITION study was funded by unrestricted grants from Novo Nordisk A/S (main industry sponsor), ASTRA Denmark, Pfizer Danmark, GlaxoSmithKline, Pharma Denmark, SERVIER Danmark,(A/S HemoCue Danmark, and A/S Novo Nordisk Scandinavia AB. Research funds also were contributed by the Danish Council for Strategic Research, Danish Research Foundation for General Practice, Danish Centre for Evaluation and Health Technology Assessment, the Aarhus University Research Foundation, Novo Nordisk Foundation, the National Board of Health, the Danish Medical Research Council, the Danish Diabetes Association, the A.P. Møller Foundation for the Advancement of Medical Science, the Bernhard and Marie Kleins Trust, the Centre for Innovation in Nursing Education, the County of Aarhus, and the Danish Council of Nursing.

Dr. Griffin said he has received lecture fees from GSK, Unilever, Eli Lilly, and MSD. Dr. Herman stated that he had nothing to disclose.

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AACE Issues Consensus Statements on Diabetes Technologies

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The American Association of Clinical Endocrinologists has issued two consensus panel statements to guide physicians in the use of diabetes technologies.

The separate statements addressing the use of continuous glucose monitoring (CGM) and insulin pump therapy were published online Oct. 13, and both will appear in the September/October issue of Endocrine Practice.

The CGM statement defines the two types of available devices. With professional CGM, the patient wears the device for 3-5 days but is unaware of the results. The physician subsequently downloads and analyzes the data to guide treatment decisions. Personal CGM devices, in contrast, are owned by the patient, who can see the results in real time. While not approved for “treatment decisions,” the data are used in conjunction with self-blood glucose monitoring to inform medication adjustments.

The document summarizes data from several randomized controlled clinical trials that have evaluated the effects of CGM in the treatment of type 1 diabetes. On the basis of those, AACE recommended personal CGM for the following patient groups:

• Those with type 1 diabetes who have hypoglycemic unawareness or frequent hypoglycemia, hemoglobin A1c (HbA1c) over target, or excess glycemic variability (such as hypoglycemia judged to be excessive, potentially disabling, or life threatening), or those who require HbA1c-lowering without increased hypoglycemia.

• Those planning pregnancy or who are pregnant.

• Children and adolescents with type 1 diabetes who have achieved HbA1c levels less than 7.0% (these patients and their families are typically highly motivated), and youth with type 1 diabetes who have HbA1c levels of at least 7.0% and are able to use the device on a near-daily basis.

In addition, the following patients might be good candidates for personal CGM, and a trial period of 2-4 weeks is recommended:

• Youth who frequently monitor their blood glucose levels.

• Committed families of young children (younger than 8 years), especially if the patient is having problems with hypoglycemia.

And, AACE advised, intermittent use of professional CGM may be useful for youth with type 1 diabetes who are experiencing changes to their diabetes regimen or have problems with nocturnal hypoglycemia/dawn phenomenon, hypoglycemia unawareness, and/or postprandial hyperglycemia.

The document also provides information about reimbursement for CGM, including advice on coding and a list of selected major U.S. private insurers’ policies regarding CGM coverage (or lack thereof). The Centers for Medicare and Medicaid Services currently reimburses only for professional CGM.

Also included are recommended next steps for research, including longer-term health outcomes studies to assess CGM durability beyond 6-12 months, cost effectiveness, and improved technologies for glucose reading and CGM/pump integration.

The insulin pump statement notes that “insulin pumps have come of age,” and that, “with their proliferation in medical practices, some guidance is necessary for prospective and current prescribers to ensure their optimal and safe use.”

That document summarizes the current state of the art with regard to continuous subcutaneous insulin delivery – pumps – noting that appropriate patient selection is critical, along with thorough assessment of their knowledge of diabetes management principles. Moreover, “selection of a provider is critical, and only those whose practice can assume full responsibility for the comprehensive pump management program should offer it.

“Patient diabetes education and a pump training plan must be implemented by a multidisciplinary team under direction of an experienced endocrinologist/diabetologist to address gaps in patient knowledge, and physicians prescribing insulin pumps for their patients should have a round-the-clock system in place to answer patients’ concerns about pump problems,” the AACE statement advises.

Topics addressed include data comparing pump therapy with multiple insulin injections, pump safety data, and cost-effectiveness analyses, along with information on the economic feasibility of using pumps in medical practices. “Hard-core” data from randomized clinical trials published in peer-reviewed journals that provide evidence for the benefits of insulin pump therapy are lacking, AACE noted.

Some, though not all, of the task force authors of both documents disclosed financial relationships with manufacturers of pumps, CGM, and glucose-lowering medications.

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The American Association of Clinical Endocrinologists has issued two consensus panel statements to guide physicians in the use of diabetes technologies.

The separate statements addressing the use of continuous glucose monitoring (CGM) and insulin pump therapy were published online Oct. 13, and both will appear in the September/October issue of Endocrine Practice.

The CGM statement defines the two types of available devices. With professional CGM, the patient wears the device for 3-5 days but is unaware of the results. The physician subsequently downloads and analyzes the data to guide treatment decisions. Personal CGM devices, in contrast, are owned by the patient, who can see the results in real time. While not approved for “treatment decisions,” the data are used in conjunction with self-blood glucose monitoring to inform medication adjustments.

The document summarizes data from several randomized controlled clinical trials that have evaluated the effects of CGM in the treatment of type 1 diabetes. On the basis of those, AACE recommended personal CGM for the following patient groups:

• Those with type 1 diabetes who have hypoglycemic unawareness or frequent hypoglycemia, hemoglobin A1c (HbA1c) over target, or excess glycemic variability (such as hypoglycemia judged to be excessive, potentially disabling, or life threatening), or those who require HbA1c-lowering without increased hypoglycemia.

• Those planning pregnancy or who are pregnant.

• Children and adolescents with type 1 diabetes who have achieved HbA1c levels less than 7.0% (these patients and their families are typically highly motivated), and youth with type 1 diabetes who have HbA1c levels of at least 7.0% and are able to use the device on a near-daily basis.

In addition, the following patients might be good candidates for personal CGM, and a trial period of 2-4 weeks is recommended:

• Youth who frequently monitor their blood glucose levels.

• Committed families of young children (younger than 8 years), especially if the patient is having problems with hypoglycemia.

And, AACE advised, intermittent use of professional CGM may be useful for youth with type 1 diabetes who are experiencing changes to their diabetes regimen or have problems with nocturnal hypoglycemia/dawn phenomenon, hypoglycemia unawareness, and/or postprandial hyperglycemia.

The document also provides information about reimbursement for CGM, including advice on coding and a list of selected major U.S. private insurers’ policies regarding CGM coverage (or lack thereof). The Centers for Medicare and Medicaid Services currently reimburses only for professional CGM.

Also included are recommended next steps for research, including longer-term health outcomes studies to assess CGM durability beyond 6-12 months, cost effectiveness, and improved technologies for glucose reading and CGM/pump integration.

The insulin pump statement notes that “insulin pumps have come of age,” and that, “with their proliferation in medical practices, some guidance is necessary for prospective and current prescribers to ensure their optimal and safe use.”

That document summarizes the current state of the art with regard to continuous subcutaneous insulin delivery – pumps – noting that appropriate patient selection is critical, along with thorough assessment of their knowledge of diabetes management principles. Moreover, “selection of a provider is critical, and only those whose practice can assume full responsibility for the comprehensive pump management program should offer it.

“Patient diabetes education and a pump training plan must be implemented by a multidisciplinary team under direction of an experienced endocrinologist/diabetologist to address gaps in patient knowledge, and physicians prescribing insulin pumps for their patients should have a round-the-clock system in place to answer patients’ concerns about pump problems,” the AACE statement advises.

Topics addressed include data comparing pump therapy with multiple insulin injections, pump safety data, and cost-effectiveness analyses, along with information on the economic feasibility of using pumps in medical practices. “Hard-core” data from randomized clinical trials published in peer-reviewed journals that provide evidence for the benefits of insulin pump therapy are lacking, AACE noted.

Some, though not all, of the task force authors of both documents disclosed financial relationships with manufacturers of pumps, CGM, and glucose-lowering medications.

The American Association of Clinical Endocrinologists has issued two consensus panel statements to guide physicians in the use of diabetes technologies.

The separate statements addressing the use of continuous glucose monitoring (CGM) and insulin pump therapy were published online Oct. 13, and both will appear in the September/October issue of Endocrine Practice.

The CGM statement defines the two types of available devices. With professional CGM, the patient wears the device for 3-5 days but is unaware of the results. The physician subsequently downloads and analyzes the data to guide treatment decisions. Personal CGM devices, in contrast, are owned by the patient, who can see the results in real time. While not approved for “treatment decisions,” the data are used in conjunction with self-blood glucose monitoring to inform medication adjustments.

The document summarizes data from several randomized controlled clinical trials that have evaluated the effects of CGM in the treatment of type 1 diabetes. On the basis of those, AACE recommended personal CGM for the following patient groups:

• Those with type 1 diabetes who have hypoglycemic unawareness or frequent hypoglycemia, hemoglobin A1c (HbA1c) over target, or excess glycemic variability (such as hypoglycemia judged to be excessive, potentially disabling, or life threatening), or those who require HbA1c-lowering without increased hypoglycemia.

• Those planning pregnancy or who are pregnant.

• Children and adolescents with type 1 diabetes who have achieved HbA1c levels less than 7.0% (these patients and their families are typically highly motivated), and youth with type 1 diabetes who have HbA1c levels of at least 7.0% and are able to use the device on a near-daily basis.

In addition, the following patients might be good candidates for personal CGM, and a trial period of 2-4 weeks is recommended:

• Youth who frequently monitor their blood glucose levels.

• Committed families of young children (younger than 8 years), especially if the patient is having problems with hypoglycemia.

And, AACE advised, intermittent use of professional CGM may be useful for youth with type 1 diabetes who are experiencing changes to their diabetes regimen or have problems with nocturnal hypoglycemia/dawn phenomenon, hypoglycemia unawareness, and/or postprandial hyperglycemia.

The document also provides information about reimbursement for CGM, including advice on coding and a list of selected major U.S. private insurers’ policies regarding CGM coverage (or lack thereof). The Centers for Medicare and Medicaid Services currently reimburses only for professional CGM.

Also included are recommended next steps for research, including longer-term health outcomes studies to assess CGM durability beyond 6-12 months, cost effectiveness, and improved technologies for glucose reading and CGM/pump integration.

The insulin pump statement notes that “insulin pumps have come of age,” and that, “with their proliferation in medical practices, some guidance is necessary for prospective and current prescribers to ensure their optimal and safe use.”

That document summarizes the current state of the art with regard to continuous subcutaneous insulin delivery – pumps – noting that appropriate patient selection is critical, along with thorough assessment of their knowledge of diabetes management principles. Moreover, “selection of a provider is critical, and only those whose practice can assume full responsibility for the comprehensive pump management program should offer it.

“Patient diabetes education and a pump training plan must be implemented by a multidisciplinary team under direction of an experienced endocrinologist/diabetologist to address gaps in patient knowledge, and physicians prescribing insulin pumps for their patients should have a round-the-clock system in place to answer patients’ concerns about pump problems,” the AACE statement advises.

Topics addressed include data comparing pump therapy with multiple insulin injections, pump safety data, and cost-effectiveness analyses, along with information on the economic feasibility of using pumps in medical practices. “Hard-core” data from randomized clinical trials published in peer-reviewed journals that provide evidence for the benefits of insulin pump therapy are lacking, AACE noted.

Some, though not all, of the task force authors of both documents disclosed financial relationships with manufacturers of pumps, CGM, and glucose-lowering medications.

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Pancreatitis Rates Higher in Adults With Diabetes : A U.K. database study of more than 75,000 diabetes patients found a highly significant increase.

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STOCKHOLM — Both the prevalence and the incidence of pancreatitis were significantly greater among adults with diabetes than in those without, in an analysis of a U.K. database comprising more than 2 million general practice adult patients.

Rates of pancreatitis have been rising in recent years, along with increases in obesity and related conditions, including gallstones and hyperlipidemia. Previous studies have identified a link between type 2 diabetes, antihyperglycemic medications, and pancreatitis, but these have mainly used small population sizes and have not stratified by age and sex, Dr. Hamidreza Mani, an endocrinologist at the University of Leicester (England), said at the meeting.

Dr. Mani and his associates used the U.K. General Practice Research Database, one of the largest patient databases in the world, comprising 2.34 million adults. Of those, 75,322 were identified with a history of type 2 diabetes. Among those, 574 (0.76%) also had a history of pancreatitis, compared with just 0.17% of the 2.2 million without diabetes.

This gave a crude hazard ratio of 4.5 for those with diabetes, compared with those without diabetes. After adjustment for age and sex, the odds ratio for a history of pancreatitis in those with diabetes, compared with those without, was 3.1, which was highly statistically significant, he said.

In all, 74,748 diabetes patients who were not found to have prevalent pancreatitis were followed forward for a mean of 3.1 years beyond a specified index date. Controls were followed for a mean of 3.2 years. There were 134 incident cases of diabetes among the diabetic group and 1,975 among the controls, giving crude incidence rates of 58 and 27 per 100,000 population, respectively. After adjustment again for age and sex, the relative risk of acute pancreatitis that was associated with diabetes was 1.47.

Striking age and sex differences were found. By sex overall, the incidence of pancreatitis among women with diabetes, compared with those without, was 1.95, whereas that rate for men was 2.23.

Among women with diabetes aged 18–39 years, the incidence of pancreatitis was nearly sixfold, compared with those without diabetes, whereas the rate among women with diabetes aged 50–59 years was actually a bit less than among those without (hazard ratio, 0.86).

Among the men, the greatest incidence occurred in the 50- to 59-year age range, with a hazard ratio of 2.9, compared with men without diabetes. In diabetic men older than 80 years of age, the incidence of pancreatitis dropped to just half that of nondiabetic men (HR, 0.53).

The reason for the sex difference is unclear. Hormonal and other physiologic differences may account for some of it, but not for the sixfold increase among young women, he commented.

The overall pancreatitis incidence of 27.4 per 100,000 among patients with diabetes in this database is far greater than the 10 per 100,000 U.K. incidence that was reported in 1998, Dr. Mani noted.

Disclosures: Dr. Mani stated that he had no disclosures.

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STOCKHOLM — Both the prevalence and the incidence of pancreatitis were significantly greater among adults with diabetes than in those without, in an analysis of a U.K. database comprising more than 2 million general practice adult patients.

Rates of pancreatitis have been rising in recent years, along with increases in obesity and related conditions, including gallstones and hyperlipidemia. Previous studies have identified a link between type 2 diabetes, antihyperglycemic medications, and pancreatitis, but these have mainly used small population sizes and have not stratified by age and sex, Dr. Hamidreza Mani, an endocrinologist at the University of Leicester (England), said at the meeting.

Dr. Mani and his associates used the U.K. General Practice Research Database, one of the largest patient databases in the world, comprising 2.34 million adults. Of those, 75,322 were identified with a history of type 2 diabetes. Among those, 574 (0.76%) also had a history of pancreatitis, compared with just 0.17% of the 2.2 million without diabetes.

This gave a crude hazard ratio of 4.5 for those with diabetes, compared with those without diabetes. After adjustment for age and sex, the odds ratio for a history of pancreatitis in those with diabetes, compared with those without, was 3.1, which was highly statistically significant, he said.

In all, 74,748 diabetes patients who were not found to have prevalent pancreatitis were followed forward for a mean of 3.1 years beyond a specified index date. Controls were followed for a mean of 3.2 years. There were 134 incident cases of diabetes among the diabetic group and 1,975 among the controls, giving crude incidence rates of 58 and 27 per 100,000 population, respectively. After adjustment again for age and sex, the relative risk of acute pancreatitis that was associated with diabetes was 1.47.

Striking age and sex differences were found. By sex overall, the incidence of pancreatitis among women with diabetes, compared with those without, was 1.95, whereas that rate for men was 2.23.

Among women with diabetes aged 18–39 years, the incidence of pancreatitis was nearly sixfold, compared with those without diabetes, whereas the rate among women with diabetes aged 50–59 years was actually a bit less than among those without (hazard ratio, 0.86).

Among the men, the greatest incidence occurred in the 50- to 59-year age range, with a hazard ratio of 2.9, compared with men without diabetes. In diabetic men older than 80 years of age, the incidence of pancreatitis dropped to just half that of nondiabetic men (HR, 0.53).

The reason for the sex difference is unclear. Hormonal and other physiologic differences may account for some of it, but not for the sixfold increase among young women, he commented.

The overall pancreatitis incidence of 27.4 per 100,000 among patients with diabetes in this database is far greater than the 10 per 100,000 U.K. incidence that was reported in 1998, Dr. Mani noted.

Disclosures: Dr. Mani stated that he had no disclosures.

STOCKHOLM — Both the prevalence and the incidence of pancreatitis were significantly greater among adults with diabetes than in those without, in an analysis of a U.K. database comprising more than 2 million general practice adult patients.

Rates of pancreatitis have been rising in recent years, along with increases in obesity and related conditions, including gallstones and hyperlipidemia. Previous studies have identified a link between type 2 diabetes, antihyperglycemic medications, and pancreatitis, but these have mainly used small population sizes and have not stratified by age and sex, Dr. Hamidreza Mani, an endocrinologist at the University of Leicester (England), said at the meeting.

Dr. Mani and his associates used the U.K. General Practice Research Database, one of the largest patient databases in the world, comprising 2.34 million adults. Of those, 75,322 were identified with a history of type 2 diabetes. Among those, 574 (0.76%) also had a history of pancreatitis, compared with just 0.17% of the 2.2 million without diabetes.

This gave a crude hazard ratio of 4.5 for those with diabetes, compared with those without diabetes. After adjustment for age and sex, the odds ratio for a history of pancreatitis in those with diabetes, compared with those without, was 3.1, which was highly statistically significant, he said.

In all, 74,748 diabetes patients who were not found to have prevalent pancreatitis were followed forward for a mean of 3.1 years beyond a specified index date. Controls were followed for a mean of 3.2 years. There were 134 incident cases of diabetes among the diabetic group and 1,975 among the controls, giving crude incidence rates of 58 and 27 per 100,000 population, respectively. After adjustment again for age and sex, the relative risk of acute pancreatitis that was associated with diabetes was 1.47.

Striking age and sex differences were found. By sex overall, the incidence of pancreatitis among women with diabetes, compared with those without, was 1.95, whereas that rate for men was 2.23.

Among women with diabetes aged 18–39 years, the incidence of pancreatitis was nearly sixfold, compared with those without diabetes, whereas the rate among women with diabetes aged 50–59 years was actually a bit less than among those without (hazard ratio, 0.86).

Among the men, the greatest incidence occurred in the 50- to 59-year age range, with a hazard ratio of 2.9, compared with men without diabetes. In diabetic men older than 80 years of age, the incidence of pancreatitis dropped to just half that of nondiabetic men (HR, 0.53).

The reason for the sex difference is unclear. Hormonal and other physiologic differences may account for some of it, but not for the sixfold increase among young women, he commented.

The overall pancreatitis incidence of 27.4 per 100,000 among patients with diabetes in this database is far greater than the 10 per 100,000 U.K. incidence that was reported in 1998, Dr. Mani noted.

Disclosures: Dr. Mani stated that he had no disclosures.

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Diabetes Education May Cut ED Return Visits

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Major Finding: After the emergency department intervention, mean blood glucose levels dropped by 174 mg/dL, HbA1c went down by at least 0.4 percentage points, and visits to the ED for hypo- or hyperglycemia were reduced by 78%.

Data Source: A pilot study of 86 patients presenting to an ED with uncontrolled hyperglycemia.

Disclosures: The study was funded by the Washington Department of Health. Bayer Pharmaceuticals contributed the A1cNow testing kits and blood glucose meters. Sanofi-Aventis and Novo Nordisk provided insulin pens. Dr. Magee disclosed that she receives support for investigator-initiated grants from Sanofi-Aventis and honoraria for speaking for Sanofi-Aventis and Novo Nordisk. Ms. Nassar stated that she has no disclosures.

SAN ANTONIO – An emergency department intervention delivered by a certified diabetes educator to patients who presented with uncontrolled hyperglycemia reduced the number of repeat visits and improved glycemic control at 6 months without increasing the risk of hypoglycemia.

Use of emergency departments (EDs) for treatment of chronic conditions is a problem both nationally and in the District of Columbia where, in 2006, there were 39,857 ED visits by individuals with diabetes at a cost of about $27 million. A 2008 Rand report estimated that a significant portion of these visits could have been prevented with prior primary care visits and appropriate self-management education, said Dr. Michelle F. Magee, an endocrinologist at Medstar Health Research Institute, Washington Hospital Center.

The Stop Emergency Department Visits for Hypoglycemia Project-DC (Step DC) pilot study – which was initiated in response to a request by ED personnel – enrolled adults who presented to the ED with blood glucose levels of 200 mg/dL or above, whether or not they had a previous diagnosis of type 2 diabetes. (Those with type 1 were excluded.) They had to be stable for discharge once their hyperglycemia was treated, with no other acute comorbidities.

Carine M. Nassar, a certified diabetes educator (CDE) and registered dietician, described the four-visit intervention, comprising three components: using a medication algorithm to achieve glycemic control, focusing on diabetes self-management education “survival skills,” and teaching patients health system navigation skills to find a primary care medical home to reduce future use of the ED for ongoing diabetes care.

The first visit took place while the patient was in the ED. It included point of care hemoglobin A1c and glucose testing, a knowledge questionnaire, and hydration plus insulin therapy. Survival skills education was taught both to those who were newly diagnosed and those who already had been diagnosed with diabetes, many of whom nonetheless lacked basic knowledge of the condition, noted Ms. Nassar, program manager at Medstar Diabetes Institute at Washington Hospital Center.

Patients were discharged with a glucose meter and a prescription for antihyperglycemic medications, based on the treatment algorithm. In general, metformin and/or sulfonylureas were used if blood glucose levels were 200–250 mg/dL, either drug or basal insulin was used for glucose levels of 251–300 mg/dL, and metformin plus insulin – either basal or NPH – was used in patients with glucose levels above 300 mg/dL. Patients who needed insulin were taught to self-administer injections before leaving the ED.

Subsequent outpatient visits took place at 24–72 hours, 2 weeks, and 4 weeks after discharge. These involved a review of blood glucose data with medication adjustments as necessary, continued education, and help with navigation to outpatient clinics or private primary care settings, depending on whether the patient had insurance and what it covered. (Only 15% were uninsured.)

The final visit at week 4 could take place over the phone if the patient so chose and was used to go over any final information, assess glucose data, and ensure that the patient had a follow-up visit in a primary care setting.

The 86 patients had a mean age of 62, 52% were male, and 93% were black. Nearly half (48%) were employed full time; 22% were unemployed. Just over a third (36%) had completed high school or an equivalent. Nearly three-quarters (71%) had never received diabetes self-management education, and 12% received it more than 3 years before the ED visit. “There was a huge knowledge deficit,” said Dr. Magee, who is also with Georgetown University, Washington.

The top three reasons for the ED visit were the inability to get an appointment with a primary care provider, cited by 42%; no primary care provider, 14.5%; and having been sent to the ED by their primary care provider, 10%. “Fully 66.6% came to the ED due to unavailability of primary care that day,” Dr. Magee said.

 

 

The mean blood glucose level at study entry was 356 mg/dL, with one patient having a level of 923 mg/dL that was treated with an insulin drip. The mean baseline HbA1c was 12%. However, that is probably an underestimate because the A1cNow point of care device used in the study has an upper limit of 13% and half of the patients had an HbA1c of greater than 13%, she said.

A total of 60% of the patients completed all four visits, 21% completed two or three, and 19% did not return for any visits after the initial one in the ED. Nearly half (48%) had seen a primary care physician or were scheduled to see one as a result of the intervention.

Among the 60 patients who completed at least three visits, there were no instances of hypoglycemia (blood glucose level of 60 mg/dL or below) on day 1, and the overall hypoglycemia rate was just 1.33% of total patient-days, representing a total of 26 hypoglycemic events over 1,956 patient days. There were no episodes of severe hypoglycemia, defined as a glucose level of 40 mg/dL or less or any event requiring assistance to treat, Dr. Magee reported.

Mean blood glucose level fell by 173 mg/dL, to 183 mg/dL from the baseline 356 mg/dL. Mean HbA1c fell by 0.4 percentage points, to 11.6%. However, again, this is likely an underestimate, she noted.

Visits to the ED for hypo- or hyperglycemia were cut by 78%, from 42 in the 6 months prior to the intervention to just 9 in the subsequent 6 months. This was a strong trend, but the sample size was too small to reach statistical significance.

On average, the CDE spent about 6 hours per patient to complete all the visits, and the supervising physician spent about 30 minutes total. The average cost of staff time per patient was about $350, compared with an average $678 for an ED visit for uncontrolled blood sugar.

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Major Finding: After the emergency department intervention, mean blood glucose levels dropped by 174 mg/dL, HbA1c went down by at least 0.4 percentage points, and visits to the ED for hypo- or hyperglycemia were reduced by 78%.

Data Source: A pilot study of 86 patients presenting to an ED with uncontrolled hyperglycemia.

Disclosures: The study was funded by the Washington Department of Health. Bayer Pharmaceuticals contributed the A1cNow testing kits and blood glucose meters. Sanofi-Aventis and Novo Nordisk provided insulin pens. Dr. Magee disclosed that she receives support for investigator-initiated grants from Sanofi-Aventis and honoraria for speaking for Sanofi-Aventis and Novo Nordisk. Ms. Nassar stated that she has no disclosures.

SAN ANTONIO – An emergency department intervention delivered by a certified diabetes educator to patients who presented with uncontrolled hyperglycemia reduced the number of repeat visits and improved glycemic control at 6 months without increasing the risk of hypoglycemia.

Use of emergency departments (EDs) for treatment of chronic conditions is a problem both nationally and in the District of Columbia where, in 2006, there were 39,857 ED visits by individuals with diabetes at a cost of about $27 million. A 2008 Rand report estimated that a significant portion of these visits could have been prevented with prior primary care visits and appropriate self-management education, said Dr. Michelle F. Magee, an endocrinologist at Medstar Health Research Institute, Washington Hospital Center.

The Stop Emergency Department Visits for Hypoglycemia Project-DC (Step DC) pilot study – which was initiated in response to a request by ED personnel – enrolled adults who presented to the ED with blood glucose levels of 200 mg/dL or above, whether or not they had a previous diagnosis of type 2 diabetes. (Those with type 1 were excluded.) They had to be stable for discharge once their hyperglycemia was treated, with no other acute comorbidities.

Carine M. Nassar, a certified diabetes educator (CDE) and registered dietician, described the four-visit intervention, comprising three components: using a medication algorithm to achieve glycemic control, focusing on diabetes self-management education “survival skills,” and teaching patients health system navigation skills to find a primary care medical home to reduce future use of the ED for ongoing diabetes care.

The first visit took place while the patient was in the ED. It included point of care hemoglobin A1c and glucose testing, a knowledge questionnaire, and hydration plus insulin therapy. Survival skills education was taught both to those who were newly diagnosed and those who already had been diagnosed with diabetes, many of whom nonetheless lacked basic knowledge of the condition, noted Ms. Nassar, program manager at Medstar Diabetes Institute at Washington Hospital Center.

Patients were discharged with a glucose meter and a prescription for antihyperglycemic medications, based on the treatment algorithm. In general, metformin and/or sulfonylureas were used if blood glucose levels were 200–250 mg/dL, either drug or basal insulin was used for glucose levels of 251–300 mg/dL, and metformin plus insulin – either basal or NPH – was used in patients with glucose levels above 300 mg/dL. Patients who needed insulin were taught to self-administer injections before leaving the ED.

Subsequent outpatient visits took place at 24–72 hours, 2 weeks, and 4 weeks after discharge. These involved a review of blood glucose data with medication adjustments as necessary, continued education, and help with navigation to outpatient clinics or private primary care settings, depending on whether the patient had insurance and what it covered. (Only 15% were uninsured.)

The final visit at week 4 could take place over the phone if the patient so chose and was used to go over any final information, assess glucose data, and ensure that the patient had a follow-up visit in a primary care setting.

The 86 patients had a mean age of 62, 52% were male, and 93% were black. Nearly half (48%) were employed full time; 22% were unemployed. Just over a third (36%) had completed high school or an equivalent. Nearly three-quarters (71%) had never received diabetes self-management education, and 12% received it more than 3 years before the ED visit. “There was a huge knowledge deficit,” said Dr. Magee, who is also with Georgetown University, Washington.

The top three reasons for the ED visit were the inability to get an appointment with a primary care provider, cited by 42%; no primary care provider, 14.5%; and having been sent to the ED by their primary care provider, 10%. “Fully 66.6% came to the ED due to unavailability of primary care that day,” Dr. Magee said.

 

 

The mean blood glucose level at study entry was 356 mg/dL, with one patient having a level of 923 mg/dL that was treated with an insulin drip. The mean baseline HbA1c was 12%. However, that is probably an underestimate because the A1cNow point of care device used in the study has an upper limit of 13% and half of the patients had an HbA1c of greater than 13%, she said.

A total of 60% of the patients completed all four visits, 21% completed two or three, and 19% did not return for any visits after the initial one in the ED. Nearly half (48%) had seen a primary care physician or were scheduled to see one as a result of the intervention.

Among the 60 patients who completed at least three visits, there were no instances of hypoglycemia (blood glucose level of 60 mg/dL or below) on day 1, and the overall hypoglycemia rate was just 1.33% of total patient-days, representing a total of 26 hypoglycemic events over 1,956 patient days. There were no episodes of severe hypoglycemia, defined as a glucose level of 40 mg/dL or less or any event requiring assistance to treat, Dr. Magee reported.

Mean blood glucose level fell by 173 mg/dL, to 183 mg/dL from the baseline 356 mg/dL. Mean HbA1c fell by 0.4 percentage points, to 11.6%. However, again, this is likely an underestimate, she noted.

Visits to the ED for hypo- or hyperglycemia were cut by 78%, from 42 in the 6 months prior to the intervention to just 9 in the subsequent 6 months. This was a strong trend, but the sample size was too small to reach statistical significance.

On average, the CDE spent about 6 hours per patient to complete all the visits, and the supervising physician spent about 30 minutes total. The average cost of staff time per patient was about $350, compared with an average $678 for an ED visit for uncontrolled blood sugar.

Major Finding: After the emergency department intervention, mean blood glucose levels dropped by 174 mg/dL, HbA1c went down by at least 0.4 percentage points, and visits to the ED for hypo- or hyperglycemia were reduced by 78%.

Data Source: A pilot study of 86 patients presenting to an ED with uncontrolled hyperglycemia.

Disclosures: The study was funded by the Washington Department of Health. Bayer Pharmaceuticals contributed the A1cNow testing kits and blood glucose meters. Sanofi-Aventis and Novo Nordisk provided insulin pens. Dr. Magee disclosed that she receives support for investigator-initiated grants from Sanofi-Aventis and honoraria for speaking for Sanofi-Aventis and Novo Nordisk. Ms. Nassar stated that she has no disclosures.

SAN ANTONIO – An emergency department intervention delivered by a certified diabetes educator to patients who presented with uncontrolled hyperglycemia reduced the number of repeat visits and improved glycemic control at 6 months without increasing the risk of hypoglycemia.

Use of emergency departments (EDs) for treatment of chronic conditions is a problem both nationally and in the District of Columbia where, in 2006, there were 39,857 ED visits by individuals with diabetes at a cost of about $27 million. A 2008 Rand report estimated that a significant portion of these visits could have been prevented with prior primary care visits and appropriate self-management education, said Dr. Michelle F. Magee, an endocrinologist at Medstar Health Research Institute, Washington Hospital Center.

The Stop Emergency Department Visits for Hypoglycemia Project-DC (Step DC) pilot study – which was initiated in response to a request by ED personnel – enrolled adults who presented to the ED with blood glucose levels of 200 mg/dL or above, whether or not they had a previous diagnosis of type 2 diabetes. (Those with type 1 were excluded.) They had to be stable for discharge once their hyperglycemia was treated, with no other acute comorbidities.

Carine M. Nassar, a certified diabetes educator (CDE) and registered dietician, described the four-visit intervention, comprising three components: using a medication algorithm to achieve glycemic control, focusing on diabetes self-management education “survival skills,” and teaching patients health system navigation skills to find a primary care medical home to reduce future use of the ED for ongoing diabetes care.

The first visit took place while the patient was in the ED. It included point of care hemoglobin A1c and glucose testing, a knowledge questionnaire, and hydration plus insulin therapy. Survival skills education was taught both to those who were newly diagnosed and those who already had been diagnosed with diabetes, many of whom nonetheless lacked basic knowledge of the condition, noted Ms. Nassar, program manager at Medstar Diabetes Institute at Washington Hospital Center.

Patients were discharged with a glucose meter and a prescription for antihyperglycemic medications, based on the treatment algorithm. In general, metformin and/or sulfonylureas were used if blood glucose levels were 200–250 mg/dL, either drug or basal insulin was used for glucose levels of 251–300 mg/dL, and metformin plus insulin – either basal or NPH – was used in patients with glucose levels above 300 mg/dL. Patients who needed insulin were taught to self-administer injections before leaving the ED.

Subsequent outpatient visits took place at 24–72 hours, 2 weeks, and 4 weeks after discharge. These involved a review of blood glucose data with medication adjustments as necessary, continued education, and help with navigation to outpatient clinics or private primary care settings, depending on whether the patient had insurance and what it covered. (Only 15% were uninsured.)

The final visit at week 4 could take place over the phone if the patient so chose and was used to go over any final information, assess glucose data, and ensure that the patient had a follow-up visit in a primary care setting.

The 86 patients had a mean age of 62, 52% were male, and 93% were black. Nearly half (48%) were employed full time; 22% were unemployed. Just over a third (36%) had completed high school or an equivalent. Nearly three-quarters (71%) had never received diabetes self-management education, and 12% received it more than 3 years before the ED visit. “There was a huge knowledge deficit,” said Dr. Magee, who is also with Georgetown University, Washington.

The top three reasons for the ED visit were the inability to get an appointment with a primary care provider, cited by 42%; no primary care provider, 14.5%; and having been sent to the ED by their primary care provider, 10%. “Fully 66.6% came to the ED due to unavailability of primary care that day,” Dr. Magee said.

 

 

The mean blood glucose level at study entry was 356 mg/dL, with one patient having a level of 923 mg/dL that was treated with an insulin drip. The mean baseline HbA1c was 12%. However, that is probably an underestimate because the A1cNow point of care device used in the study has an upper limit of 13% and half of the patients had an HbA1c of greater than 13%, she said.

A total of 60% of the patients completed all four visits, 21% completed two or three, and 19% did not return for any visits after the initial one in the ED. Nearly half (48%) had seen a primary care physician or were scheduled to see one as a result of the intervention.

Among the 60 patients who completed at least three visits, there were no instances of hypoglycemia (blood glucose level of 60 mg/dL or below) on day 1, and the overall hypoglycemia rate was just 1.33% of total patient-days, representing a total of 26 hypoglycemic events over 1,956 patient days. There were no episodes of severe hypoglycemia, defined as a glucose level of 40 mg/dL or less or any event requiring assistance to treat, Dr. Magee reported.

Mean blood glucose level fell by 173 mg/dL, to 183 mg/dL from the baseline 356 mg/dL. Mean HbA1c fell by 0.4 percentage points, to 11.6%. However, again, this is likely an underestimate, she noted.

Visits to the ED for hypo- or hyperglycemia were cut by 78%, from 42 in the 6 months prior to the intervention to just 9 in the subsequent 6 months. This was a strong trend, but the sample size was too small to reach statistical significance.

On average, the CDE spent about 6 hours per patient to complete all the visits, and the supervising physician spent about 30 minutes total. The average cost of staff time per patient was about $350, compared with an average $678 for an ED visit for uncontrolled blood sugar.

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Prediabetes Not a Motivator for Weight Loss

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Major Finding: Weight loss did not differ significantly between those with and without prediabetes (7.0 vs. 5.6 pounds, respectively).

Data Source: A substudy of 101 individuals with prediabetes enrolled in a 12-week behavioral weight-loss program.

Disclosures: Dr. Homko disclosed that she serves on the advisory board of Abbott Diabetes Care.

SAN ANTONIO – Overweight individuals who knew that they had prediabetes did not lose any more weight than did those who did not have the condition, in a preliminary analysis of 103 overweight participants in a 12-week behavioral weight-loss program.

The findings were contrary to expectations. “Our hypothesis was that individuals who perceive themselves to be at increased risk for developing diabetes would lose more weight than individuals who perceive their risk to be lower,” said Carol J. Homko, Ph.D., a certified diabetes educator and registered nurse.

The data come from a secondary analysis of a larger randomized study designed to look at the effect of telemedicine on weight-loss maintenance 1 year following the weight-loss program. All 103 subjects participated in the same weekly group sessions, held at local churches and facilitated by both health care professionals (mostly registered dieticians and health psychologists) and a lay facilitator who was a member of the church. The 90-minute sessions included diet, exercise, and behavioral change counseling. Each group included 12–15 participants.

They had a mean age of 51 years (adults aged 18–75 were included) and body mass index of 35.5 kg/m

Risk perception was assessed with the same survey used in the Diabetes Prevention Program (Diabetes Care 2003;26:2543–8), and included measures of personal control, worry, optimistic bias, comparative disease risk, comparative environmental risk, diabetes risk knowledge, unknown risk, and “dread risk.” Across the board, there were no differences in risk perception from baseline through 12 weeks in any of those measures, said Dr. Homko of the department of medicine at Temple University, Philadelphia.

It's not clear why people who know they have prediabetes don't perceive themselves to be at greater risk for diabetes than are those without that diagnosis, but one possible explanation is that the people who chose to participate in a weight-loss program did so because they were already aware of the risks associated with excess weight and the potential impact on their health, she said in an interview.

Participants lost a mean of 6.3 pounds, and weight losses did not differ significantly between those with and without prediabetes (7.0 vs. 5.6 pounds, respectively).

Not surprisingly, weight loss correlated with progression to diabetes among the 53 with prediabetes. The 28 who reverted to normal glucose tolerance had lost an average of 11.3 pounds at 12 weeks, compared with 5.6 pounds in the 18 who remained prediabetic and 3.6 pounds in the 7 who progressed to type 2 diabetes. Those differences were statistically significant, she said.

Although the findings from this study regarding risk perception may be disappointing, the bright side is that weight loss of just 5% was associated with conversion to normal glucose tolerance in individuals with prediabetes, Dr. Homko pointed out. “There is strong evidence to suggest that weight loss and increased activity can slow the progression to type 2 diabetes,” she said.

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Major Finding: Weight loss did not differ significantly between those with and without prediabetes (7.0 vs. 5.6 pounds, respectively).

Data Source: A substudy of 101 individuals with prediabetes enrolled in a 12-week behavioral weight-loss program.

Disclosures: Dr. Homko disclosed that she serves on the advisory board of Abbott Diabetes Care.

SAN ANTONIO – Overweight individuals who knew that they had prediabetes did not lose any more weight than did those who did not have the condition, in a preliminary analysis of 103 overweight participants in a 12-week behavioral weight-loss program.

The findings were contrary to expectations. “Our hypothesis was that individuals who perceive themselves to be at increased risk for developing diabetes would lose more weight than individuals who perceive their risk to be lower,” said Carol J. Homko, Ph.D., a certified diabetes educator and registered nurse.

The data come from a secondary analysis of a larger randomized study designed to look at the effect of telemedicine on weight-loss maintenance 1 year following the weight-loss program. All 103 subjects participated in the same weekly group sessions, held at local churches and facilitated by both health care professionals (mostly registered dieticians and health psychologists) and a lay facilitator who was a member of the church. The 90-minute sessions included diet, exercise, and behavioral change counseling. Each group included 12–15 participants.

They had a mean age of 51 years (adults aged 18–75 were included) and body mass index of 35.5 kg/m

Risk perception was assessed with the same survey used in the Diabetes Prevention Program (Diabetes Care 2003;26:2543–8), and included measures of personal control, worry, optimistic bias, comparative disease risk, comparative environmental risk, diabetes risk knowledge, unknown risk, and “dread risk.” Across the board, there were no differences in risk perception from baseline through 12 weeks in any of those measures, said Dr. Homko of the department of medicine at Temple University, Philadelphia.

It's not clear why people who know they have prediabetes don't perceive themselves to be at greater risk for diabetes than are those without that diagnosis, but one possible explanation is that the people who chose to participate in a weight-loss program did so because they were already aware of the risks associated with excess weight and the potential impact on their health, she said in an interview.

Participants lost a mean of 6.3 pounds, and weight losses did not differ significantly between those with and without prediabetes (7.0 vs. 5.6 pounds, respectively).

Not surprisingly, weight loss correlated with progression to diabetes among the 53 with prediabetes. The 28 who reverted to normal glucose tolerance had lost an average of 11.3 pounds at 12 weeks, compared with 5.6 pounds in the 18 who remained prediabetic and 3.6 pounds in the 7 who progressed to type 2 diabetes. Those differences were statistically significant, she said.

Although the findings from this study regarding risk perception may be disappointing, the bright side is that weight loss of just 5% was associated with conversion to normal glucose tolerance in individuals with prediabetes, Dr. Homko pointed out. “There is strong evidence to suggest that weight loss and increased activity can slow the progression to type 2 diabetes,” she said.

Major Finding: Weight loss did not differ significantly between those with and without prediabetes (7.0 vs. 5.6 pounds, respectively).

Data Source: A substudy of 101 individuals with prediabetes enrolled in a 12-week behavioral weight-loss program.

Disclosures: Dr. Homko disclosed that she serves on the advisory board of Abbott Diabetes Care.

SAN ANTONIO – Overweight individuals who knew that they had prediabetes did not lose any more weight than did those who did not have the condition, in a preliminary analysis of 103 overweight participants in a 12-week behavioral weight-loss program.

The findings were contrary to expectations. “Our hypothesis was that individuals who perceive themselves to be at increased risk for developing diabetes would lose more weight than individuals who perceive their risk to be lower,” said Carol J. Homko, Ph.D., a certified diabetes educator and registered nurse.

The data come from a secondary analysis of a larger randomized study designed to look at the effect of telemedicine on weight-loss maintenance 1 year following the weight-loss program. All 103 subjects participated in the same weekly group sessions, held at local churches and facilitated by both health care professionals (mostly registered dieticians and health psychologists) and a lay facilitator who was a member of the church. The 90-minute sessions included diet, exercise, and behavioral change counseling. Each group included 12–15 participants.

They had a mean age of 51 years (adults aged 18–75 were included) and body mass index of 35.5 kg/m

Risk perception was assessed with the same survey used in the Diabetes Prevention Program (Diabetes Care 2003;26:2543–8), and included measures of personal control, worry, optimistic bias, comparative disease risk, comparative environmental risk, diabetes risk knowledge, unknown risk, and “dread risk.” Across the board, there were no differences in risk perception from baseline through 12 weeks in any of those measures, said Dr. Homko of the department of medicine at Temple University, Philadelphia.

It's not clear why people who know they have prediabetes don't perceive themselves to be at greater risk for diabetes than are those without that diagnosis, but one possible explanation is that the people who chose to participate in a weight-loss program did so because they were already aware of the risks associated with excess weight and the potential impact on their health, she said in an interview.

Participants lost a mean of 6.3 pounds, and weight losses did not differ significantly between those with and without prediabetes (7.0 vs. 5.6 pounds, respectively).

Not surprisingly, weight loss correlated with progression to diabetes among the 53 with prediabetes. The 28 who reverted to normal glucose tolerance had lost an average of 11.3 pounds at 12 weeks, compared with 5.6 pounds in the 18 who remained prediabetic and 3.6 pounds in the 7 who progressed to type 2 diabetes. Those differences were statistically significant, she said.

Although the findings from this study regarding risk perception may be disappointing, the bright side is that weight loss of just 5% was associated with conversion to normal glucose tolerance in individuals with prediabetes, Dr. Homko pointed out. “There is strong evidence to suggest that weight loss and increased activity can slow the progression to type 2 diabetes,” she said.

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All Teens With PCOS Need an OGTT, Regardless of Weight

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Major Finding: Impaired glucose tolerance was found in eight of the NIH-defined PCOS adolescent patients (14.5%) and 10 of the AES-defined group (16%). When the second group was divided into obese and nonobese subgroups, IGT was present in 16% of both groups.

Data Source: A study of 70 adolescent girls referred to a specialty clinic for menstrual irregularity.

Disclosures: Dr. Flannery stated that she had no financial disclosures.

ORLANDO — More than 10% of non-obese adolescent girls with polycystic ovary syndrome were found to have impaired glucose tolerance in a study of 70 girls who had been referred to a specialty clinic for menstrual irregularity.

The finding suggests that all girls and women with polycystic ovary syndrome (PCOS) – not just those who are overweight or obese – should be evaluated with an oral glucose tolerance test (OGTT), said Dr. Clare A. Flannery of the Yale Multidisciplinary Adolescent PCOS Program and the department of endocrinology–internal medicine at Yale University, New Haven, Conn.

“Without an OGTT, the presence of impaired glucose metabolism is underestimated in lean adolescents with PCOS since their other parameters of insulin resistance may be in normal range. There is a need for a standardized OGTT for every adolescent with PCOS, regardless of weight,” she said.

The study was conducted at the Yale PCOS clinic, where patients referred for menstrual irregularity are seen by an endocrinologist, a gynecologist, and a nutritionist. All patients also receive a transabdominal pelvic ultrasound, androgen panel, fasting lipid testing, and a 75-g OGTT. A group of 80 patients who were enrolled in an ongoing cohort study had a mean age of 15.6 years and mean body mass index (BMI) of 31.4 kg/m

Because there are no established criteria for diagnosing PCOS in adolescence, two of three professional guidelines for diagnosing PCOS in adults were used for the study: The 1990 National Institutes of Health criteria (Blackwell Scientific Publications, 1992:377-84), which includes irregular menses and clinical or biochemical evidence of high androgens with the exclusion of other disorders, and the 2006 Androgen Excess Society (AES) criteria, which allow ultrasound findings of PCOS as a substitute for irregular menses (J. Clin. Endocrinol. Metab. 2006;91:4237-45).

(The 2003 Rotterdam criteria [Human Reproduction 2004;19:41-7] were not used because the definition is less strict and could include adolescents with hypothalamic amenorrhea, she noted.)

Ten adolescents were excluded from analysis because they were either already on metformin or had missing OGTT data. Of the remaining 70, 55 (79%) met the NIH criteria for PCOS diagnosis and 64 (91%) met the AES criteria. One patient who met both criteria was found to have impaired fasting glucose, and another who met both definitions had type 2 diabetes. Impaired glucose tolerance (IGT) was found in eight of the NIH-defined PCOS patients (14.5%) and 10 of the AES-defined group (16%).

Among the 64 who met the AES PCOS criteria, 40 were obese (BMI of 95th percentile by age or greater). Mean BMI was 36 kg/m

“The nonobese girls were just as likely to have impaired glucose tolerance as their obese counterparts. If we had not indiscriminately applied the OGTT to all our patients, the abnormal glucose metabolism of the nonobese girls may have been missed,” she commented.

In contrast to the OGTT finding, other metabolic characteristics did appear to be driven by obesity rather than PCOS. Fasting glucose was greater – although still within normal range – among the obese patients (86 vs. 82 mg/dL), and there was a trend toward increased insulin resistance among those in the obese group, as measured by the homeostatic model assessment. Lipid abnormalities and other parameters of insulin resistance also worsened as weight increased, with both differences in C-reactive protein and high density lipid protein reaching statistical significance.

Dr. Flannery recommended that physicians use the AES guidelines for performing an OGTT in all girls and women with PCOS, regardless of age or BMI, noting that the most recent guidelines from the American Diabetes Association recommend use of OGTT only in overweight adolescents with additional risk factors. “If we had applied the ADA guidelines, we would have missed IGT in many of our adolescents,” she said.

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Major Finding: Impaired glucose tolerance was found in eight of the NIH-defined PCOS adolescent patients (14.5%) and 10 of the AES-defined group (16%). When the second group was divided into obese and nonobese subgroups, IGT was present in 16% of both groups.

Data Source: A study of 70 adolescent girls referred to a specialty clinic for menstrual irregularity.

Disclosures: Dr. Flannery stated that she had no financial disclosures.

ORLANDO — More than 10% of non-obese adolescent girls with polycystic ovary syndrome were found to have impaired glucose tolerance in a study of 70 girls who had been referred to a specialty clinic for menstrual irregularity.

The finding suggests that all girls and women with polycystic ovary syndrome (PCOS) – not just those who are overweight or obese – should be evaluated with an oral glucose tolerance test (OGTT), said Dr. Clare A. Flannery of the Yale Multidisciplinary Adolescent PCOS Program and the department of endocrinology–internal medicine at Yale University, New Haven, Conn.

“Without an OGTT, the presence of impaired glucose metabolism is underestimated in lean adolescents with PCOS since their other parameters of insulin resistance may be in normal range. There is a need for a standardized OGTT for every adolescent with PCOS, regardless of weight,” she said.

The study was conducted at the Yale PCOS clinic, where patients referred for menstrual irregularity are seen by an endocrinologist, a gynecologist, and a nutritionist. All patients also receive a transabdominal pelvic ultrasound, androgen panel, fasting lipid testing, and a 75-g OGTT. A group of 80 patients who were enrolled in an ongoing cohort study had a mean age of 15.6 years and mean body mass index (BMI) of 31.4 kg/m

Because there are no established criteria for diagnosing PCOS in adolescence, two of three professional guidelines for diagnosing PCOS in adults were used for the study: The 1990 National Institutes of Health criteria (Blackwell Scientific Publications, 1992:377-84), which includes irregular menses and clinical or biochemical evidence of high androgens with the exclusion of other disorders, and the 2006 Androgen Excess Society (AES) criteria, which allow ultrasound findings of PCOS as a substitute for irregular menses (J. Clin. Endocrinol. Metab. 2006;91:4237-45).

(The 2003 Rotterdam criteria [Human Reproduction 2004;19:41-7] were not used because the definition is less strict and could include adolescents with hypothalamic amenorrhea, she noted.)

Ten adolescents were excluded from analysis because they were either already on metformin or had missing OGTT data. Of the remaining 70, 55 (79%) met the NIH criteria for PCOS diagnosis and 64 (91%) met the AES criteria. One patient who met both criteria was found to have impaired fasting glucose, and another who met both definitions had type 2 diabetes. Impaired glucose tolerance (IGT) was found in eight of the NIH-defined PCOS patients (14.5%) and 10 of the AES-defined group (16%).

Among the 64 who met the AES PCOS criteria, 40 were obese (BMI of 95th percentile by age or greater). Mean BMI was 36 kg/m

“The nonobese girls were just as likely to have impaired glucose tolerance as their obese counterparts. If we had not indiscriminately applied the OGTT to all our patients, the abnormal glucose metabolism of the nonobese girls may have been missed,” she commented.

In contrast to the OGTT finding, other metabolic characteristics did appear to be driven by obesity rather than PCOS. Fasting glucose was greater – although still within normal range – among the obese patients (86 vs. 82 mg/dL), and there was a trend toward increased insulin resistance among those in the obese group, as measured by the homeostatic model assessment. Lipid abnormalities and other parameters of insulin resistance also worsened as weight increased, with both differences in C-reactive protein and high density lipid protein reaching statistical significance.

Dr. Flannery recommended that physicians use the AES guidelines for performing an OGTT in all girls and women with PCOS, regardless of age or BMI, noting that the most recent guidelines from the American Diabetes Association recommend use of OGTT only in overweight adolescents with additional risk factors. “If we had applied the ADA guidelines, we would have missed IGT in many of our adolescents,” she said.

Major Finding: Impaired glucose tolerance was found in eight of the NIH-defined PCOS adolescent patients (14.5%) and 10 of the AES-defined group (16%). When the second group was divided into obese and nonobese subgroups, IGT was present in 16% of both groups.

Data Source: A study of 70 adolescent girls referred to a specialty clinic for menstrual irregularity.

Disclosures: Dr. Flannery stated that she had no financial disclosures.

ORLANDO — More than 10% of non-obese adolescent girls with polycystic ovary syndrome were found to have impaired glucose tolerance in a study of 70 girls who had been referred to a specialty clinic for menstrual irregularity.

The finding suggests that all girls and women with polycystic ovary syndrome (PCOS) – not just those who are overweight or obese – should be evaluated with an oral glucose tolerance test (OGTT), said Dr. Clare A. Flannery of the Yale Multidisciplinary Adolescent PCOS Program and the department of endocrinology–internal medicine at Yale University, New Haven, Conn.

“Without an OGTT, the presence of impaired glucose metabolism is underestimated in lean adolescents with PCOS since their other parameters of insulin resistance may be in normal range. There is a need for a standardized OGTT for every adolescent with PCOS, regardless of weight,” she said.

The study was conducted at the Yale PCOS clinic, where patients referred for menstrual irregularity are seen by an endocrinologist, a gynecologist, and a nutritionist. All patients also receive a transabdominal pelvic ultrasound, androgen panel, fasting lipid testing, and a 75-g OGTT. A group of 80 patients who were enrolled in an ongoing cohort study had a mean age of 15.6 years and mean body mass index (BMI) of 31.4 kg/m

Because there are no established criteria for diagnosing PCOS in adolescence, two of three professional guidelines for diagnosing PCOS in adults were used for the study: The 1990 National Institutes of Health criteria (Blackwell Scientific Publications, 1992:377-84), which includes irregular menses and clinical or biochemical evidence of high androgens with the exclusion of other disorders, and the 2006 Androgen Excess Society (AES) criteria, which allow ultrasound findings of PCOS as a substitute for irregular menses (J. Clin. Endocrinol. Metab. 2006;91:4237-45).

(The 2003 Rotterdam criteria [Human Reproduction 2004;19:41-7] were not used because the definition is less strict and could include adolescents with hypothalamic amenorrhea, she noted.)

Ten adolescents were excluded from analysis because they were either already on metformin or had missing OGTT data. Of the remaining 70, 55 (79%) met the NIH criteria for PCOS diagnosis and 64 (91%) met the AES criteria. One patient who met both criteria was found to have impaired fasting glucose, and another who met both definitions had type 2 diabetes. Impaired glucose tolerance (IGT) was found in eight of the NIH-defined PCOS patients (14.5%) and 10 of the AES-defined group (16%).

Among the 64 who met the AES PCOS criteria, 40 were obese (BMI of 95th percentile by age or greater). Mean BMI was 36 kg/m

“The nonobese girls were just as likely to have impaired glucose tolerance as their obese counterparts. If we had not indiscriminately applied the OGTT to all our patients, the abnormal glucose metabolism of the nonobese girls may have been missed,” she commented.

In contrast to the OGTT finding, other metabolic characteristics did appear to be driven by obesity rather than PCOS. Fasting glucose was greater – although still within normal range – among the obese patients (86 vs. 82 mg/dL), and there was a trend toward increased insulin resistance among those in the obese group, as measured by the homeostatic model assessment. Lipid abnormalities and other parameters of insulin resistance also worsened as weight increased, with both differences in C-reactive protein and high density lipid protein reaching statistical significance.

Dr. Flannery recommended that physicians use the AES guidelines for performing an OGTT in all girls and women with PCOS, regardless of age or BMI, noting that the most recent guidelines from the American Diabetes Association recommend use of OGTT only in overweight adolescents with additional risk factors. “If we had applied the ADA guidelines, we would have missed IGT in many of our adolescents,” she said.

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Pharmacist Phone Calls Improved Diabetes Rx Adherence

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Major Finding: At 12 months, the likelihood of an oral medication adherence rate above 80% was 4.77 times greater among the intervention group than among controls, a significant difference despite wide confidence intervals.

Data Source: A randomized controlled study of 265 patients with type 2 diabetes conducted with pharmacists at four Safeway pharmacies in Washington state.

Disclosures: The study was funded by a grant from the American Association of Diabetes Educators' Education and Research Foundation.

SAN ANTONIO — A personalized phone call from a retail chain store pharmacist to patients who missed diabetes prescription refills significantly improved medication adherence at 1 year in a study of 265 patients with type 2 diabetes.

“Because adults with diabetes visit pharmacies more often than they visit any other health professional [setting], it is believed there is an untapped opportunity for pharmacists to provide self-management education and support for medications,” said certified diabetes educator Peggy S. Odegard, Pharm.D.

The randomized, controlled Medication Adherence Program (MAP) study was conducted at four pharmacies inside Safeway grocery stores in Washington state. When a prescription refill for an oral glucose-lowering medication was missed by 6 days, a pharmacist would call the patients to ask why they had missed the refill and whether they would like to refill it now. Depending on the response, the pharmacist would offer individualized advice and education.

A follow-up phone call was made at 1 week to 1 month after the intervention to further assess the patients' needs and address any problems.

The subjects had all been using the pharmacy consistently for a year or longer.

The 145 controls, who were not called when refills were missed, were slightly younger, with a mean age of 61 years, compared with 65 years for the 120 who received the phone call intervention. The groups' other baseline characteristics were similar, including sex (a little more than half were women), the number of different medications they were taking, and the proportion who were on insulin (23% in both groups).

Among 119 patients who reported problems with taking their medications, 27% cited “difficulty with taking medication,” 26% said they simply “forgot to order refills,” and 8% “forgot to pick up refills.” Of those with “difficulty taking medication,” the most common difficulty listed was “remembering dose.”

Adherence was assessed by the change in “medication possession ratio” (MPR),” or the number of days of medication supplied in a prescription fill divided by the number of days until the prescription was refilled. For example, a 30-day supply that is filled and then refilled in 30 days would yield an MPR of 1.0. But if a patient receives a 30-day prescription but doesn't refill it for 60 days, the MPR would be 0.5, or half the adherence rate expected, explained Dr. Odegard, of the University of Washington, Seattle, in an interview.

At baseline, MPR for diabetes medications did not differ between the two groups (0.86 for the intervention group and 0.84 for controls). However, the proportion of patients with an MPR greater than 0.8 was slightly higher in the intervention group than in the controls (74.4% vs. 65.2%), meaning that it would be harder to prove that the intervention worked because the patients in that group already were somewhat more adherent, Dr. Odegard pointed out.

Over 12 months, the pharmacists conducted an average of 3.4 phone call interventions (or occasionally in-person interventions) per patient, and were reimbursed $10 per intervention. Interventions lasted an average of 12.6 minutes each. In addition to diabetes education (including advice on prevention of medication side effects) and adherence support (including integration of medication dosing with daily activities), pharmacists helped to optimize the patients' regimen with the prescriber and/or helped with economic adjustment (for example, a change to generic).

At 12 months, the MPR was significantly improved in the intervention group (up to 0.90 from 0.86), whereas in the control group the MPR declined slightly (from 0.84 to 0.82). The difference in MPR between the two groups at 12 months also was significant. Moreover, the likelihood of an oral medication adherence rate greater than 80% (MPR 0.80 or higher) was 4.77 times greater among the intervention group than in the controls. This difference was significant despite wide confidence intervals, said Dr. Odegard.

Dr. Odegard and her associates are hoping to integrate this type of program into local pharmacy chains. Several remaining challenges include the fact that patients don't always pick up their own medications, some might use both community and mail order pharmacies, and some might have multiple physicians for their diabetes care.

 

 

During the question-and-answer period, Dr. Odegard remarked that such programs could provide a significant revenue stream to pharmacies. She and her colleagues are currently conducting a cost analysis.

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Major Finding: At 12 months, the likelihood of an oral medication adherence rate above 80% was 4.77 times greater among the intervention group than among controls, a significant difference despite wide confidence intervals.

Data Source: A randomized controlled study of 265 patients with type 2 diabetes conducted with pharmacists at four Safeway pharmacies in Washington state.

Disclosures: The study was funded by a grant from the American Association of Diabetes Educators' Education and Research Foundation.

SAN ANTONIO — A personalized phone call from a retail chain store pharmacist to patients who missed diabetes prescription refills significantly improved medication adherence at 1 year in a study of 265 patients with type 2 diabetes.

“Because adults with diabetes visit pharmacies more often than they visit any other health professional [setting], it is believed there is an untapped opportunity for pharmacists to provide self-management education and support for medications,” said certified diabetes educator Peggy S. Odegard, Pharm.D.

The randomized, controlled Medication Adherence Program (MAP) study was conducted at four pharmacies inside Safeway grocery stores in Washington state. When a prescription refill for an oral glucose-lowering medication was missed by 6 days, a pharmacist would call the patients to ask why they had missed the refill and whether they would like to refill it now. Depending on the response, the pharmacist would offer individualized advice and education.

A follow-up phone call was made at 1 week to 1 month after the intervention to further assess the patients' needs and address any problems.

The subjects had all been using the pharmacy consistently for a year or longer.

The 145 controls, who were not called when refills were missed, were slightly younger, with a mean age of 61 years, compared with 65 years for the 120 who received the phone call intervention. The groups' other baseline characteristics were similar, including sex (a little more than half were women), the number of different medications they were taking, and the proportion who were on insulin (23% in both groups).

Among 119 patients who reported problems with taking their medications, 27% cited “difficulty with taking medication,” 26% said they simply “forgot to order refills,” and 8% “forgot to pick up refills.” Of those with “difficulty taking medication,” the most common difficulty listed was “remembering dose.”

Adherence was assessed by the change in “medication possession ratio” (MPR),” or the number of days of medication supplied in a prescription fill divided by the number of days until the prescription was refilled. For example, a 30-day supply that is filled and then refilled in 30 days would yield an MPR of 1.0. But if a patient receives a 30-day prescription but doesn't refill it for 60 days, the MPR would be 0.5, or half the adherence rate expected, explained Dr. Odegard, of the University of Washington, Seattle, in an interview.

At baseline, MPR for diabetes medications did not differ between the two groups (0.86 for the intervention group and 0.84 for controls). However, the proportion of patients with an MPR greater than 0.8 was slightly higher in the intervention group than in the controls (74.4% vs. 65.2%), meaning that it would be harder to prove that the intervention worked because the patients in that group already were somewhat more adherent, Dr. Odegard pointed out.

Over 12 months, the pharmacists conducted an average of 3.4 phone call interventions (or occasionally in-person interventions) per patient, and were reimbursed $10 per intervention. Interventions lasted an average of 12.6 minutes each. In addition to diabetes education (including advice on prevention of medication side effects) and adherence support (including integration of medication dosing with daily activities), pharmacists helped to optimize the patients' regimen with the prescriber and/or helped with economic adjustment (for example, a change to generic).

At 12 months, the MPR was significantly improved in the intervention group (up to 0.90 from 0.86), whereas in the control group the MPR declined slightly (from 0.84 to 0.82). The difference in MPR between the two groups at 12 months also was significant. Moreover, the likelihood of an oral medication adherence rate greater than 80% (MPR 0.80 or higher) was 4.77 times greater among the intervention group than in the controls. This difference was significant despite wide confidence intervals, said Dr. Odegard.

Dr. Odegard and her associates are hoping to integrate this type of program into local pharmacy chains. Several remaining challenges include the fact that patients don't always pick up their own medications, some might use both community and mail order pharmacies, and some might have multiple physicians for their diabetes care.

 

 

During the question-and-answer period, Dr. Odegard remarked that such programs could provide a significant revenue stream to pharmacies. She and her colleagues are currently conducting a cost analysis.

Major Finding: At 12 months, the likelihood of an oral medication adherence rate above 80% was 4.77 times greater among the intervention group than among controls, a significant difference despite wide confidence intervals.

Data Source: A randomized controlled study of 265 patients with type 2 diabetes conducted with pharmacists at four Safeway pharmacies in Washington state.

Disclosures: The study was funded by a grant from the American Association of Diabetes Educators' Education and Research Foundation.

SAN ANTONIO — A personalized phone call from a retail chain store pharmacist to patients who missed diabetes prescription refills significantly improved medication adherence at 1 year in a study of 265 patients with type 2 diabetes.

“Because adults with diabetes visit pharmacies more often than they visit any other health professional [setting], it is believed there is an untapped opportunity for pharmacists to provide self-management education and support for medications,” said certified diabetes educator Peggy S. Odegard, Pharm.D.

The randomized, controlled Medication Adherence Program (MAP) study was conducted at four pharmacies inside Safeway grocery stores in Washington state. When a prescription refill for an oral glucose-lowering medication was missed by 6 days, a pharmacist would call the patients to ask why they had missed the refill and whether they would like to refill it now. Depending on the response, the pharmacist would offer individualized advice and education.

A follow-up phone call was made at 1 week to 1 month after the intervention to further assess the patients' needs and address any problems.

The subjects had all been using the pharmacy consistently for a year or longer.

The 145 controls, who were not called when refills were missed, were slightly younger, with a mean age of 61 years, compared with 65 years for the 120 who received the phone call intervention. The groups' other baseline characteristics were similar, including sex (a little more than half were women), the number of different medications they were taking, and the proportion who were on insulin (23% in both groups).

Among 119 patients who reported problems with taking their medications, 27% cited “difficulty with taking medication,” 26% said they simply “forgot to order refills,” and 8% “forgot to pick up refills.” Of those with “difficulty taking medication,” the most common difficulty listed was “remembering dose.”

Adherence was assessed by the change in “medication possession ratio” (MPR),” or the number of days of medication supplied in a prescription fill divided by the number of days until the prescription was refilled. For example, a 30-day supply that is filled and then refilled in 30 days would yield an MPR of 1.0. But if a patient receives a 30-day prescription but doesn't refill it for 60 days, the MPR would be 0.5, or half the adherence rate expected, explained Dr. Odegard, of the University of Washington, Seattle, in an interview.

At baseline, MPR for diabetes medications did not differ between the two groups (0.86 for the intervention group and 0.84 for controls). However, the proportion of patients with an MPR greater than 0.8 was slightly higher in the intervention group than in the controls (74.4% vs. 65.2%), meaning that it would be harder to prove that the intervention worked because the patients in that group already were somewhat more adherent, Dr. Odegard pointed out.

Over 12 months, the pharmacists conducted an average of 3.4 phone call interventions (or occasionally in-person interventions) per patient, and were reimbursed $10 per intervention. Interventions lasted an average of 12.6 minutes each. In addition to diabetes education (including advice on prevention of medication side effects) and adherence support (including integration of medication dosing with daily activities), pharmacists helped to optimize the patients' regimen with the prescriber and/or helped with economic adjustment (for example, a change to generic).

At 12 months, the MPR was significantly improved in the intervention group (up to 0.90 from 0.86), whereas in the control group the MPR declined slightly (from 0.84 to 0.82). The difference in MPR between the two groups at 12 months also was significant. Moreover, the likelihood of an oral medication adherence rate greater than 80% (MPR 0.80 or higher) was 4.77 times greater among the intervention group than in the controls. This difference was significant despite wide confidence intervals, said Dr. Odegard.

Dr. Odegard and her associates are hoping to integrate this type of program into local pharmacy chains. Several remaining challenges include the fact that patients don't always pick up their own medications, some might use both community and mail order pharmacies, and some might have multiple physicians for their diabetes care.

 

 

During the question-and-answer period, Dr. Odegard remarked that such programs could provide a significant revenue stream to pharmacies. She and her colleagues are currently conducting a cost analysis.

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Diabetes Education Cut Hospital Admissions

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Major Finding: In 2007, the adjusted cost per member per month of plan members with diabetes with commercial insurance was $923 among those who received diabetes education, compared with $1,072 among those who did not. For Medicare enrollees, those figures were $1,241 and $1,322, respectively.

Data Source: Ongoing claims database analysis of approximately 20 million lives, including both Medicare and commercially insured members. In 2007, the database contained 166,931 individuals with diabetes who had commercial insurance and 56,345 on Medicare.

Disclosures: The study was funded by the AADE. Mr. Duncan had no further disclosures.

SAN ANTONIO — Data continue to show that diabetes education saves money.

Last year, the findings of an analysis of 3 years' worth of data from a large national claims database showed that patients with diabetes who receive diabetes education incur lower costs than do those who have not received the education (Diabetes Educ. 2009;35:752–60).

Now, preliminary findings from a new analysis of the same database show that the cost reduction comes mainly from a drop in hospital admissions, and that ongoing diabetes education beyond the initial sessions received at diagnosis are necessary to produce the cost savings.

The findings were presented by actuarial consultant Ian Duncan, president of Solucia Consulting. His firm conducted the analysis for the American Association of Diabetes Educators (AADE) using data from Solucia's claims database of about 20 million individuals, including both Medicare and commercially insured members. In 2007, the database contained 166,931 individuals with diabetes who had commercial insurance and 56,345 who were on Medicare.

“We all know how much you do for patients, how much you improve their lifestyle and help them cope with their condition. But the kinds of people we work with — the insurance payers (Medicaid agencies, Medicare, and health plans) — are interested in whether the investment for the services you provide brings a return to them in terms of the costs and the claims that the patients incur,” said Mr. Duncan, also of the department of health administration at Georgetown University in Washington.

In 2007, the adjusted cost per member per month of plan members with diabetes who were commercially insured was $923 among those who received diabetes education, compared with $1,072 among those who did not. For Medicare enrollees, those figures were $1,241 and $1,322, respectively. Those differences were significant for both groups.

The follow-up, risk-adjusted analysis of patients who were continuously enrolled in 2005–2008 showed a significant difference in costs for the commercially insured patients ($985 for the 3,094 who received diabetes education vs. $1,043 for the 31,075 who did not), but there were no differences in the Medicare group, which included just 898 patients who received diabetes education and 23,342 who did not (nearly $1,400 for both).

However, when the frequency of diabetes education was factored in, it became clear that enrollees who received two or more education sessions incurred lower costs than did those who received one or no sessions.

In the commercially insured group in 2008, costs per patient per month were $845 for those receiving at least two education sessions, $863 for those who had just one session, and $907 for those with no diabetes education. In the Medicare group, the costs for those with zero and one session were nearly identical ($1,343 and $1,337, respectively), whereas the patients who did receive diabetes education that was covered by Medicare cost $1,267.50 per month. Neither quite reached statistical significance.

These differences were seen even though more diabetes education was associated with higher medication compliance and thus greater pharmacy costs. In 2008, costs for glucose-lowering drugs were nearly identical for those with commercial insurance who received no education sessions or just one ($76 and $78, respectively) but were significantly higher for those who had at least two sessions ($99). Similarly, those figures in the Medicare group were $69 and $70, compared with $81, respectively.

Reductions in hospital admissions in the group receiving diabetes education more than made up for the higher pharmacy cost. In 2008, there were just 180 per 1,000 admissions for diabetes patients with commercial insurance who received two or more diabetes education sessions, compared with 212 per 1,000 for those with one session and 221 per 1,000 for no sessions.

The difference was not as striking in Medicare, where those figures were 709, 665, and 735 per 1,000, respectively.

Other than the AADE funding for this study, Mr. Duncan stated that he had no further disclosures.

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Major Finding: In 2007, the adjusted cost per member per month of plan members with diabetes with commercial insurance was $923 among those who received diabetes education, compared with $1,072 among those who did not. For Medicare enrollees, those figures were $1,241 and $1,322, respectively.

Data Source: Ongoing claims database analysis of approximately 20 million lives, including both Medicare and commercially insured members. In 2007, the database contained 166,931 individuals with diabetes who had commercial insurance and 56,345 on Medicare.

Disclosures: The study was funded by the AADE. Mr. Duncan had no further disclosures.

SAN ANTONIO — Data continue to show that diabetes education saves money.

Last year, the findings of an analysis of 3 years' worth of data from a large national claims database showed that patients with diabetes who receive diabetes education incur lower costs than do those who have not received the education (Diabetes Educ. 2009;35:752–60).

Now, preliminary findings from a new analysis of the same database show that the cost reduction comes mainly from a drop in hospital admissions, and that ongoing diabetes education beyond the initial sessions received at diagnosis are necessary to produce the cost savings.

The findings were presented by actuarial consultant Ian Duncan, president of Solucia Consulting. His firm conducted the analysis for the American Association of Diabetes Educators (AADE) using data from Solucia's claims database of about 20 million individuals, including both Medicare and commercially insured members. In 2007, the database contained 166,931 individuals with diabetes who had commercial insurance and 56,345 who were on Medicare.

“We all know how much you do for patients, how much you improve their lifestyle and help them cope with their condition. But the kinds of people we work with — the insurance payers (Medicaid agencies, Medicare, and health plans) — are interested in whether the investment for the services you provide brings a return to them in terms of the costs and the claims that the patients incur,” said Mr. Duncan, also of the department of health administration at Georgetown University in Washington.

In 2007, the adjusted cost per member per month of plan members with diabetes who were commercially insured was $923 among those who received diabetes education, compared with $1,072 among those who did not. For Medicare enrollees, those figures were $1,241 and $1,322, respectively. Those differences were significant for both groups.

The follow-up, risk-adjusted analysis of patients who were continuously enrolled in 2005–2008 showed a significant difference in costs for the commercially insured patients ($985 for the 3,094 who received diabetes education vs. $1,043 for the 31,075 who did not), but there were no differences in the Medicare group, which included just 898 patients who received diabetes education and 23,342 who did not (nearly $1,400 for both).

However, when the frequency of diabetes education was factored in, it became clear that enrollees who received two or more education sessions incurred lower costs than did those who received one or no sessions.

In the commercially insured group in 2008, costs per patient per month were $845 for those receiving at least two education sessions, $863 for those who had just one session, and $907 for those with no diabetes education. In the Medicare group, the costs for those with zero and one session were nearly identical ($1,343 and $1,337, respectively), whereas the patients who did receive diabetes education that was covered by Medicare cost $1,267.50 per month. Neither quite reached statistical significance.

These differences were seen even though more diabetes education was associated with higher medication compliance and thus greater pharmacy costs. In 2008, costs for glucose-lowering drugs were nearly identical for those with commercial insurance who received no education sessions or just one ($76 and $78, respectively) but were significantly higher for those who had at least two sessions ($99). Similarly, those figures in the Medicare group were $69 and $70, compared with $81, respectively.

Reductions in hospital admissions in the group receiving diabetes education more than made up for the higher pharmacy cost. In 2008, there were just 180 per 1,000 admissions for diabetes patients with commercial insurance who received two or more diabetes education sessions, compared with 212 per 1,000 for those with one session and 221 per 1,000 for no sessions.

The difference was not as striking in Medicare, where those figures were 709, 665, and 735 per 1,000, respectively.

Other than the AADE funding for this study, Mr. Duncan stated that he had no further disclosures.

Major Finding: In 2007, the adjusted cost per member per month of plan members with diabetes with commercial insurance was $923 among those who received diabetes education, compared with $1,072 among those who did not. For Medicare enrollees, those figures were $1,241 and $1,322, respectively.

Data Source: Ongoing claims database analysis of approximately 20 million lives, including both Medicare and commercially insured members. In 2007, the database contained 166,931 individuals with diabetes who had commercial insurance and 56,345 on Medicare.

Disclosures: The study was funded by the AADE. Mr. Duncan had no further disclosures.

SAN ANTONIO — Data continue to show that diabetes education saves money.

Last year, the findings of an analysis of 3 years' worth of data from a large national claims database showed that patients with diabetes who receive diabetes education incur lower costs than do those who have not received the education (Diabetes Educ. 2009;35:752–60).

Now, preliminary findings from a new analysis of the same database show that the cost reduction comes mainly from a drop in hospital admissions, and that ongoing diabetes education beyond the initial sessions received at diagnosis are necessary to produce the cost savings.

The findings were presented by actuarial consultant Ian Duncan, president of Solucia Consulting. His firm conducted the analysis for the American Association of Diabetes Educators (AADE) using data from Solucia's claims database of about 20 million individuals, including both Medicare and commercially insured members. In 2007, the database contained 166,931 individuals with diabetes who had commercial insurance and 56,345 who were on Medicare.

“We all know how much you do for patients, how much you improve their lifestyle and help them cope with their condition. But the kinds of people we work with — the insurance payers (Medicaid agencies, Medicare, and health plans) — are interested in whether the investment for the services you provide brings a return to them in terms of the costs and the claims that the patients incur,” said Mr. Duncan, also of the department of health administration at Georgetown University in Washington.

In 2007, the adjusted cost per member per month of plan members with diabetes who were commercially insured was $923 among those who received diabetes education, compared with $1,072 among those who did not. For Medicare enrollees, those figures were $1,241 and $1,322, respectively. Those differences were significant for both groups.

The follow-up, risk-adjusted analysis of patients who were continuously enrolled in 2005–2008 showed a significant difference in costs for the commercially insured patients ($985 for the 3,094 who received diabetes education vs. $1,043 for the 31,075 who did not), but there were no differences in the Medicare group, which included just 898 patients who received diabetes education and 23,342 who did not (nearly $1,400 for both).

However, when the frequency of diabetes education was factored in, it became clear that enrollees who received two or more education sessions incurred lower costs than did those who received one or no sessions.

In the commercially insured group in 2008, costs per patient per month were $845 for those receiving at least two education sessions, $863 for those who had just one session, and $907 for those with no diabetes education. In the Medicare group, the costs for those with zero and one session were nearly identical ($1,343 and $1,337, respectively), whereas the patients who did receive diabetes education that was covered by Medicare cost $1,267.50 per month. Neither quite reached statistical significance.

These differences were seen even though more diabetes education was associated with higher medication compliance and thus greater pharmacy costs. In 2008, costs for glucose-lowering drugs were nearly identical for those with commercial insurance who received no education sessions or just one ($76 and $78, respectively) but were significantly higher for those who had at least two sessions ($99). Similarly, those figures in the Medicare group were $69 and $70, compared with $81, respectively.

Reductions in hospital admissions in the group receiving diabetes education more than made up for the higher pharmacy cost. In 2008, there were just 180 per 1,000 admissions for diabetes patients with commercial insurance who received two or more diabetes education sessions, compared with 212 per 1,000 for those with one session and 221 per 1,000 for no sessions.

The difference was not as striking in Medicare, where those figures were 709, 665, and 735 per 1,000, respectively.

Other than the AADE funding for this study, Mr. Duncan stated that he had no further disclosures.

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