ADA 2010

Monday, June 28

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8:00 a.m. – 10:00 a.m.

Cardiovascular Complications of Diabetes
(includes Edwin Bierman Lecture)
Ira J. Goldberg, MD
Chapin Theater
NDEP Symposium
Translating New Research into a
Public Health Campaign and Tools for
Supporting Behavior Change
Room 224

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10:15 a.m. – 11:45 a.m.

National Scientific & Health Care
Achievement Awards Presentation and
Outstanding Scientific Achievement
Award Lecture
Martin G. Myers, Jr., MD, PhD
Hall D

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12:00 p.m. – 2:00 p.m.

General Poster Session/
Guided Audio Poster Tours
Hall C

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12:30 p.m. – 1:45 p.m.

Interest Group Discussions

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2:15 p.m. – 4:15 p.m.

Implications of the NAVIGATOR Trial for
Prevention of Diabetes and Cardiovascular
Disease in Subjects with Impaired
Glucose Tolerance
Chapin Theater
Updates on GLP-1 Agonists
Valencia Ballroom AB
Joint ADA/AACC Symposium
Point of Care Devices for Glucose and HbA1C—
Are They Up to the Task?
Room 311

IN HIS PRESIDENTIAL ADDRESS SUNDAY, RICHARD M. BERGENSTAL, MD, said that teams of diabetes care providers working together can stop diabetes and fulfill the goals of the recently enacted health care reform legislation by providing patient-centered care.

“I know patient-centered team care works because I’ve seen it in action at the International Diabetes Center over these last 27 years,” said Dr. Bergenstal, ADA President, Medicine & Science, who is also Executive Director of the International Diabetes Center (IDC) at Park Nicollet Institute in Minneapolis and Clinical Professor in the Department of Medicine at the University of Minnesota.

The IDC’s team care model involves the patient as a crucial member of the health care team in the management of diabetes. The multidisciplinary team includes clinicians, diabetes educators, nurses, dietitians, and social workers providing staged diabetes management using standards of care developed by the ADA, Dr. Bergenstal said.

The best outcomes for diabetes patients are consistently found in clinical research trials because patients enrolled in the trials have easy access to comprehensive care, reduced or no medication costs, team support, and patient-centered care that emphasizes patient accountability for self-management, he added.

“Don’t you think if our clinic patients had immediate access to care, no worries about the cost of medication, frequent contact with the health care team, and team support and they understood their treatment targets, we could probably go a long way toward achieving our treatment goals?” Dr. Bergenstal asked.

He also stressed the value of multicenter pilot studies and projects in providing patient-centered diabetes care that meets the goals of health care reform. “We have a hypothesis that patient-centered team care is most likely to meet our goals, and it is supported by preliminary studies and expert summary of the literature,” Dr. Bergenstal said. “Therefore, shouldn’t we expect that every insurance company will now pay for patient-centered team care today? I’m afraid the answer is ‘no,’ but I think we are ready for effective multicenter pilot studies.”

He urged audience members to get involved in advocating for diabetes team care and greater funding for research.

Following Dr. Bergenstal’s address, Robert A. Rizza, MD, the recipient of this year’s Banting Medal for Scientific Achievement, delivered this year’s Banting Lecture on “The Liver as a Prime Target for Individual-ized Therapy in Diabetes—Implications for Therapy.”

“People with type 2 diabetes have excessive rates of glucose production both before and after eating,” said Dr. Rizza, Professor of Medicine and Executive Dean for Research at the Mayo Clinic College of Medicine. “Increased rates of gluco-neogenesis and perhaps glucogenolysis contribute to excessive rates of glucose production.

“In addition, hepatic and muscle glucose uptake are impaired in type 2 diabetes,” he continued. “When combined with defects in the timing and amount of insulin secretion, as well as a lack of suppression of glucagon release, these abnormalities cause both fasting and postprandial hyperglycemia.”

Therefore, the goal is to develop agents that restore glucose production, gluco-neogenesis, glucogenolysis, hepatic and muscle glucose uptake, as well as insulin and glucagon secretion, Dr. Rizza said after reviewing a variety of studies providing evidence for his conclusions.

“The premise of these and other studies by colleagues both in and outside of man is that an understanding of the pathogenesis of type 2 diabetes enables the development of therapies that correct specific metabolic defects in a given individual,” he said. “However, the data I have shown you are derived from groups, not individuals. What we do not yet have is sufficient knowledge to truly individualize therapies. In my opinion, this approach will be the norm in the clinical setting in the not too distant future.

“When this occurs,” Dr. Rizza said, “I, as well as many other investigators, believe that therapies tailored to each person’s uniqueness will be more effective and have a lower risk.”

THE PREVALENCE OF TYPE 2 diabetes is rising dramatically around the globe, and it threatens to overwhelm the health systems of many developing countries and the economies of all nations.

According to Frank B. Hu, MD, PhD, who delivered the annual Kelly West Lecture yesterday afternoon at the Scientific Sessions, most cases of type 2 diabetes can be prevented with diet and lifestyle modifications. But adopting healthy diets and lifestyles is difficult, he conceded, and requires changes both in individual behavior and in dietary and social environments.

Dr. Hu, who is Professor of Medicine at Harvard Medical School and Professor of Nutrition and Epidemiology at the Harvard School of Public Health, cited a number of diet and lifestyle intervention trials demonstrating the effectiveness of these interventions in reducing the risk of diabetes. These studies, which include the Chinese Da Qing Diabetes Study, the Finnish Diabetes Prevention Study, and the U.S. Diabetes Prevention Program, “have demonstrated that the benefits of dietary and lifestyle intervention can be sustained over the long term, even 10 years after the intervention had stopped,” he said.

“It was remarkable that in the Chinese Da Qing study there was still a 40 percent reduction in diabetes risk in the intervention group at 20 years’ follow up,” Dr. Hu said. “That’s 40 years after the intervention had stopped. It is also remarkable to note that almost everyone in the control group had converted from IGT to diabetes at the end of the follow up period. So the risk of doing nothing is really serious and unacceptable in terms of reducing the risk of type 2 diabetes.”

Dr. Hu also cited a study of diet and life-style interventions that he and his colleagues conducted showing that being overweight or obese was the single most important predictor of the development of diabetes among a group of low-risk women. The study results also showed that lack of exercise, a poor diet, and cigarette smoking were all associated with a significantly increased risk of diabetes.

“I think everyone knows that physical activity is extremely important for the prevention of type 2 diabetes, but what testing usually ignores is the other side of the coin—the sedentary behaviors,” Dr. Hu said. “In the U.S. and other countries, TV watching is the most prevalent and pervasive sedentary behavior. In our study we found that sedentary behavior, especially TV watching, is associated with a significant risk of developing type 2 diabetes.”

Dr. Hu and his research group have conducted detailed analyses of numerous dietary and lifestyle factors associated with the risk of type 2 diabetes, including sugar-sweetened beverages and dietary patterns.

He said many populations around the world are moving away from their traditional diets to Western diets that include consumption of foods high in sugar, fat, and carbohydrates that increase the risk of type 2 diabetes. In a study of the consumption of white rice and the risk of diabetes among women in Shanghai, researchers found that substituting 50 grams per day of brown rice for white rice reduced the risk of diabetes by 16 percent because brown rice is minimally processed and induces lower insulin responses, Dr. Hu noted.

Other studies have shown that interactions between certain genetic variants, such as the TCF7L2 and FTO variants, increase the risk of diabetes associated with dietary carbohydrates and sedentary behavior in people with these genetic phenotypes, he said.

“Data from both observational and interventional studies, even though they are still preliminary, provide evidence that lifestyle factors can actually counteract or even abolish the genetic risk associated with many of the variants that have been associated with obesity and type 2 diabetes,” said Dr. Hu.

CREDITED WITH DIRECTLY mentoring 40 diabetic foot experts around the world, David G. Armstrong, DPM, PhD, delivered the annual Roger Pecoraro Lecture yesterday afternoon during an Oral Presentations session on Foot Complications.

Dr. Armstrong, who is Professor of Surgery and Director of the Southern Arizona Limb Salvage Alliance, titled his award lecture “Healing (and Preventing) the Diabetic Foot Wound: A Marriage of Team, Technology and Tenacity.”

“Every 30 minutes someone loses a leg because of a landmine, and every 30 minutes that’s a tragedy,” he said. “But that happens every 30 seconds because of diabetes.”

Yet there is encouraging data to indicate that an interdisciplinary approach is reducing amputations, Dr. Armstrong said. The “Toe and Flow” model defines who takes primacy between the foot specialist and a vascular specialist in order to run a successful amputation prevention service.

Dr. Armstrong offered several questions as a guide to managing foot lesions, the first being: What am I going to take off this wound that can help it heal? Beyond debridement of nonviable tissue, the most important consideration is pressure, he said.

“The two modalities most commonly prescribed, the total contact cast and the removable cast walker, are equal to each other in the laboratory in terms of their ability to offload,” Dr. Armstrong said. “We also know, unfortunately, that they are not equal in the clinical practice.”

Recent data suggests that patients make full use of the removable aspect of the removable cast walker, which results in the cast being used for only 28 percent of daily activity. The solution was to use dressings that do not require frequent changes with the removable cast walker, thereby arranging a marriage of the modalities.

The second question—How do we assess this wound?—is complicated by deficiencies in the various wound classification systems. “This has been a significant area of interest to us since there is so much ambiguity,” Dr. Armstrong said. “The trouble with many of them is they hadn’t taken things we thought were important in literature like depth, infection, and ischemia.”

One classification system, the Meggitt-Wagner Ulcer Classification System, did consider these aspects but did not allow for them to coexist. That led Dr. Armstrong’s group to create the University of Texas Diabetic Foot Wound Classification System, where grade (depth) and stage (infection/ischemia) are considered for every wound.

The final question Dr. Armstrong said care providers need to ask is, How might I prevent recurrence? To this end, risk categories have been developed that consider neuropathy, deformity, peripheral vascular disease, and history of pathology. Dr. Armstrong also noted that a comprehensive foot examination and risk assessment was published by the ADA’s Task Force of the Foot Care Interest Group, with endorsement by the American Association of Clinical Endocrinologists.

FOLLOWING THE 2009 publication in Diabetologia by Hemkens, et al., of a German study investigating the risk of malignant neoplasms and mortality in diabetes patients treated with either human insulin or one of three insulin analogs, multiple articles appeared in the mainstream press implicating insulin glargine with increased cancer risk. During yesterday morning’s symposium on Controversies Relating Cancer with Diabetes, Obesity, and Insulin, four experts presented data to help clarify a subject fraught with recent controversy.

Jeffrey A. Johnson, PhD, Professor at the University of Alberta in Edmonton, began the session by noting the strong and consistent epidemiological evidence of increased risk of various cancers and mortality in patients with diabetes. “As we have gained success in management of cardiovascular disease and cardiovascular risk factors in our diabetic population, it’s not surprising that we’re seeing an increase in the cause of death being cancer among the diabetic population,” Dr. Johnson said.

Some of the mechanisms implicated by the epidemiological evidence include obesity and health behaviors, hyperinsulinemia, and displaced priorities (the diabetic population has lower compliance with cancer screening). Though hyperglycemia is also implicated, reducing blood sugar levels does not affect cancer risk.

In a 2006 issue of Diabetes Care, Dr. Johnson’s group published a population-based study from the Saskatchewan province comparing the risk of cancer mortality for people with type 2 diabetes using different antidiabetic agents. Using metformin as a reference group, a cohort of 10,309 patients at a 5.4-year follow-up showed a 30 percent increased risk of cancer mortality when using sulfonylurea monotherapy and a 90 percent increase when insulin was added.

Derek LeRoith, MD, PhD, Professor of Medicine at the Mt. Sinai Medical Center in New York, then discussed his findings using a mouse model of type 2 diabetes. Muscle IGF-I receptor (IGF-IR)-lysine-arginine (MKR) mice are resistant to the metabolic actions of both insulin and adiponectin. “This simulates what we see in type 2 diabetes except for one very important issue—they’re not obese,” Dr. LeRoith said.

This led to the study of insulin receptor isoforms in breast cancer. Whereas Insulin Receptor B (IR-B) is responsible for metabolic effects, Insulin Receptor A (IR-A) has both metabolic and mitogenic properties and displays high levels of expression in fetal as well as some in neoplastic tissues.

“If you look at tumors taken from a woman’s breast cancer and examine the insulin receptors, what you’ll notice is that the high-est expression of insulin receptor is associated the worst prognosis. Furthermore, many of these receptors are IR-A,” Dr. LeRoith said.

John M. Lachin, ScD, Professor at The Biostatistics Center at George Washington University, then presented a lecture titled “Insulin Glargine and Cancer: Fact and Fallacies.”

Following a review of the differences between randomized controlled clinical trials and observational studies, Dr. Lachin discussed the importance of statistical adjustments. Not all covariate imbalances introduce bias, in which case adjustment itself introduces bias, he said.

Referring to the 2009 German article in Diabetologia, Dr. Lachin noted that with no adjustment for other factors, there was about a 16 percent reduction in cancer risk among those receiving glargine insulin versus human insulin. “However, there was a difference in the distribution of the actual doses that were administered, and when you adjust for a difference in dose, you go from a 14 percent risk reduction to a 14 percent risk increase,” he said.

Reasons for the dose imbalance may be due to unmeasured patient factors that are differentially distributed within groups. In other words, high glargine doses may have been administered only to severely ill patients. This would make it impossible to statistically adjust for the reason for the dose imbalance.

Jay S. Skyler, MD, Professor at the University of Miami Miller School of Medicine, concluded the session with his presentation “Diabetes, Insulin Therapy and Cancer: Lessons from the Diabetologia Story.”

“Online in Diabetologia on June 26 of last year appeared four papers. The German paper that Dr. Lachin just meticulously analyzed and three other papers,” Dr. Skyler said. “There was also an editorial from the editor, Dr. Edwin A. M. Gale, and president of the EASD [European Association for the Study of Diabetes] Ulf Smith trying to put these in perspective and raise a number of issues.”

At the same time, the EASD issued a press release titled “Possible Link Between Insulin Glargine and Cancer Prompts Urgent Call for Research.” Sensational headlines soon appeared in the mainstream press.

“Headlines which suggested that glargine causes cancer are unsubstantiated, unwarranted, and unproven,” Dr. Skyler concluded.

CARDIOVASCULAR DISEASE IS A major cause of death in patients with diabetes, but the process by which diabetes affects atherosclerosis and cardiac muscle function is not clearly understood, even though researchers have been investigating the process for more than five decades.

In this morning’s Edwin Bierman Lecture in the Chapin Theater, Ira J. Goldberg, MD, the Dickinson Richards Professor of Medicine and Chief of the Division of Preventive Medicine and Nutrition at Columbia University College of Physicians and Surgeons, New York, will examine the latest research, including his own, that could shed light on how diabetes leads to cardiovascular diseases.

“We still don’t have the answers,” said Dr. Goldberg, who will present his award lecture during this morning’s Oral Presentations session titled Cardiovascular Complications of Diabetes. “I will talk mostly about research in animal models and how these models have helped us understand how diabetes is toxic to the heart.”

Research with animal models has shown that some of the cardiovascular complications of diabetes can be reproduced, including changes in lipid profiles and perhaps the development of atherosclerosis. “The hope has been that researchers could reproduce vascular disease in these models. However, some of the models of diabetes have linked diabetes to vascular disease, but other diabetic models have not,” Dr. Goldberg said.

“For the animals that do not develop complications of diabetes, understanding why the animals are genetically different is, I believe, the key to understanding processes that lead to cardiovascular disease in humans,” he added.

Dr. Goldberg will discuss some of his own and others’ research into one particular gene that is present in humans but missing in mice—the human aldose reductase transgene—and its possible effects on cardiovascular disease in patients with diabetes. Aldose reductase is a multifunctional enzyme that reduces aldehydes. Under diabetic conditions, it converts glucose into sorbitol, which is then converted to fructose.

“A reasonable body of research suggests that fructose may be a toxic sugar, probably more toxic than glucose,” Dr. Goldberg said.

His research with colleagues has shown that mice have much lower levels of aldose reductase expression than humans, and these low levels are probably insufficient to generate toxic byproducts. Human aldose reductase expression in low-density lipo-protein receptor knockout mice, however, appears to exacerbate vascular disease, but only under diabetic conditions.

“I will also describe research we are doing in collaboration with investigators at New York University in another animal model looking at regression or improvement of atherosclerosis after we lower cholesterol levels in this model. We have found that in the setting of diabetes, resolution of the atherosclerotic process is defective. In normal animals, if we reduce cholesterol levels, we can reduce atherosclerosis. But in the diabetic model, lowering cholesterol does not reduce atherosclerosis,” Dr. Goldberg explained.

“The clinical implication of animal model research into cardiovascular disease under diabetic conditions is that if we can identify an enzyme responsible for the toxic process in blood vessels that leads to cardiovascular disease, pharmaceutical companies could then develop an inhibitor that lowers the chances of patients with diabetes developing heart disease to be equivalent to that of everybody else,” Dr. Goldberg said.

During the same two-hour Oral Presentations session, which begins at 8:00 a.m., investigators will present six abstracts related to the cardiovascular complications of diabetes.

The studies examine:

• Effects of low-density lipoprotein cholesterol complexes on cardiovascular disease in patients with type 1 diabetes
• Association of endothelial dysfunction with arterial stiffness in hypertensive patients with type 2 diabetes
• Relationship between levels of postprandial glucose-dependent insulinotrophic polypeptides and cardiovascular function
• Use of liraglutide in lowering systolic blood pressure
• Induction of insulin resistance and impairment of cardiomyocyte function by factors secreted from human epicardial fat
• Association of coronary artery calcium with glycemic variability in men with type 1 diabetes.

CONTROVERSIES SURROUNDING THE use of point of care devices in both clinical and outpatient settings will be discussed at today’s Joint ADA/AACC Symposium Point of Care Devices for Glucose and HbA1C—Are They Up to the Task? The two-hour session begins at 2:15 p.m. in Room 311.

Mitchell G. Scott, PhD, will open with his presentation on “Glucose Meters—Need for Greater Accuracy (Lab Perspective).” Dr. Scott is Professor of Pathology and Immunology and Co-Medical Director of Clinical Chemistry in the Division of Laboratory and Genomic Medicine at Washington University School of Medicine in St. Louis.

“Handheld glucose meters have been used in hospitals to monitor diabetic patients for more than 20 years, but with the implementation of tight glycemic control protocols, they are increasingly being used for a purpose for which they were never designed. They were designed for self-monitoring by diabetics in an outpatient setting,” Dr. Scott said.

“Implementation of tight glycemic control protocols to improve outcomes in critical care became commonplace throughout the last decade, and this was done by frequent glucose monitoring and IV insulin,” he continued.

“The original study showing this benefit did not use glucose meters. It used blood gas analyzers with electrodes, which are as accurate as central laboratory glucose methods,” Dr. Scott noted. “As tight glycemic control protocols spread, most institutions were using glucose meters for this purpose. These frequent readings were then used to adjust intravenous insulin doses. In some protocols, relatively small changes in glucose would lead to doubling of the insulin infusion rate.”

Next, Richard Hellman, MD, FACP, FACE, will present “Glucose Meters—Need for Greater Accuracy (Clinical Perspective).” Dr. Hellman is Clinical Professor of Medicine at the University of Missouri, Kansas City School of Medicine.

“Although self-management blood glucose techniques have revolutionized the care of patients with diabetes, the core of this method is that the glucose measurements from point of care meters are accurate and precise and can be relied on in all clinical settings,” Dr. Hellman said. “The key point I will be making is that many of the meters are not at all up to the task in numerous clinical settings.”

The FDA reported 13 deaths due to falsely elevated blood glucose levels measured using the GHPQQ method for people on peritoneal dialysis. “They were not really high, but were reported as being high by point of care glucose meters. The methodology used was vulnerable to interfering substances. In these cases, the substance in the dialysis fluid that could be converted to maltose was read by these meters as glucose. So the blood sugars seemed to be too high and the patients were given more insulin when, in fact, the blood sugars were too low, and it caused death,” Dr. Hellman said.

“This series of tragedies, which occurred in different places at different times, is just an extreme example of the fact that many of the meters in common use have vulnerabilities,” Dr. Hellman added. “I will discuss some of the pitfalls the clinician may face in providing tight glycemic control in inpatient and outpatient settings.”

Finally, David B. Sacks, MB, ChB, FACP, FRCPath, will present “Point of Care Testing for A1C—Is It Good Enough?” Dr. Sacks is Associate Professor of Pathology at Harvard Medical School and Medical Director of Clinical Chemistry at Brigham and Women’s Hospital in Boston.

“Hemoglobin A1C testing, which is used to monitor long-term glucose control, is important in terms of therapy and is also a good predictor of the risk for developing complications,” Dr. Sacks said. “However, the ADA in its guidelines for using hemoglobin A1C for diagnosis and screening specifically excluded point of care testing devices because they are not sufficiently accurate.”

The National Glycohemoglobin Standardization Program (NGSP) organizes instrument standardization. The program has two major components.

“One, the NGSP works with manufacturers to standardize the instruments. But that only tells you how the instrument works in the manufacturer’s hands,” Dr. Sacks said.

“The second component is how the instrument works in the labs, and that’s evaluated through proficiency testing,” he continued. “However, point of care testing is waived, which means it doesn’t have to participate in proficiency testing, so there’s no way to monitor how well these devices perform in the hands of the people who actually do the point of care testing. A recent study that looked at eight commercial point of care testing devices found that only two of them were deemed to be acceptable.”

Sunday, June 27

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8:00 a.m. – 10:00 a.m.

Controversies Relating Cancer with
Diabetes, Obesity, and Insulin
Valencia Ballroom AB

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10:15 a.m. – 12:15 p.m.

President, Medicine & Science Address
Richard M. Bergenstal, MD
Banting Lecture
Robert A. Rizza, MD
Hall D

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12:00 p.m. – 2:00 p.m.

General Poster Session/
Guided Audio Poster Tours
Hall C

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12:30 p.m. – 1:45 p.m.

Interest Group Discussions

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2:00 p.m. – 2:45 p.m.

Kelly West Lecture
Frank B. Hu, MD, PhD
Chapin Theater

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2:00 p.m. – 4:00 p.m.

Joint ADA/JDRF Symposium
The Artificial Pancreas—A Goal within Reach?
Room 311
Foot Complications (includes Roger
Pecoraro Lecture)
David G. Armstrong, DPM, PhD
Room 414

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4:15 p.m. – 6:15 p.m.

HEALTHY Study
Middle School-Based Intervention to
Reduce Diabetes Risk
Valencia Ballroom AB

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6:30 p.m. – 7:45 p.m.

Presidents Poster Session and Reception
Hall C

CHRISTINE T. TOBIN, RN, MBA, CDE, ADA PRESIDENT, HEALTH CARE & EDUCATION, began her presidential address yesterday morning by asking the audience to disregard common meeting etiquette.

“This is one session you can take your cell phones out,” she said. “Go to your text messaging function and dial in 25383, and the message you type in is ‘ACT.’”

This was her clever way of soliciting donations for ADA’s STOP DIABETES campaign. Each time you text ‘ACT’ to 25383, you’re making a $10 donation to the ADA’s Research Foundation to fund cutting edge diabetes research through the campaign. Text donations will be accepted through Monday and will be paid through your monthly phone statement.

“And I do want you to know that I tried five times to get it work, so I’ve donated $50 to support diabetes research just this morning,” Ms. Tobin noted before beginning her formal lecture.

In today’s diverse health care system, she said, education is important for both patients and providers, and education and teaching are major aspects of delivering high quality diabetes care. “The goal today is to increase the knowledge and skills so people with diabetes are able to competently and confidently render self-care behavior for themselves regardless of where they are,” Ms. Tobin said.

Challenges to achieving this goal extend beyond compliance and motivation issues and include demographics and illiteracy in the adult client population. Numeracy can also be extremely important in diabetes care.

“I think the scariest [example of this] was someone who should have been getting ‘point two’ of insulin on their pump, but they thought it should be ‘two,’” Ms. Tobin said. “She couldn’t understand, she was an older woman and probably had some cognitive impairment. I finally said, ‘Think of it like shopping at the grocery store. I want you to get 20 cents worth.’”

Despite the challenges of a rapidly changing health care environment, the focus re-mains on the patient, and a team approach is always required, Ms. Tobin concluded.

Following Ms. Tobin’s presentation, Belinda P. Childs, ARNP, MN, CDE, BC-ADM, spoke of her experiences as a diabetes team member in Wichita, Kansas. Winner of the ADA’s 2010 Outstanding Educator in Diabetes Award, Ms. Childs paid homage to her home-land in her lecture title, “From the Land of Oz: Brain, Heart, Courage, and Power.”

“We start out on this long road of care and education with great dreams of what we’ll accomplish and how we’ll change the world,” Ms. Childs said. “But it doesn’t take long for doubts to set in and for each of us to realize the obstacle in our path.”

Her own journey began 31 years ago when doctors Richard and Diane Guthrie hired her as a research coordinator at the University of Kansas School of Medicine in Wichita. She operated the Clinical Model Biostator, which measured blood glucose every five seconds, produced a glucose reading every minute, and maintained blood sugar in a preset, near-perfect range using a computer-based algorithm.

“1980 proved to be an amazing year for me and for the treatment of diabetes. Our team initiated our first insulin pump in May of 1980,” Ms. Childs recalled. “I recently received a Facebook message from one of our patients back then and she reminded me that this is her 30th year of continuous use on an insulin pump.

“My trip down that ‘yellow brick road’ began in grand style,” she continued. “But the most important and significant part of that time in my life as it is related to diabetes was the vision and the team approach to diabetes care that the Guthries promoted.”

Ms. Childs and the Guthries’ team left the University of Kansas in 1985 and eventually became Mid-America Diabetes Associates, which is how they’re still known today. “We were determined to reach our version of Oz. For us that was a conviction to provide state-of-the-art diabetes care and education and empower people with diabetes,” Ms. Childs said.

THE HEALTHY STUDY WAS A MIDDLE school-based, three-year primary prevention trial that was designed to determine if interventions that encourage healthy behaviors lower risk factors for type 2 diabetes in adolescents. Results of the study will be reported today during a symposium titled HEALTHY Study—Middle School-Based Intervention to Reduce Diabetes Risk, which will begin at 4:15 p.m. in Valencia Ballroom AB.

The first speaker, Kathryn Hirst, PhD, will describe the study’s rationale and design. Dr. Hirst is Research Professor, PI, at the HEALTHY Coordinating Center, George Washington University Biostatistics Center in Rockville, MD.

HEALTHY was a randomized cluster study in which the unit of randomization was the school, not the child. Students were recruited at the start of their 6th grade year in fall 2006 and followed until the end of their 8th grade year in spring 2009. The study involved 42 middle schools across the United States. In each of seven cities, six schools were randomized—three to the intervention and three to the control condition. Students at both the intervention and control schools received the same health screening.

The intervention integrated four components: the school nutrition environment, physical education class activities, behavior change initiatives, and educational and promotional communications activities.

Following Dr. Hirst, Gary D. Foster, PhD, will present “Primary Endpoints (Adiposity-Related Endpoints, Glucose, and Insulin).” Dr. Foster is a Professor of Medicine and Public Health and Director of the Center for Obesity Research and Education at Temple University in Philadelphia.

“When we looked at the primary outcome, which was the combined prevalence of overweight and obesity, we found that both groups reduced the rates of overweight and obesity combined. That’s a BMI greater than the 85th percentile. Both groups—control and intervention schools—reduced BMI by 4 percent,” Dr. Foster said.

“When we looked at other outcomes, such as BMI z-score, waist circumference above the 90th percentile, and insulin, intervention schools had greater reductions in those measures than did control schools. And there was also a trend for greater reductions in obesity in the intervention schools than in the control schools,” Dr. Foster continued.

“One of the surprising findings is that both intervention and control schools showed reductions in the combined prevalence of overweight and obesity, suggesting that overweight and obesity rates may be declining in the United States,” he added. “There appears to be not just a flattening but a decrease of overweight and obesity rates in children who are at high risk. And I think that’s potentially encouraging news.”

Marsha D. Marcus, PhD, will follow Dr. Foster with a discussion of “Secondary Endpoints (Lipids, Blood Pressure, Fitness and Secular Trends).” Dr. Marcus is Professor of Psychiatry and Psychology, and Chief of the Behavioral Medicine Program at Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center.

Lipid profiles, including cholesterol, triglycerides, and high-density lipoprotein, were among the secondary outcome measures. “The basic finding is that there were no differences between intervention and control schools at the end of three years in the lipid outcomes,” Dr. Marcus said.

“Changes in fi tness in both the control and intervention schools were equivalent,” she added. “There were few differences in the level of fitness between students in intervention and control schools. Fitness was low at both assessment points despite intervention.”

Dr. Marcus also noted that although the quality of the food was improved substantially in the intervention schools, those changes in the schools’ food environment were not obviously associated with overall outcomes.