Ram D. Pathak

Construction of a Multisite DataLink Using Electronic Health Records for the Identification, Surveillance, Prevention, and Management of Diabetes Mellitus: The SUPREME-DM Project

Introduction Electronic health record (EHR) data enhance opportunities for conducting surveillance of diabetes. The objective of this study was to identify the number of people with diabetes from a diabetes DataLink developed as part of the SUPREME-DM (SUrveillance, PREvention, and ManagEment of Diabetes Mellitus) project, a consortium of 11 integrated health systems that use comprehensive EHR data for research. Methods We identified all members of 11 health care systems who had any enrollment from January 2005 through December 2009. For these members, we searched inpatient and outpatient diagnosis codes, laboratory test results, and pharmaceutical dispensings from January 2000 through December 2009 to create indicator variables that could potentially identify a person with diabetes. Using this information, we estimated the number of people with diabetes and among them, the number of incident cases, defined as indication of diabetes after at least 2 years of continuous health system enrollment. Results The 11 health systems contributed 15,765,529 unique members, of whom 1,085,947 (6.9%) met 1 or more study criteria for diabetes. The nonstandardized proportion meeting study criteria for diabetes ranged from 4.2% to 12.4% across sites. Most members with diabetes (88%) met multiple criteria. Of the members with diabetes, 428,349 (39.4%) were incident cases. Conclusion The SUPREME-DM DataLink is a unique resource that provides an opportunity to conduct comparative effectiveness research, epidemiologic surveillance including longitudinal analyses, and population-based care management studies of people with diabetes. It also provides a useful data source for pragmatic clinical trials of prevention or treatment interventions.

Trends in Diabetes Incidence Among 7 Million Insured Adults, 2006–2011 The SUPREME-DM Project

An observational cohort analysis was conducted within the Surveillance, Prevention, and Management of Diabetes Mellitus (SUPREME-DM) DataLink, a consortium of 11 integrated health-care delivery systems with electronic health records in 10 US states. Among nearly 7 million adults aged 20 years or older, we estimated annual diabetes incidence per 1,000 persons overall and by age, sex, race/ethnicity, and body mass index. We identified 289,050 incident cases of diabetes. Age- and sex-adjusted population incidence was stable between 2006 and 2010, ranging from 10.3 per 1,000 adults (95% confidence interval (CI): 9.8, 10.7) to 11.3 per 1,000 adults (95% CI: 11.0, 11.7). Adjusted incidence was significantly higher in 2011 (11.5, 95% CI: 10.9, 12.0) than in the 2 years with the lowest incidence. A similar pattern was observed in most prespecified subgroups, but only the differences for persons who were not white were significant. In 2006, 56% of incident cases had a glycated hemoglobin (hemoglobin A1c) test as one of the pair of events identifying diabetes. By 2011, that number was 74%. In conclusion, overall diabetes incidence in this population did not significantly increase between 2006 and 2010, but increases in hemoglobin A1c testing may have contributed to rising diabetes incidence among nonwhites in 2011.

Severe Hypoglycemia Requiring Medical Intervention in a Large Cohort of Adults With Diabetes Receiving Care in U.S. Integrated Health Care Delivery Systems: 2005–2011

OBJECTIVE Appropriate glycemic control is fundamental to diabetes care, but aggressive glucose targets and intensive therapy may unintentionally increase episodes of hypoglycemia. We quantified the burden of severe hypoglycemia requiring medical intervention in a well-defined population of insured individuals with diabetes receiving care in integrated health care delivery systems across the U.S. RESEARCH DESIGN AND METHODS This observational cohort study included 917,440 adults with diabetes receiving care during 2005 to 2011 at participating SUrveillance, PREvention, and ManagEment of Diabetes Mellitus (SUPREME-DM) network sites. Severe hypoglycemia rates were based on any occurrence of hypoglycemia-related ICD-9 codes from emergency department or inpatient medical encounters and reported overall and by age, sex, comorbidity status, antecedent A1C level, and medication use. RESULTS Annual rates of severe hypoglycemia ranged from 1.4 to 1.6 events per 100 person-years. Rates of severe hypoglycemia were higher among those with older age, chronic kidney disease, congestive heart failure, cardiovascular disease, depression, and higher A1C levels, and in users of insulin, insulin secretagogues, or β-blockers (P < 0.001 for all). Changes in severe hypoglycemia occurrence over time were not clinically significant in the cohort as a whole but were observed in subgroups of individuals with chronic kidney disease, congestive heart failure, and cardiovascular disease. CONCLUSIONS Risk of severe hypoglycemia in clinical settings is considerably higher in identifiable patient subgroups than in randomized controlled trials. Strategies that reduce the risk of hypoglycemia in high-risk patients are needed.

Preventable Major Cardiovascular Events Associated With Uncontrolled Glucose, Blood Pressure, and Lipids and Active Smoking in Adults With Diabetes With and Without Cardiovascular Disease: A Contemporary Analysis

OBJECTIVE The objective of this study was to assess the incidence of major cardiovascular (CV) hospitalization events and all-cause deaths among adults with diabetes with or without CV disease (CVD) associated with inadequately controlled glycated hemoglobin (A1C), high LDL cholesterol (LDL-C), high blood pressure (BP), and current smoking. RESEARCH DESIGN AND METHODS Study subjects included 859,617 adults with diabetes enrolled for more than 6 months during 2005–2011 in a network of 11 U.S. integrated health care organizations. Inadequate risk factor control was classified as LDL-C ≥100 mg/dL, A1C ≥7% (53 mmol/mol), BP ≥140/90 mm Hg, or smoking. Major CV events were based on primary hospital discharge diagnoses for myocardial infarction (MI) and acute coronary syndrome (ACS), stroke, or heart failure (HF). Five-year incidence rates, rate ratios, and average attributable fractions were estimated using multivariable Poisson regression models. RESULTS Mean (SD) age at baseline was 59 (14) years; 48% of subjects were female, 45% were white, and 31% had CVD. Mean follow-up was 59 months. Event rates per 100 person-years for adults with diabetes and CVD versus those without CVD were 6.0 vs. 1.7 for MI/ACS, 5.3 vs. 1.5 for stroke, 8.4 vs. 1.2 for HF, 18.1 vs. 40 for all CV events, and 23.5 vs. 5.0 for all-cause mortality. The percentages of CV events and deaths associated with inadequate risk factor control were 11% and 3%, respectively, for those with CVD and 34% and 7%, respectively, for those without CVD. CONCLUSIONS Additional attention to traditional CV risk factors could yield further substantive reductions in CV events and mortality in adults with diabetes.

Intensification of antihyperglycemic therapy among patients with incident diabetes: a Surveillance Prevention and Management of Diabetes Mellitus (SUPREME-DM) study

Antihyperglycemic medication intensification practices among patients with incident diabetes are incompletely understood. We characterized the first intensification the year after oral antihyperglycemic medication initiation among incident diabetes patients.

Randomized Trial of Telephone Outreach to Improve Medication Adherence and Metabolic Control in Adults With Diabetes

OBJECTIVE Medication nonadherence is a major obstacle to better control of glucose, blood pressure (BP), and LDL cholesterol in adults with diabetes. Inexpensive effective strategies to increase medication adherence are needed. RESEARCH DESIGN AND METHODS In a pragmatic randomized trial, we randomly assigned 2,378 adults with diabetes mellitus who had recently been prescribed a new class of medication for treating elevated levels of glycated hemoglobin (A1C) ≥8% (64 mmol/mol), BP ≥140/90 mmHg, or LDL cholesterol ≥100 mg/dL, to receive 1) one scripted telephone call from a diabetes educator or clinical pharmacist to identify and address nonadherence to the new medication or 2) usual care. Hierarchical linear and logistic regression models were used to assess the impact on 1) the first medication fill within 60 days of the prescription; 2) two or more medication fills within 180 days of the prescription; and 3) clinically significant improvement in levels of A1C, BP, or LDL cholesterol. RESULTS Of the 2,378 subjects, 89.3% in the intervention group and 87.4% in the usual-care group had sufficient data to analyze study outcomes. In intent-to-treat analyses, intervention was not associated with significant improvement in primary adherence, medication persistence, or intermediate outcomes of care. Results were similar across subgroups of patients defined by age, sex, race/ethnicity, and study site, and when limiting the analysis to those who completed the intended intervention. CONCLUSIONS This low-intensity intervention did not significantly improve medication adherence or control of glucose, BP, or LDL cholesterol. Wide use of this strategy does not appear to be warranted; alternative approaches to identify and improve medication adherence and persistence are needed.

Rapid reduction of severely elevated serum triglycerides with insulin infusion, gemfibrozil and niacin.

The conventional methods of treatment of severe hypertriglyceridemia are dietary restriction and lipid lowering medications, mainly fibric acid derivatives. In the medical literature, use of insulin infusion to treat hypertriglyceridemia has not been highlighted sufficiently. We report a 53-year-old male who presented with a four-day history of epigastric pain. The patient’s clinical history was significant for hypertriglyceridemia, type-2 diabetes mellitus with medication noncompliance, obesity, status post-gastric bypass surgery, and alcohol abuse with prior admissions for detoxification. Physical examination revealed mild epigastric tenderness. Laboratory studies revealed severely elevated serum triglyceride (TG) level (8116 mg/dL). Computed tomography (CT) scan of the abdomen exhibited no evidence of pancreatitis. Regular insulin infusion was started at 3 U/h and gradually increased to 7–10 U/h. Dextrose infusion was titrated to avoid hypoglycemia and maintain blood glucose levels below 150 mg/dL. Gemfibrozil and niacin were also started. After 24 hours, his TG levels were decreased to 2501 mg/dL. Insulin infusion was continued for about 48 hours. A low carbohydrate diet excluding simple carbohydrates was given. The patient’s serum TG levels normalized over a period of one month. Thus insulin infusion can be considered a safe modality of treatment for rapid reduction of serum TG in addition to fibrates and niacin.

A Google Glass Application to Support Shoppers With Dietary Management of Diabetes

We read with great interest the article titled “New Wearable Computers Move Ahead: Google Glass and Smart Wigs” by Dr David C. Klonoff published in the January 2014 issue of the Journal of Diabetes Science and Technology.1 Wearable computers have enormous potential to assist in diabetes management. Here, we further discuss a Google Glass application with the potential to advise and track dietary choices. Maintaining an appropriate diet is an important part of diabetes care.2 Because purchased food items are likely to be consumed regardless of nutritional value, dietary control begins at the supermarket. On-the-spot decision support tools may help shoppers make smarter food choices. Current approaches include educational materials and smartphone applications designed to inform shoppers of nutritional value. However, the abundance of food options in US supermarkets makes memorizing all of the necessary information cumbersome. It may be possible to employ an application that displays caloric density (calories/oz) and glycemic index as the user shops by scanning the barcodes of products loaded into the cart; it may even be possible to provide healthier alternatives if a poorly scoring food is scanned. The ability to provide real-time information in a hands-free and private manner makes Google Glass an ideal platform on which to build a tool to promote healthy choices in the supermarket. As an example, imagine a shopper with diabetes standing in the produce section trying to decide on a vegetable side dish (see the video available at: https://www.youtube.com/watch?v=UoUx1aFNES8). The shopper picks up the sweet corn, asks Google Glass to determine its glycemic index, and notes a score of 60. Next, the shopper performs the same actions for a bunch of broccoli, with Google Glass indicating a score of 10. The ease of using the Google Glass device to obtain real-time decision support in a simple, private, and hands-free way may increase the willingness or ability of patients with diabetes or members of their household to follow important dietary recommendations. At present, the Google Glass technology is cost prohibitive, but prices are expected to fall as Google opens this technology to the consumer market later this year. Recent announcements regarding establishment of a partnership between Google and the Luxottica Group eyeglass company suggest this will happen in the near future.3 Regardless, the technology must be affordable for the average patient to warrant further development. In addition, older patients need to be considered in designing the user interface. A large number of patients with diabetes are older and may not be comfortable with newer technology. The Google Glass “Diabetes Shopping” application4 built at Marshfield Clinical Research Foundation is in proof-of-concept stages, but has considerable room for growth in the areas of tracking and cataloguing, establishing connections to social media and peer support, providing alerts for calories or food choices, capturing cumulative calorie intake, and health coaching. The Google Glass diabetes application has the potential to improve diabetes management by improving dietary choices while shopping and the potential to do much more.

Who Must We Target Now to Minimize Future Cardiovascular Events and Total Mortality?: Lessons From the Surveillance, Prevention and Management of Diabetes Mellitus (SUPREME-DM) Cohort Study.

Background— Examining trends in cardiovascular events and mortality in US health systems can guide the design of targeted clinical and public health strategies to reduce cardiovascular events and mortality rates. Methods and Results— We conducted an observational cohort study from 2005 to 2011 among 1.25 million diabetic subjects and 1.25 million nondiabetic subjects from 11 health systems that participate in the Surveillance, Prevention and Management of Diabetes Mellitus (SUPREME-DM) DataLink. Annual rates (per 1000 person-years) of myocardial infarction/acute coronary syndrome ( International Classification of Diseases - Ninth Revision , 410.0–410.91, 411.1–411.8), stroke ( International Classification of Diseases - Ninth Revision , 430–432.9, 433–434.9), heart failure ( International Classification of Diseases - Ninth Revision, 428–428.9), and all-cause mortality were monitored by diabetes mellitus (DM) status, age, sex, race/ethnicity, and a prior cardiovascular history. We observed significant declines in cardiovascular events and mortality rates in subjects with and without DM. However, there was substantial variation by age, sex, race/ethnicity, and prior cardiovascular history. Mortality declined from 44.7 to 27.1 ( P P =0.03) for those with DM only, and from 18.9 to 13.0 ( P P =0.10) and stroke rates (1.6–1.6; P =0.77) did not decline and heart failure rates increased (0.9–1.15; P =0.0005). Conclusions— To sustain improvements in myocardial infarction, stroke, heart failure, and mortality, health systems that have successfully focused on care improvement in high-risk adults with DM or CVD must broaden their improvement strategies to target lower risk adults who have not yet developed DM or CVD.Background—Examining trends in cardiovascular events and mortality in US health systems can guide the design of targeted clinical and public health strategies to reduce cardiovascular events and mortality rates. Methods and Results—We conducted an observational cohort study from 2005 to 2011 among 1.25 million diabetic subjects and 1.25 million nondiabetic subjects from 11 health systems that participate in the Surveillance, Prevention and Management of Diabetes Mellitus (SUPREME-DM) DataLink. Annual rates (per 1000 person-years) of myocardial infarction/acute coronary syndrome (International Classification of Diseases-Ninth Revision, 410.0–410.91, 411.1–411.8), stroke (International Classification of Diseases-Ninth Revision, 430–432.9, 433–434.9), heart failure (International Classification of Diseases-Ninth Revision, 428–428.9), and all-cause mortality were monitored by diabetes mellitus (DM) status, age, sex, race/ethnicity, and a prior cardiovascular history. We observed significant declines in cardiovascular events and mortality rates in subjects with and without DM. However, there was substantial variation by age, sex, race/ethnicity, and prior cardiovascular history. Mortality declined from 44.7 to 27.1 (P<0.0001) for those with DM and cardiovascular disease (CVD), from 11.2 to 10.9 (P=0.03) for those with DM only, and from 18.9 to 13.0 (P<0.0001) for those with CVD only. Yet, in the ≈85% of subjects with neither DM nor CVD, overall mortality (7.0 to 6.8; P=0.10) and stroke rates (1.6–1.6; P=0.77) did not decline and heart failure rates increased (0.9–1.15; P=0.0005). Conclusions—To sustain improvements in myocardial infarction, stroke, heart failure, and mortality, health systems that have successfully focused on care improvement in high-risk adults with DM or CVD must broaden their improvement strategies to target lower risk adults who have not yet developed DM or CVD.

Prevalence of chronic kidney disease among individuals with diabetes in the SUPREME-DM Project, 2005–2011

AIMS Diabetes is a leading cause of chronic kidney disease (CKD). Different methods of CKD ascertainment may impact prevalence estimates. We used data from 11 integrated health systems in the United States to estimate CKD prevalence in adults with diabetes (2005-2011), and compare the effect of different ascertainment methods on prevalence estimates. METHODS We used the SUPREME-DM DataLink (n = 879,312) to estimate annual CKD prevalence. Methods of CKD ascertainment included: diagnosis codes alone, impaired estimated glomerular filtration rate (eGFR) alone (eGFR < 60 mL/min/1.73 m(2)), albuminuria alone (spot urine albumin creatinine ratio > 30 mg/g or equivalent), and combinations of these approaches. RESULTS CKD prevalence was 20.0% using diagnosis codes, 17.7% using impaired eGFR, 11.9% using albuminuria, and 32.7% when one or more method suggested CKD. The criteria had poor concordance. After age- and sex-standardization to the 2010 U.S. Census population, prevalence using diagnosis codes increased from 10.7% in 2005 to 14.3% in 2011 (P < 0.001). The prevalence using eGFR decreased from 9.7% in 2005 to 8.6% in 2011 (P < 0.001). CONCLUSIONS Our data indicate that CKD prevalence and prevalence trends differ according to the CKD ascertainment method, highlighting the necessity for multiple sources of data to accurately estimate and track CKD prevalence.