Epidemiology of Diabetes Interventions and Complications (EDIC)

Design, implementation, and preliminary results of a long-term follow-up of the Diabetes Control and Complications Trial cohort

Harry Shamoon, P. Cleary, A. Barnie, S. Genuth, C. Maffin, W. Tamborlane, J. Wesche, D. Nathan

Research output: Contribution to journalArticle

399 Citations (Scopus)

Abstract

OBJECTIVE - The Diabetes Control and Complications Trial (DCCT) demonstrated the powerful impact of glycemic control on the early manifestations of microvascular complications. Contemporary prospective data on the evolution of macrovascular and late microvascular complications of type 1 diabetes are limited. The Epidemiology of Diabetes Interventions and Complications (EDIC) study is a multicenter, longitudinal, observational study designed to use the well-characterized DCCT cohort of >1,400 patients to determine the long-term effects of prior separation of glycemic levels on micro- and macrovascular outcomes. RESEARCH DESIGN AND METHODS - Using a standardized annual history and physical examination, 28 EDIC clinical centers that were DCCT clinics will follow the EDIC cohort for 10 years. Annual evaluation also includes resting electrocardiogram, Doppler ultrasound measurements of ankle/arm blood pressure, and screening for nephropathy At regular intervals, a timed 4-h urine is collected, lipid profiles are obtained, and stereoscopic fundus photographs are taken. In addition, dual B- mode Doppler ultrasound scans of the common and internal carotid arteries will be performed at years 1 and 6 and at study end. RESULTS - Written informed consent was obtained from 96% of the DCCT subjects. The participants, compared with nonparticipants, tended to have better glycemic control at the completion of the DCCT and were more likely to have their diabetes care provided by DCCT personnel. The EDIC baseline measurement stratified by sex delineates multiple cardiovascular disease risk factor differences such as age (older in men), waist-to-hip ratio (higher in men), HDL cholesterol (lower in men), hypertension (more prevalent in men), and maximum intimal-medial thickness of common and internal carotid arteries (thicker in men). Of the original conventional treatment group, 69% have changed to continuous subcutaneous insulin infusion or multiple daily injections. Although the mean HbA(1c) difference between the intensive and conventional treatment groups narrowed at EDIC years 1 and 2, HbA(1c) remained significantly lower in the intensive group. Of all expected clinic visits, 95% were completed, and the quality of EDIC data is very similar to that observed in the DCCT. CONCLUSIONS - Although obvious problems exist in extended follow-up studies of completed clinical trials. These are balanced by the value of continued systematic observation of the DCCT cohort. In contrast to other epidemiologic studies, EDIC will provide 1) definitive data on type 1 as distinct from type 2 diabetes; 2) reliance on prospective rather than on cross-sectional analysis; 3) long-term follow-up in a large population; 4) consistent use of objective, reliable measures of outcomes and glycemia; and 5) observation of patients from before the onset of complications.

Original languageEnglish (US)
Pages (from-to)99-111
Number of pages13
JournalDiabetes Care
Volume22
Issue number1
DOIs
StatePublished - Jan 1999
Externally publishedYes

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Diabetes Complications
Epidemiology
Doppler Ultrasonography
Common Carotid Artery
Observation
Subcutaneous Infusions
Waist-Hip Ratio
Internal Carotid Artery
Ambulatory Care
Informed Consent
Type 1 Diabetes Mellitus
Ankle
Type 2 Diabetes Mellitus
HDL Cholesterol
Physical Examination
Observational Studies
Longitudinal Studies
Epidemiologic Studies
Electrocardiography
Arm

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

Epidemiology of Diabetes Interventions and Complications (EDIC) : Design, implementation, and preliminary results of a long-term follow-up of the Diabetes Control and Complications Trial cohort. / Shamoon, Harry; Cleary, P.; Barnie, A.; Genuth, S.; Maffin, C.; Tamborlane, W.; Wesche, J.; Nathan, D.

In: Diabetes Care, Vol. 22, No. 1, 01.1999, p. 99-111.

Research output: Contribution to journalArticle

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abstract = "OBJECTIVE - The Diabetes Control and Complications Trial (DCCT) demonstrated the powerful impact of glycemic control on the early manifestations of microvascular complications. Contemporary prospective data on the evolution of macrovascular and late microvascular complications of type 1 diabetes are limited. The Epidemiology of Diabetes Interventions and Complications (EDIC) study is a multicenter, longitudinal, observational study designed to use the well-characterized DCCT cohort of >1,400 patients to determine the long-term effects of prior separation of glycemic levels on micro- and macrovascular outcomes. RESEARCH DESIGN AND METHODS - Using a standardized annual history and physical examination, 28 EDIC clinical centers that were DCCT clinics will follow the EDIC cohort for 10 years. Annual evaluation also includes resting electrocardiogram, Doppler ultrasound measurements of ankle/arm blood pressure, and screening for nephropathy At regular intervals, a timed 4-h urine is collected, lipid profiles are obtained, and stereoscopic fundus photographs are taken. In addition, dual B- mode Doppler ultrasound scans of the common and internal carotid arteries will be performed at years 1 and 6 and at study end. RESULTS - Written informed consent was obtained from 96{\%} of the DCCT subjects. The participants, compared with nonparticipants, tended to have better glycemic control at the completion of the DCCT and were more likely to have their diabetes care provided by DCCT personnel. The EDIC baseline measurement stratified by sex delineates multiple cardiovascular disease risk factor differences such as age (older in men), waist-to-hip ratio (higher in men), HDL cholesterol (lower in men), hypertension (more prevalent in men), and maximum intimal-medial thickness of common and internal carotid arteries (thicker in men). Of the original conventional treatment group, 69{\%} have changed to continuous subcutaneous insulin infusion or multiple daily injections. Although the mean HbA(1c) difference between the intensive and conventional treatment groups narrowed at EDIC years 1 and 2, HbA(1c) remained significantly lower in the intensive group. Of all expected clinic visits, 95{\%} were completed, and the quality of EDIC data is very similar to that observed in the DCCT. CONCLUSIONS - Although obvious problems exist in extended follow-up studies of completed clinical trials. These are balanced by the value of continued systematic observation of the DCCT cohort. In contrast to other epidemiologic studies, EDIC will provide 1) definitive data on type 1 as distinct from type 2 diabetes; 2) reliance on prospective rather than on cross-sectional analysis; 3) long-term follow-up in a large population; 4) consistent use of objective, reliable measures of outcomes and glycemia; and 5) observation of patients from before the onset of complications.",
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T2 - Design, implementation, and preliminary results of a long-term follow-up of the Diabetes Control and Complications Trial cohort

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AU - Cleary, P.

AU - Barnie, A.

AU - Genuth, S.

AU - Maffin, C.

AU - Tamborlane, W.

AU - Wesche, J.

AU - Nathan, D.

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N2 - OBJECTIVE - The Diabetes Control and Complications Trial (DCCT) demonstrated the powerful impact of glycemic control on the early manifestations of microvascular complications. Contemporary prospective data on the evolution of macrovascular and late microvascular complications of type 1 diabetes are limited. The Epidemiology of Diabetes Interventions and Complications (EDIC) study is a multicenter, longitudinal, observational study designed to use the well-characterized DCCT cohort of >1,400 patients to determine the long-term effects of prior separation of glycemic levels on micro- and macrovascular outcomes. RESEARCH DESIGN AND METHODS - Using a standardized annual history and physical examination, 28 EDIC clinical centers that were DCCT clinics will follow the EDIC cohort for 10 years. Annual evaluation also includes resting electrocardiogram, Doppler ultrasound measurements of ankle/arm blood pressure, and screening for nephropathy At regular intervals, a timed 4-h urine is collected, lipid profiles are obtained, and stereoscopic fundus photographs are taken. In addition, dual B- mode Doppler ultrasound scans of the common and internal carotid arteries will be performed at years 1 and 6 and at study end. RESULTS - Written informed consent was obtained from 96% of the DCCT subjects. The participants, compared with nonparticipants, tended to have better glycemic control at the completion of the DCCT and were more likely to have their diabetes care provided by DCCT personnel. The EDIC baseline measurement stratified by sex delineates multiple cardiovascular disease risk factor differences such as age (older in men), waist-to-hip ratio (higher in men), HDL cholesterol (lower in men), hypertension (more prevalent in men), and maximum intimal-medial thickness of common and internal carotid arteries (thicker in men). Of the original conventional treatment group, 69% have changed to continuous subcutaneous insulin infusion or multiple daily injections. Although the mean HbA(1c) difference between the intensive and conventional treatment groups narrowed at EDIC years 1 and 2, HbA(1c) remained significantly lower in the intensive group. Of all expected clinic visits, 95% were completed, and the quality of EDIC data is very similar to that observed in the DCCT. CONCLUSIONS - Although obvious problems exist in extended follow-up studies of completed clinical trials. These are balanced by the value of continued systematic observation of the DCCT cohort. In contrast to other epidemiologic studies, EDIC will provide 1) definitive data on type 1 as distinct from type 2 diabetes; 2) reliance on prospective rather than on cross-sectional analysis; 3) long-term follow-up in a large population; 4) consistent use of objective, reliable measures of outcomes and glycemia; and 5) observation of patients from before the onset of complications.

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