Diabetes Care, Vol 10, Issue 1 1-19, Copyright © 1987 by American Diabetes Association

ARTICLES

Diabetes Control and Complications Trial (DCCT): results of feasibility study. The DCCT Research Group

The Diabetes Control and Complications Trial (DCCT) is a multicenter, randomized, clinical study designed to determine whether an intensive treatment regimen directed at maintaining blood glucose concentrations as close to normal as possible will affect the appearance or progression of early vascular complications in patients with insulin-dependent diabetes mellitus (IDDM). We present the baseline characteristics and 1-yr results of the initial cohort of 278 subjects randomized in phase II of the trial, a phase designed to answer several feasibility questions before initiating a full-scale trial. During phase II, recruitment was completed on schedule. The 191 adults and 87 adolescents were randomized either to standard treatment (90 adults and 42 adolescents), designed to approximate conventional diabetes treatment, or to experimental treatment (101 adults and 45 adolescents), designed to achieve near-normal blood glucose and HbA1c concentrations. With few exceptions, baseline demographic, ophthalmologic, renal, and other medical characteristics were evenly distributed by randomization between the two treatment groups in both age strata. Glycemic control at baseline, as assessed by HbA1c concentrations and by blood glucose profiles, was comparable between the treatment groups in both age strata. The treatment strategies employed produced statistically significant and clinically meaningful differences in HbA1c concentrations and blood glucose profiles between the experimental- and standard-group subjects for both adults and adolescents. These differences were maintained throughout the feasibility phase. Except for an increased incidence of hypoglycemia in the experimental group, the two treatment regimens maintained or improved the clinical well-being of subjects in both groups. Adherence and completeness of follow-up were excellent (greater than 95%), and the methods employed to measure biochemical and pathologic characteristics of IDDM proved to be reliable, reproducible, and precise. The feasibility phase of the DCCT demonstrated that a complex multicenter, randomized study of the relationship between diabetes control and complications can be performed. The full-scale, long-term trial therefore has been initiated.
CiteULike    Del.icio.us    Digg    Reddit    Technorati    What's this?

This article has been cited by other articles:

				E S Kilpatrick Haemoglobin A1c in the diagnosis and monitoring of diabetes mellitus J. Clin. Pathol., September 1, 2008; 61(9): 977 - 982. [Abstract] [Full Text] [PDF]

				E. S. Kilpatrick, A. S. Rigby, and S. L. Atkin The Effect of Glucose Variability on the Risk of Microvascular Complications in Type 1 Diabetes Diabetes Care, July 1, 2006; 29(7): 1486 - 1490. [Abstract] [Full Text] [PDF]

				R. J. McCarter, J. M. Hempe, and S. A. Chalew Mean Blood Glucose and Biological Variation Have Greater Influence on HbA1c Levels Than Glucose Instability: An analysis of data from the Diabetes Control and Complications Trial Diabetes Care, February 1, 2006; 29(2): 352 - 355. [Abstract] [Full Text] [PDF]

				S. M Kosecki, P. T Rodgers, and M. B Adams Glycemic Monitoring in Diabetics with Sickle Cell Plus {beta}-Thalassemia Hemoglobinopathy Ann. Pharmacother., September 1, 2005; 39(9): 1557 - 1560. [Abstract] [Full Text] [PDF]

				S. Rodriguez-Segade, J. Rodriguez, D. Mayan, and F. Camina Plasma Albumin Concentration Is a Predictor of HbA1c Among Type 2 Diabetic Patients, Independently of Fasting Plasma Glucose and Fructosamine Diabetes Care, February 1, 2005; 28(2): 437 - 439. [Full Text] [PDF]

				S. A. Chalew, J. M. Hempe, and R. J. McCarter Biological Variation in HbA1c Predicts Risk of Retinopathy and Nephropathy in Type 1 Diabetes: Response to Genuth, Lachin, and Nathan Diabetes Care, January 1, 2005; 28(1): 234 - 235. [Full Text] [PDF]

				M. D. Breyer, E. Bottinger, F. C. Brosius III, T. M. Coffman, R. C. Harris, C. W. Heilig, K. Sharma, and for the AMDCC Mouse Models of Diabetic Nephropathy J. Am. Soc. Nephrol., January 1, 2005; 16(1): 27 - 45. [Abstract] [Full Text] [PDF]

				D. E. Goldstein, R. R. Little, R. A. Lorenz, J. I. Malone, D. Nathan, C. M. Peterson, and D. B. Sacks Tests of Glycemia in Diabetes Diabetes Care, July 1, 2004; 27(7): 1761 - 1773. [Full Text] [PDF]

				R. J. McCarter, J. M. Hempe, R. Gomez, and S. A. Chalew Biological Variation in HbA1c Predicts Risk of Retinopathy and Nephropathy in Type 1 Diabetes Diabetes Care, June 1, 2004; 27(6): 1259 - 1264. [Abstract] [Full Text] [PDF]

				The California Medi-Cal Type 2 Diabetes Study Grou Closing the Gap: Effect of Diabetes Case Management on Glycemic Control Among Low-Income Ethnic Minority Populations: The California Medi-Cal Type 2 Diabetes Study Diabetes Care, January 1, 2004; 27(1): 95 - 103. [Abstract] [Full Text] [PDF]

				E. Martz Living with Insulin-Dependent Diabetes: Life Can Still Be Sweet Rehabil Couns Bull, October 1, 2003; 47(1): 51 - 57. [Abstract] [PDF]

				J. Q. Purnell, R. K. Dev, M. W. Steffes, P. A. Cleary, J. P. Palmer, I. B. Hirsch, J. E. Hokanson, and J. D. Brunzell Relationship of Family History of Type 2 Diabetes, Hypoglycemia, and Autoantibodies to Weight Gain and Lipids With Intensive and Conventional Therapy in the Diabetes Control and Complications Trial Diabetes, October 1, 2003; 52(10): 2623 - 2629. [Abstract] [Full Text] [PDF]

				S. D. Madsen, G. I. Roisman, and W. A. Collins The Intersection of Adolescent Development and Intensive Intervention: Age-Related Psychosocial Correlates of Treatment Regimens in the Diabetes Control and Complication Trial J. Pediatr. Psychol., July 1, 2002; 27(5): 451 - 459. [Abstract] [Full Text] [PDF]

				C. L. Rohlfing, H.-M. Wiedmeyer, R. R. Little, J. D. England, A. Tennill, and D. E. Goldstein Defining the Relationship Between Plasma Glucose and HbA1c: Analysis of glucose profiles and HbA1c in the Diabetes Control and Complications Trial Diabetes Care, February 1, 2002; 25(2): 275 - 278. [Abstract] [Full Text] [PDF]

				E. Tsui, A. Barnie, S. Ross, R. Parkes, and B. Zinman Intensive Insulin Therapy With Insulin Lispro: A randomized trial of continuous subcutaneous insulin infusion versus multiple daily insulin injection Diabetes Care, October 1, 2001; 24(10): 1722 - 1727. [Abstract] [Full Text] [PDF]

				C. D. Miller, L. S. Phillips, D. C. Ziemer, D. L. Gallina, C. B. Cook, and I. M. El-Kebbi Hypoglycemia in Patients With Type 2 Diabetes Mellitus Arch Intern Med, July 9, 2001; 161(13): 1653 - 1659. [Abstract] [Full Text] [PDF]

				J. I. Malone, A. D. Morrison, P. R. Pavan, and D. D. Cuthbertson Prevalence and Significance of Retinopathy in Subjects With Type 1 Diabetes of Less Than 5 Years' Duration Screened for the Diabetes Control and Complications Trial Diabetes Care, March 1, 2001; 24(3): 522 - 526. [Abstract] [Full Text]

				E. S Kilpatrick Glycated haemoglobin in the year 2000 J. Clin. Pathol., May 1, 2000; 53(5): 335 - 339. [Full Text] [PDF]

				G. F. Lewis, A. Carpentier, D. Bilinski, A. Giacca, and M. Vranic Counterregulatory Response to Hypoglycemia Differs According to the Insulin Delivery Route, But Does Not Affect Glucose Production in Normal Humans J. Clin. Endocrinol. Metab., March 1, 1999; 84(3): 1037 - 1046. [Abstract] [Full Text]

				F. D. Wolinsky, K. W. Wyrwich, N. A. Nienaber, and W. M. Tierney Generic versus Disease-Specific Health Status Measures: An Example Using Coronary Artery Disease and Congestive Heart Failure Patients Eval Health Prof, June 1, 1998; 21(2): 216 - 243. [Abstract] [PDF]

				B. Gaster and I. B. Hirsch The Effects of Improved Glycemic Control on Complications in Type 2 Diabetes Arch Intern Med, January 26, 1998; 158(2): 134 - 140. [Abstract] [Full Text] [PDF]

				A. S. Krolewski, L. M.B. Laffel, M. Krolewski, M. Quinn, and J. H. Warram Glycosylated Hemoglobin and the Risk of Microalbuminuria in Patients with Insulin-Dependent Diabetes Mellitus N. Engl. J. Med., May 11, 1995; 332(19): 1251 - 1255. [Abstract] [Full Text] [PDF]

				The Diabetes Control and Complications Trial Resea The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes Mellitus N. Engl. J. Med., September 30, 1993; 329(14): 977 - 986. [Abstract] [Full Text]