This Article  • References  • Full text PDF  • Reply to article  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Contact me when this article is cited  Related Content  • Similar articles in this journal  Social Bookmarking   What's this?

The Diabetes Control and Complications Trial

The Diabetes Control and Complications Trial Research Group

Arch Ophthalmol. 1995;113(1):36-51.

Abstract
Objective
To determine the magnitude of the decrease in the risk of retinopathy progression observed with intensive treatment and its relationship to baseline retinopathy severity and duration of follow-up.

Design
Randomized clinical trial, with 3 to 9 years of follow-up.

Setting and Patients
Between 1983 and 1989, 29 centers enrolled 1441 patients with insulin-dependent diabetes mellitus aged 13 to 39 years, including 726 patients with no retinopathy and a duration of diabetes of 1 to 5 years (primary prevention cohort) and 715 patients with very mild to moderate nonproliferative diabetic retinopathy and a duration of diabetes of 1 to 15 years (secondary intervention cohort). Ninety-five percent of all scheduled examinations were completed.

Interventions
Intensive treatment consisted of the administration of insulin at least three times a day by injection or pump, with doses adjusted based on self-blood glucose monitoring and with the goal of normoglycemia. Conventional treatment consisted of one or two daily insulin injections.

Outcome Measures
Change between baseline and follow-up visits on the Early Treatment Diabetic Retinopathy Study retinopathy severity scale, assessed with masked gradings of stereoscopic color fundus photographs obtained every 6 months.

Results
Cumulative 8.5-year rates of retinopathy progression by three or more steps at two consecutive visits were 54.1% with conventional treatment and 11.5% with intensive treatment in the primary prevention cohort and 49.2% and 17.1% in the secondary intervention cohort. At the 6- and 12-month visits, a small adverse effect of intensive treatment was noted ("early worsening"), followed by a beneficial effect that increased in magnitude with time. Beyond 3.5 years of follow-up, the risk of progression was five or more times lower with intensive treatment than with conventional treatment. Once progression occurred, subsequent recovery was at least two times more likely with intensive treatment than with conventional treatment. Treatment effects were similar in all baseline retinopathy severity subgroups.

Conclusion
The results of the Diabetes Control and Complications Trial strongly support the recommendation that most patients with insulin-dependent diabetes mellitus use intensive treatment, aiming for levels of glycemia as close to the nondiabetic range as is safely possible.

Author Affiliations
From the Diabetes Control and Complications Trial. A complete list of participants in this study appears at the end of this article.

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Exploratory Analysis of Diabetic Retinopathy Progression Through 3 Years in a Randomized Clinical Trial That Compares Intravitreal Triamcinolone Acetonide With Focal/Grid Photocoagulation
Bressler et al.
Arch Ophthalmol 2009;127:1566-1571.
ABSTRACT | FULL TEXT  

Adult Stature and Diabetes Complications in Patients With Type 1 Diabetes: The FinnDiane Study and the Diabetes Control and Complications Trial
Waden et al.
Diabetes 2009;58:1914-1920.
ABSTRACT | FULL TEXT  

Modern-Day Clinical Course of Type 1 Diabetes Mellitus After 30 Years' Duration: The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications and Pittsburgh Epidemiology of Diabetes Complications Experience (1983-2005)
Diabetes Control and Complications Trial/Epidemiol
Arch Intern Med 2009;169:1307-1316.
ABSTRACT | FULL TEXT  

Assessment of 193 Candidate Genes for Retinopathy in African Americans With Type 1 Diabetes
Roy et al.
Arch Ophthalmol 2009;127:605-612.
ABSTRACT | FULL TEXT  

Diabetes and Obesity: A Challenge for Every Ophthalmologist
Gardner and Gabbay
Arch Ophthalmol 2009;127:328-329.
FULL TEXT  

Glucose Control and Vascular Complications in Veterans with Type 2 Diabetes
Duckworth et al.
NEJM 2009;360:129-139.
ABSTRACT | FULL TEXT  

Prolonged Effect of Intensive Therapy on the Risk of Retinopathy Complications in Patients With Type 1 Diabetes Mellitus: 10 Years After the Diabetes Control and Complications Trial
Diabetes Control and Complications Trial/Epidemiol
Arch Ophthalmol 2008;126:1707-1715.
ABSTRACT | FULL TEXT  

The English national screening programme for sight-threatening diabetic retinopathy
Scanlon
J Med Screen 2008;15:1-4.
ABSTRACT | FULL TEXT  

Influence of Flickering Light on the Retinal Vessels in Diabetic Patients
Mandecka et al.
Diabetes Care 2007;30:3048-3052.
ABSTRACT | FULL TEXT  

The North Jutland County Diabetic Retinopathy Study (NCDRS) 2. Non-ophthalmic parameters and clinically significant macular oedema
Knudsen et al.
Br J Ophthalmol 2007;91:1593-1595.
ABSTRACT | FULL TEXT  

Etiology and natural history of diabetic retinopathy: An overview
Morello
Am J Health Syst Pharm 2007;64:S3-S7.
ABSTRACT | FULL TEXT  

Computer Modeling of Diabetes and Its Complications: A report on the Fourth Mount Hood Challenge Meeting
The Mount Hood 4 Modeling Group
Diabetes Care 2007;30:1638-1646.
ABSTRACT | FULL TEXT  

Clinical Outcomes and Cost-Effectiveness of Retinopathy Screening in Youth With Type 1 Diabetes
Huo et al.
Diabetes Care 2007;30:362-363.
FULL TEXT  

High Glucose, High Insulin, and Their Combination Rapidly Induce Laminin-{beta}1 Synthesis by Regulation of mRNA Translation in Renal Epithelial Cells
Mariappan et al.
Diabetes 2007;56:476-485.
ABSTRACT | FULL TEXT  

The North Jutland County Diabetic Retinopathy Study: population characteristics
Knudsen et al.
Br J Ophthalmol 2006;90:1404-1409.
ABSTRACT | FULL TEXT  

High Glucose Blunts Vascular Endothelial Growth Factor Response to Hypoxia via the Oxidative Stress-Regulated Hypoxia-Inducible Factor/Hypoxia-Responsible Element Pathway
Katavetin et al.
J. Am. Soc. Nephrol. 2006;17:1405-1413.
ABSTRACT | FULL TEXT  

Effect of Perioperative Glycemic Control in Progression of Diabetic Retinopathy and Maculopathy
Suto et al.
Arch Ophthalmol 2006;124:38-45.
ABSTRACT | FULL TEXT  

The Age-Related Eye Disease Study Severity Scale for Age-Related Macular Degeneration: AREDS Report No. 17
Age-Related Eye Disease Study Research Group
Arch Ophthalmol 2005;123:1484-1498.
ABSTRACT | FULL TEXT  

Hemoglobin A1c Measurements over Nearly Two Decades: Sustaining Comparable Values throughout the Diabetes Control and Complications Trial and the Epidemiology of Diabetes Interventions and Complications Study
Steffes et al.
Clin. Chem. 2005;51:753-758.
ABSTRACT | FULL TEXT  

Retinal Artery and Vein Diameters during Pregnancy in Diabetic Women
Larsen et al.
IOVS 2005;46:709-713.
ABSTRACT | FULL TEXT  

Under-recognised paradox of neuropathy from rapid glycaemic control
Leow and Wyckoff
Postgrad. Med. J. 2005;81:103-107.
ABSTRACT | FULL TEXT  

A Prospective Study of Serum Lipids and Risk of Diabetic Macular Edema in Type 1 Diabetes
Miljanovic et al.
Diabetes 2004;53:2883-2892.
ABSTRACT | FULL TEXT  

The Prevalence of Diabetic Retinopathy Among Adults in the United States
Arch Ophthalmol 2004;122:552-563.
 

Diabetic Retinopathy and Serum Lipoprotein Subclasses in the DCCT/EDIC Cohort
Lyons et al.
IOVS 2004;45:910-918.
ABSTRACT | FULL TEXT  

DCCT: the study that forever changed the nature of treatment of type 1 diabetes: Diabetes Control and Complications Trial -- a glycaemic control study in type 1 diabetes
Skyler
British Journal of Diabetes & Vascular Disease 2004;4:29-32.
 

Leg Ulcers and Pain: A Review
Cooper et al.
INT J LOW EXTREM WOUNDS 2003;2:189-197.
ABSTRACT  

Sustained Effect of Intensive Treatment of Type 1 Diabetes Mellitus on Development and Progression of Diabetic Nephropathy: The Epidemiology of Diabetes Interventions and Complications (EDIC) Study
Writing Team for the Diabetes Control and Complica
JAMA 2003;290:2159-2167.
ABSTRACT | FULL TEXT  

Diabetic Retinopathy: Contemporary prevalence in a well-controlled population
Brown et al.
Diabetes Care 2003;26:2637-2642.
ABSTRACT | FULL TEXT  

Has the Frequency of Proliferative Diabetic Retinopathy Declined in the U.S.?
Klein
Diabetes Care 2003;26:2691-2692.
FULL TEXT  

{beta}-Cell Function and the Development of Diabetes-Related Complications in the Diabetes Control and Complications Trial
Steffes et al.
Diabetes Care 2003;26:832-836.
ABSTRACT | FULL TEXT  

The Incidence of Retinopathy 10 Years After Diagnosis in Young Adult People With Diabetes: Results from the nationwide population-based Diabetes Incidence Study in Sweden (DISS)
Henricsson et al.
Diabetes Care 2003;26:349-354.
ABSTRACT | FULL TEXT  

Correlation between erythrocyte aldose reductase level and human diabetic retinopathy
Oishi et al.
Br J Ophthalmol 2002;86:1363-1366.
ABSTRACT | FULL TEXT  

Effect of Intensive Therapy on the Microvascular Complications of Type 1 Diabetes Mellitus
The Writing Team for the Diabetes Control and Comp
JAMA 2002;287:2563-2569.
ABSTRACT | FULL TEXT  

Eating Disorders in Adolescent Girls and Young Adult Women With Type 1 Diabetes
Daneman et al.
Diabetes Spectr. 2002;15:83-105.
FULL TEXT  

Blood pressure control and diabetic retinopathy
Klein and Klein
Br J Ophthalmol 2002;86:365-367.
FULL TEXT  

Risk of Developing Retinopathy in Diabetes Control and Complications Trial Type 1 Diabetic Patients With Good or Poor Metabolic Control
Zhang et al.
Diabetes Care 2001;24:1275-1279.
ABSTRACT | FULL TEXT  

Glycohemoglobin: A Primary Predictor of the Development or Reversal of Complications of Diabetes Mellitus
Krishnamurti and Steffes
Clin. Chem. 2001;47:1157-1165.
ABSTRACT | FULL TEXT  

Response to Cundy
Nathan et al.
Diabetes Care 2001;24:795-796.
FULL TEXT  

How Many Steps of Progression of Diabetic Retinopathy Are Meaningful?: The Wisconsin Epidemiologic Study of Diabetic Retinopathy
Klein et al.
Arch Ophthalmol 2001;119:547-553.
ABSTRACT | FULL TEXT  

Surrogate Outcomes for Clinical Trials: Use With Caution
Chew
Arch Ophthalmol 2001;119:576-578.
FULL TEXT  

Rise in Albuminuria and Blood Pressure in Patients Who Progressed to Diabetic Nephropathy in the Diabetes Control and Complications Trial
THOMAS et al.
J. Am. Soc. Nephrol. 2001;12:333-340.
ABSTRACT | FULL TEXT  

Alterations of the Blood-Retinal Barrier and Retinal Thickness in Preclinical Retinopathy in Subjects With Type 2 Diabetes
Lobo et al.
Arch Ophthalmol 2000;118:1364-1369.
ABSTRACT | FULL TEXT  

Retinopathy and Nephropathy in Patients with Type 1 Diabetes Four Years after a Trial of Intensive Therapy
The Diabetes Control and Complications Trial/Epide
NEJM 2000;342:381-389.
ABSTRACT | FULL TEXT  

Insulin-Induced Vascular Endothelial Growth Factor Expression in Retina
Lu et al.
IOVS 1999;40:3281-3286.
ABSTRACT | FULL TEXT  

Prevalence and risk factors for diabetic retinopathy among Omani diabetics
Haddad and Saad
Br J Ophthalmol 1998;82:901-906.
ABSTRACT | FULL TEXT  

Early Worsening of Diabetic Retinopathy in the Diabetes Control and Complications Trial
The Diabetes Control and Complications Trial Resea
Arch Ophthalmol 1998;116:874-886.
ABSTRACT | FULL TEXT  

Worsening of Diabetic Retinopathy After Improvement of Glycemic Control
Davis
Arch Ophthalmol 1998;116:931-932.
FULL TEXT  

Retinal Vessel Changes in Galactose-Fed Dogs
Kobayashi et al.
Arch Ophthalmol 1998;116:785-789.
ABSTRACT | FULL TEXT  

Why some cases of retinopathy worsen when diabetic control improves
Chantelau and Kohner
BMJ 1997;315:1105-1106.
FULL TEXT  

Diabetic retinopathy in people aged 70 years or older. The Oulu Eye Study
Hirvela and Laatikainen
Br J Ophthalmol 1997;81:214-217.
ABSTRACT | FULL TEXT  

Diabetic retinopathy in pregnancy
BEST and CHAKRAVARTHY
Br J Ophthalmol 1997;81:249-251.
FULL TEXT  

Lifetime Benefits and Costs of Intensive Therapy as Practiced in the Diabetes Control and Complications Trial
The Diabetes Control and Complications Trial Resea
JAMA 1996;276:1409-1415.
ABSTRACT  

Ophthalmology
Levin
JAMA 1996;275:1834-1836.
ABSTRACT  

A Comparison of the Study Populations in the Diabetes Control and Complications Trial and the Wisconsin Epidemiologic Study of Diabetic Retinopathy
Diabetes Control and Complications Trial Research et al.
Arch Intern Med 1995;155:745-754.
ABSTRACT