Home
Clinical Trials
Diabetes Control and Complica...

Diabetes Control and Complications Trial (DCCT)

Last Updated: 2010-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

1441 participants

Study Classification

INTERVENTIONAL

Study Start Date

1983-08-31

Study Completion Date

1993-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Background. Long-term microvascular and neurologic complications cause major morbidity and mortality in patients with insulin-dependent diabetes mellitus (IDDM). We examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of these complications.

Methods. A total of 1441 patients with IDDM -- 726 with no retinopathy at base line (the primary-prevention cohort) and 715 with mild retinopathy (the secondary-intervention cohort) were randomly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections. The patients were followed for a mean of 6.5 years, and the appearance and progression of retinopathy and other complications were assessed regularly.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Depression and Diabetes Control Trial

NCT02675257

Diabetes Mellitus Affective Disorders Depression +3 more

COMPLETED NA

Diabetes IN-CHARGE: Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation

NCT00182026

Diabetes Mellitus, Type 2

UNKNOWN NA

Clinical Effects of Pulsatile Insulin Delivery on Cognitive Function- Phase 1

NCT00228865

Diabetes Mellitus

TERMINATED PHASE2/PHASE3

Effects of My Diabetes Care on Patient Outcomes

NCT05451914

Diabetes Mellitus, Type 2

COMPLETED NA

Type 2 Diabetes and the Brain in Adolescents

NCT03461510

Type 2 Diabetes Mellitus Obesity Pediatric Obesity +3 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Insulin

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Eligibility Criteria:

* The major criteria for eligibility included insulin dependence, as evidenced by deficient C-peptide secretion; an age of 13 to 39 years; and the absence of hypertension, hypercholesterolemia, and severe diabetic complications or medical conditions. To be eligible for the primary-prevention cohort, patients were required to have had insulin dependent diabetes mellitus (IDDM) for one to five years, to have no retinopathy as detected by seven-field stereoscopic fundus photography, and to have urinary albumin excretion of less than 40 mg per 24 hours. To be eligible for the secondary-intervention cohort, the patients were required to have IDDM for 1 to 15 years, to have very-mild to moderate nonproliferative retinopathy, and to have urinary albumin excretion of less than 200 mg per 24 hours.

Minimum Eligible Age

13 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Oscar B. Crofford, M.D.

Role: STUDY_CHAIR

Vanderbilt University

Carolyn Siebert, M.P.H.

Role: STUDY_DIRECTOR

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Patricia A. Cleary, M.S.

Role: PRINCIPAL_INVESTIGATOR

George Washington University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California

La Jolla, California, United States

Site Status

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

University of South Florida College of Medicine

Tampa, Florida, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

DCCT Central Autonomic Coding Unit

Springfield, Illinois, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

University of Maryland

Baltimore, Maryland, United States

Site Status

George Washington University, Biostatistics Center

Rockville, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Joslin Diabetes Center, Inc.

Boston, Massachusetts, United States

Site Status

University of Michigan, Sattelite-Henry Ford Hospital

Ann Arbor, Michigan, United States

Site Status