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Type 1 Diabetes MellitusNCT00360815

Diabetes Control and Complications Trial (DCCT)

A study testing Insulin in people with Type 1 Diabetes Mellitus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 38 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 13 to 39 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Insulin
How many people
1,441 participants
Where
38 sitesin 2 countries
Study dates
Aug 1983to Apr 1993
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 39 years
  • All sexes
  • Child, Adult

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.

Trial locations and contacts

38 sites in 2 countries.

38 sites in 2 countries

United States35 sites

  • University of New Mexico School of Medicine

    Albuquerque, New Mexico, 87131

  • University of Michigan, Sattelite-Henry Ford Hospital

    Ann Arbor, Michigan, 48109-0832

  • University of Maryland

    Baltimore, Maryland, 21201

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Joslin Diabetes Center, Inc.

    Boston, Massachusetts, 02215

  • Medical University of South Carolina

    Charleston, South Carolina, 29403-5851

  • Northwestern University

    Chicago, Illinois, 60611

  • Case Western Reserve University, Lakeside Hospital

    Cleveland, Ohio, 44106

  • Backup DCCT Central HbA1c Lab

    Columbia, Missouri, 65201

  • University of Missouri

    Columbia, Missouri, 65212

  • University of Texas

    Dallas, Texas, 75235

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • University of Iowa

    Iowa City, Iowa, 52242

  • University of California

    La Jolla, California, 92093-0620

  • DCCT Central Ophthalmologic Reading Unit, Fundus Photo Reading Center

    Madison, Wisconsin, 53705-0240

  • University of Tennessee

    Memphis, Tennessee, 38163

  • International Diabetes Center

    Minneapolis, Minnesota, 55416

  • DCCT Central Nutrition Coding Unit

    Minneapolis, Minnesota, 55454-1015

  • DCCT Central ECG Reading Unit

    Minneapolis, Minnesota, 55455-1015

  • DCCT Central Biochemistry Laboratory

    Minneapolis, Minnesota, 55455-9980

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Vanderbilt University, Diabetes Research and Training Center

    Nashville, Tennessee, 37212

  • Vanderbilt University

    Nashville, Tennessee, 37232-2230

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Cornell University Medical College, The New York Hospital

    New York, New York, 10021

  • University of Pennsylvania, The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh, Children's Hospital

    Pittsburgh, Pennsylvania, 15213-3417

  • DCCT Central Neurobehavioral Coding Unit

    Pittsburgh, Pennsylvania, 15213

  • Mayo Foundation

    Rochester, Minnesota, 55905

  • George Washington University, Biostatistics Center

    Rockville, Maryland, 20852

  • University of Washington

    Seattle, Washington, 98195

  • DCCT Central Autonomic Coding Unit

    Springfield, Illinois, 62702

  • Washington University at St. Louis

    St Louis, Missouri, 63110

  • University of South Florida College of Medicine

    Tampa, Florida, 33612

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461

Other trials in United States

Canada3 sites

  • University of Western Ontario

    London, Ontario, N6A 5A5

  • University of Toronto, Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

  • University of Washington (British Columbia Satellite)

    Vancouver, British Columbia, V5Z 3N9

Other trials in Canada

About this study

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.

Being tested
Insulin
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2006 (estimated)
  2. Study startAug 1983
  3. Study completionApr 1993

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,441 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00360815
Sponsor's protocol ID
N01-DK-6-2204-A (completed)
Status last verified
Mar 2010
First submitted
2 Aug 2006
Last updated
2 Mar 2010
Results posted
No

Publications

  • Limonte CP, Gao X, Roshandel D, Bebu I, Karger AB, Lorenzi GM, de Boer IH, Perkins BA, Paterson AD; DCCT/EDIC Research Group. Genetic Risk Factors for Kidney Function in Individuals with Type 1 Diabetes. Clin J Am Soc Nephrol. 2026 Jun 29. doi: 10.2215/CJN.0000001111. Online ahead of print.

    PubMed 42371715

  • Rubin M, Kazakia G, Braffett BH, Gregory NS, Lin MH, Trapani V, de Boer IH, Agarwal S, Burghardt A, Guo XE, Gubitosi-Klug R, Schwartz AV; DCCT/EDIC Research Group. Bone microarchitecture assessed by High-resolution peripheral quantitative computed tomography in type 1 diabetes: the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications study. JBMR Plus. 2025 Oct 22;9(12):ziaf167. doi: 10.1093/jbmrpl/ziaf167. eCollection 2025 Dec.

    PubMed 41235023

  • Braffett BH, El Ghormli L, Martin C, White NH, Hirsch IB, Bantle A, Carlson A, Leschek E, Gubitosi-Klug R, Soliman EZ, Vella A, Perkins BA, Bebu I, Pop-Busui R; DCCT/EDIC Research Group. Cardiovascular autonomic neuropathy defined by indices of heart rate variability is associated with cardiovascular disease: a longitudinal cohort study of participants with type 1 diabetes. Cardiovasc Diabetol. 2025 Aug 13;24(1):334. doi: 10.1186/s12933-025-02856-9.

    PubMed 40804720

  • Aiello LP, Blodi B, Gao X, Sun JK, Gubitosi-Klug RA, White NH, Hainsworth D, Lorenzi GM, Bebu I; DCCT/EDIC Research Group. Ultra-Widefield and Early Treatment Diabetic Retinopathy Study 7-Field Grading of Diabetic Retinopathy. JAMA Ophthalmol. 2024 Sep 1;142(9):856-863. doi: 10.1001/jamaophthalmol.2024.2890.

    PubMed 39145984

  • Helmink MAG, Hageman SHJ, Visseren FLJ, de Ranitz-Greven WL, de Valk HW, van Sloten TT, Westerink J. Variability in benefit from intensive insulin therapy on cardiovascular events in individuals with type 1 diabetes: A post hoc analysis of the DCCT/EDIC study. Diabet Med. 2023 Nov;40(11):e15183. doi: 10.1111/dme.15183. Epub 2023 Jul 24.

    PubMed 37470718

  • Khatri M, Ryan CM, Gao X, de Boer IH, Braffett BH, Molitch M, Karger AB, Lorenzi GM, Lee P, Trapani VR, Lachin JM, Jacobson AM. CKD Associates with Cognitive Decline in Middle-Aged and Older Adults with Long-Standing Type 1 Diabetes. Kidney360. 2023 Aug 1;4(8):1058-1071. doi: 10.34067/KID.0000000000000178. Epub 2023 Jun 9.

    PubMed 37291722

  • Lachin JM, Bebu I, Gao X, Nathan DM, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Research Group. Association of Estimated Time-in-Range Capillary Glucose Levels Versus HbA1c With Progression of Microvascular Complications in the Diabetes Control and Complications Trial. Diabetes Care. 2022 Oct 1;45(10):2445-2448. doi: 10.2337/dc21-2298.

    PubMed 35972222

  • Martin CL, Trapani VR, Backlund JC, Lee P, Braffett BH, Bebu I, Lachin JM, Jacobson AM, Gubitosi-Klug R, Herman WH; DCCT/EDIC Research Group. Physical Function in Middle-aged and Older Adults With Type 1 Diabetes: Long-term Follow-up of the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study. Diabetes Care. 2022 Sep 1;45(9):2037-2045. doi: 10.2337/dc21-2119.

    PubMed 35880807

  • Jacobson AM, Braffett BH, Erus G, Ryan CM, Biessels GJ, Luchsinger JA, Bebu I, Gubitosi-Klug RA, Desiderio L, Lorenzi GM, Trapani VR, Lachin JM, Bryan RN, Habes M, Nasrallah IM; DCCT/EDIC Research Group. Brain Structure Among Middle-aged and Older Adults With Long-standing Type 1 Diabetes in the DCCT/EDIC Study. Diabetes Care. 2022 Aug 1;45(8):1779-1787. doi: 10.2337/dc21-2438.

    PubMed 35699949

  • Gubitosi-Klug RA, Braffett BH, Bebu I, Johnson ML, Farrell K, Kenny D, Trapani VR, Meadema-Mayer L, Soliman EZ, Pop-Busui R, Lachin JM, Bergenstal RM, Tamborlane WV. Continuous Glucose Monitoring in Adults With Type 1 Diabetes With 35 Years Duration From the DCCT/EDIC Study. Diabetes Care. 2022 Mar 1;45(3):659-665. doi: 10.2337/dc21-0629.

    PubMed 35076697

  • Carlson NE, Horton KW, Hokanson JE, Cleary PA, Jacobs DR Jr, Brunzell JD, Purnell JQ; DCCT/EDIC research group. Weight gain trajectories and obesity rates in intensive and conventional treatments of type 1 diabetes from the DCCT compared with a control population without diabetes. Diabet Med. 2022 May;39(5):e14794. doi: 10.1111/dme.14794. Epub 2022 Jan 26.

    PubMed 35040196

  • Perkins BA, Bebu I, Gao X, Karger AB, Hirsch IB, Karanchi H, Molitch ME, Zinman B, Lachin JM, de Boer IH. Early Trajectory of Estimated Glomerular Filtration Rate and Long-term Advanced Kidney and Cardiovascular Complications in Type 1 Diabetes. Diabetes Care. 2022 Mar 1;45(3):585-593. doi: 10.2337/dc21-1883.

    PubMed 35015817

  • Boyko EJ, Zelnick LR, Braffett BH, Pop-Busui R, Cowie CC, Lorenzi GM, Gubitosi-Klug R, Zinman B, de Boer IH. Risk of Foot Ulcer and Lower-Extremity Amputation Among Participants in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study. Diabetes Care. 2022 Feb 1;45(2):357-364. doi: 10.2337/dc21-1816.

    PubMed 35007329

  • Steigmann L, Miller R, Trapani VR, Giannobile WV, Braffett BH, Pop-Busui R, Lorenzi G, Herman WH, Sarma AV; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Type 1 diabetes and oral health: Findings from the Epidemiology of Diabetes Interventions and Complications (EDIC) study. J Diabetes Complications. 2022 Apr;36(4):108120. doi: 10.1016/j.jdiacomp.2021.108120. Epub 2022 Jan 3.

    PubMed 35000860

  • Polak JF, Backlund JC, Budoff M, Raskin P, Bebu I, Lachin JM; DCCT/EDIC Research Group. Coronary Artery Disease Events and Carotid Intima-Media Thickness in Type 1 Diabetes in the DCCT/EDIC Cohort. J Am Heart Assoc. 2021 Dec 21;10(24):e022922. doi: 10.1161/JAHA.121.022922. Epub 2021 Dec 7.

    PubMed 34873921

Questions about this trial

What is this clinical trial studying?

A study testing Insulin in people with Type 1 Diabetes Mellitus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 38 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00360815, which also lists 92 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2010.

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