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Type 1 Diabetes MellitusNCT00360893

Epidemiology of Diabetes Interventions and Complications (EDIC)

An observational study of Type 1 Diabetes Mellitus, run by George Washington University.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The Diabetes Control and Complications Trial (DCCT,1983-1993) compared intensive therapy aimed at near-normal glycemia versus conventional therapy with no specific glucose targets in 1441 subjects with type 1 diabetes (T1DM) over a mean follow-up of 6.5 years. Read more about this study

Who is it for?
Ages 19 to 45 years
Conditions the study is for
Type 1 Diabetes Mellitus
How many people
1,441 participants
Where
No sites listed yet
Study dates
Apr 1994to Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 19 to 45 years
  • All sexes
  • Adult

Study population: Participants originally enrolled in the Diabetes Control and Complications Trial (DCCT) (N01-DK-6-2204-A).

Participants originally enrolled in the Diabetes Control and Complications Trial (DCCT) (N01-DK-6-2204-A).

About this study

The Diabetes Control and Complications Trial (DCCT,1983-1993) compared intensive therapy aimed at near-normal glycemia versus conventional therapy with no specific glucose targets in 1441 subjects with type 1 diabetes (T1DM) over a mean follow-up of 6.5 years. Intensive therapy reduced the risks of retinopathy, nephropathy, and neuropathy by 35-76%. The level of glycemia was the primary determinant of complications. We also described the adverse effects of intensive therapy; assessed its effects on cardiovascular disease (CVD) risk factors, neurocognition and quality of life; and projected the lifetime health-economic impact. After the primary DCCT results were reported in 1993, intensive therapy aiming for a HbA1c <7% was adopted world-wide as standard-of-care for T1DM.

The Epidemiology of Diabetes Interventions and Complications (EDIC, 1994-present) is the observational follow-up study of the DCCT cohort. Micro- and cardio-vascular complications and a wide range of established and putative risk factors, including genetic and epigenetic factors, have been measured with standardized methods, carefully documented and events adjudicated. EDIC has notably shown that the early beneficial effects of intensive versus conventional therapy on complications persisted for ~15 years despite the convergence of HbA1c levels in the two groups during EDIC, a novel concept termed metabolic memory. Prior intensive therapy was also shown to reduce substantially the risk of CVD events and mortality.

The overarching goals for the current cycle (2022-2027) are to study the occurrence and identify potentially modifiable risk factors of the more advanced microvascular and cardiovascular complications and physical and cognitive dysfunction that are occurring with increasing diabetes duration and age. With increasing longevity, the increased adiposity that has affected patients with T1DM, including EDIC participants, has potential adverse consequences. Thus, the impact of diabetes duration, aging and adiposity on morbidities and their underlying risk factors will be studied. The results will guide treatment priorities as T1DM patients age.

Medical subject headings
Diabetes Mellitus, Type 1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2022-2027 Cycle

    Advanced microvascular complications (retinopathy, kidney disease, neuropathy), major CVD events or early subclinical, changes in physical and cognitive dysfunction, fibrosis and steatosis, obstructive sleep apnea

    Measured: Eyes (Yrs 32-33, 2025-26); Kidney (annually); Nerves (Yrs 29-31, 33-34, 2022-26); CVD events (continuous, adjudicated annually); Physical (Yrs 29-31, 2022-24); Cognitive (Yrs 32-33, 2025-26); Liver (Yrs 29-31, 2022-24); Sleep (Yrs 29-31, 2022-24).

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 startApr 1994
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,441 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00360893
Sponsor's protocol ID
N01-DK-6-2204
Other IDs
U01DK094176
Status last verified
Oct 2026
First submitted
3 Aug 2006
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: NIDDK Central Repository

Publications

  • DCCT/EDIC Research Group; Nathan DM, Bebu I, Hainsworth D, Klein R, Tamborlane W, Lorenzi G, Gubitosi-Klug R, Lachin JM. Frequency of Evidence-Based Screening for Retinopathy in Type 1 Diabetes. N Engl J Med. 2017 Apr 20;376(16):1507-1516. doi: 10.1056/NEJMoa1612836.

    PubMed 28423305

  • Writing Group for the DCCT/EDIC Research Group; Orchard TJ, Nathan DM, Zinman B, Cleary P, Brillon D, Backlund JY, Lachin JM. Association between 7 years of intensive treatment of type 1 diabetes and long-term mortality. JAMA. 2015 Jan 6;313(1):45-53. doi: 10.1001/jama.2014.16107.

    PubMed 25562265

  • Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study Research Group; Jacobson AM, Musen G, Ryan CM, Silvers N, Cleary P, Waberski B, Burwood A, Weinger K, Bayless M, Dahms W, Harth J. Long-term effect of diabetes and its treatment on cognitive function. N Engl J Med. 2007 May 3;356(18):1842-52. doi: 10.1056/NEJMoa066397.

    PubMed 17476010

  • Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 Dec 22;353(25):2643-53. doi: 10.1056/NEJMoa052187.

    PubMed 16371630

  • Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group; Lachin JM, Genuth S, Cleary P, Davis MD, Nathan DM. Retinopathy and nephropathy in patients with type 1 diabetes four years after a trial of intensive therapy. N Engl J Med. 2000 Feb 10;342(6):381-9. doi: 10.1056/NEJM200002103420603.

    PubMed 10666428

  • Braffett BH, Bebu I, El Ghormli L, Cowie CC, Sivitz WI, Pop-Busui R, Larkin ME, Gubitosi-Klug RA, Nathan DM, Lachin JM, Dagogo-Jack S; DCCT/EDIC Research Group. Cardiometabolic Risk Factors and Incident Cardiovascular Disease Events in Women vs Men With Type 1 Diabetes. JAMA Netw Open. 2022 Sep 1;5(9):e2230710. doi: 10.1001/jamanetworkopen.2022.30710.

    PubMed 36074461

  • Writing Team for the DCCT/EDIC Research Group; Gubitosi-Klug RA, Sun W, Cleary PA, Braffett BH, Aiello LP, Das A, Tamborlane W, Klein R. Effects of Prior Intensive Insulin Therapy and Risk Factors on Patient-Reported Visual Function Outcomes in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Cohort. JAMA Ophthalmol. 2016 Feb;134(2):137-45. doi: 10.1001/jamaophthalmol.2015.4606.

    PubMed 26584339

  • DCCT/EDIC Research Group; Aiello LP, Sun W, Das A, Gangaputra S, Kiss S, Klein R, Cleary PA, Lachin JM, Nathan DM. Intensive diabetes therapy and ocular surgery in type 1 diabetes. N Engl J Med. 2015 Apr 30;372(18):1722-33. doi: 10.1056/NEJMoa1409463.

    PubMed 25923552

  • DCCT/EDIC Research Group; de Boer IH, Sun W, Cleary PA, Lachin JM, Molitch ME, Steffes MW, Zinman B. Intensive diabetes therapy and glomerular filtration rate in type 1 diabetes. N Engl J Med. 2011 Dec 22;365(25):2366-76. doi: 10.1056/NEJMoa1111732. Epub 2011 Nov 12.

    PubMed 22077236

  • Writing Team for the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. 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. JAMA. 2003 Oct 22;290(16):2159-67. doi: 10.1001/jama.290.16.2159.

    PubMed 14570951

  • Nathan DM, Lachin J, Cleary P, Orchard T, Brillon DJ, Backlund JY, O'Leary DH, Genuth S; Diabetes Control and Complications Trial; Epidemiology of Diabetes Interventions and Complications Research Group. Intensive diabetes therapy and carotid intima-media thickness in type 1 diabetes mellitus. N Engl J Med. 2003 Jun 5;348(23):2294-303. doi: 10.1056/NEJMoa022314.

    PubMed 12788993

  • Writing Team for the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Effect of intensive therapy on the microvascular complications of type 1 diabetes mellitus. JAMA. 2002 May 15;287(19):2563-9. doi: 10.1001/jama.287.19.2563.

    PubMed 12020338

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes Mellitus, run by George Washington University.

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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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.

What does the primary outcome measure?

2022-2027 Cycle (time frame: Eyes (Yrs 32-33, 2025-26); Kidney (annually); Nerves (Yrs 29-31, 33-34, 2022-26); CVD events (continuous, adjudicated annually); Physical (Yrs 29-31, 2022-24); Cognitive (Yrs 32-33, 2025-26); Liver (Yrs 29-31, 2022-24); Sleep (Yrs 29-31, 2022-24).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00360893, which also lists 104 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 27 Oct 2026.

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