Epidemiology of Diabetes Interventions and Complications (EDIC)

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 284-94
    NCT ID: NCT00360893
    Sponsor Protocol Number: EDIC

About this study

OBJECTIVE— The Diabetes Control and Complications Trial (DCCT) demonstrated the powerful impact of glycemic control on the early manifestations of microvascular complications.

Contemporary prospective data on the evolution of macrovascular and late micro vascular complications of type 1 diabetes are limited. The Epidemiology of Diabetes Interventions and Complications (EDIC) study is a multicenter, longitudinal, observational study designed to use the well-characterized DCCT cohort of 1,400 patients to determine the long-term effects of prior separation of glycemic levels on micro- and macrovascular outcomes. EDIC is in its 13th year of followup. The study is expecting to last until 2016.

RESEARCH DESIGN AND METHODS— Using a standardized annual history and physical examination, 28 EDIC clinical centers that were DCCT clinics will follow the EDIC cohort for 10 years. Annual evaluation also includes resting electro c a rdiogram, Doppler ultrasound measurements of ankle/arm blood pressure, and screening for nephropathy. At regular intervals, a timed 4-h urine is collected, lipid pro files are obtained, and stereoscopic fundus photographs are taken. In addition, dual B-mode Doppler ultrasound scans of the common and internal carotid arteries will be perf o rmed at years 1 and 6 and at study end.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

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

Revised sub-study protocol, The Relationship of Hypoglycemia and Cardiac Rhythm in Long-Term Type 1 Diabetes (Hypoglycemia-Arrhythmia Study), Version 2, March 16, 2017

  • Addition of excluding people with a cardiac pacemaker from the sub-study; 
  • Addition of asking sub-study participants to sync their Fitbit on their own electronic device; and
  • Revised Participant Home Instructions and Device Mailing Instructions. 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

F Service, M.D., Ph.D.

Contact us for the latest status

Contact information:

Georgia Ziegler

(507)255-4225

ziegler.georgia@mayo.edu

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CLS-20312142

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