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Type 1 Diabetes Extension Study
NCT02734277 · National Institute of Allergy and Infectious Diseases (NIAID)
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
Depending upon a participant's level of insulin production, participation may be as short as one return visit or a maximum of five years. Evaluation visits will include:
* Overall health assessments
* Blood and urine collections
* Mixed meal tolerance test (MMTTs) for certain participants, per protocol.
Eligibility criteria
Inclusion Criteria:
* Prior participant in an Immune Tolerance Network (ITN) executive committee approved T1DM study.
* Ability to sign informed consent/assent (as applicable for children).
Exclusion Criteria:
* Any medical condition that in the opinion of the principal investigator would interfere with safe completion of the trial; or
* Inability to comply with the study visit schedule and required assessments.
Study design
Enrollment target: 111 participants
Age groups: child, adult
Timeline
Starts: 2016-08-18
Estimated completion: 2028-08
Last updated: 2026-03-10
Primary outcomes
- • Change in Beta Cell Function by MMTT-Stimulated Mean C-peptide Area Under the Curve (AUC) (Baseline (Visit 0) to Month 60 (Year 5))
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) · nih
With: Immune Tolerance Network (ITN)
Contacts & investigators
InvestigatorLinda A. DiMeglio, MD, MPH,MA · study_chair, Riley Hospital for Children at Indiana University Health
All locations (12)
UCSF School of MedicineRecruiting
San Francisco, California, United States
Stanford UniversityRecruiting
Stanford, California, United States
University of Colorado School of Medicine: Barbara Davis Center for DiabetesRecruiting
Aurora, Colorado, United States
Yale UniversityCompleted
New Haven, Connecticut, United States
Emory UniversityWithdrawn
Atlanta, Georgia, United States
Indiana University Riley Hospital for ChildrenRecruiting
Indianapolis, Indiana, United States
University of Iowa Health Care Division of Pediatric EndocrinologyRecruiting
Iowa City, Iowa, United States
Joslin Diabetes CenterRecruiting
Boston, Massachusetts, United States
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
Children's Mercy HospitalRecruiting
Kansas City, Missouri, United States
Sanford ResearchCompleted
Sioux Falls, South Dakota, United States
Benaroya Research InstituteRecruiting
Seattle, Washington, United States