Recruiting

Type 1 Diabetes

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT02734277

Conditions

Type 1 Diabetes Mellitus

T1DM

T1D

Eligibility Criteria

Sex: All

Age: 8 - 35

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This is a multi-center, prospective, non-interventional study that focuses on the long- term effects following participation in selected ITN new-onset Type1 Diabetes Mellitus studies with immunomodulatory agents (T1DM, T1D).

This observational study will:

  • follow participants to determine how long they continue to produce insulin, and
  • will also assess how changes in the immune system over time relate to the ability to produce insulin.

This information could help design better therapies for type 1 diabetes in the future.

Conditions

Type 1 Diabetes Mellitus

T1DM

T1D

Study ID

NCT02734277

Start date

Aug 18, 2016

Status verified date

Mar, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 35

Healthy Volunteers: Not accepted

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

111 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1: Detectable C-peptide by MMTT

Participants with detectable C-peptide at their:

  • Last Immune Tolerance Network (ITN) T1DM week 104 study visit,
  • Last AbATE (NCT00129259) follow-up visit, or
  • Last ITN066AI T1DES visit

Detectable C-peptide is defined as a value above the lower limit of detection.

Group 2:Undetectable C-peptide by MMTT

Participants without detectable C-peptide at their:

  • Last ITN T1DM week 104 study visit,
  • Last AbATE follow-up visit, or last
  • ITN066AI T1DES visit

Undetectable C-peptide is defined as a value below the lower limit of detection.

Primary outcome measure

  • Change in Beta Cell Function by MMTT-Stimulated Mean C-peptide Area Under the Curve (AUC) [ Time Frame: Baseline (Visit 0) to Month 60 (Year 5) ]

Central Contacts and Locations

Locations

UCSF School of Medicine

Recruiting

San Francisco, California, United States, 94143

Contacts

Rebecca Wesch

415-476-5984rebecca.wesch@ucsf.edu

Principal Investigator:

Stephen Gitelman, MD

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Trudy Esrey

650-498-4450tesrey@stanford.edu

Principal Investigator:

Darrell Wilson, MD

University of Colorado School of Medicine: Barbara Davis Center for Diabetes

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Mara Kinney

(303) 724-8272MARA.KINNEY@ucdenver.edu

Principal Investigator:

Peter Gottlieb, MD

Indiana University Riley Hospital for Children

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Ellie Ryan

317-278-7037elmryan@iu.edu

Maria Spall

317-278-7034malnicho@iu.edu

Principal Investigator:

Linda DiMeglio, MD, MPH

University of Iowa Health Care Division of Pediatric Endocrinology

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Joanne Cabbage

319-356-4035joanne-cabbage@uiowa.edu

Principal Investigator:

Michael Tansey, MD

Joslin Diabetes Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Site Public Contact

888-813-8669T1DTrials@joslin.harvard.edu

Principal Investigator:

Jason Gaglia, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55454

Contacts

Anne Street

612-625-9709stree065@umn.edu

Principal Investigator:

Antoinette Moran, MD

Benaroya Research Institute

Recruiting

Seattle, Washington, United States, 98101

Contacts

Katie Bennett

(206) 341-8945kbennett@benaroyaresearch.org

Principal Investigator:

Sandra Lord, MD

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Jun 29, 2026

Last verified

Mar, 2026

Keywords

  • Insulin
  • Glucose Intolerance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2026-06-29.