Type 1 Diabetes Extension Study

This study is looking at the long-term effects on people who previously participated in certain Type 1 Diabetes (T1D) studies that used treatments to change the immune system. We want to understand how long participants continue to make their own insulin and how changes in their immune system relate to this ability. This information could help researchers develop better treatments for T1D in the future. You can join if you are between 8 and 35 years old and have previously been in an Immune Tolerance Network (ITN) approved T1D study. The main goal is to see how your beta cell function (your body's ability to make insulin) changes over 5 years.

Study design: This is an observational study, meaning no new treatments are given. It plans to enroll 111 participants.
What's involved: You will have health assessments, blood and urine collections, and possibly Mixed Meal Tolerance Tests (MMTTs). Your participation could range from one visit to a maximum of five years.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for up to 60 months (5 years) to assess changes in beta cell function.

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Type 1 Diabetes Extension Study

Recruiting

Not specifiedAges 8–35Observational

National Institute of Allergy and Infectious Diseases (NIAID)

~111 participants

Updated 2026-06-29 on ClinicalTrials.gov

At a glance

Recruiting sites

8 of 12 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in Beta Cell Function by MMTT-Stimulated Mean C-peptide Area Under the Curve (AUC)

Measured over Baseline (Visit 0) to Month 60 (Year 5)

Conditions

Type 1 Diabetes Mellitus

T1DM

T1D

Where it's being run

12 sites across 11 states

California2

Colorado1

Connecticut1

Georgia1

Indiana1

Iowa1

Massachusetts1

Minnesota1

Study leadership

Linda A. DiMeglio, MD, MPH,MA · STUDY_CHAIR · Riley Hospital for Children at Indiana University Health

Who to contact

Rebecca Wesch

[email protected]

415-476-5984

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Prior participant in an Immune Tolerance Network (ITN) executive committee approved T1DM study.

Ability to sign informed consent/assent (as applicable for children).

Exclusion

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.

What this trial measures

Change in Beta Cell Function by MMTT-Stimulated Mean C-peptide Area Under the Curve (AUC)Baseline (Visit 0) to Month 60 (Year 5)
Evaluation of changes in beta cell function over time will be measured by mixed-meal tolerance test (MMTT) -Stimulated mean C-Peptide area under the curve (AUC). C-peptide is released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. Detectable C-peptide is defined as any value during a MMTT of ≥0.15 ng/mL.

Trialytics