Type 1 Diabetes Extension Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-18

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 1 Diabetes Mellitus T1DM T1D

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

8 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No