Type 1 Diabetes Extension Study (T1DES)

December 6, 2023 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • UCSF School of Medicine
        • Contact:
        • Principal Investigator:
          • Stephen Gitelman, MD
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University
        • Contact:
        • Principal Investigator:
          • Darrell Wilson, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado School of Medicine: Barbara Davis Center for Diabetes
        • Contact:
        • Principal Investigator:
          • Peter Gottlieb, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Yale University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kevan Herold, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Withdrawn
        • Emory University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Riley Hospital for Children
        • Contact:
        • Contact:
        • Principal Investigator:
          • Linda DiMeglio, MD, MPH
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Health Care Division of Pediatric Endocrinology
        • Contact:
        • Principal Investigator:
          • Michael Tansey, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Joslin Diabetes Center
        • Contact:
        • Principal Investigator:
          • Jason Gaglia, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • University of Minnesota
        • Contact:
        • Principal Investigator:
          • Antoinette Moran, MD
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wayne Moore, Md, PhD
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
    • Washington
      • Seattle, Washington, United States, 98101
        • Recruiting
        • Benaroya Research Institute
        • Principal Investigator:
          • Sandra Lord, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Former participants in Immune Tolerance Network (ITN) new-onset Type 1 Diabetes Mellitus (T1DM) studies with immunomodulatory agents as the intervention.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)

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.
Baseline (Visit 0) to Month 60 (Year 5)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Insulin Use in Units per Kilogram Body Weight Per Day
Time Frame: Baseline (Visit 0) to Month 60 (Year 5)
The need to use exogenous insulin is an indication that the body is not producing enough endogenous insulin. Higher amounts of insulin use indicate higher disease activity.
Baseline (Visit 0) to Month 60 (Year 5)
Change in HbA1C
Time Frame: Baseline (Visit 0) to Month 60 (Year 5)
Glycosylated hemoglobin (HbA1c) is a measure of the average plasma concentration of blood sugar (glucose) over the previous three months and measures the level of optimal management of underlying disease.
Baseline (Visit 0) to Month 60 (Year 5)
Count of Participant-Reported Major Hypoglycemic Events
Time Frame: Baseline (Visit 0) to Month 60 (Year 5)
Major hypoglycemic events are defined as a glucose concentration <55 mg/dL (grades 2-5, NCI-CTCAE version 4.03), or clinically: involving seizure(s) or involving loss of consciousness (coma), or requiring assistance from another individual in order to recover.
Baseline (Visit 0) to Month 60 (Year 5)
Time to Undetectable C-Peptide
Time Frame: Baseline (Visit 0) to Month 60 (Year 5)
To assess the longevity of beta cell function, time to undetectable C-peptide will be evaluated using Kaplan-Meier survival estimates.
Baseline (Visit 0) to Month 60 (Year 5)
Frequency of Grade 3 or Higher Adverse Events (AEs) of Interest
Time Frame: Baseline (Visit 0) to Month 60 (Year 5)

Events of interest include but are not limited to:

  • Opportunistic and serious infections
  • Malignancy
  • Cardiovascular disease
  • Development of autoimmune disease(s)
  • Hypersensitivity reactions to unrelated allergens

Reference for Grade 3 or higher AEs: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 (June 14, 2010).
Baseline (Visit 0) to Month 60 (Year 5)
Severity of Grade 3 or Higher Adverse Events (AEs) of Interest
Time Frame: Baseline (Visit 0) to Month 60 (Year 5)

Events of interest include but are not limited to:

  • Opportunistic and serious infections
  • Malignancy
  • Cardiovascular disease
  • Development of autoimmune disease(s)
  • Hypersensitivity reactions to unrelated allergens

Reference for Grade 3 or higher AEs: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 (June 14, 2010).
Baseline (Visit 0) to Month 60 (Year 5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Immune Tolerance Network (ITN)

Investigators

  • Study Chair: Linda A. DiMeglio, MD, MPH,MA, Riley Hospital for Children at Indiana University Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2016

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

April 6, 2016

First Submitted That Met QC Criteria

April 6, 2016

First Posted (Estimated)

April 12, 2016

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAIT ITN066AI
  • NIAID CRMS ID#: 20722 (Other Identifier: DAIT NIAID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The plan is to share data in: 1.)ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools that are available to researchers who register online and subsequently receive DAIT approval; and 2.)TrialShare, a clinical trials research portal developed by the Immune Tolerance Network that makes data from the consortium's clinical trials publicly available without charge.

IPD Sharing Time Frame

After completion of the study.

IPD Sharing Access Criteria

Will be available to the public.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 1 Diabetes Mellitus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe