Type 1 Diabetes Extension Study
T1DES
2 other identifiers
observational
111
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2016
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2016
CompletedFirst Posted
Study publicly available on registry
April 12, 2016
CompletedStudy Start
First participant enrolled
August 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
March 10, 2026
March 1, 2026
12 years
April 6, 2016
March 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Beta Cell Function by MMTT-Stimulated Mean C-peptide Area Under the Curve (AUC)
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 Outcomes (6)
Change in Insulin Use in Units per Kilogram Body Weight Per Day
Baseline (Visit 0) to Month 60 (Year 5)
Change in HbA1C
Baseline (Visit 0) to Month 60 (Year 5)
Count of Participant-Reported Major Hypoglycemic Events
Baseline (Visit 0) to Month 60 (Year 5)
Time to Undetectable C-Peptide
Baseline (Visit 0) to Month 60 (Year 5)
Frequency of Grade 3 or Higher Adverse Events (AEs) of Interest
Baseline (Visit 0) to Month 60 (Year 5)
- +1 more secondary outcomes
Study Arms (2)
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.
Eligibility Criteria
Former participants in Immune Tolerance Network (ITN) new-onset Type 1 Diabetes Mellitus (T1DM) studies with immunomodulatory agents as the intervention.
You may qualify if:
- Prior participant in an Immune Tolerance Network (ITN) executive committee approved T1DM study.
- Ability to sign informed consent/assent (as applicable for children).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
UCSF School of Medicine
San Francisco, California, 94143, United States
Stanford University
Stanford, California, 94305, United States
University of Colorado School of Medicine: Barbara Davis Center for Diabetes
Aurora, Colorado, 80045, United States
Yale University
New Haven, Connecticut, 06519, United States
Emory University
Atlanta, Georgia, 30322, United States
Indiana University Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
University of Iowa Health Care Division of Pediatric Endocrinology
Iowa City, Iowa, 52242, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
University of Minnesota
Minneapolis, Minnesota, 55454, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Sanford Research
Sioux Falls, South Dakota, 57104, United States
Benaroya Research Institute
Seattle, Washington, 98101, United States
Related Publications (3)
Herold KC, Gitelman SE, Ehlers MR, Gottlieb PA, Greenbaum CJ, Hagopian W, Boyle KD, Keyes-Elstein L, Aggarwal S, Phippard D, Sayre PH, McNamara J, Bluestone JA; AbATE Study Team. Teplizumab (anti-CD3 mAb) treatment preserves C-peptide responses in patients with new-onset type 1 diabetes in a randomized controlled trial: metabolic and immunologic features at baseline identify a subgroup of responders. Diabetes. 2013 Nov;62(11):3766-74. doi: 10.2337/db13-0345. Epub 2013 Jul 8.
PMID: 23835333BACKGROUNDRigby MR, Harris KM, Pinckney A, DiMeglio LA, Rendell MS, Felner EI, Dostou JM, Gitelman SE, Griffin KJ, Tsalikian E, Gottlieb PA, Greenbaum CJ, Sherry NA, Moore WV, Monzavi R, Willi SM, Raskin P, Keyes-Elstein L, Long SA, Kanaparthi S, Lim N, Phippard D, Soppe CL, Fitzgibbon ML, McNamara J, Nepom GT, Ehlers MR. Alefacept provides sustained clinical and immunological effects in new-onset type 1 diabetes patients. J Clin Invest. 2015 Aug 3;125(8):3285-96. doi: 10.1172/JCI81722. Epub 2015 Jul 20.
PMID: 26193635BACKGROUNDRigby MR, DiMeglio LA, Rendell MS, Felner EI, Dostou JM, Gitelman SE, Patel CM, Griffin KJ, Tsalikian E, Gottlieb PA, Greenbaum CJ, Sherry NA, Moore WV, Monzavi R, Willi SM, Raskin P, Moran A, Russell WE, Pinckney A, Keyes-Elstein L, Howell M, Aggarwal S, Lim N, Phippard D, Nepom GT, McNamara J, Ehlers MR; T1DAL Study Team. Targeting of memory T cells with alefacept in new-onset type 1 diabetes (T1DAL study): 12 month results of a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Diabetes Endocrinol. 2013 Dec;1(4):284-94. doi: 10.1016/S2213-8587(13)70111-6. Epub 2013 Sep 23.
PMID: 24622414BACKGROUND
Related Links
Biospecimen
* Blood or urine tests as needed to follow-up on potential long term safety concerns with a particular therapeutic agent * Blood and urine samples for additional studies related to your diabetes
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Linda A. DiMeglio, MD, MPH,MA
Riley Hospital for Children at Indiana University Health
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2016
First Posted
April 12, 2016
Study Start
August 18, 2016
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
March 10, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- After completion of the study.
- Access Criteria
- Will be available to the public.
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.