Type 1 Diabetes Extension Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes Mellitus, T1DM, T1D. Basic parameters: 8 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Primary outcome measures
- 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)]
Secondary outcome measures (6)
- Change in Insulin Use in Units per Kilogram Body Weight Per Day [Time frame: Baseline (Visit 0) to Month 60 (Year 5)]
- Change in HbA1C [Time frame: 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)]
- Time to Undetectable C-Peptide [Time frame: 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)]
- Severity of Grade 3 or Higher Adverse Events (AEs) of Interest [Time frame: Baseline (Visit 0) to Month 60 (Year 5)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 12 centers
- UCSF School of Medicine — San Francisco
- Stanford University — Stanford
- University of Colorado School of Medicine: Barbara Davis Center for Diabetes — Aurora
- Yale University — New Haven
- Emory University — Atlanta
- Indiana University Riley Hospital for Children — Indianapolis
- University of Iowa Health Care Division of Pediatric Endocrinology — Iowa City
- Joslin Diabetes Center — Boston
- … and 4 more centers
Publications
- 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 responde PMID 23835333
- Rigby 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 di PMID 26193635
- Rigby 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 (T PMID 24622414
Identifiers
NCT: NCT02734277 · DAIT ITN066AI · NIAID CRMS ID#: 20722