An observational study in Type 1 Diabetes Mellitus, T1DM and T1D, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Recruiting at 12 sites in United States. Open to participants aged 8 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
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:
This information could help design better therapies for type 1 diabetes in the future.
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:
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 111 is below the median of 125 across 792 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Former participants in Immune Tolerance Network (ITN) new-onset Type 1 Diabetes Mellitus (T1DM) studies with immunomodulatory agents as the intervention.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Time frame: Baseline (Visit 0) to Month 60 (Year 5)
Change in Insulin Use in Units per Kilogram Body Weight Per Day
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.
Time frame: Baseline (Visit 0) to Month 60 (Year 5)
Change in HbA1C
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.
Time frame: Baseline (Visit 0) to Month 60 (Year 5)
Count of Participant-Reported Major Hypoglycemic Events
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.
Time frame: Baseline (Visit 0) to Month 60 (Year 5)
Time to Undetectable C-Peptide
To assess the longevity of beta cell function, time to undetectable C-peptide will be evaluated using Kaplan-Meier survival estimates.
Time frame: Baseline (Visit 0) to Month 60 (Year 5)
Frequency of Grade 3 or Higher Adverse Events (AEs) of Interest
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).
Time frame: Baseline (Visit 0) to Month 60 (Year 5)
Severity of Grade 3 or Higher Adverse Events (AEs) of Interest
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).
Time frame: Baseline (Visit 0) to Month 60 (Year 5)
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Plan to share: Yes — 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.
Time frame: After completion of the study.
Access criteria: Will be available to the public.
Data sharing details ↗ · www.immport.org
Started Jun 2016 (actual). Primary completion is estimated for Aug 2028, 146 months after the start.
Of 249 non-industry observational studies under Diabetes Mellitus, Type 1, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 78. This study's planned 146 months is above that.
Counting every sponsor, half of 299 studies reached it within 30 months; a quarter within 12 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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National Institute of Allergy and Infectious Diseases (NIAID) →