Type 1 Diabetes Extension Study

Recruiting

• Conditions: Type 1 Diabetes Mellitus; T1D; T1DM

• Registration Number: NCT02734277
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

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 Timeline

• Study First Submitted: 2016-04-06
• Study First Submitted QC: 2016-04-06
• Study First Posted: 2016-04-12
• Study Start: 2016-08-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 111

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).

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Beta Cell Function by MMTT-Stimulated Mean C-peptide Area Under the Curve (AUC)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Insulin Use in Units per Kilogram Body Weight Per Day	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.
Time to Undetectable C-Peptide	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.
Change in HbA1C	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.
Count of Participant-Reported Major Hypoglycemic Events	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.
Severity of Grade 3 or Higher Adverse Events (AEs) of Interest	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).
Frequency of Grade 3 or Higher Adverse Events (AEs) of Interest	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).

Trial Locations

Locations (12)

Benaroya Research Institute; 🇺🇸 Seattle, Washington, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Indiana University Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States

UCSF School of Medicine; 🇺🇸 San Francisco, California, United States

Stanford University; 🇺🇸 Stanford, California, United States

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States

University of Iowa Health Care Division of Pediatric Endocrinology; 🇺🇸 Iowa City, Iowa, United States

Sanford Research; 🇺🇸 Sioux Falls, South Dakota, United States

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

University of Colorado School of Medicine: Barbara Davis Center for Diabetes; 🇺🇸 Aurora, Colorado, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States