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.
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
111
UCSF School of Medicine
San Francisco, California, United States
RECRUITINGStanford University
Stanford, California, United States
RECRUITINGUniversity of Colorado School of Medicine: Barbara Davis Center for Diabetes
Aurora, Colorado, United States
RECRUITINGYale University
New Haven, Connecticut, United States
COMPLETEDEmory University
Atlanta, Georgia, United States
WITHDRAWNIndiana University Riley Hospital for Children
Indianapolis, Indiana, United States
RECRUITINGUniversity of Iowa Health Care Division of Pediatric Endocrinology
Iowa City, Iowa, United States
RECRUITINGJoslin Diabetes Center
Boston, Massachusetts, United States
RECRUITINGUniversity of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGChildren's Mercy Hospital
Kansas City, Missouri, United States
COMPLETED...and 2 more locations
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)
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