T1D, T1DM, Type 1 Diabetes Mellitus
Conditions
Keywords
Insulin, Glucose Intolerance
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.
Interventions
None listed
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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). |
| 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). |
Countries
United States
Contacts
STUDY_CHAIRLinda A. DiMeglio, MD, MPH,MA
Riley Hospital for Children at Indiana University Health
Outcome results
None listed