Type 1 Diabetes Extension Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-35
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Prior participant in an Immune Tolerance Network (ITN) executive committee approved T1DM study.
Ability to sign informed consent/assent (as applicable for children).
Disqualifiers
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.
Trial population
Former participants in Immune Tolerance Network (ITN) new-onset Type 1 Diabetes Mellitus (T1DM) studies with immunomodulatory agents as the intervention.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
111 Participants
are grouped into 2 trial groupsGroup A: Group 1: Detectable C-peptide by MMTT
Group B: Group 2:Undetectable C-peptide by MMTT
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National Institute of Allergy and Infectious Diseases (NIAID)
Lead sponsor
Immune Tolerance Network (ITN)
Collaborator
Source ClinicalTrials.gov