To further our understanding of the immunologic mechanisms underlying maintenance and loss of beta cell function by evaluating the relationship between longitudinal changes in beta cell function and changes over time in biomarkers known to be associated with a response to immune modulating treatments which were used in prior clinical trials (Refer to ClinicalTrials.gov records NCT00129259 and NCT00965458).
Type 1 diabetes mellitus (T1DM) is an autoimmune disease.This means that the immune system (the part of the body that helps fight infections) mistakenly attacks the cells that produce insulin (beta cells in the pancreas). As beta cells are destroyed by the immune cells, the ability to produce insulin is decreased and diabetes develops. Insulin helps keep blood glucose levels normal.
People with diabetes who have the ability to produce some of their own insulin (even though they still need to take insulin) may be able to achieve better glucose control than people who produce no insulin at all. Better glucose control has been shown to reduce the long-term complications of diabetes.
Several Immune Tolerance Network (ITN) drug treatment studies have been completed and have shown that some participants with new onset T1DM had partial disease remissions with therapy. Prior participants in these trials, had measured insulin secretion, at six month intervals, up to two years after diabetes diagnosis. It is unclear, however, if any of the interventions have produced a continuing disease remission in patients. For persons who have completed drug treatment trials, longer term follow-up is important for continued evaluation for effect of therapy on insulin production.
Type 1 DiabetesDiabetes MellitusInsulinGlucose IntolerancePrior ITN027AI Study Participants-NCT00129259Prior ITN045AI Study Participants-NCT00965458
You can join if…
Open to people ages 8–35
Prior participation in protocol ITN027AI AbATE(NCT00129259) or protocol ITN045AI T1DAL(NCT00965458) studies
Ability to sign informed consent/assent (as applicable for children)
You CAN'T join if...
Any medical condition that in the opinion of the principal investigator would interfere with safe completion of the trial.
Inability to comply with the study visit schedule and required assessments
UCSF School of Medicineaccepting new patients San Francisco, California, 94143, United States
Benaroya Research Instituteaccepting new patients Seattle, Washington, 98101, United States
Children's Mercy Hospitalaccepting new patients Kansas City, Missouri, 64108, United States
University of Iowa Health Care Division of Pediatric Endocrinologynot yet accepting patients Iowa City, Iowa, 52242, United States
Indiana University Riley Hospital for Childrenaccepting new patients Indianapolis, Indiana, 46202, United States
Emory Universitynot yet accepting patients Atlanta, Georgia, 30322, United States
Yale Universityaccepting new patients New Haven, Connecticut, 06519, United States
accepting new patients
National Institute of Allergy and Infectious Diseases (NIAID)