RECRUITING

Type 1 Diabetes Extension Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Type 1 Diabetes Extension Study

Quick Facts

Study Start:2016-08-18
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02734277

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 35 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Prior participant in an Immune Tolerance Network (ITN) executive committee approved T1DM study.
  2. * Ability to sign informed consent/assent (as applicable for children).
  1. * Any medical condition that in the opinion of the principal investigator would interfere with safe completion of the trial; or
  2. * Inability to comply with the study visit schedule and required assessments.

Contacts and Locations

Principal Investigator

Linda A. DiMeglio, MD, MPH,MA
STUDY_CHAIR
Riley Hospital for Children at Indiana University Health

Study Locations (Sites)

UCSF School of Medicine
San Francisco, California, 94143
United States
Stanford University
Stanford, California, 94305
United States
University of Colorado School of Medicine: Barbara Davis Center for Diabetes
Aurora, Colorado, 80045
United States
Yale University
New Haven, Connecticut, 06519
United States
Emory University
Atlanta, Georgia, 30322
United States
Indiana University Riley Hospital for Children
Indianapolis, Indiana, 46202
United States
University of Iowa Health Care Division of Pediatric Endocrinology
Iowa City, Iowa, 52242
United States
Joslin Diabetes Center
Boston, Massachusetts, 02215
United States
University of Minnesota
Minneapolis, Minnesota, 55454
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
Sanford Research
Sioux Falls, South Dakota, 57104
United States
Benaroya Research Institute
Seattle, Washington, 98101
United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

  • Linda A. DiMeglio, MD, MPH,MA, STUDY_CHAIR, Riley Hospital for Children at Indiana University Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-08-18
Study Completion Date2025-03

Study Record Updates

Study Start Date2016-08-18
Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

  • Insulin
  • Glucose Intolerance

Additional Relevant MeSH Terms

  • Type 1 Diabetes Mellitus
  • T1DM
  • T1D