Type 1 Diabetes Extension Study

Part of paid clinical trials in San Francisco, California.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT02734277
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 35 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Aug 18, 2016
Status verified
Mar 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
111 participants (estimated)

Arms

  • Arm: Group 1: Detectable C-peptide by MMTT
    Participants with detectable C-peptide at their: * Last Immune Tolerance Network (ITN) T1DM week 104 study visit, * Last AbATE (NCT00129259) follow-up visit, or * Last ITN066AI T1DES visit Detectable C-peptide is defined as a value above the lower limit of detection.
  • Arm: Group 2:Undetectable C-peptide by MMTT
    Participants without detectable C-peptide at their: * Last ITN T1DM week 104 study visit, * Last AbATE follow-up visit, or last * ITN066AI T1DES visit Undetectable C-peptide is defined as a value below the lower limit of detection.

Primary Outcome Measure

Change in Beta Cell Function by MMTT-Stimulated Mean C-peptide Area Under the Curve (AUC) [ Time Frame: Baseline (Visit 0) to Month 60 (Year 5) ]

Locations (12)

FacilityCityStateZIPSite coordinators
UCSF School of MedicineSan FranciscoCalifornia94143
Rebecca Wesch
[email protected]
415-476-5984
Stephen Gitelman, MD (PRINCIPAL_INVESTIGATOR)
Stanford UniversityStanfordCalifornia94305
Trudy Esrey
[email protected]
650-498-4450
Darrell Wilson, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado School of Medicine: Barbara Davis Center for DiabetesAuroraColorado80045
Mara Kinney
[email protected]
303-724-8272
Peter Gottlieb, MD (PRINCIPAL_INVESTIGATOR)
Yale UniversityNew HavenConnecticut06519-
Emory UniversityAtlantaGeorgia30322-
Indiana University Riley Hospital for ChildrenIndianapolisIndiana46202
Ellie Ryan
[email protected]
317-278-7037
Maria Spall
[email protected]
317-278-7034
Linda DiMeglio, MD, MPH (PRINCIPAL_INVESTIGATOR)
University of Iowa Health Care Division of Pediatric EndocrinologyIowa CityIowa52242
Joanne Cabbage
[email protected]
319-356-4035
Michael Tansey, MD (PRINCIPAL_INVESTIGATOR)
Joslin Diabetes CenterBostonMassachusetts02215
Site Public Contact
[email protected]
888-813-8669
Jason Gaglia, MD (PRINCIPAL_INVESTIGATOR)
University of MinnesotaMinneapolisMinnesota55454
Anne Street
[email protected]
612-625-9709
Antoinette Moran, MD (PRINCIPAL_INVESTIGATOR)
Children's Mercy HospitalKansas CityMissouri64108
Marissa Beidelschies
[email protected]
816-760-5918
Jennifer Dolan
[email protected]
(816) 760-8876
Wayne Moore, MD, PhD (PRINCIPAL_INVESTIGATOR)
Sanford ResearchSioux FallsSouth Dakota57104-
Benaroya Research InstituteSeattleWashington98101
Katie Bennett
[email protected]
206-341-8945
Sandra Lord, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
UCSF School of Medicine· San Francisco, CAStanford University· Stanford, CAUniversity of Colorado School of Medicine: Barbara Davis Center for Diabetes· Aurora, COYale University· New Haven, CTEmory University· Atlanta, GAIndiana University Riley Hospital for Children· Indianapolis, IN

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