Type 1 Diabetes Extension Study (T1DES)

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Enrolling

Conditions: Type 1 Diabetes Mellitus; T1D; T1DM

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT02734277

DAIT ITN066AI

NIAID CRMS ID#: 20722 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 111 estimated patients

Sex: All

Ages: 8 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

111 participants in 2 patient groups

Group 1: Detectable C-peptide by MMTT

Description:

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.

Group 2:Undetectable C-peptide by MMTT

Description:

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.