Skip to main content
OpenTrials
Recruiting

NCT Number: NCT02734277

Type 1 Diabetes Extension Study

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Immune System Diseases Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases T1D T1DM

Age range

8 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSF School of Medicine, San Francisco, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. Change in Insulin Use in Units per Kilogram Body Weight Per Day

    Time frame: Baseline (Visit 0) to Month 60 (Year 5)

    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.

  2. Change in HbA1C

    Time frame: Baseline (Visit 0) to Month 60 (Year 5)

    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.

  3. Count of Participant-Reported Major Hypoglycemic Events

    Time frame: Baseline (Visit 0) to Month 60 (Year 5)

    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.

  4. Time to Undetectable C-Peptide

    Time frame: Baseline (Visit 0) to Month 60 (Year 5)

    To assess the longevity of beta cell function, time to undetectable C-peptide will be evaluated using Kaplan-Meier survival estimates.

  5. Frequency of Grade 3 or Higher Adverse Events (AEs) of Interest

    Time frame: Baseline (Visit 0) to Month 60 (Year 5)

    Events of interest include but are not limited to:

    • Opportunistic and serious infections
    • Malignancy
    • Cardiovascular disease
    • Development of autoimmune disease(s)
    • Hypersensitivity reactions to unrelated allergens

    Reference for Grade 3 or higher AEs: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 (June 14, 2010).

  6. Severity of Grade 3 or Higher Adverse Events (AEs) of Interest

    Time frame: Baseline (Visit 0) to Month 60 (Year 5)

    Events of interest include but are not limited to:

    • Opportunistic and serious infections
    • Malignancy
    • Cardiovascular disease
    • Development of autoimmune disease(s)
    • Hypersensitivity reactions to unrelated allergens

    Reference for Grade 3 or higher AEs: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 (June 14, 2010).

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

  • Immune Tolerance Network (ITN)

Registry information

Acronym: T1DES

Important dates

Study start
2016
Primary completion
2028
Study completion
2028
First posted
Apr 12, 2016
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.