Type 1 Diabetes Extension Study (T1DES)

  • STATUS
    Recruiting
  • End date
    Mar 23, 2025
  • participants needed
    111
  • sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
Updated on 24 February 2022
diabetes
insulin
immune tolerance

Summary

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.

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.

Details
Condition Type 1 Diabetes Mellitus, T1DM, T1D
Clinical Study IdentifierNCT02734277
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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