Status:

COMPLETED

Ecological Momentary Assessment Study of Adolescents and Young Adults With Type 1 Diabetes (EMA-T1D)

Lead Sponsor:

University of Michigan

Collaborating Sponsors:

Juvenile Diabetes Research Foundation

Conditions:

Type 1 Diabetes

Eligibility:

All Genders

13-26 years

Brief Summary

This single site investigator-initiated prospective observational study will enroll up to 150 participants 13-26 years of age with Type 1 diabetes (T1D) and utilize ecological momentary assessment met...

Eligibility Criteria

Inclusion

  • Diagnosis of type 1 diabetes for at least six months
  • Fluent in spoken and written English
  • Willing to carry around their mobile phone during the home monitoring period with daily access to cellular or WiFi connectivity
  • Willing to wear a continuous glucose monitor (CGM) device during the home monitoring period

Exclusion

  • Any social or medical condition that would, in the opinion of the Principal Investigator (PI), prevent complete participation in the study or would pose significant hazard to the subject's participation
  • Skin conditions or diseases that would interfere with the CGM sensor placement or accuracy (such as extensive psoriasis, extensive eczema, scarring, etc.)
  • Scheduled X-ray, MRI, CT scan, or high-frequency electrical heat (diathermy) treatment during the period of CGM wear (or any other activity that would necessitate CGM sensor or insulin pump removal) that cannot be scheduled around or accommodated within the study assessment windows
  • Currently pregnant or plan to become pregnant during participation in the study

Key Trial Info

Start Date :

November 7 2023

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 10 2025

Estimated Enrollment :

47 Patients enrolled

Trial Details

Trial ID

NCT06129994

Start Date

November 7 2023

End Date

August 10 2025

Last Update

October 6 2025

Active Locations (1)

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1

University of Michigan

Ann Arbor, Michigan, United States, 48109