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

University of Michigan logo

University of Michigan

Status

Completed

Conditions

Type 1 Diabetes

Treatments

Other: Observational

Study type

Observational

Funder types

Other

Identifiers

NCT06129994
HUM00234964

Details and patient eligibility

About

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 methods (EMA) to examine associations between different diabetes psychological domains (distress, anxiety, and depression) in real-time on self-efficacy, self-management behaviors, and glycemic outcomes.

Enrollment

47 patients

Sex

All

Ages

13 to 26 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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

Trial design

47 participants in 1 patient group

Study Group
Description:
Participants will complete the observational study over the 15 day study period
Treatment:
Other: Observational

Trial contacts and locations

1

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Central trial contact

Emily Dhadphale

Data sourced from clinicaltrials.gov

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