NCT06129994

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 47 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 13 Years – 26 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
OTHER	Observational	Participants will complete an in-person baseline study visit with fasting blood draw, medical and health history, anthropometrics and vital signs, and surveys. If participants are not currently using a CGM, one will be placed. The LifeData study mobile app will be installed on the participant's smartphone. Over the two-week home monitoring period, participants will be asked to wear the CGM and respond to EMA questions three times daily. After the end of the home monitoring period, a remote visit will be performed in which the CGM will be removed by the study participant at home; the study team will obtain all data available from the CGM and insulin pump (if available); and surveys will be collected.

Timeline

• Start date: 2023-11-07
• Primary completion: 2025-08-10
• Completion: 2025-08-10
• First posted: 2023-11-13
• Last updated: 2025-10-06

Locations

1 site across 1 country: United States