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

Recruiting

• Conditions: Type 1 Diabetes
• Interventions: Other: Observational

• Registration Number: NCT06129994
• Lead Sponsor: University of Michigan

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-30
• Study Start: 2023-11-07
• Study First Submitted QC: 2023-11-10
• Study First Posted: 2023-11-13
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01
• Primary Completion: 2025-10
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	Observational	Participants will complete the observational study over the 15 day study period

Primary Outcome Measures

Name	Time	Method
Ecological Momentary Assessment (EMA) methods for measuring depression	Home monitoring (days 1-14)	Depression score via EMA
Ecological Momentary Assessment (EMA) methods for measuring diabetes distress	Home monitoring (days 1-14)	Diabetes distress score via EMA
Ecological Momentary Assessment (EMA) methods for measuring anxiety	Home monitoring (days 1-14)	Anxiety score via EMA

Secondary Outcome Measures

Name	Time	Method
Hemoglobin A1c	Baseline	Hemoglobin A1c
Glycemic Outcomes	Home monitoring (days 1-14)	Percent Time in range (70-180mg/dl), Percent time with low glucose readings (\<70mg/dl), Percent time with high glucose (\>180mg/dl)

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States