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

NCT ID: NCT06129994

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 47 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-07
• Study Completion Date: 2025-08-10

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.

Conditions

Type 1 Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study Group

Participants will complete the observational study over the 15 day study period

Observational

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Iyengar

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Iyengar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00234964

Identifier Type: -

Identifier Source: org_study_id