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

NCT06129994 | Completed

• 1 other identifier: HUM00234964
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Ecological Momentary Assessment (EMA) methods for measuring diabetes distress

  Diabetes distress score via EMA

  Home monitoring (days 1-14)

• Ecological Momentary Assessment (EMA) methods for measuring anxiety

  Anxiety score via EMA

  Home monitoring (days 1-14)

• Ecological Momentary Assessment (EMA) methods for measuring depression

  Depression score via EMA

  Home monitoring (days 1-14)

Secondary Outcomes (2)

• Glycemic Outcomes

  Home monitoring (days 1-14)

• Hemoglobin A1c

  Baseline

Study Arms (1)

Study Group

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

Other: Observational

Interventions

Observational 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.

Study Group

Eligibility Criteria

• Age: 13 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants must meet eligibility criteria to be enrolled

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Optional serum and plasma biospecimens retained for the purpose of future research

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Jennifer Iyengar, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 13, 2023
• Study Start: November 7, 2023
• Primary Completion: August 10, 2025
• Study Completion: August 10, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)