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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: Observational

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Emily Dhadphale; Phone Number: 734-936-6042; Email: ehirschf@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Emily Dhadphale; Email: ehirschf@med.umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants must meet eligibility criteria to be enrolled

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study Group; Participants will complete the observational study over the 15 day study period

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Juvenile Diabetes Research Foundation
• Investigators: Principal Investigator: Jennifer Iyengar, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: HUM00234964

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No