Ecological Momentary Assessment Study of Adolescents and Young Adults With Type 1 Diabetes (EMA-T1D)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | 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.
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Outcome Measures
Primary Outcome Measures
- 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
- Ecological Momentary Assessment (EMA) methods for measuring depression [Home monitoring (days 1-14)]
Depression score via EMA
Secondary Outcome Measures
- 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)
- Hemoglobin A1c [Baseline]
Hemoglobin A1c
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of type 1 diabetes for at least six months
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Fluent in spoken and written English
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Willing to carry around their mobile phone during the home monitoring period with daily access to cellular or WiFi connectivity
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Willing to wear a continuous glucose monitor (CGM) device during the home monitoring period
Exclusion Criteria:
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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
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Skin conditions or diseases that would interfere with the CGM sensor placement or accuracy (such as extensive psoriasis, extensive eczema, scarring, etc.)
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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
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Currently pregnant or plan to become pregnant during participation in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
- Juvenile Diabetes Research Foundation
Investigators
- Principal Investigator: Jennifer Iyengar, MD, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00234964