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 Type
OBSERVATIONAL
Enrollment
47
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.
University of Michigan
Ann Arbor, Michigan, United States
Ecological Momentary Assessment (EMA) methods for measuring diabetes distress
Diabetes distress score via EMA
Time frame: Home monitoring (days 1-14)
Ecological Momentary Assessment (EMA) methods for measuring anxiety
Anxiety score via EMA
Time frame: Home monitoring (days 1-14)
Ecological Momentary Assessment (EMA) methods for measuring depression
Depression score via EMA
Time frame: Home monitoring (days 1-14)
Glycemic Outcomes
Percent Time in range (70-180mg/dl), Percent time with low glucose readings (\<70mg/dl), Percent time with high glucose (\>180mg/dl)
Time frame: Home monitoring (days 1-14)
Hemoglobin A1c
Hemoglobin A1c
Time frame: Baseline
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