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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Participants will complete the observational study over the 15 day study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants must meet eligibility criteria to be enrolled
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Iyengar, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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Optional serum and plasma biospecimens retained for the purpose of future research
|
Hemoglobin A1c
| Baseline |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |