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Diabetic ketoacidosis (DKA) results in significant morbidity and healthcare utilization and is the main contributor to loss of life expectancy in people with diabetes mellitus type 1 (T1DM) <50 years old. This suggests the need to develop interventions to reduce DKA events. Innovative features of newer continuous glucose monitoring devices offer opportunities for novel strategies to reduce DKA. Designating a family member, friend, or caregiver as a Follower was associated with reduction in HbA1C, increased time in range, and improvement in quality of life metrics in people with T1DM. However, the previously published studies are limited as they were either retrospective, survey-based, or do not overlap with our proposed cohort involving adults ages 18-65 with T1DM (prior prospective studies involved either pregnant women with T1DM or adults ≥60 years of age with T1DM). This study is a randomized controlled trial pilot study to evaluate an intervention (FAM) using a Follower, Action Plan, and Remote Monitoring of glucose data to reduce severe hyperglycemia, a modifiable risk factor for DKA, in adults with T1DM at high risk for DKA. The intervention uses real-time glucose data sharing with a Follower (family member, friend, or caregiver) and personalized diabetes education provided to the dyad (person with T1DM and their chosen Follower). The overall hypothesis is that the FAM intervention will improve glycemia with the primary outcome studied in this preliminary pilot study being percentage of time spent with glucose ≥250 mg/dL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Active Comparator | anticipate 8 CGM and 2 non-CGM user dyads in the control group |
|
| intervention group | Experimental | anticipate 8 CGM and 2 non-CGM user dyads in the intervention group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAM intervention consisting of a Follower of glucose data, Action Plan, and Remote Monitoring of glucose data | Device | using remote monitoring and real-time glucose data sharing with a Follower. |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of time with severe hyperglycemia | number of continuous glucose monitoring or blood glucose monitoring readings with glucose ≥250 mg/dL divided by the total number of readings | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hyperglycemia - Continuous Glucose Monitor glucose monitor (CGM) metrics | -Percentage of time glucose >180 mg/dL | 90 days |
| Severe hyperglycemia >400 mg/dL - Continuous Glucose Monitor glucose monitor (CGM) metrics |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization for DKA | -The number of DKA-related hospitalizations for each participant will be recorded | 90 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Kohlenberg, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
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randomized 1:1 to the intervention or control groups
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| standard of care | Other | self reported HbA1C or GMI |
|
-Percentage of time glucose >400 mg/dL
| 90 days |
| Hypoglycemia - continuous glucose monitor | -Percentage of time glucose< 70 mg/dL | 90 days |
| Hemoglobin A1c | -HbA1c | days 0 and 90 |
| Level 2 Hypoglycemia - Continuous Glucose Monitor | -Percentage of time glucose < 54 mg/dL | 90 days |
| Time in Range - Continuous Glucose Monitor | -Percentage of time glucose is 70 - 180 mg/dL | 90 days |
| Glycemic variability - Continuous Glucose Monitor | -Glycemic variability | 90 days |
| Glucose Management Indicator - Continuous Glucose Monitor | -Glucose Management Indicator | 90 days |
| Number of glucose reading/day - Blood Glucose Monitor | -Number of glucose readings/day | 90 days |
| Hyperglycemia - Blood Glucose Monitor | -Percentage of time glucose <180 mg/dL | 90 days |
| Severe Hyperglycemia > 400 mg/dL - Blood Glucose Monitor | -Percentage of time glucose >400 mg/dL | 90 days |
| Hypoglycemia - Blood Glucose Monitor | -Percentage of time glucose< 70 mg/dL | 90 days |
| Level 2 Hypoglycemia -Blood Glucose Monitor | -Percentage of time glucose < 54 mg/dL | 90 days |
| Time in Range - Blood Glucose Monitor | -Percentage of time glucose is 70 - 180 mg/dL | 90 days |
| Ketone assessment | -Frequency and severity of ketonuria assessed using urine ketone test strips | 90 days |
| Assessment of the intervention's efficacy and its burden on participants | -Questionnaire | 90 days |
| Hypoglycemic Confidence Scale |
| 90 days |
| Diabetes Distress Scale for Adults with T1DM |
| 90 days |
| Diabetes Empowerment Scale |
| 90 days |
| 36-Item Short-Form Health Survey | -Questionnaire | 90 days |
| Hypoglycemic Confidence Scale for Partners of Adults with T1DM |
| 90 days |
| Diabetes Distress Scale for Partners of Adults with T1DM |
| 90 days |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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