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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
22
using remote monitoring and real-time glucose data sharing with a Follower.
self reported HbA1C or GMI
University of Minnesota
Minneapolis, Minnesota, United States
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
Time frame: 90 days
Hyperglycemia - Continuous Glucose Monitor glucose monitor (CGM) metrics
-Percentage of time glucose \>180 mg/dL
Time frame: 90 days
Severe hyperglycemia >400 mg/dL - Continuous Glucose Monitor glucose monitor (CGM) metrics
-Percentage of time glucose \>400 mg/dL
Time frame: 90 days
Hypoglycemia - continuous glucose monitor
-Percentage of time glucose\< 70 mg/dL
Time frame: 90 days
Hemoglobin A1c
-HbA1c
Time frame: days 0 and 90
Level 2 Hypoglycemia - Continuous Glucose Monitor
-Percentage of time glucose \< 54 mg/dL
Time frame: 90 days
Time in Range - Continuous Glucose Monitor
-Percentage of time glucose is 70 - 180 mg/dL
Time frame: 90 days
Glycemic variability - Continuous Glucose Monitor
-Glycemic variability
Time frame: 90 days
Glucose Management Indicator - Continuous Glucose Monitor
-Glucose Management Indicator
Time frame: 90 days
Number of glucose reading/day - Blood Glucose Monitor
-Number of glucose readings/day
Time frame: 90 days
Hyperglycemia - Blood Glucose Monitor
-Percentage of time glucose \<180 mg/dL
Time frame: 90 days
Severe Hyperglycemia > 400 mg/dL - Blood Glucose Monitor
-Percentage of time glucose \>400 mg/dL
Time frame: 90 days
Hypoglycemia - Blood Glucose Monitor
-Percentage of time glucose\< 70 mg/dL
Time frame: 90 days
Level 2 Hypoglycemia -Blood Glucose Monitor
-Percentage of time glucose \< 54 mg/dL
Time frame: 90 days
Time in Range - Blood Glucose Monitor
-Percentage of time glucose is 70 - 180 mg/dL
Time frame: 90 days
Ketone assessment
-Frequency and severity of ketonuria assessed using urine ketone test strips
Time frame: 90 days
Assessment of the intervention's efficacy and its burden on participants
-Questionnaire
Time frame: 90 days
Hypoglycemic Confidence Scale
* Likert Scale * Minimum value: Not Confident At All * Maximum value: Very Confident
Time frame: 90 days
Diabetes Distress Scale for Adults with T1DM
* Likert Scale * Minimum value: A Very Serious Problem * Maximum value: Not a Problem
Time frame: 90 days
Diabetes Empowerment Scale
* Likert Scale * Minimum value: Strongly Disagree * Maximum value: Strongly Agree
Time frame: 90 days
36-Item Short-Form Health Survey
-Questionnaire
Time frame: 90 days
Hypoglycemic Confidence Scale for Partners of Adults with T1DM
* Likert Scale * Minimum value: Not Confident At All * Maximum value: Very Confident
Time frame: 90 days
Diabetes Distress Scale for Partners of Adults with T1DM
* Likert Scale * Minimum value: A great deal * Maximum value: Not at all
Time frame: 90 days
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