FAM (Follower, Action Plan, and Remote Monitoring) Intervention to Reduce Severe Hyperglycemia in Adults With Type 1 Diabetes Mellitus at Risk for Diabetic Ketoacidosis
- Conditions
- Type 1 Diabetes
- Registration Number
- NCT06114186
- Lead Sponsor
- University of Minnesota
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- People with T1DM for ≥1 year ages 18 - 65
- HbA1C ≥7.5.0% - 14.0%
- If the person with T1DM uses a CGM, the CGM must have the capability of real-time data sharing including glycemic alerts with a Follower (including but not limited to Dexcom G6 or G7 or FreeStyle Libre 2 or 3, or Medtronic Guardian Sensor 3)
- Follower (family member or friend ages 18 years and older) willing to participate in the study and "follow" glucose data and who was no self-reported cognitive impairment
- Ability of the dyad (participant and Follower) to communicate and provide consent in English
- CGM users: ≥50% personal CGM use and ≥50% Dexcom G6 Pro CGM use during the pre-intervention period (days -14 to -1)
- Non CGM users: ≥50% Dexcom G6 Pro CGM use and average ≥2 BGM readings/day during the pre-intervention period (days -14 to -1)
- Prisoner
- Active treatment with a sodium-glucose cotransporter-2 inhibitor or planning to start a sodium-glucose cotransporter-2 inhibitor in the next 6 months
- Active malignancy with the exception of non-melanoma skin cancer
- Hospice
- Skin conditions that inhibit wearing a CGM sensor and known severe allergy to adhesives
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method percentage of time with severe hyperglycemia 90 days number of continuous glucose monitoring or blood glucose monitoring readings with glucose ≥250 mg/dL divided by the total number of readings
- Secondary Outcome Measures
Name Time Method Hyperglycemia - Continuous Glucose Monitor glucose monitor (CGM) metrics 90 days -Percentage of time glucose \>180 mg/dL
Glycemic variability - Continuous Glucose Monitor 90 days -Glycemic variability
Level 2 Hypoglycemia - Continuous Glucose Monitor 90 days -Percentage of time glucose \< 54 mg/dL
Severe hyperglycemia >400 mg/dL - Continuous Glucose Monitor glucose monitor (CGM) metrics 90 days -Percentage of time glucose \>400 mg/dL
Hypoglycemia - continuous glucose monitor 90 days -Percentage of time glucose\< 70 mg/dL
Hemoglobin A1c days 0 and 90 -HbA1c
Time in Range - Continuous Glucose Monitor 90 days -Percentage of time glucose is 70 - 180 mg/dL
Number of glucose reading/day - Blood Glucose Monitor 90 days -Number of glucose readings/day
Glucose Management Indicator - Continuous Glucose Monitor 90 days -Glucose Management Indicator
Level 2 Hypoglycemia -Blood Glucose Monitor 90 days -Percentage of time glucose \< 54 mg/dL
Assessment of the intervention's efficacy and its burden on participants 90 days -Questionnaire
Hyperglycemia - Blood Glucose Monitor 90 days -Percentage of time glucose \<180 mg/dL
Severe Hyperglycemia > 400 mg/dL - Blood Glucose Monitor 90 days -Percentage of time glucose \>400 mg/dL
Hypoglycemia - Blood Glucose Monitor 90 days -Percentage of time glucose\< 70 mg/dL
Time in Range - Blood Glucose Monitor 90 days -Percentage of time glucose is 70 - 180 mg/dL
Ketone assessment 90 days -Frequency and severity of ketonuria assessed using urine ketone test strips
Hypoglycemic Confidence Scale 90 days * Likert Scale
* Minimum value: Not Confident At All
* Maximum value: Very ConfidentDiabetes Distress Scale for Adults with T1DM 90 days * Likert Scale
* Minimum value: A Very Serious Problem
* Maximum value: Not a ProblemDiabetes Empowerment Scale 90 days * Likert Scale
* Minimum value: Strongly Disagree
* Maximum value: Strongly Agree36-Item Short-Form Health Survey 90 days -Questionnaire
Hypoglycemic Confidence Scale for Partners of Adults with T1DM 90 days * Likert Scale
* Minimum value: Not Confident At All
* Maximum value: Very ConfidentDiabetes Distress Scale for Partners of Adults with T1DM 90 days * Likert Scale
* Minimum value: A great deal
* Maximum value: Not at all
Trial Locations
- Locations (1)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota🇺🇸Minneapolis, Minnesota, United StatesJacob KohlenbergContact