Clinical trial NCT06114186: FAM (Follower, Action Plan, and Remote Monitoring) Intervention to Reduce Severe Hyperglycemia in Adults With Type 1 Diabetes Mellitus at Risk for Diabetic Ketoacidosis
Official title: FAM (Follower, Action Plan, and Remote Monitoring) Intervention to Reduce Severe Hyperglycemia in Adults With Type 1 Diabetes Mellitus at Risk for Diabetic Ketoacidosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Type 1 Diabetes
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized 1:1 to the intervention or control groups
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: percentage of time with severe hyperglycemia
timeFrame: 90 days
Secondary outcomes:
measure: Hyperglycemia - Continuous Glucose Monitor glucose monitor (CGM) metrics
timeFrame: 90 days
measure: Severe hyperglycemia >400 mg/dL - Continuous Glucose Monitor glucose monitor (CGM) metrics
timeFrame: 90 days
measure: Hypoglycemia - continuous glucose monitor
timeFrame: 90 days
measure: Hemoglobin A1c
timeFrame: days 0 and 90
measure: Level 2 Hypoglycemia - Continuous Glucose Monitor
timeFrame: 90 days
measure: Time in Range - Continuous Glucose Monitor
timeFrame: 90 days
measure: Glycemic variability - Continuous Glucose Monitor
timeFrame: 90 days
measure: Glucose Management Indicator - Continuous Glucose Monitor
timeFrame: 90 days
measure: Number of glucose reading/day - Blood Glucose Monitor
timeFrame: 90 days
measure: Hyperglycemia - Blood Glucose Monitor
timeFrame: 90 days
measure: Severe Hyperglycemia > 400 mg/dL - Blood Glucose Monitor
timeFrame: 90 days
measure: Hypoglycemia - Blood Glucose Monitor
timeFrame: 90 days
measure: Level 2 Hypoglycemia -Blood Glucose Monitor
timeFrame: 90 days
measure: Time in Range - Blood Glucose Monitor
timeFrame: 90 days
measure: Ketone assessment
timeFrame: 90 days
measure: Assessment of the intervention's efficacy and its burden on participants
timeFrame: 90 days
measure: Hypoglycemic Confidence Scale
timeFrame: 90 days
measure: Diabetes Distress Scale for Adults with T1DM
timeFrame: 90 days
measure: Diabetes Empowerment Scale
timeFrame: 90 days
measure: 36-Item Short-Form Health Survey
timeFrame: 90 days
measure: Hypoglycemic Confidence Scale for Partners of Adults with T1DM
timeFrame: 90 days
measure: Diabetes Distress Scale for Partners of Adults with T1DM
timeFrame: 90 days
Other outcomes:
measure: Hospitalization for DKA
timeFrame: 90 days
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jacob Kohlenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: