Status:
RECRUITING
FAM (Follower, Action Plan, and Remote Monitoring) Intervention to Reduce Severe Hyperglycemia in Adults With Type 1 Diabetes Mellitus at Risk for Diabetic Ketoacidosis
Lead Sponsor:
University of Minnesota
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06114186
Start Date
January 16 2024
End Date
December 31 2025
Last Update
April 22 2025
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55414