FAM (Follower, Action Plan, and Remote Monitoring) Intervention to Reduce Severe Hyperglycemia in Adults With Type 1 Diabetes Mellitus at Risk for Diabetic Ketoacidosis

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 Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: FAM intervention consisting of a Follower of glucose data, Action Plan, and Remote Monitoring of glucose data; Other: standard of care

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; anticipate 8 CGM and 2 non-CGM user dyads in the control group	Device: FAM intervention consisting of a Follower of glucose data, Action Plan, and Remote Monitoring of glucose data; using remote monitoring and real-time glucose data sharing with a Follower.
Experimental: intervention group; anticipate 8 CGM and 2 non-CGM user dyads in the intervention group	Other: standard of care; self reported HbA1C or GMI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	-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	Likert Scale; Minimum value: Not Confident At All; Maximum value: Very Confident	90 days
Diabetes Distress Scale for Adults with T1DM	Likert Scale; Minimum value: A Very Serious Problem; Maximum value: Not a Problem	90 days
Diabetes Empowerment Scale	Likert Scale; Minimum value: Strongly Disagree; Maximum value: Strongly Agree	90 days
36-Item Short-Form Health Survey	-Questionnaire	90 days
Hypoglycemic Confidence Scale for Partners of Adults with T1DM	Likert Scale; Minimum value: Not Confident At All; Maximum value: Very Confident	90 days
Diabetes Distress Scale for Partners of Adults with T1DM	Likert Scale; Minimum value: A great deal; Maximum value: Not at all	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization for DKA	-The number of DKA-related hospitalizations for each participant will be recorded	90 days

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Jacob Kohlenberg, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Actual): February 11, 2026
• Study Completion (Actual): February 11, 2026

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: October 29, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: MED-2023-32321

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No