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

NCT06114186 | Completed Early Phase 1 FDA Device

• 1 other identifier: MED-2023-32321
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Hyperglycemia - Continuous Glucose Monitor glucose monitor (CGM) metrics

  90 days

• Severe hyperglycemia >400 mg/dL - Continuous Glucose Monitor glucose monitor (CGM) metrics

  90 days

• Hypoglycemia - continuous glucose monitor

  90 days

• Hemoglobin A1c

  days 0 and 90

• Level 2 Hypoglycemia - Continuous Glucose Monitor

  90 days

Other Outcomes (1)

• Hospitalization for DKA

  90 days

Study Arms (2)

control group

ACTIVE COMPARATOR

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

intervention group

EXPERIMENTAL

anticipate 8 CGM and 2 non-CGM user dyads in the intervention group

Other: standard of care

Interventions

standard of care OTHER

self reported HbA1C or GMI

intervention group

FAM intervention consisting of a Follower of glucose data, Action Plan, and Remote Monitoring of glucose data DEVICE

using remote monitoring and real-time glucose data sharing with a Follower.

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jacob Kohlenberg, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized 1:1 to the intervention or control groups

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: November 2, 2023
• Study Start: March 28, 2024
• Primary Completion: February 11, 2026
• Study Completion: February 11, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (1)