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

• Sponsor: University of Minnesota (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06114186
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 25

Study Details

Study Description

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 the effectiveness of 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 study hypothesizes that the FAM intervention will reduce the percentage of time spent with glucose ≥250 mg/dL compared to standard care alone.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes	Device: FAM intervention consisting of a Follower of glucose data, Action Plan, and Remote Monitoring of glucose data; Other: standard of care	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomized 1:1 to the intervention or control groupsrandomized 1:1 to the intervention or control groups
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Nov 30, 2025
• Anticipated Study Completion Date: Nov 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: control group anticipate 20 CGM and 5 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 20 CGM and 5 non-CGM user dyads in the intervention group	Other: standard of care; self reported HbA1C or GMI

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• People with T1DM for ≥1 year ages 18 - 65

• HbA1C ≥8.0% - 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Minnesota

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT06114186
• Other Study ID Numbers: MED-2023-32321
• First Posted: Nov 2, 2023
• Last Update Posted: Nov 2, 2023
• Last Verified: Oct 1, 2023

• 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
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hyperglycemia; Ketosis; Diabetic Ketoacidosis

Study Results

No Results Posted as of Nov 2, 2023