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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06114186
• Other study ID #: MED-2023-32321
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 16, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University of Minnesota
• Contact: Jacob Kohlenberg, MD
• Phone: 612-624-1469
• Email: endoresT1DM[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetic Ketoacidosis
• Hyperglycemia
• Ketosis
• Type 1 Diabetes

Intervention

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.

Other:
• standard of care
self reported HbA1C or GMI

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospitalization for DKA	-The number of DKA-related hospitalizations for each participant will be recorded	90 days
Primary	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	Hyperglycemia - Continuous Glucose Monitor glucose monitor (CGM) metrics	-Percentage of time glucose >180 mg/dL	90 days
Secondary	Severe hyperglycemia >400 mg/dL - Continuous Glucose Monitor glucose monitor (CGM) metrics	-Percentage of time glucose >400 mg/dL	90 days
Secondary	Hypoglycemia - continuous glucose monitor	-Percentage of time glucose< 70 mg/dL	90 days
Secondary	Hemoglobin A1c	-HbA1c	days 0 and 90
Secondary	Level 2 Hypoglycemia - Continuous Glucose Monitor	-Percentage of time glucose < 54 mg/dL	90 days
Secondary	Time in Range - Continuous Glucose Monitor	-Percentage of time glucose is 70 - 180 mg/dL	90 days
Secondary	Glycemic variability - Continuous Glucose Monitor	-Glycemic variability	90 days
Secondary	Glucose Management Indicator - Continuous Glucose Monitor	-Glucose Management Indicator	90 days
Secondary	Number of glucose reading/day - Blood Glucose Monitor	-Number of glucose readings/day	90 days
Secondary	Hyperglycemia - Blood Glucose Monitor	-Percentage of time glucose <180 mg/dL	90 days
Secondary	Severe Hyperglycemia > 400 mg/dL - Blood Glucose Monitor	-Percentage of time glucose >400 mg/dL	90 days
Secondary	Hypoglycemia - Blood Glucose Monitor	-Percentage of time glucose< 70 mg/dL	90 days
Secondary	Level 2 Hypoglycemia -Blood Glucose Monitor	-Percentage of time glucose < 54 mg/dL	90 days
Secondary	Time in Range - Blood Glucose Monitor	-Percentage of time glucose is 70 - 180 mg/dL	90 days
Secondary	Ketone assessment	-Frequency and severity of ketonuria assessed using urine ketone test strips	90 days
Secondary	Assessment of the intervention's efficacy and its burden on participants	-Questionnaire	90 days
Secondary	Hypoglycemic Confidence Scale	Likert Scale; Minimum value: Not Confident At All; Maximum value: Very Confident	90 days
Secondary	Diabetes Distress Scale for Adults with T1DM	Likert Scale; Minimum value: A Very Serious Problem; Maximum value: Not a Problem	90 days
Secondary	Diabetes Empowerment Scale	Likert Scale; Minimum value: Strongly Disagree; Maximum value: Strongly Agree	90 days
Secondary	36-Item Short-Form Health Survey	-Questionnaire	90 days
Secondary	Hypoglycemic Confidence Scale for Partners of Adults with T1DM	Likert Scale; Minimum value: Not Confident At All; Maximum value: Very Confident	90 days
Secondary	Diabetes Distress Scale for Partners of Adults with T1DM	Likert Scale; Minimum value: A great deal; Maximum value: Not at all	90 days