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Completed

NCT Number: NCT06114186

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard of care

Other

self reported HbA1C or GMI

Primary outcomes

  1. percentage of time with severe hyperglycemia

    Time frame: 90 days

    number of continuous glucose monitoring or blood glucose monitoring readings with glucose ≥250 mg/dL divided by the total number of readings

Secondary outcomes

  1. Hyperglycemia - Continuous Glucose Monitor glucose monitor (CGM) metrics

    Time frame: 90 days

    -Percentage of time glucose >180 mg/dL

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

    Time frame: 90 days

    -Percentage of time glucose >400 mg/dL

  3. Hypoglycemia - continuous glucose monitor

    Time frame: 90 days

    -Percentage of time glucose< 70 mg/dL

  4. Hemoglobin A1c

    Time frame: days 0 and 90

    -HbA1c

  5. Level 2 Hypoglycemia - Continuous Glucose Monitor

    Time frame: 90 days

    -Percentage of time glucose < 54 mg/dL

  6. Time in Range - Continuous Glucose Monitor

    Time frame: 90 days

    -Percentage of time glucose is 70 - 180 mg/dL

  7. Glycemic variability - Continuous Glucose Monitor

    Time frame: 90 days

    -Glycemic variability

  8. Glucose Management Indicator - Continuous Glucose Monitor

    Time frame: 90 days

    -Glucose Management Indicator

  9. Number of glucose reading/day - Blood Glucose Monitor

    Time frame: 90 days

    -Number of glucose readings/day

  10. Hyperglycemia - Blood Glucose Monitor

    Time frame: 90 days

    -Percentage of time glucose <180 mg/dL

  11. Severe Hyperglycemia > 400 mg/dL - Blood Glucose Monitor

    Time frame: 90 days

    -Percentage of time glucose >400 mg/dL

  12. Hypoglycemia - Blood Glucose Monitor

    Time frame: 90 days

    -Percentage of time glucose< 70 mg/dL

  13. Level 2 Hypoglycemia -Blood Glucose Monitor

    Time frame: 90 days

    -Percentage of time glucose < 54 mg/dL

  14. Time in Range - Blood Glucose Monitor

    Time frame: 90 days

    -Percentage of time glucose is 70 - 180 mg/dL

  15. Ketone assessment

    Time frame: 90 days

    -Frequency and severity of ketonuria assessed using urine ketone test strips

  16. Assessment of the intervention's efficacy and its burden on participants

    Time frame: 90 days

    -Questionnaire

  17. Hypoglycemic Confidence Scale

    Time frame: 90 days

    • Likert Scale
    • Minimum value: Not Confident At All
    • Maximum value: Very Confident

  18. Diabetes Distress Scale for Adults with T1DM

    Time frame: 90 days

    • Likert Scale
    • Minimum value: A Very Serious Problem
    • Maximum value: Not a Problem

  19. Diabetes Empowerment Scale

    Time frame: 90 days

    • Likert Scale
    • Minimum value: Strongly Disagree
    • Maximum value: Strongly Agree

  20. 36-Item Short-Form Health Survey

    Time frame: 90 days

    -Questionnaire

  21. Hypoglycemic Confidence Scale for Partners of Adults with T1DM

    Time frame: 90 days

    • Likert Scale
    • Minimum value: Not Confident At All
    • Maximum value: Very Confident

  22. Diabetes Distress Scale for Partners of Adults with T1DM

    Time frame: 90 days

    • Likert Scale
    • Minimum value: A great deal
    • Maximum value: Not at all

Other outcomes

  1. Hospitalization for DKA

    Time frame: 90 days

    -The number of DKA-related hospitalizations for each participant will be recorded

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 2, 2023
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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