Type 1 Diabetes
Conditions
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.
Interventions
DEVICEFAM 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.
OTHERstandard of care
self reported HbA1C or GMI
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
randomized 1:1 to the intervention or control groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hyperglycemia - Continuous Glucose Monitor glucose monitor (CGM) metrics | 90 days | -Percentage of time glucose \>180 mg/dL |
| Severe hyperglycemia >400 mg/dL - Continuous Glucose Monitor glucose monitor (CGM) metrics | 90 days | -Percentage of time glucose \>400 mg/dL |
| Hypoglycemia - continuous glucose monitor | 90 days | -Percentage of time glucose\< 70 mg/dL |
| Hemoglobin A1c | days 0 and 90 | -HbA1c |
| Level 2 Hypoglycemia - Continuous Glucose Monitor | 90 days | -Percentage of time glucose \< 54 mg/dL |
| Time in Range - Continuous Glucose Monitor | 90 days | -Percentage of time glucose is 70 - 180 mg/dL |
| Glycemic variability - Continuous Glucose Monitor | 90 days | -Glycemic variability |
| Glucose Management Indicator - Continuous Glucose Monitor | 90 days | -Glucose Management Indicator |
| Number of glucose reading/day - Blood Glucose Monitor | 90 days | -Number of glucose readings/day |
| Hyperglycemia - Blood Glucose Monitor | 90 days | -Percentage of time glucose \<180 mg/dL |
| Severe Hyperglycemia > 400 mg/dL - Blood Glucose Monitor | 90 days | -Percentage of time glucose \>400 mg/dL |
| Hypoglycemia - Blood Glucose Monitor | 90 days | -Percentage of time glucose\< 70 mg/dL |
| Level 2 Hypoglycemia -Blood Glucose Monitor | 90 days | -Percentage of time glucose \< 54 mg/dL |
| Time in Range - Blood Glucose Monitor | 90 days | -Percentage of time glucose is 70 - 180 mg/dL |
| Ketone assessment | 90 days | -Frequency and severity of ketonuria assessed using urine ketone test strips |
| Assessment of the intervention's efficacy and its burden on participants | 90 days | -Questionnaire |
| Hypoglycemic Confidence Scale | 90 days | * Likert Scale * Minimum value: Not Confident At All * Maximum value: Very Confident |
| Diabetes Distress Scale for Adults with T1DM | 90 days | * Likert Scale * Minimum value: A Very Serious Problem * Maximum value: Not a Problem |
| Diabetes Empowerment Scale | 90 days | * Likert Scale * Minimum value: Strongly Disagree * Maximum value: Strongly Agree |
| 36-Item Short-Form Health Survey | 90 days | -Questionnaire |
| Hypoglycemic Confidence Scale for Partners of Adults with T1DM | 90 days | * Likert Scale * Minimum value: Not Confident At All * Maximum value: Very Confident |
| Diabetes Distress Scale for Partners of Adults with T1DM | 90 days | * Likert Scale * Minimum value: A great deal * Maximum value: Not at all |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJacob Kohlenberg, MD
University of Minnesota
Outcome results
None listed