Intervention to reduce severe hyperglycemia in adults with type 1 diabetes
FAM (Follower, Action Plan, and Remote Monitoring) Intervention to Reduce Severe Hyperglycemia in Adults With Type 1 Diabetes Mellitus at Risk for Diabetic Ketoacidosis
This study is testing a new way to help adults with type 1 diabetes lower their high blood sugar levels and reduce the risk of serious complications by using continuous glucose monitoring and support from a family member or friend.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06114186 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the FAM intervention, which includes a Follower monitoring glucose data, an Action Plan, and Remote Monitoring for adults aged 18-65 with type 1 diabetes mellitus (T1DM) at risk for diabetic ketoacidosis (DKA). The study aims to assess whether this innovative approach can effectively reduce DKA events by leveraging continuous glucose monitoring technology. Participants will be randomly assigned to receive the intervention alongside standard care, with the goal of improving glycemic control and quality of life metrics. The trial specifically targets individuals with elevated HbA1C levels and requires the involvement of a supportive Follower.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with type 1 diabetes for at least one year and an HbA1C between 7.5% and 14.0%.
Not a fit: Patients who are prisoners or those actively treated with sodium-glucose cotransporter-2 inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the risk of diabetic ketoacidosis and improve overall health outcomes for patients with type 1 diabetes.
How similar studies have performed: Previous studies have shown some success with similar interventions, but this specific approach targeting younger adults with T1DM is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Jacob Kohlenberg, MD — University of Minnesota
- Study coordinator: Jacob Kohlenberg, MD
- Email: endoresT1DM@umn.edu
- Phone: 612-624-1469
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.