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NCT06114186 · ClinicalTrials.gov registry record · Early Phase 1
FAM (Follower, Action Plan, and Remote Monitoring) Intervention to Reduce Severe Hyperglycemia in Adults With Type 1 Diabetes Mellitus at Risk for Diabetic Ketoacidosis
A Early Phase 1 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 22
- Enrollment target
NCT06114186: Completed Early Phase 1 study, sponsored by University of Minnesota.
NCT06114186 is a Early Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 22 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06114186, a Early Phase 1 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 22 participants
- Enrollment target
Study 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.
Primary Outcome
number of continuous glucose monitoring or blood glucose monitoring readings with glucose ≥250 mg/dL divided by the total number of readings
Interventions
- OTHER standard of care
- DEVICE FAM intervention consisting of a Follower of glucose data, Action Plan, and Remote Monitoring of glucose data
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2024-03-28 |
| Est. Completion | 2026-02-11 |
| Phase | Early Phase 1 |
What the finished NCT06114186 record still lists
NCT06114186 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which standard of care is the first listed.
NCT06114186 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06114186 about?
NCT06114186 is a clinical study titled "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 n...
What is the current status of trial NCT06114186?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 22 participants. The study started on 2024-03-28. Estimated completion is 2026-02-11.
What interventions are being tested in trial NCT06114186?
The interventions under investigation include: standard of care (OTHER), FAM intervention consisting of a Follower of glucose data, Action Plan, and Remote Monitoring of glucose data (DEVICE).
Who is sponsoring clinical trial NCT06114186?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06114186's enrollment target sits among peer trials
22 1104th of 2000 higher than 871 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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