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NCT05941000 · ClinicalTrials.gov registry record · NA
Continuous Glucose Monitoring and Behavioral Change Intervention for People With Type 2 Diabetes and Diabetes Distress
A NA study, sponsored by Northwell Health.
- Completed
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT05941000: Completed NA study, sponsored by Northwell Health.
NCT05941000 is a NA study that has completed, run by Northwell Health. The registered enrollment target is 3 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05941000, a NA study, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study Summary
The purpose of this study is to use a Personalized Trial (N-of-1) design to test the effect of an intervention that pairs continuous glucose monitoring (CGM) with text message-delivered behavior change interventions for physical activity and mood on outcomes of glycemic regulation and diabetes distress among adults with type 2 diabetes and diabetes distress. Participants (n=60) will be given CGM sensors and a FitBit watch to wear during the 10-week study. Participants will complete a two-week baseline/run-in period, during which the participants usual blood glucose and physical activity will be monitored. After successful completion of the run-in period, participants will enter an eight-week intervention period, during which the participant will be randomized to either of two arms, which will both receive two interventions in alternating order - 1) CGM paired with behavioral intervention for physical activity and 2) CGM paired with behavioral intervention for mood. Every two weeks, participants will complete self-report measures assessing mood and health-related behavior and a hemoglobin A1C test. At the end of the trial, participants will receive a summary of the data to help the participants learn more about the responses to the two interventions and to inform investigators about the feasibility of an N-of-1 study design for future research and clinical applications.
Primary Outcome
Time in range will be measured continuously using the Freestyle Libre CGM. Participants will place a CGM sensor every two weeks throughout the 10-week study. Time in range will be aggregated to compute the percent of time (0-100%) that a person spends with their blood glucose levels in the target range of 70-180 mg/dL for each assessment time period (the two-week baseline/run-in and the four two-week intervention blocks). Higher time in range values reflect better blood glucose management. Score
Interventions
- BEHAVIORAL Self-Monitoring of Behavior for Physical Activity
- BEHAVIORAL Action Planning for Physical Activity
- BEHAVIORAL Self-Monitoring of Behavior for Mood
- BEHAVIORAL Action Planning for Mood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2024-09-10 |
| Est. Completion | 2025-02-28 |
| Phase | NA |
What the finished NCT05941000 record still lists
NCT05941000 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 4 interventions - of which Self-Monitoring of Behavior for Physical Activity is the first listed.
NCT05941000 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05941000 about?
NCT05941000 is a clinical study titled "Continuous Glucose Monitoring and Behavioral Change Intervention for People With Type 2 Diabetes and Diabetes Distress". The purpose of this study is to use a Personalized Trial (N-of-1) design to test the effect of an intervention that pairs continuous glucose monitoring (CGM) with text message-delivered behavior change interventions for physical activity and mood on outcomes of glycemic regulation and diabetes distr...
What is the current status of trial NCT05941000?
This trial is currently completed. It is a NA study. The enrollment target is 3 participants. The study started on 2024-09-10. Estimated completion is 2025-02-28.
What interventions are being tested in trial NCT05941000?
The interventions under investigation include: Self-Monitoring of Behavior for Physical Activity (BEHAVIORAL), Action Planning for Physical Activity (BEHAVIORAL), Self-Monitoring of Behavior for Mood (BEHAVIORAL), Action Planning for Mood (BEHAVIORAL).
Who is sponsoring clinical trial NCT05941000?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05941000's enrollment target sits among peer trials
3 1996th of 2000 higher than 4 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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