NCT05941000Completed
Continuous Glucose Monitoring and Behavioral Change Intervention for People With Type 2 Diabetes and Diabetes Distress
Continuous Glucose Monitoring Paired With Remotely Delivered Behavior Change Technique Interventions for Glycemic Management and Diabetes Distress Among Adults With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 3 (actual)
- First submitted
- 29 Jun 2023
- Start date
- Sept 2024
- Primary completion date
- Feb 2025
- Lead sponsor
- Northwell Health
- Diseases
- Type 2 diabetes
- NCT number
- NCT05941000
What you commit to
- Study type: Interventional
- Participants enrolled: 3
- From Sept 2024 to the primary completion date, Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently on dialysis
- Currently using CGM
Other
- Inability to comply with study protocol during 2-week run-in
- Does not speak English
- Unavailable for follow-up
- Pregnancy
Who the study is looking for
- Adults aged 45 years or older
- Diagnosis of type 2 diabetes
- Suboptimal hemoglobin A1C (≥8.0%)
- Positive screen for diabetes distress (Diabetes Distress Scale≥3.0)
- Access to and capable of using a smart cellular phone
- Ambulatory and never informed by clinician that it was not advisable/safe to participate in a low-intensity walking
Age in the registry: 45 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northwell Health - Institute of Health System Science Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.