Feasibility of a Diabetes Self-Management Program With Continuous Glucose Monitoring for Adults With Type 2 Diabetes
Part of paid clinical trials in Manhasset, New York.
- Sponsor
- Northwell Health
- Study ID
- NCT07743307
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- The DECIDE Self-Management Program — BEHAVIORALDECIDE is an evidence-based diabetes self-management support program that uses problem-solving skills training to educate and empower individuals in managing their diabetes. For this study, it has been adapted to include education and support around CGM use. The program will be delivered virtually by a trained facilitator over 9 weeks.
- Continuous Glucose Monitoring (CGM) — BEHAVIORALParticipants will be provided Freestyle Libre CGM sensors to wear during the intervention and follow-up periods (up to 22 weeks). CGM includes a small sensor attached to the arm that provides real-time glucose data by connecting via Bluetooth to an application on a smartphone. The sensor will be replaced every 2 weeks, and participants will be able to see their glucose values on their personal smartphone device.
Study Details
The purpose of this study is to determine if combining a virtual diabetes self-management program (DECIDE®) with continuous glucose monitoring (CGM) is practical and well-received by adults with type 2 diabetes. Twenty participants will attend the 9-week, virtual DECIDE Self-Management Program. They will receive CGM sensors to wear during the 22-week study to track their blood sugar. Participants will complete questionnaires at three time points -- at baseline, 1 week after the DECIDE Program ends, and 3 months after the DECIDE Program ends. They will also complete a blood draw to measure hemoglobin A1C at baseline and 3 months after the intervention ends. Additionally, they will complete a brief interview after the program ends to gather insights into participants' experiences with the program. The study aims to examine whether this integrated approach will be both feasible and acceptable, potentially leading to better diabetes management and improved health outcomes.
Key Dates
- First listed
- Aug 3, 2026
- Start date
- Aug 1, 2026
- Status verified
- Jul 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: DECIDE Self-Management Program + CGMParticipants will receive: 1. The 9-week, virtually delivered DECIDE Self-Management Program. 2. Continuous glucose monitoring (CGM) sensors
Primary Outcome Measure
Feasibility of the intervention [ Time Frame: These outcomes will be monitored continuously throughout study completion, approximately 6 months ]
Central Contacts
- Elizabeth A Vrany516-600-1483
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Northwell Heath | Manhasset | New York | 11030 | Elizabeth A Vrany, PhD |
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