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 — BEHAVIORAL
    DECIDE 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) — BEHAVIORAL
    Participants 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 + CGM
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
Northwell HeathManhassetNew York11030
Elizabeth A Vrany, PhD

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