Type 2 Diabetes
Conditions
Keywords
Type 2 diabetes, Continuous glucose monitoring, Diabetes self-management, Behavioral intervention
Brief summary
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.
Detailed description
The overall objective of this project is to pilot and evaluate the feasibility and acceptability of an intervention that combines CGM with a virtually delivered, research-tested diabetes self-management program called DECIDE®, delivered over 9 weeks. We will recruit 20 adults with type 2 diabetes who receive care at Northwell Health, the largest healthcare provider in New York state. Participants will receive the 9-week DECIDE Program as well as CGM sensors to wear during the full 22-week study. Participants will be asked to complete questionnaires to assess diabetes distress, health-related problem-solving, diabetes knowledge, and diabetes self-management behaviors at baseline, 1-week post-intervention, and 3-months post-intervention. They will complete a home blood draw at baseline and 3-months post-intervention. And they will complete a qualitative interview at 1-week post-intervention to assess the acceptability of the intervention. Data related to feasibility will be collected throughout (e.g., rates of recruitment and retention, DECIDE session completion, CGM initiation, and CGM maintenance). The aims of this study are: 1) to determine the feasibility and acceptability of an intervention pairing DECIDE with CGMs and 2) to explore change in diabetes clinical and behavioral factors between the start of the study and 3 months after the intervention ends. This work will lead to the development of an accessible, acceptable, and usable intervention that has the potential to provide diabetes self-management support virtually, augmented by CGM, to improve diabetes outcomes for people with type 2 diabetes.
Interventions
BEHAVIORALThe DECIDE Self-Management Program
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.
BEHAVIORALContinuous Glucose Monitoring (CGM)
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.
Sponsors
Northwell Health
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Albert Einstein College of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
No masking
Intervention model description
This study uses a single-arm design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older * Diagnosis of type 2 diabetes * Suboptimal hemoglobin A1C (8.0% or greater) based on a laboratory result in the past 3 months * Access to and capability of using a smart cellular device * Smart cellular device compatible with the Freestyle Libre CGM smartphone application * Capable of giving informed consent
Exclusion criteria
* Currently using CGM * Non-English speaking * Unavailable to attend the virtual DECIDE group * Unavailable for follow-up * Currently pregnant * Currently on dialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the intervention | These outcomes will be monitored continuously throughout study completion, approximately 6 months | Feasibility will be assessed as identification of the eligible patient population in the EHR, study recruitment and retention rates, DECIDE enrollment and session completion rates, and CGM initiation and maintenance rates. |
| Acceptability of the intervention | 1-week post-intervention | Acceptability will be assessed by brief interviews with the 20 participants to obtain perspectives on the acceptability of the implementation as well as the intervention and its components (DECIDE Program; CGM initiation and engagement). |
Countries
United States
Outcome results
None listed