Examining the Feasibility of Pairing a Diabetes Self-Management Program With Continuous Glucose Monitoring for Adults With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of the intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
No masking
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Currently using CGM
- •Non-English speaking
- •Unavailable to attend the virtual DECIDE group
- •Unavailable for follow-up
- •Currently pregnant
- •Currently on dialysis
结局指标
主要结局
Feasibility of the intervention
时间窗: 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
时间窗: 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).
次要结局
未报告次要终点