Enhancing Digitally Delivered Diabetes Education With Real-Time CGM: A Comparative Study in People With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
The current research study will add continuous glucose monitoring devices to the evidence-based text messaging diabetes education program for patients with type 2 diabetes for 6 months. Results on the effectiveness of this intervention will be compared for non-insulin using patients.
详细描述
The current research study seeks to investigate the impact of incorporating Continuous Glucose Monitoring (CGM) into the evidence-based text messaging diabetes education program, Dulce Digital, focusing on individuals with Type 2 Diabetes (T2D) who are not on insulin therapy. This innovative approach stems from the rationale that real-time continuous glucose monitoring (CGM) can offer valuable insights into glycemic control, thereby enhancing diabetes self-management. In standard care, individuals with T2D, particularly those not on insulin, may not routinely have access to CGM devices. The CGM device, an integral part of recommended diabetes therapy, is FDA approved for use in all people with diabetes. However, reimbursement for CGM devices varies by health plans, and currently, Centers for Medicare & Medicaid Services (CMS) does not reimburse for their use in non-insulin-using diabetes, except in cases of repeated severe hypoglycemia. Despite this, the investigators hypothesize that there are both clinical and financial benefits to providing a CGM device during diabetes self-management education for individuals with non-insulin-using T2D. This study aims to determine if adding a CGM device for this patient category yields significant benefits, contributing to the understanding of the potential advantages and informing future diabetes care practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Diagnosed with type 2 diabetes
- •Are not currently using a CGM
- •Are not using insulin therapies
- •Speak English, Spanish or Arabic
- •Have A1c between 7.5% and 12.0% in last 90 days
- •Have a cellphone that can receive/send text messages and counts steps
排除标准
- •Are using insulin therapies
- •Are pregnant
- •Are currently using a CGM
- •Are currently participating in another diabetes-related study
研究组 & 干预措施
CGM Group
Participants will be provided continuous glucose monitors (Dexcom G7) to monitor blood glucose for the entire duration of this study (i.e., one new device every 10 days for a total of 18 devices to last up to 6 months).
干预措施: Dulce Digital Text Messaging Intervention (Other)
CGM Group
Participants will be provided continuous glucose monitors (Dexcom G7) to monitor blood glucose for the entire duration of this study (i.e., one new device every 10 days for a total of 18 devices to last up to 6 months).
干预措施: CGM Device (Other)
Usual Care Blood Glucose Monitoring Group
Participants will use standard blood glucose monitoring devices that are covered by health insurance.
干预措施: Dulce Digital Text Messaging Intervention (Other)
结局指标
主要结局
HbA1c
时间窗: 6 months
Measures participants A1c using lab results provided from healthcare provider.
次要结局
- CGM Metric Time Below Range(6 months)
- CGM Metric Time in Range(6 months)
- Summary of Diabetes Self Care Activities (SDSCA) Survey(6 months)
- CGM Metric Time above Range(6 months)
- Diabetes Distress Scale(6 months)
