Continuous Glucose Monitoring in People With Prediabetes: a 12-month Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Change in CGM-derived % TA140
研究概览
简要总结
The purpose of the ReTURN study is to understand how glycemia, specifically percent of time above 140 mg/dL (TA140), changes over time in people who are randomized to receive either continuous glucose monitoring (CGM)-guided care or usual care (UC) for 12 months. CGM-guided care includes daily use of a CGM system along with education and support. The hypothesis is that change in CGM-derived metrics from Baseline to Month 12 will show a larger improvement (reduction) in the CGM-Guided Lifestyle Change arm than the UC arm.
详细描述
The intention of the CGM-Guided Lifestyle Care intervention is to help CGM users make optimal use of their real-time and retrospective CGM data for the purpose of identifying and making behavior changes that reduce TA140. The CGM device will be positioned as a tool that guides its user to develop and maintain a personalized approach to eating, movement, and other behaviors such as sleep and stress management, which can all help bring glucose into a "healthy" range.
The proposed CGM-based intervention aims to explore an alternative approach to caring for people with prediabetes using a flexible, predominantly virtual approach. The emphasis on choosing healthy lifestyle behaviors, such as high-quality eating patterns and engaging in physical activity is similar to existing DPPs, while the mix of synchronous and asynchronous virtual care education, along with the personalized, actionable glycemic data reduces some of the known barriers to participation in current Diabetes Prevention Programs (DPPs) (e.g. rigid schedules, time). The emphasis on encouraging participants to use their own glucose data to see in real-time what healthy lifestyle choices work best for them is also a key differentiator from past approaches, which has the potential to lead to more sustainable behavior changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Provision of signed and dated informed consent form
- •> 18 years of age
- •Documented diagnosis of prediabetes based on the most recent A1c of 5.7% to 6.4% (inclusive) collected within the last 12 months; or with investigator approval based on a history of A1c 5.7% to 6.4% (inclusive)
- •Point-of-care A1c between 5.7% and 6.4% (inclusive) at screening visit
- •A minimum of 7 days of glucose data with documented % time above 140 mg/dL of > 15% on a study-provided blinded CGM during the baseline assessment period
- •Ready and able to make lifestyle changes to prevent or delay the onset of T2D; this may include changes to food intake, physical activity, sleep, and stress (e.g. ready to: make dietary changes, willing to aim for > 150 mins of physical activity/week, etc.)
- •Has a personal smartphone that is compatible with all study-required devices and apps (e.g. FreeStyle Libre family, Fitbit)
- •Willing to download study-related apps and keep them updated and open on phone as required throughout the study (e.g. FreeStyle Libre family)
- •Has regular access to Wi-Fi
- •Willing and able to consistently view and use CGM data on a personal smartphone for up to 54 weeks
- •Willing and able to continuously wear a study provided CGM sensor (back of the arm) and a study provided Fitbit activity tracker (band around the wrist) for up to 54 weeks
- •Willing to attend in person and virtual study visits, willing to read MyChart messages, and willing to comply with all other study procedures and lifestyle considerations (Section 5.3, Lifestyle Considerations) for the duration of the study
- •Speak and read in English
排除标准
- •Diagnosis of Type 1 diabetes or Type 2 diabetes (A1c >6.4%)
- •Taking or actively planning to take anti-hyperglycemic medications (e.g. Metformin, SGLT2i, GLP-1 RA)
- •Taking or actively planning to take prescription weight loss medications (e.g. Phentermine, Topiramate, Naltrexone, Orlistat)
- •Taking or actively planning to take a GLP-1 RA for any reason
- •Known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin
- •Currently using or actively planning to use personal CGM, or have used personal CGM in last 30 days
- •Started taking within the last 16 weeks or actively planning to take a glucocorticoid (oral or injected), statin, thiazide diuretic, second-generation antipsychotic, or HIV medications, as these agents may increase the risk of developing T2D
- •Skin conditions that are not compatible with CGM wear
- •Taking or planning to regularly take more than 500 mg of Vitamin C per day (due to potential for false glucose elevations)
- •Planning pregnancy, pregnant, or lactating
- •Actively participating in or planning to participate in a treatment program for prediabetes (e.g. a diabetes prevention program) or a clinical intervention study related to cardiometabolic health
- •Unsuitable for participation due to any other cause, including but not limited to significant comorbidities, as determined by PI or MD oversight (e.g. examples for consideration, advanced cancer, unstable heart disease, active eating disorders, planned surgeries, cognitive impairments)
研究组 & 干预措施
CGM-Guided Lifestyle Care
The CGM-guided care arm (the study intervention) includes three components 1) daily use of a real-time CGM system, 2) core CGM-guided lifestyle resources, and 3) personalized CGM-guided lifestyle education and support. The education and support is provided via one 60-minute in-person education and counseling session, six 30-minute virtual systematic CGM data review and lifestyle assessment sessions, and three asynchronous systematic CGM data review and lifestyle assessment messages sent via the electronic health record. The intervention content is provided by a registered dietitian nutritionist and focuses on using CGM data to help people optimize food choices, physical activity levels, sleep patterns, and stress management for improved prediabetes management.
干预措施: CGM-guided care (Behavioral)
Usual Care (UC)
Participants in the UC arm will receive generalized healthy lifestyle guidance and glycemic assessment (e.g. A1c, fasting glucose) at Baseline and at M12. Participants in the UC arm will also receive guidance for finding local diabetes prevention programs. The UC arm aligns with current practice for people with prediabetes.
结局指标
主要结局
Change in CGM-derived % TA140
时间窗: Baseline to 12 months
次要结局
未报告次要终点