Transform Type 2: Examining How Meal-Delivery and Education Resources Affect Prediabetes and Type 2 Diabetes Symptoms and Self-Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Change in mean glucose time in range from baseline at Week 12
研究概览
简要总结
The purpose of this research is to understand the impact of medically tailored meals on health-related biometrics (e.g., glucose time-in-range, waist-hip ratio, cholesterol) and how providing medically tailored meals promotes engagement in diabetes education and drives information-seeking behavior.
详细描述
The purpose of this research is to understand the impact of medically tailored meals on health-related biometrics (e.g., glucose time-in-range, waist-hip ratio) and how providing medically tailored meals promotes engagement in diabetes education and drives information-seeking behavior. Secondary purposes are to characterize the relationship between information-seeking behaviors and glycemic control; to characterize the relationship between psychometric survey results and program engagement, biometrics, and information-seeking behaviors; and to understand how meal provision and materials influence program satisfaction and adherence to healthy diabetes-related behaviors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Be a patient, employee, or employee dependent at Utica Park Clinic in Oklahoma
- •Be diagnosed with type 2 diabetes, prediabetes, and/or have an A1c result of 5.7 percent or above
- •Be above an ideal weight (for example, body mass index [BMI] greater than or equal to 25)
- •18 years of age or older
- •Have UnitedHealthcare insurance for 1 year+
- •Have an active e-mail address
- •Have a smartphone with access to the internet that is compatible with the Dexcom G6 app
排除标准
- •Be undergoing any form of cancer treatment
- •Be pregnant or breastfeeding
- •Have allergies to nightshade vegetable (e.g., bell peppers, potatoes, tomatoes) or legumes (e.g., green beans, peas), or tree nuts
- •Currently taking anti-psychotic medications to control schizophrenia and bipolar disorders, as well as other mental disorders including dementia, major depression, and even drug addiction
- •Be currently taking insulin
- •Be currently taking sulfonylureas
结局指标
主要结局
Change in mean glucose time in range from baseline at Week 12
时间窗: Week 0 and Week 12
Percentage of time estimated glucose value (EGV) from CGM is between 70 mg/dL and 180 mg/dL, measured daily with weekly composite results
Change in mean glucose time in range from baseline at Week 6
时间窗: Week 0 and Week 6
Percentage of time estimated glucose value (EGV) from continuous glucose monitor (CGM) is between 70 mg/dL and 180 mg/dL, measured daily with weekly composite results
Change in mean glucose time in range from baseline at Week 16
时间窗: Week 0 and Week 16
Percentage of time estimated glucose value (EGV) from CGM is between 70 mg/dL and 180 mg/dL, measured daily with weekly composite results
次要结局
- Change in self-reported waist-to-hip ratio(Weekly, Weeks 0-12)
- Change in blood test results from baseline(Week 0, Week 12)
- Change in CGM-derived glucose features from baseline(Week 0, Week 6, Week 12, and Week 16)
- Change in self-reported blood pressure(Weekly, Weeks 0-12)
研究者
Shane Hoversten
Senior Research Fellow
UnitedHealth Group