Transform Type 2: Examining Meal-Delivery and Education for Diabetes Self-Care
- Conditions
- PreDiabetesDiabetes Mellitus, Type 2
- Registration Number
- NCT04810026
- Lead Sponsor
- UnitedHealth Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in mean glucose time in range from baseline at Week 12 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 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 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
- Secondary Outcome Measures
Name Time Method Change in self-reported waist-to-hip ratio Weekly, Weeks 0-12 waist circumference, hip circumference, self-reported weekly; calculated by dividing the waist circumference by the hip circumference
Change in blood test results from baseline Week 0, Week 12 Difference in measurements of HbA1c, HDL cholesterol, total cholesterol, LDL cholesterol, triglycerides, and high-sensitivity C-reactive protein (hs-CRP) obtained from blood tests
Change in CGM-derived glucose features from baseline Week 0, Week 6, Week 12, and Week 16 Average of EGVs, percentage time above and below range (\< 70 mg/dL or \>180 mg/dL), and glucose variability (standard deviation of EGVs), measured via daily with weekly composite results
Change in self-reported blood pressure Weekly, Weeks 0-12 blood pressure, self-reported weekly
Trial Locations
- Locations (1)
OptumLabs
🇺🇸Minnetonka, Minnesota, United States
OptumLabs🇺🇸Minnetonka, Minnesota, United States