Prediction of Glycemic Response Study (PROGRESS)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,070
- 试验地点
- 1
- 主要终点
- Gylcemic response profiles
研究概览
简要总结
The purpose of PROGRESS is to engage and intensively monitor 1000 individuals' dietary intake, activity levels, and continuous glucose values over 10 days, link to clinical events out to 3-years, and use that data along with genomic, microbiome, electronic health record (EHR), and other biomarker data to develop a predictive model of individual glucose responses to nutrient intake in individuals with and without type 2 diabetes.
详细描述
Interested individuals will be directed to download the MyDataHelps™ (CareEvolution) mobile app to register and provide informed consent as well as prompt completion of surveys, share their electronic health record data and link the digital health technologies to be used in the study. Participants may be asked to schedule an initial virtual meeting (telephone or videoconference) with the research coordinator who will welcome and walk them through the study.
Once a participant has completed on-boarding, they will be asked to fill out a baseline health, lifestyle, and medical history surveys and, upon completion, invited to request a biosamples study kit to be delivered to their home. This biosamples kit will include:
- Salivary kit for genomics analysis
- Gut microbiome kit
- Home micro-puncture single-use blood collection
Additional study materials and devices include:
- A wrist-worn activity, heart rate and sleep monitor.
- A Dexcom 6 continuous glucose monitor (CGM) and application kit
- A standardized snack bar meal (2 per fasting days)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years.
排除标准
- •Type 1 diabetes mellitus
- •Unable to participate in or comply with any of the testing modules asked during the study
- •Currently pregnant
- •Prior bariatric surgery
- •Chemotherapy or radiation treatment for cancer in the past year
- •Inflammatory bowel disease
- •Known skin allergy to adhesives and nickel (or other contraindications to continuous glucose monitoring)
- •Currently taking any oral steroids(these medications may impact glucose levels)
- •Antibiotic use in the last 3 months prior to the start of the study or planned use during the duration of the study
- •Non-dietary, supplemental probiotic use either daily or weekly
- •Hospice care
- •End stage renal disease
结局指标
主要结局
Gylcemic response profiles
时间窗: 10-days
Distinguish differences in individual glycemic response characteristics as measured by the continuous glucose monitor (mg/dl) and macronutrients (carbohydrates, fats, and proteins) in participants with (n = 500) and without type 2 diabetes (n = 500) matched for age, sex, BMI.
次要结局
未报告次要终点
研究者
Ed Ramos
Director, Digital Clinical Trials
Scripps Translational Science Institute