CGM- and Behavior-based Large Health Model for Just-in-time Diabetes Management
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
研究概览
简要总结
The primary objective of this research, funded by Samsung Strategic Alliance for Research and Technology, is to develop multi-modal foundation models that integrate Continuous Glucose Monitoring (CGM) data with patient behavior data (food intake, medication, and physical activity) to improve real-time glucose prediction and personalized diabetes management for patients with Type 2 diabetes (T2D), delivered via mobile apps and digital health tools.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old
- •Registered patient under Johns Hopkins Medicine (JHM)
- •Type 2 Diabetes diagnosis
- •Diabetes managed by a primary care physician or endocrinologist at JHM
- •Android Smartphone user
- •Must have a Dexcom G7 or FreeStyle Libre 3 CGM and using a mobile app to access their CGM data (G7 or Libre 3 apps)
- •2 weeks of usage (with at least 50% wear time) prior to study participation required
- •CGM Time in Range of <70% in 14 days prior to enrollment
- •Must be able to read, understand, and communicate in English
- •Must not have hearing or vision impairments
- •Willingness to Download the Welldoc app
- •Agree to wear a SAMSUNG Galaxy Watch at least 12 hours per day
- •Download SAMSUNG Health (Non-SAMSUNG Phone user)
- •Download Google Health Connect
- •Use CGM at least 80% of the time
- •Take a photo of all meals
排除标准
- •Non-English speaker
- •Has hearing or vision impairment
- •Use of an insulin pump (i.e. automated insulin delivery system)
- •Diagnosed with other forms of diabetes (e.g. Type 1 Diabetes, Latent Autoimmune Diabetes in Adults (LADA), Maturity-Onset Diabetes of the Young (MODY), or Gestational diabetes)
- •Non-Android smartphone user (i.e., Apple iOS)
- •CGM time-below-range > 4% (i.e. hypoglycemia) in the 14 days prior to enrollment.
- •Hospitalization for Diabetic Ketoacidosis (DKA) or severe hypoglycemic episode within the previous 6 months.
研究组 & 干预措施
Adults With Type 2 Diabetes Using CGM
Adults with type 2 diabetes receiving care through Johns Hopkins Medicine will participate in a single site observational cohort study. Participants will continue usual diabetes care and will not receive a treatment intervention from the study team. Participants will contribute CGM, smartwatch, app-based behavioral, and electronic medical record data for development and validation of glucose prediction models. Study-generated messages and summary reports will be reviewed by the study team and will not be delivered to participants.
干预措施: Digital Health Data Collection System (Device)