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临床试验/NCT03612999
NCT03612999已完成不适用

Data Acquisition to Model Glycemic Response to Food and Other Events Using Real-Time Continuous Glucose Monitoring (RT-CGM)

Savvysherpa, Inc.2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2018年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
2
主要终点
Glucose Level (mg./dl.)

研究概览

简要总结

To learn about individual glycemic response to physiological and psychological conditions across a diverse population, the investigators will collect sensor and lifestyle data directly from participants as they engage in daily activities. The investigators will collect real-time glucose data from a continuous glucose monitor (CGM) system; accelerometer, aggregated activity, and sleep data from a wrist-worn activity tracker; mood and experiential data; and food information. Non-sensor data will be collected using a paper log, or via a study app when available.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

入选标准

  • Be at least 18 years old
  • Be able to read, speak, and understand English
  • Have a primary care provider

排除标准

  • Not receive or require kidney dialysis
  • Not be pregnant
  • Not have type 1 diabetes
  • Not have type 2 diabetes and be prescribed three or more daily injections of insulin

结局指标

主要结局

Glucose Level (mg./dl.)

时间窗: 20 days per participant

Estimated glucose concentration (mg./dl.) sampled every five minutes by a continuous glucose monitor (CGM).

次要结局

  • Food Consumption (type and quantity)(20 days per participant)
  • Activity level (steps per hour)(20 days per participant)
  • Sensor wear time (wear / no-wear intervals)(20 days per participant)
  • Transmitter life expectancy (number of minutes)(20 days per participant)
  • Activities of daily living (free form)(20 days per participant)
  • Psychological state (free-form)(20 days per participant)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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