NCT03612999

Data Acquisition to Model Glycemic Response

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Savvysherpa, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	Dexcom continuous glucose monitor	Continuous glucose monitors (CGMs) record subjects glucose levels
DEVICE	Fitbit activity tracker	Activity trackers will record subjects' physical activity, heart rate, and sleep.
BEHAVIORAL	Subjects record daily activity	Subjects will record their daily activities, either on paper or on a secure texting app.
BEHAVIORAL	Subjects record psychological state	Subjects will record their psychological state, either on paper or on a secure texting app.

Timeline

• Start date: 2018-05-31
• Primary completion: 2020-09-23
• Completion: 2020-09-23
• First posted: 2018-08-02
• Last updated: 2021-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study