Data Acquisition to Model Glycemic Response

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Dexcom continuous glucose monitor; Device: Fitbit activity tracker; Behavioral: Subjects record daily activity; Behavioral: Subjects record psychological state

• Registration Number: NCT03612999
• Lead Sponsor: Savvysherpa, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-31
• Study First Submitted: 2018-07-23
• Study First Submitted QC: 2018-07-27
• Study First Posted: 2018-08-02
• Status Verified: 2020-09
• Primary Completion: 2020-09-23
• Study Completion: 2020-09-23
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CGM and Activity Tracker	Dexcom continuous glucose monitor	Subjects receive a continuous glucose monitor (CGM) and activity tracker and are instructed to record daily activities and psychological data.
CGM and Activity Tracker	Subjects record daily activity	Subjects receive a continuous glucose monitor (CGM) and activity tracker and are instructed to record daily activities and psychological data.
CGM and Activity Tracker	Subjects record psychological state	Subjects receive a continuous glucose monitor (CGM) and activity tracker and are instructed to record daily activities and psychological data.
CGM and Activity Tracker	Fitbit activity tracker	Subjects receive a continuous glucose monitor (CGM) and activity tracker and are instructed to record daily activities and psychological data.

Primary Outcome Measures

Name	Time	Method
Glucose Level (mg./dl.)	20 days per participant	Estimated glucose concentration (mg./dl.) sampled every five minutes by a continuous glucose monitor (CGM).

Secondary Outcome Measures

Name	Time	Method
Food Consumption (type and quantity)	20 days per participant	Food items as described by user in food logs, along with time of consumption.
Activity level (steps per hour)	20 days per participant	Activity level (steps per hour) as determined from data from wrist-worn accelerometer
Sensor wear time (wear / no-wear intervals)	20 days per participant	Participants will log intervals in which they are and are not wearing the CGM over the course of their participation in the study.
Activities of daily living (free form)	20 days per participant	Participants may log any activity of daily living they choose, including social interactions, house work, and leisure activities. Activities are described by users and logged in interval form with start-time and end-times.
Transmitter life expectancy (number of minutes)	20 days per participant	In cases where participants wear sensors until the end of the transmitter's life, the number of minutes transmitter was operational.
Psychological state (free-form)	20 days per participant	Participants may log any psychological information they choose including mood, energy level, or cognitive function. Psychological states are described by users and logged with time or interval in which that psychological state was experienced.

Trial Locations

Locations (1)

Savvysherpa, LLC; 🇺🇸 Minnetonka, Minnesota, United States