Data Acquisition to Model Glycemic Response (SDI)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Dexcom continuous glucose monitor; Device: Fitbit activity tracker; Behavioral: Subjects record daily activity; Behavioral: Subjects record psychological state

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minnetonka, Minnesota, United States, 55343
      • Savvysherpa, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CGM and Activity Tracker; Subjects receive a continuous glucose monitor (CGM) and activity tracker and are instructed to record daily activities and psychological data.

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity level (steps per hour)	Activity level (steps per hour) as determined from data from wrist-worn accelerometer	20 days per participant
Food Consumption (type and quantity)	Food items as described by user in food logs, along with time of consumption.	20 days per participant
Activities of daily living (free form)	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.	20 days per participant
Psychological state (free-form)	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.	20 days per participant
Sensor wear time (wear / no-wear intervals)	Participants will log intervals in which they are and are not wearing the CGM over the course of their participation in the study.	20 days per participant
Transmitter life expectancy (number of minutes)	In cases where participants wear sensors until the end of the transmitter's life, the number of minutes transmitter was operational.	20 days per participant

Collaborators and Investigators

• Sponsor: Savvysherpa, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2018
• Primary Completion (Actual): September 23, 2020
• Study Completion (Actual): September 23, 2020

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Pro00022817

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No