Data Acquisition to Model Glycemic Response

Study Overview
=================
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.

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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: Dexcom continuous glucose monitor
* Device: Fitbit activity tracker
* Behavioral: Subjects record daily activity
* Behavioral: Subjects record psychological state


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGM and Activity Tracker<br>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<br>* Continuous glucose monitors (CGMs) record subjects glucose levels<br>Device: Fitbit activity tracker<br>* Activity trackers will record subjects' physical activity, heart rate, and sleep.<br>Behavioral: Subjects record daily activity<br>* Subjects will record their daily activities, either on paper or on a secure texting app.<br>Behavioral: Subjects record psychological state<br>* Subjects will record their psychological state, either on paper or on a secure texting app.<br>|

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 |