Healthy
Conditions
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.
Interventions
Continuous glucose monitors (CGMs) record subjects glucose levels
DEVICEFitbit activity tracker
Activity trackers will record subjects' physical activity, heart rate, and sleep.
BEHAVIORALSubjects record daily activity
Subjects will record their daily activities, either on paper or on a secure texting app.
BEHAVIORALSubjects record psychological state
Subjects will record their psychological state, either on paper or on a secure texting app.
Sponsors
Savvysherpa, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Level (mg./dl.) | 20 days per participant | Estimated glucose concentration (mg./dl.) sampled every five minutes by a continuous glucose monitor (CGM). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Food Consumption (type and quantity) | 20 days per participant | Food items as described by user in food logs, along with time of consumption. |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed