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OpenTrials
Completed

NCT Number: NCT03612999

Data Acquisition to Model Glycemic Response

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Savvysherpa, LLC

Minnetonka, Minnesota, 55343, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexcom continuous glucose monitor

Device

Continuous glucose monitors (CGMs) record subjects glucose levels

Fitbit activity tracker

Device

Activity trackers will record subjects' physical activity, heart rate, and sleep.

Subjects record daily activity

Behavioral

Subjects will record their daily activities, either on paper or on a secure texting app.

Subjects record psychological state

Behavioral

Subjects will record their psychological state, either on paper or on a secure texting app.

Primary outcomes

  1. Glucose Level (mg./dl.)

    Time frame: 20 days per participant

    Estimated glucose concentration (mg./dl.) sampled every five minutes by a continuous glucose monitor (CGM).

Secondary outcomes

  1. Activity level (steps per hour)

    Time frame: 20 days per participant

    Activity level (steps per hour) as determined from data from wrist-worn accelerometer

  2. Food Consumption (type and quantity)

    Time frame: 20 days per participant

    Food items as described by user in food logs, along with time of consumption.

  3. Activities of daily living (free form)

    Time frame: 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.

  4. Psychological state (free-form)

    Time frame: 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.

  5. Sensor wear time (wear / no-wear intervals)

    Time frame: 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.

  6. Transmitter life expectancy (number of minutes)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Savvysherpa, Inc.

Industry

Registry information

Official study title

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

Acronym: SDI

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 2, 2018
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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