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Data Acquisition to Model Glycemic Response

NCT03612999 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2021-03-17

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Savvysherpa, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2020-09-23
Completion
2020-09-23
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03612999 on ClinicalTrials.gov