Data Acquisition to Model Glycemic Response (SDI)

Savvysherpa

Status: Completed

Conditions: Healthy

Treatments: Device: Dexcom continuous glucose monitor; Device: Fitbit activity tracker; Behavioral: Subjects record psychological state; Behavioral: Subjects record daily activity

Study type: Interventional

Funder types: Industry

Identifiers

NCT03612999

Pro00022817

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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102 participants in 1 patient group

CGM and Activity Tracker

Experimental group

Description:

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

Treatment:

Device: Fitbit activity tracker

Behavioral: Subjects record psychological state

Device: Dexcom continuous glucose monitor

Behavioral: Subjects record daily activity