Improving Glycemic Control Using a Virtual Weight Control Program and Continuous Glucose Monitoring

NAActive, not recruitingINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

August 22, 2023

Primary Completion Date

November 15, 2025

Study Completion Date

November 15, 2025

Conditions
Diabetes MellitusType 2 DiabetesObesity
Interventions
BEHAVIORAL

WW Intervention

The core of the WW food program is the Points® system which assigns each food and beverage a Points® value. Participants will be assigned a personalized daily and weekly Points® Budget, based on reported goals, and designed to create an energy deficit, using the Mifflin St-Jeor formula, which uses age, sex, height, and weight to estimate resting energy expenditure. Participants will also be provided with the FreeStyle Libre 2 Flash Glucose Monitoring System, which is intended to monitor interstitial fluid glucose levels to aid users in the management of diabetes. The System consists of the following primary components: 1) A disposable sensor that incorporates a subcutaneously implanted electrochemical glucose sensor and associated on-body electronics, and 2) A disposable, sensor application device, which is used to adhere the sensor to the skin of the user and to insert the sensor tail just below the surface of the skin.

BEHAVIORAL

Usual Care

The Usual Care arm will continue to receive routine medical care by their provider, in addition to a 50-minute virtual, on-line session with a Registered Dietician, with additional materials at the time of their 6- and 12-month follow-up assessments.

Trial Locations (3)

27101

Wake Forest University Health Sciences, Winston-Salem

70808

Pennington Biomedical Research Center, Baton Rouge

94305

Stanford University, Stanford

All Listed Sponsors
collaborator

WW International Inc

INDUSTRY

lead

Pennington Biomedical Research Center

OTHER

NCT05935514 - Improving Glycemic Control Using a Virtual Weight Control Program and Continuous Glucose Monitoring | Biotech Hunter | Biotech Hunter