Digital Weight Management + Glucose Monitoring for Type 2 Diabetes
(VITAL-CGM Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byTracey L McLaughlin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Pennington Biomedical Research Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study is a randomized clinical trial with the primary aim examining the efficacy of a novel integrated solution of a digitally delivered behavioral weight management program tailored for diabetes utilizing a continuous glucose monitor (CGM) built into the WW digital platform for adults with type 2 diabetes (T2D) for the reduction of HbA1c.

Research Team

Jamy Ard, MD

Principal Investigator

Wake Forest University Health Sciences

Tracey L McLaughlin, MD

Principal Investigator

Stanford University

Peter T Katzmarzyk, PhD

Principal Investigator

Pennington Biomedical Research Center

Eligibility Criteria

This trial is for adults with type 2 diabetes who are interested in managing their weight and blood sugar levels. Participants should be willing to use a digital weight management program and a continuous glucose monitor.

Treatment Details

Interventions

WW Intervention (Behavioural Intervention)

Trial OverviewThe study tests if integrating a behavioral weight management program, specifically designed for diabetics into the WW (formerly Weight Watchers) digital platform along with continuous glucose monitoring can help reduce HbA1c levels.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: WW InterventionExperimental Treatment1 Intervention

Participants in the intervention arm will receive a voucher code that provides 12 months of access to the WW program and instructions for redeeming the code by study staff. The program will include access to weekly Virtual Workshops and the WW App. WW is a widely available, commercial behavioral weight management program that encourages healthy habits in the areas of food, activity, mindset, and sleep, with topics tailored specific to T2D. Participants will also be provided with the FreeStyle Libre 2 Flash Glucose Monitoring System to wear for the duration of the trial.

Group II: Usual CareActive Control1 Intervention

Patients in the Usual Care group will continue to receive routine medical care by their healthcare provider. In addition, within 4 weeks of the baseline visit, participants in the Usual Care group will receive one 50-minute virtual on-line session of nutrition counseling with a registered dietitian with additional materials at the time of their 6- and 12-month follow-up assessments, based on current recommendations of the American Diabetes Association.