WeightWatchers and CGM: New Trial Studies Using Both

Researchers are recruiting adults with both type 2 diabetes and obesity to test if the combination of CGM and WeightWatchers helps lower A1C.  

Clinical Trials Identifier: NCT05935514

Trial Name: Improving Glycemic Control Using a Virtual Weight Control Program and Continuous Glucose Monitoring (VITAL-CGM)

Diabetes Type: Adults with type 2 diabetes and obesity

Trial Sponsor: Pennington Biomedical Research Center

What is the trial researching?

This study will examine how well using the combination of continuous glucose monitors (CGM) and the WeightWatchers digital platform reduces A1C among adults with type 2 diabetes and obesity. The study will enroll roughly 400 participants and last about one year. 

Participants will be randomly assigned to either the CGM and Weight Watchers intervention or usual care from their healthcare providers, including one virtual session with a dietician. In addition to measuring A1C, researchers will examine changes in body weight, blood pressure, diabetes distress, and treatment satisfaction. 

The WeightWatchers platform encourages healthy habits with a focus on food, physical activity, mindset, and sleep. Participants in the CGM and WeightWatchers group will receive a FreeStyle Libre 2 continuous glucose monitor and access to a WeightWatchers platform that is designed for people with type 2 diabetes. The platform includes access to weekly virtual workshops and the WeightWatchers app. 

Why is this important?

There are many different approaches to weight loss, including diet and nutrition, physical activity, medications, weight loss surgery, and coaching apps like WeightWatchers. 

Maintaining a healthy body weight can help prevent diabetes complications; even a small amount of weight loss (5-10%) can have major benefits for diabetes management and overall well-being. 

A previous study of WeightWatchers for people with type 2 diabetes saw participants reduce their A1C by nearly 1% and lose nearly 6% of their body weight. Participants also decreased their waist circumference by more than two inches and reduced diabetes distress by about 10%. 

This suggests that WeightWatchers may be an effective strategy for people with type 2 diabetes to manage both blood glucose levels and body weight. 

Are you interested?

You may be eligible if you have: 

• Type 2 diabetes and are between 18-70 years old

• An A1C of 7.5-11%

• Overweight or obesity, defined as a BMI of 25-50

• Had a stable regimen of medications that can affect weight or diabetes outcomes for at least three months

• Had a stable weight (of plus or minus 5%) over the previous three months, or six months if you are taking medications that impact weight like GLP-1 receptor agonists 

• Access to a smartphone or device that can download the WeightWatchers app

You are not eligible to participate if you have: 

• Type 1 diabetes

• Participated in a structured weight management program or used a CGM within the past three months

• Had weight loss surgery 

See a full list of inclusion/exclusion criteria here. 

This study is recruiting at four sites throughout the US: 
1. Stanford University, Stanford, California
Contact: Tracey L McLaughlin, MD    650-721-1300    tracey.mclaughlin@stanford.edu   
Contact: Jasmine Yang       jasminey@stanford.edu   

2. Pennington Biomedical Research Center, Baton Rouge, Louisiana
Contact: Peter T Katzmarzyk, PhD       peter.katzmarzyk@pbrc.edu   
Website: https://www.pbrc.edu/research-trials/view-all-current.aspx?studyid=397 

3. Brigham and Women's Hospital, Boston, Massachusetts
Contact: Vanita R Aroda, MD    617-732-5661    varoda@bwh.harvard.edu   

4. Wake Forest University Health Sciences, Winston-Salem, North Carolina
Contact: Jamy D Ard, MD       jard@wakehealth.edu   
Website: https://www1.wakehealth.edu/beinvolved/eng/studies/IRB00098711