Digital Weight Management + Glucose Monitoring for Type 2 Diabetes

(VITAL-CGM Trial)

Not currently recruiting at 4 trial locations

Overseen By Peter T Katzmarzyk, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Disqualifiers: Type 1 diabetes, Cancer, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a digital weight management program combined with a continuous glucose monitor can help manage type 2 diabetes by lowering blood sugar levels (HbA1c). Participants will use a digital platform, WW (Weight Watchers), to access weekly workshops, track food and activity, and use a glucose monitor. Ideal candidates have had type 2 diabetes for at least two years and are willing to make diet and lifestyle changes. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance diabetes management strategies.

Will I have to stop taking my current medications?

The trial requires that you be on a stable regimen of medications that can affect weight or diabetes outcomes for at least 3 months before joining. This means you should not stop taking your current medications if they are stable and related to weight or diabetes management.

What prior data suggests that this digital weight management and glucose monitoring solution is safe for adults with type 2 diabetes?

Research has shown that the WW (Weight Watchers) program is generally safe for people with Type 2 diabetes. One study examined real-world data and found that adults who joined the program experienced no major safety issues. Another study compared the WW program to other diabetes prevention programs and found significant improvements in participants without major side effects. These findings suggest that the WW program is safe and effective for weight and diabetes management. Overall, studies indicate that using the WW program alongside a glucose monitoring system is a safe option for people with Type 2 diabetes, with no reports of serious problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the WW Intervention for managing Type 2 Diabetes because it combines digital weight management with continuous glucose monitoring, offering a holistic approach to the condition. Unlike traditional methods that might focus solely on medication or diet changes, this treatment uses the WW App and Virtual Workshops to promote healthy habits in food, activity, mindset, and sleep, tailored specifically for those with diabetes. Additionally, the inclusion of the FreeStyle Libre 2 Flash Glucose Monitoring System allows for real-time glucose tracking, empowering participants to make informed lifestyle choices. This comprehensive approach could potentially lead to better overall diabetes management and improved quality of life.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Research has shown that the WW program, specially adapted for people with type 2 diabetes (T2D), can help control blood sugar and promote weight loss. One study found that participants experienced significant improvements in managing their blood sugar levels. On average, they lost 21% of their body weight over 12 months, which is substantial. Weight loss is important because extra weight can worsen diabetes symptoms. In this trial, participants in the WW Intervention arm will use the program along with a continuous glucose monitor (CGM) to track their blood sugar in real-time, potentially leading to better diabetes management. Overall, these findings suggest that the WW program could be a helpful tool for people with T2D who want to improve their health. ^{3 4 6 7 8}

Who Is on the 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

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the intervention arm will receive a 12-month access to the WW program, including weekly Virtual Workshops and use of the WW App plus FreeStyle Libre 2 continuous glucose sensors.

12 months

Weekly virtual workshops

Follow-up

Participants are monitored for changes in HbA1c, glucose variability, and other health metrics at 6 and 12 months.

12 months

Assessments at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• WW Intervention

Trial Overview The 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.

How Is the Trial Designed?

Group I: WW Intervention Experimental Treatment 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials

314

Recruited

183,000+

WW International Inc

Industry Sponsor

Trials

25

Recruited

5,300+

WW International Inc.

Collaborator

Trials

5

Recruited

1,200+

Published Research Related to This Trial

The OnTrack smartphone app, designed to predict and prevent dietary lapses using machine learning, was found to be feasible and acceptable among 43 participants in an 8-week weight loss program, with high user satisfaction reported.

Participants using OnTrack experienced an average weight loss of 3.13% and a reduction in unplanned dietary lapses, indicating the app's potential effectiveness in supporting weight management efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OnTrack: development and feasibility of a smartphone app designed to predict and prevent dietary lapses. Forman, EM., Goldstein, SP., Zhang, F., et al.[2023]

A systematic review of 24 mHealth studies on obesity and diabetes treatment showed that over 50% reported positive outcomes, including weight loss and blood glucose reduction, indicating the potential effectiveness of mobile technologies in managing chronic diseases.

Despite promising results, most studies had small sample sizes and short intervention durations, highlighting the need for future research with larger groups and longer follow-up periods to better assess the long-term efficacy of mHealth interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Application and Effectiveness of mHealth Interventions for Obesity and Diabetes Treatment and Self-Management. Wang, Y., Xue, H., Huang, Y., et al.[2023]

Digital self-monitoring of diet and physical activity is effective in promoting weight loss, with a mean difference of -2.87 kg and a significant reduction in calorie intake of approximately 182 calories per day, based on a meta-analysis of 12 randomized controlled trials involving adults with obesity or overweight.

Tailored interventions that provide personalized advice were found to be significantly more effective than non-tailored approaches, highlighting the importance of customization in digital self-monitoring programs for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does self-monitoring diet and physical activity behaviors using digital technology support adults with obesity or overweight to lose weight? A systematic literature review with meta-analysis. Berry, R., Kassavou, A., Sutton, S.[2021]

A systematic review of 21 randomized controlled trials found strong evidence that mobile technology interventions can lead to short-term weight loss in overweight and obese adults, with moderate evidence for medium-term effects.

The review highlighted the importance of improving future trial reporting, suggesting that weight loss should be reported as a percentage and emphasizing the need for long-term follow-up and assessments of cost-effectiveness and patient acceptability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions employing mobile technology for overweight and obesity: an early systematic review of randomized controlled trials. Bacigalupo, R., Cudd, P., Littlewood, C., et al.[2022]

Self-reported weights in a weight loss trial showed increasing underestimation over time, with an average difference of -0.5 kg at 6 months and -1.1 kg at 24 months, indicating that participants were less accurate in reporting their weights as the study progressed.

Participants who accurately reported their weights were more likely to achieve the weight loss goal, with a 9% misclassification rate in achieving the 5% weight loss goal when using self-reported weights compared to clinic measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal accuracy of web-based self-reported weights: results from the Hopkins POWER Trial. Jerome, GJ., Dalcin, A., Coughlin, JW., et al.[2022]

Technology-based interventions for weight loss, particularly those incorporating multiple key components like self-monitoring and counselor feedback, can lead to significant weight loss compared to standard care, as shown in 13 out of 27 reviewed trials.

However, there is currently no evidence that these interventions improve quality of life, and more research is needed to determine the best ways to use technology effectively in weight loss programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-based interventions in the treatment of overweight and obesity: A systematic review. Raaijmakers, LC., Pouwels, S., Berghuis, KA., et al.[2022]

The study involved 809 Brazilian adults with overweight and obesity, using the Behaviour Change Wheel (BCW) framework to develop a web platform aimed at promoting weight loss through targeted behavior changes over a 24-week intervention.

The platform's functionalities were categorized based on the BCW components, showing that motivation-driven features were accessed the most, indicating their potential effectiveness in engaging users, while capability-driven features had lower usage, suggesting areas for improvement in behavior diagnosis and implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the Behaviour Change Wheel for Designing an Online Platform for Healthy Weight Loss - "POEmaS". Beleigoli, AM., Andrade, AQ., Diniz, MFH., et al.[2022]

The use of digital self-management solutions for Type 2 diabetes, such as DM4All and DiaWatch, led to significant improvements in metabolic outcomes, including reductions in HbA1c, body weight, blood pressure, and cholesterol levels over an average follow-up of 8 months in 100 patients.

Compared to a control group, the ProEmpower participants showed significantly better improvements in cardiovascular risk factors, highlighting the efficacy of digital technologies in enhancing diabetes management and promoting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of a digitally supported approach for self-management of type 2 diabetes mellitus. De Luca, V., Bozzetto, L., Giglio, C., et al.[2023]

Citations

1. corporate.ww.com corporate.ww.com/news/news-details/2025/WeightWatchers-for-Business-Annual-Report-Shows-Breakthrough-Weight-Loss-Results-and-Health-Outcomes/default.aspx

WeightWatchers for Business Annual Report Shows ... Superior weight loss outcomes: In a recent WeightWatchers Clinic study, members lost 21% of their body weight at 12 months, outperforming ...

2. diabetesjournals.org diabetesjournals.org/diabetes/article-xml/71/Supplement_1/567-P/145155

567-P: A Weight Management Program Tailored for Adults ... Conclusions: The widely available WW program, modified for those with T2D, had favorable and clinically meaningful effects on glycemic control, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2475299123208859

Effects on Glycemic Control, Weight, Hunger, and Quality of ... The widely available and scalable WW program, modified for those with T2D, had favorable and clinically meaningful effects on glycemic control, body weight, ...

4. business.weightwatchers.com business.weightwatchers.com/hubfs/WWHS%20B2B%202022%20(MELD)/WWHS%20Diabetes%20Trial%20Infographic_2022.pdf

13% 5.7% 9.8% 0.75 13.2% Nine in ten people living with diabetes are also living with overweight or obesity, and. 30% - 53% of new type 2 diabetes cases in the U.S. are linked to ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4985082/

Comparison of Commercial and Self-Initiated Weight Loss ... We compared the Weight Watchers weight-management program (n = 112) with Your Game Plan to Prevent Type 2 Diabetes, a program developed by the National Diabetes ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11589532/

Twelve‐month analysis of real‐world evidence from a ... This retrospective observational study analyzed real‐world data from adults who initiated AOM treatment with the WeightWatchers (WW) Clinic telehealth program.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01601574

Weight Loss Study for People With Type 2 Diabetes The purpose of this study is to determine whether the Weight Watchers program modified for use by people with Type 2 diabetes results in more improvements ...

8. web.musc.edu web.musc.edu/about/news-center/2016/11/02/study-puts-weight-watchers-to-the-test-for-type-2-diabetes

Study puts Weight Watchers to the test for Type 2 diabetes The multi-site study's results were statistically and clinically significant, O'Neil said. “The Weight Watchers people were significantly better ...