Digital Weight Management + Glucose Monitoring for Type 2 Diabetes

(VITAL-CGM Trial)

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

152 Participants Needed

What You Need to Know Before You Apply

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.

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.

Is the digital weight management and glucose monitoring treatment safe for humans?

The research articles reviewed do not provide specific safety data for the digital weight management and glucose monitoring treatment, but they highlight the need for more studies to validate the safety and efficacy of mobile health applications for weight management. ^{1 2 3 4 5}

What makes the Digital Weight Management + Glucose Monitoring treatment unique for Type 2 Diabetes?

This treatment is unique because it combines digital weight management with glucose monitoring, using real-time data and personalized interventions to help prevent dietary lapses and improve self-management of Type 2 Diabetes. It leverages digital technologies to empower patients, promoting behavior change and motivation, which is different from traditional treatments that may not offer such personalized and immediate support. ^{6 7 8 9 10}

What data supports the effectiveness of the WW Intervention treatment for managing type 2 diabetes?

Research shows that digital health tools, like those used in the WW Intervention, can help people with obesity and diabetes lose weight and lower blood sugar levels. These tools often include self-monitoring and personalized feedback, which have been effective in supporting weight loss and improving health outcomes. ^{7 10 11 12 13}

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

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]

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]

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]

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]

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. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Application and Effectiveness of mHealth Interventions for Obesity and Diabetes Treatment and Self-Management. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Weight loss/maintenance as an effective tool for controlling type 2 diabetes: novel methodology to sustain weight reduction. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Technology-based interventions in the treatment of overweight and obesity: A systematic review. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Using the Behaviour Change Wheel for Designing an Online Platform for Healthy Weight Loss - "POEmaS". [2022]

5. England 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. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

Patterns and Predictors of Engagement With Digital Self-Monitoring During the Maintenance Phase of a Behavioral Weight Loss Program: Quantitative Study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Interventions employing mobile technology for overweight and obesity: an early systematic review of randomized controlled trials. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Smartphone applications to aid weight loss and management: current perspectives. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Using mHealth technology to enhance self-monitoring for weight loss: a randomized trial. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Longitudinal accuracy of web-based self-reported weights: results from the Hopkins POWER Trial. [2022]

11. England pubmed.ncbi.nlm.nih.gov

OnTrack: development and feasibility of a smartphone app designed to predict and prevent dietary lapses. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical outcomes of a digitally supported approach for self-management of type 2 diabetes mellitus. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Dietary assessment methods used in adult digital weight loss interventions: A systematic literature review. [2023]