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Behavioural Intervention

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

N/A
Recruiting
Led By Tracey L McLaughlin, MD
Research Sponsored by Pennington Biomedical Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18.0 - <70 years of age
Participant-reported diagnosis of type 2 diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 months
Awards & highlights

VITAL-CGM Trial Summary

This trial examines if a digital weight management program can help reduce diabetes symptoms in adults with type 2 diabetes.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
There may not be direct side effects from participating as this trial involves non-invasive interventions like lifestyle changes and monitoring rather than medication. However, changing diet and exercise routines could cause discomfort or fatigue.

VITAL-CGM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

VITAL-CGM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in HbA1c% at 6 months
Secondary outcome measures
Change in HbA1c% at 12 months
Change in diabetes distress at 12 months
Change in diabetes distress at 6 months
+16 more
Other outcome measures
Change in Body Mass Index at 12 months
Change in Body Mass Index at 6 months
Change in average glucose at 12 months
+55 more

VITAL-CGM Trial Design

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.

Find a Location

Who is running the clinical trial?

WW International Inc.UNKNOWN
4 Previous Clinical Trials
1,138 Total Patients Enrolled
Pennington Biomedical Research CenterLead Sponsor
305 Previous Clinical Trials
181,640 Total Patients Enrolled
Tracey L McLaughlin, MDPrincipal InvestigatorStanford University

Media Library

WW Intervention (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05935514 — N/A
Type 2 Diabetes Research Study Groups: WW Intervention, Usual Care
Type 2 Diabetes Clinical Trial 2023: WW Intervention Highlights & Side Effects. Trial Name: NCT05935514 — N/A
WW Intervention (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05935514 — N/A
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05935514 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May I be included in the proceedings of this clinical research?

"Applicants to this trial should have a pre-existing diabetes diagnosis and be between 18 - 69 years old. A total of 396 patients are being recruited in the study."

Answered by AI

How many centers are administering this research?

"4 venues are currently hosting the clinical trial, such as Pennington Biomedical Research Center in Baton Rouge and Brigham and Women's Hospital in Boston. Wake Forest University Health Sciences is also running the study from Greensboro with additional sites scattered across America."

Answered by AI

Are any openings available to volunteer for this experiment?

"The clinical trial listed on clinicaltrials.gov is not presently recruiting candidates, as it was first posted on August 1st 2023 and last updated June 29th 2023. However, there are 2,320 other trials actively taking partcipants at this time."

Answered by AI

Is this research project open to those under three-quarters of a century in age?

"Qualified applicants for this experimental medication must fall between 18 and 69 years of age."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Wake Forest University Health Sciences
Stanford University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
2
0

What questions have other patients asked about this trial?

Yes, How long is the trial and what does it consist of?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

To get help and for diabetes. My numbers still high despite taking a lot of medication like metformin, glyburide, insulin (20 units). I want to loose more weight & walking doesn’t seem to work anymore.
PatientReceived 1 prior treatment
I have been searching for something like this. I don’t have enough money since I just lost my job and need motivation to loose weight but always find myself tired. I would love to work with someone that will help me and will motivate me.
PatientReceived 1 prior treatment
I have been struggling with unstable bld sugars. I have changed my diet but am still symptomatic. I was put on ozempic but had to stop due to severe side effects. I was just recently put on jardiance . I am concerned about my bld sugars affecting my vision and kidneys.
PatientReceived no prior treatments
My readings have always been high high cholesterol blood pressure diabetic so everything just goes hand in hand my triglycerides have been over 1400 I just took blood work for that that's why I know that reading but if I can be helped with this study I surely like to try it.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Improving Glycemic Control Using a Virtual Weight Control Program and Continuous Glucose Monitoring
Peter T. Katzmarzyk 2023. "Improving Glycemic Control Using a Virtual Weight Control Program and Continuous Glucose Monitoring". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05935514.
~198 spots leftby Dec 2024
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