Improving Glycemic Control Using a Virtual Weight Control Program and Continuous Glucose Monitoring

NCT05935514 | Completed

• 1 other identifier: PBRC 2022-048
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Diabetes Mellitus; Type 2 Diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c% at 6 months

  Hemoglobin A1c levels (%) are measured using standard laboratory methods

  Baseline to 6 months

Secondary Outcomes (19)

• Change in HbA1c% at 12 months

  Baseline and 12 months

• Percent weight loss at 6 months

  Baseline and 6 months

• Percent weight loss at 12 months

  Baseline and 12 months

• Change in systolic blood pressure at 6 months

  Baseline and 6 months

• Change in systolic blood pressure at 12 months

  Baseline and 12 months

Other Outcomes (58)

• Change in Body Mass Index at 6 months

  Baseline and 6 months

• Change in Body Mass Index at 12 months

  Baseline and 12 months

• Change in waist circumference at 6 months

  Baseline and 6 months

Study Arms (2)

WW Intervention

EXPERIMENTAL

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.

Behavioral: WW Intervention

Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Usual Care

Interventions

WW Intervention BEHAVIORAL

The core of the WW food program is the Points® system which assigns each food and beverage a Points® value. Participants will be assigned a personalized daily and weekly Points® Budget, based on reported goals, and designed to create an energy deficit, using the Mifflin St-Jeor formula, which uses age, sex, height, and weight to estimate resting energy expenditure. Participants will also be provided with the FreeStyle Libre 2 Flash Glucose Monitoring System, which is intended to monitor interstitial fluid glucose levels to aid users in the management of diabetes. The System consists of the following primary components: 1) A disposable sensor that incorporates a subcutaneously implanted electrochemical glucose sensor and associated on-body electronics, and 2) A disposable, sensor application device, which is used to adhere the sensor to the skin of the user and to insert the sensor tail just below the surface of the skin.

WW Intervention

Usual Care BEHAVIORAL

The Usual Care arm will continue to receive routine medical care by their provider, in addition to a 50-minute virtual, on-line session with a Registered Dietician, with additional materials at the time of their 6- and 12-month follow-up assessments.

Usual Care

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \<70 years of age
• Participant-reported diagnosis of type 2 diabetes
• HbA1c 7.5%-11% (inclusive)
• Overweight or obesity (BMI 25-50 kg/m2 or BMI 23-50 kg/m2 if Asian or Asian American)
• On stable regimen of medications that can affect weight or diabetes outcomes for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted)
• Weight stable (+/- 5%) over previous:
• months
• Or 6 months if on medications that impact weight like GLP-1 diabetes medications.
• Willingness to attend weekly WW Virtual Workshops and Weekly Check-Ins and participate in WW Digital program
• Willingness to lose weight through a diet and lifestyle change intervention
• Access to a smartphone/tablet that can download the WW app
• Willingness to wear a continuous glucose monitor for duration of the trial
• Willing and able to provide a valid email address for use in the study
• Be able to communicate (oral and written) in English
• Be under the care of a physician who will be responsible for managing the subject's diabetes and a participant who is willing to give release to provide their treating MD with information about the trial

You may not qualify if:

• Participation in a structured, formal weight control program within the past 3 months
• Use of a continuous glucose monitor within the past 3 months (consistently for 4 weeks or more where blood sugar recordings could be seen/monitored in real time)
• Weight loss surgery (sleeve or bypass)
• History of major surgery within 6 months of enrollment
• Type 1 diabetes
• More than 1 severe hypoglycemic event (requiring emergency medical services) in the past 12 months, unless the participant's physician provides written clearance for participation
• Any history of significant kidney or liver disease or malnutrition that in investigator judgment should exclude participation
• Hemoglobinopathy that interferes with measurement of HbA1c
• Class II or higher congestive heart failure
• Unstable heart disease (an ongoing workup or treatment for a cardiac symptom such as unstable angina, coronary ischemia)
• Presence of implanted cardiac defibrillator
• Blood pressure ≥160/100 mm Hg. If a potential participant has a blood pressure ≥160/100 mm Hg it is acceptable to re-test this potential participant within one week of the original test
• Thyroid disease for which the participant is untreated or has had treatment changed within the last 6 months. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 2 months is acceptable
• Orthopedic limitations that would interfere with ability to engage in regular physical activity
• Uncontrolled gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• WW International Inc: collaborator

Study Sites (3)

Stanford University

Stanford, California, 94305, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27101, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter T Katzmarzyk, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

• Jamy D Ard, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Tracey L McLaughlin, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 7, 2023
• Study Start: August 22, 2023
• Primary Completion: October 23, 2025
• Study Completion: October 23, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data and supporting information will be available 1 year after the publication of the primary outcome paper.
• Access Criteria: Upon reasonable request to the principal investigator.

Locations

US (3)