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

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2 Diabetes, Obesity

In brief

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.

Key facts

Study ID

NCT05935514

Run by

Pennington Biomedical Research Center

People needed

152

Starts

2023-08-22

Expected to finish

2025-10-23

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18.0 - <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:
• 3 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
• Be able to provide informed consent

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
• Current cancer or cancer treatment, or a history of cancer or cancer treatment within the last 3 years. Exceptions include 1) successfully resected non-melanoma carcinoma of the skin, 2) basal or squamous cell skin cancer, 3) stage 0 non-invasive carcinoma of the cervix, 4) stage 0 non-invasive prostate cancer
• Dementia, psychiatric illness, or substance abuse that may interfere with adherence (e.g., illness that is currently unstable or resistant to first-line therapy; substance abuse in the past year)
• History of clinically diagnosed eating disorder including anorexia nervosa or bulimia nervosa.
• Women who are pregnant, lactating, trying to become pregnant or unwilling to use an effective means of birth control
• Currently consuming >14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and unwilling to limit intake to less than 3 drinks per day during study participation
• Participation in another clinical trial within 30 days prior to enrollment
• Participation in WW anytime in the last 12 months
• Any other condition or factor which in the opinion of the study physician or investigator makes it inadvisable for the candidate to participate in the trial

Where it is running

• Stanford University — Stanford, California, United States
• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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