Improving Glycemic Control Using a Virtual Weight Control Program and Continuous Glucose Monitoring (VITAL-CGM)
Diabetes Mellitus, Type 2 Diabetes, Obesity
About this trial
This is an interventional treatment trial for Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria: 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) 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 Exclusion Criteria: Participation in a structured, formal weight control program within the past 3 months Use of a continuous glucose monitor within the past 3 months 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
Sites / Locations
- Stanford UniversityRecruiting
- Pennington Biomedical Research CenterRecruiting
- Brigham and Women's Hospital
- Wake Forest University Health SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
WW Intervention
Usual Care
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.
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.