Clinical trial NCT05935514: Improving Glycemic Control Using a Virtual Weight Control Program and Continuous Glucose Monitoring
Official title: Improving Glycemic Control Using a Virtual Weight Control Program and Continuous Glucose Monitoring in Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Type 2 Diabetes
Obesity
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: WW International Inc
First posted: 2023-07-07
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study is a 12-month, two-arm, parallel controlled trial. Up to 396 adults with overweight or obesity and type 2 diabetes will be randomized to either 1) intervention, or 2) usual care. The intervention arm will participate in the WW program modified for people with T2D including weekly Virtual Workshops and use of the WW App plus FreeStyle Libre 2 continuous glucose sensors. The WW program is a widely available, commercial weight management program that encourages healthy habits in the areas of food, activity, mindset, and sleep, with topics specific to diabetes. Participants in the usual care arm will receive their normal, usual care from their healthcare providers in addition to a session with a Registered Dietician at baseline. All participants will participate in the collection of patient-reported outcomes at baseline and at 6 and 12 months.

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 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

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 (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

Primary outcomes:
measure: Change in HbA1c% at 6 months
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in HbA1c% at 12 months
timeFrame: Baseline and 12 months
measure: Percent weight loss at 6 months
timeFrame: Baseline and 6 months
measure: Percent weight loss at 12 months
timeFrame: Baseline and 12 months
measure: Change in systolic blood pressure at 6 months
timeFrame: Baseline and 6 months
measure: Change in systolic blood pressure at 12 months
timeFrame: Baseline and 12 months
measure: Change in diastolic blood pressure at 6 months
timeFrame: Baseline and 6 months
measure: Change in diastolic blood pressure at 12 months
timeFrame: Baseline and 12 months
measure: Change in diabetes distress at 6 months
timeFrame: Baseline and 6 months
measure: Change in diabetes distress at 12 months
timeFrame: Baseline and 12 months
measure: Change in diabetes treatment satisfaction at 6 months
timeFrame: Baseline and 6 months
measure: Change in diabetes treatment satisfaction at 12 months
timeFrame: Baseline and 12 months
measure: Change in quality of life at 6 months
timeFrame: Baseline and 6 months
measure: Change in quality of life at 12 months
timeFrame: Baseline and 12 months
measure: Percentage of patients achieving 3% weight loss at 6 months
timeFrame: Baseline and 6 months
measure: Percentage of patients achieving 3% weight loss at 12 months
timeFrame: Baseline and 12 months
measure: Percentage of patients achieving 5% weight loss at 6 months
timeFrame: Baseline and 6 months
measure: Percentage of patients achieving 5% weight loss at 12 months
timeFrame: Baseline and 12 months
measure: Percentage of patients achieving 10% weight loss at 6 months
timeFrame: Baseline and 6 months
measure: Percentage of patients achieving 10% weight loss at 12 months
timeFrame: Baseline and 12 months
Other outcomes:
measure: Change in Body Mass Index at 6 months
timeFrame: Baseline and 6 months
measure: Change in Body Mass Index at 12 months
timeFrame: Baseline and 12 months
measure: Change in waist circumference at 6 months
timeFrame: Baseline and 6 months
measure: Change in waist circumference at 12 months
timeFrame: Baseline and 12 months
measure: Change in physical activity at 6 months
timeFrame: Baseline and 6 months
measure: Change in physical activity at 12 months
timeFrame: Baseline and 12 months
measure: Change in dietary intake at 6 months
timeFrame: Baseline and 6 months
measure: Change in dietary intake at 12 months
timeFrame: Baseline and 12 months
measure: Change in diabetes medications at 6 months
timeFrame: Baseline and 6 months
measure: Change in diabetes medications at 12 months
timeFrame: Baseline and 12 months
measure: Change in perceived stress at 6 months
timeFrame: Baseline and 6 months
measure: Change in perceived stress at 12 months
timeFrame: Baseline and 12 months
measure: Change in well-being at 6 months
timeFrame: Baseline and 6 months
measure: Change in well-being at 12 months
timeFrame: Baseline and 12 months
measure: Change in habit strength at 6 months
timeFrame: Baseline and 6 months
measure: Change in habit strength at 12 months
timeFrame: Baseline and 12 months
measure: Change in food cravings at 6 months
timeFrame: Baseline and 6 months
measure: Change in food cravings at 12 months
timeFrame: Baseline and 12 months
measure: Change in emotional eating at 6 months
timeFrame: Baseline and 6 months
measure: Change in emotional eating at 12 months
timeFrame: Baseline and 12 months
measure: Change in hunger at 6 months
timeFrame: Baseline and 6 months
measure: Change in hunger at 12 months
timeFrame: Baseline and 12 months
measure: Change in self compassion at 6 months
timeFrame: Baseline and 6 months
measure: Change in self compassion at 12 months
timeFrame: Baseline and 12 months
measure: Change in weight bias at 6 months
timeFrame: Baseline and 6 months
measure: Change in weight bias at 12 months
timeFrame: Baseline and 12 months
measure: Change in dietary restraint/disinhibition at 6 months
timeFrame: Baseline and 6 months
measure: Change in dietary restraint/disinhibition at 12 months
timeFrame: Baseline and 12 months
measure: Change in body appreciation at 6 months
timeFrame: Baseline and 6 months
measure: Change in body appreciation at 12 months
timeFrame: Baseline and 12 months
measure: Change in proportion of patients achieving HbA1c% <=6.5% at 6 months
timeFrame: Baseline and 6 months
measure: Change in proportion of patients achieving HbA1c% <=6.5% at 12 months
timeFrame: Baseline and 12 months
measure: Change in satisfaction and engagement with the intervention at 6 months
timeFrame: Baseline and 6 months
measure: Change in satisfaction and engagement with the intervention at 12 months
timeFrame: Baseline and 12 months
measure: Change in eating disorders at 6 months
timeFrame: Baseline and 6 months
measure: Change in eating disorders at 12 months
timeFrame: Baseline and 12 months
measure: Cost-effectiveness of the intervention at 6 months
timeFrame: Baseline and 6 months
measure: Cost-effectiveness of the intervention at 12 months
timeFrame: Baseline and 12 months
measure: Change in time in range between 70 and 180 mg/dl of glucose at 6 months
timeFrame: Baseline and 6 months
measure: Change in time in range between 70 and 180 mg/dl of glucose at 12 months
timeFrame: Baseline and 12 months
measure: Change in time in range between 70 and 140 mg/dl of glucose at 6 months
timeFrame: Baseline and 6 months
measure: Change in time in range between 70 and 140 mg/dl of glucose at 12 months
timeFrame: Baseline and 12 months
measure: Change in time in range between 140 and 180 mg/dl of glucose at 6 months
timeFrame: Baseline and 6 months
measure: Change in time in range between 140 and 180 mg/dl of glucose at 12 months
timeFrame: Baseline and 12 months
measure: Change in time spent above 180 mg/dl of glucose at 6 months
timeFrame: Baseline and 6 months
measure: Change in time spent above 180 mg/dl of glucose at 12 months
timeFrame: Baseline and 12 months
measure: Change in time spent above 250 mg/dl of glucose at 6 months
timeFrame: Baseline and 6 months
measure: Change in time spent above 250 mg/dl of glucose at 12 months
timeFrame: Baseline and 12 months
measure: Change in time spent below 70 mg/dl of glucose at 6 months
timeFrame: Baseline and 6 months
measure: Change in time spent below 70 mg/dl of glucose at 12 months
timeFrame: Baseline and 12 months
measure: Change in time spent below 54 mg/dl of glucose at 6 months
timeFrame: Baseline and 6 months
measure: Change in time spent below 54 mg/dl of glucose at 12 months
timeFrame: Baseline and 12 months
measure: Change in average glucose at 6 months
timeFrame: Baseline and 6 months
measure: Change in average glucose at 12 months
timeFrame: Baseline and 12 months
measure: Change in glucose variability (standard deviation) at 6 months
timeFrame: Baseline and 6 months
measure: Change in glucose variability (standard deviation) at 12 months
timeFrame: Baseline and 12 months
measure: Change in glucose variability (coefficient of variation) at 6 months
timeFrame: Baseline and 6 months
measure: Change in glucose variability (coefficient of variation) at 12 months
timeFrame: Baseline and 12 months
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Pennington Biomedical Research Center
name: Peter T Katzmarzyk, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Jamy D Ard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Tracey L McLaughlin, MD
role: PRINCIPAL_INVESTIGATOR
References: