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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Glycemic Control Using a Virtual Weight Control Program and Continuous Glucose Monitoring in Adults With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2 Diabetes, Obesity

Intervention / Treatment
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* Behavioral: WW Intervention
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WW Intervention<br>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<br>* 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.<br>|
| Active Comparator: Usual Care<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c% at 6 months | Hemoglobin A1c levels (%) are measured using standard laboratory methods | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c% at 12 months | Hemoglobin A1c levels (%) are measured using standard laboratory methods | Baseline and 12 months | 
| Percent weight loss at 6 months | Body weight is measured using standard methods with the patient wearing light clothing | Baseline and 6 months | 
| Percent weight loss at 12 months | Body weight is measured using standard methods with the patient wearing light clothing | Baseline and 12 months | 
| Change in systolic blood pressure at 6 months | Systolic blood pressure is measured using standard clinical methods | Baseline and 6 months | 
| Change in systolic blood pressure at 12 months | Systolic blood pressure is measured using standard clinical methods | Baseline and 12 months | 
| Change in diastolic blood pressure at 6 months | Diastolic blood pressure is measured using standard clinical methods | Baseline and 6 months | 
| Change in diastolic blood pressure at 12 months | Diastolic blood pressure is measured using standard clinical methods | Baseline and 12 months | 
| Change in diabetes distress at 6 months | The Diabetes Distress Scale (DDS-17) contains 17 total items with 4 subscales: Emotional Burden (items 1, 3, 8, 11, 14), Physician-related distress (items 2, 4, 9, 15), Regimen-related distress (items 5, 6, 10, 12, 16), and Interpersonal distress (7, 13, 17). The total score is calculated by taking an average of participant responses to all 17 items. In the same manner, each subscale can have its own score by taking an average of subscale specific participant responses. A mean item score of 3 or higher is considered moderate distress and a level of distress worthy of clinical attention. The Diabetes Distress scale has been tested for reliability and validity in US based populations and abroad. | Baseline and 6 months | 
| Change in diabetes distress at 12 months | The Diabetes Distress Scale (DDS-17) contains 17 total items with 4 subscales: Emotional Burden (items 1, 3, 8, 11, 14), Physician-related distress (items 2, 4, 9, 15), Regimen-related distress (items 5, 6, 10, 12, 16), and Interpersonal distress (7, 13, 17). The total score is calculated by taking an average of participant responses to all 17 items. In the same manner, each subscale can have its own score by taking an average of subscale specific participant responses. A mean item score of 3 or higher is considered moderate distress and a level of distress worthy of clinical attention. The Diabetes Distress scale has been tested for reliability and validity in US based populations and abroad. | Baseline and 12 months | 
| Change in diabetes treatment satisfaction at 6 months | This survey is an 8-item survey that measures satisfaction of treatment plan for diabetes that includes use of medications, diet, and lifestyle change methods. DTSQ is not only used for comparisons between different treatment strategies but also used to assess quality of diabetes care in clinical settings. Each question is scored from zero to six, and the scores are summed, with higher scores indicating higher treatment satisfaction. | Baseline and 6 months | 
| Change in diabetes treatment satisfaction at 12 months | This survey is an 8-item survey that measures satisfaction of treatment plan for diabetes that includes use of medications, diet, and lifestyle change methods. DTSQ is not only used for comparisons between different treatment strategies but also used to assess quality of diabetes care in clinical settings. Each question is scored from zero to six, and the scores are summed, with higher scores indicating higher treatment satisfaction. | Baseline and 12 months | 
| Change in quality of life at 6 months | The Impact of Weight on Quality of Life-Lite is a validated self-report measure for an individuals perception of how their weight affects their day-to-day life. There are 31 items rated on a Likert scale 5-Always True to 1-Never True. Items are broken into subscales for physical function, self-esteem, sexual life, public distress, and work. Scale scores are obtained by adding item scores, and the total score is obtained by adding scale scores. Higher scores indicate poorer quality of life. Transformed scores range from 0 to 100, with higher scores indicating greater quality of life. | Baseline and 6 months | 
| Change in quality of life at 12 months | The Impact of Weight on Quality of Life-Lite is a validated self-report measure for an individuals perception of how their weight affects their day-to-day life. There are 31 items rated on a Likert scale 5-Always True to 1-Never True. Items are broken into subscales for physical function, self-esteem, sexual life, public distress, and work. Scale scores are obtained by adding item scores, and the total score is obtained by adding scale scores. Higher scores indicate poorer quality of life. Transformed scores range from 0 to 100, with higher scores indicating greater quality of life. | Baseline and 12 months | 
| Percentage of patients achieving 3% weight loss at 6 months | Body weight is measured using standard methods with the patient wearing light clothing | Baseline and 6 months | 
| Percentage of patients achieving 3% weight loss at 12 months | Body weight is measured using standard methods with the patient wearing light clothing | Baseline and 12 months | 
| Percentage of patients achieving 5% weight loss at 6 months | Body weight is measured using standard methods with the patient wearing light clothing | Baseline and 6 months | 
| Percentage of patients achieving 5% weight loss at 12 months | Body weight is measured using standard methods with the patient wearing light clothing | Baseline and 12 months | 
| Percentage of patients achieving 10% weight loss at 6 months | Body weight is measured using standard methods with the patient wearing light clothing | Baseline and 6 months | 
| Percentage of patients achieving 10% weight loss at 12 months | Body weight is measured using standard methods with the patient wearing light clothing | Baseline and 12 months |