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

Pennington Biomedical Research Center152 enrolled

Overview

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.

This study is a 12-month, two-arm, parallel controlled trial. A total of 152 adults with overweight or obesity and type 2 diabetes were 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

152

Conditions

Diabetes Mellitus Type 2 Diabetes Obesity

Interventions

WW InterventionBEHAVIORAL

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.

Usual CareBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (3)

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

Outcomes

Primary Outcomes

Change in HbA1c% at 6 months

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

Time frame: Baseline to 6 months

Secondary Outcomes

Change in HbA1c% at 12 months

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

Time frame: Baseline and 12 months

Percent weight loss at 6 months

Body weight is measured using standard methods with the patient wearing light clothing

Time frame: Baseline and 6 months

Percent weight loss at 12 months

Body weight is measured using standard methods with the patient wearing light clothing

Time frame: Baseline and 12 months

Change in systolic blood pressure at 6 months

Systolic blood pressure is measured using standard clinical methods

Time frame: Baseline and 6 months

Change in systolic blood pressure at 12 months

Systolic blood pressure is measured using standard clinical methods

Time frame: Baseline and 12 months

Change in diastolic blood pressure at 6 months

Diastolic blood pressure is measured using standard clinical methods

Time frame: Baseline and 6 months

Change in diastolic blood pressure at 12 months

Diastolic blood pressure is measured using standard clinical methods

Data from ClinicalTrials.gov

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