Improving Glycemic Control Using a Virtual Weight Control Program and Continuous Glucose Monitoring in Adults With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 6
- 主要终点
- Change in HbA1c% at 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
排除标准
- •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
研究组 & 干预措施
WW Intervention
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.
干预措施: WW Intervention (Behavioral)
Usual Care
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.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Change in HbA1c% at 6 months
时间窗: Baseline to 6 months
Hemoglobin A1c levels (%) are measured using standard laboratory methods
次要结局
- Percentage of patients achieving 5% weight loss at 12 months(Baseline and 12 months)
- Change in systolic blood pressure at 12 months(Baseline and 12 months)
- Change in diastolic blood pressure at 6 months(Baseline and 6 months)
- Change in diabetes distress at 6 months(Baseline and 6 months)
- Percent weight loss at 12 months(Baseline and 12 months)
- Change in systolic blood pressure at 6 months(Baseline and 6 months)
- Percentage of patients achieving 10% weight loss at 12 months(Baseline and 12 months)
- Change in diabetes distress at 12 months(Baseline and 12 months)
- Change in diabetes treatment satisfaction at 6 months(Baseline and 6 months)
- Change in diabetes treatment satisfaction at 12 months(Baseline and 12 months)
- Change in quality of life at 12 months(Baseline and 12 months)
- Change in HbA1c% at 12 months(Baseline and 12 months)
- Percent weight loss at 6 months(Baseline and 6 months)
- Percentage of patients achieving 3% weight loss at 6 months(Baseline and 6 months)
- Percentage of patients achieving 10% weight loss at 6 months(Baseline and 6 months)
- Change in diastolic blood pressure at 12 months(Baseline and 12 months)
- Change in quality of life at 6 months(Baseline and 6 months)
- Percentage of patients achieving 3% weight loss at 12 months(Baseline and 12 months)
- Percentage of patients achieving 5% weight loss at 6 months(Baseline and 6 months)
研究者
Peter T. Katzmarzyk
Professor
Pennington Biomedical Research Center