Enhancing Cardiometabolic Care Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change in HbA1c at 6 months from baseline
研究概览
简要总结
The goal of this study is to evaluate a digital chronic disease self-management program designed to provide virtual support and guidance for patients with type 2 diabetes.
详细描述
Approximately 45% of patients with type 2 diabetes do not achieve adequate glycemic control (A1C < 7%). When diabetes is uncontrolled, complications develop that threaten health and endanger life. This study will make an effort to address this growing health challenge and to reduce the burden of diabetes in this population. More broadly, this study will have important implications and benefits for the growing diabetes population in the U.S. Study results will inform future interventions to reduce diabetes and improve outcomes. A better understanding of the efficacy of a digital chronic disease self-management program will directly benefit the participants of the program but, in the future, has the potential to more broadly benefit this population throughout the nation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults at least 18 years of age and less than 65 years of age
- •Overweight (BMI ≥ 25 kg/m2, or BMI ≥ 23 kg/m2 if of Asian descent)
- •Uncontrolled type 2 diabetes (HbA1C ≥7.5% and ≤12%)
- •Diagnosed with type 2 diabetes at least 6 months ago, but not more than 10 years ago
- •Has a compatible smartphone running either Android Operating System 5.0 or higher, or iPhone 7 or later, running iOS 11 or higher.
- •Willing to set up an online account
- •An email address in regular use
- •Ambulatory (e.g., living at home and not in a skilled nursing facility)
- •Able to speak, understand, and read English
排除标准
- •A diagnosis of Type 1 diabetes
- •Currently pregnant or postpartum (within 4 weeks)
- •Currently using a continuous glucose monitor to manage diabetes
- •Known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin
- •Skin lesions, scarring, redness, infection or edema at the continuous glucose monitor application sites (upper arm) that could interfere with sensor placement or the accuracy of interstitial glucose measurements
- •An active eating disorder such as anorexia or bulimia (not including binge-eating disorder) for which he/she has received treatment in the past 12 months
- •Alcohol or substance abuse that impairs ability to participate in the program
- •Unable to engage in physical activity for more than 2 months over the next 6 months (i.e. due to injury or recent or planned surgery)
- •Any of the following in the past 3 months AND are not medically cleared by your physician to exercise: Transient ischemic attack or stroke; Heart attack (myocardial infarction); Hospitalization for congestive heart failure; Cardiac surgery (such as coronary artery bypass grafting (CABG), coronary artery stenting); Bariatric/gastric bypass surgery
- •Received a solid Organ Transplant (kidney, liver, etc.) within the past 6 months
- •Recent (within the last 6 months) or planned cancer treatment (chemotherapy, radiation, bone marrow transplant, cancer-related surgery - not including hormonal chemotherapy, such as tamoxifen).
- •On dialysis treatment
- •Taking steroids or prednisone (high doses) or getting cortisone injection
- •Stage 4-5 Chronic Kidney Disease
- •Class 3-4 Congestive Heart Failure
- •Participation in diabetes education in the last 30 days
研究组 & 干预措施
Matched Control
A de-identified dataset of control subjects matched on baseline demographics and clinical characteristics will be cultivated for comparison to the active intervention arm.
Online Diabetes Self-Management Education and Support (DSMES) Program
Participants will receive access to a 6-month online DSMES program that includes several components that are standard to DSMES. Participants receive online curriculum, access to a live Certified Diabetes Care and Education Specialist (CDCES), interactive group message forums, and connected devices for monitoring food intake, weight, physical activity and glucose levels.
干预措施: Online Diabetes Self-Management Education and Support (DSMES) Program (Behavioral)
结局指标
主要结局
Change in HbA1c at 6 months from baseline
时间窗: Baseline, 6 months
Non-fasting venous blood sample
次要结局
- Change in weight at 6 months from baseline(Baseline, 6 months)
- Change in medication adherence at 6 months from baseline(Baseline, 6 months)