Use of Continuous Glucose Monitoring in Non-Diabetic Population to Compliment Signos Mobile Health Platform: Comprehensive Weight Optimization Program and Customized Lifestyle Modifications
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Signos Inc
- 入组人数
- 31,187
- 试验地点
- 2
- 主要终点
- Change in weight
研究概览
简要总结
Metabolic syndrome and resulting downstream health effects remains a growing health concern. In published trials, the use of continuous glucose monitoring (CGM) assists behavioral changes efforts, leading to improved adherence and results from diet and exercise changes in individuals with obesity, pre-diabetes and diabetes. Mobile health (mHealth) platforms provide satisfactory, easy-to-use tools that help participants in the pursuit of weight change goals. We hypothesize that the use of CGM data and targeted coaching and nutrition education will assist with weight optimization goals in the general (non-diabetic) population using the Signos mHealth platform, with associated health benefits.
详细描述
The scope of this study is to enroll existing and new Signos users in a volunteer study that utilizes a continuous glucose monitor (CGM) and mobile health application [Signos] to optimize general wellness and body weight and composition. This is a no more than minimal risk study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years and above
- •Own a smartphone and be willing to install the Signos App to use the app, receive messages or notifications, and input weight and other data.
- •Willingness to complete questionaries or other surveys
- •Able to speak and read English
排除标准
- •Medical diagnosis of Type 1 Diabetes
- •Medical diagnosis of Type 2 Diabetes
- •Current medical diagnosis of an eating disorder (anorexia or bulimia) or previously struggled with disordered eating behaviors with current BMI less than 24
- •Medical conditions (e.g., such as seizure disorder) requiring a specific medical diet.
- •Inborn errors of metabolism such as phenylketonuria (PKU), glycogen storage disease, fructose intolerance, Maple Sugar Urine Disease (MSUD).
- •Chronic or severe disease (e.g, chronic obstructive pulmonary disease [COPD], coronary artery disease, cerebrovascular accident [CVA], or cardiac arrhythmia) that would preclude a subject from safely participating in dietary recommendations and/or physical activity
- •History of Gastric bypass or other bariatric surgery
- •History of 10 or more soft tissue skin infections (such as cellulitis or abscesses)
- •Intolerable skin reaction from adhesive
- •Currently taking any of the following medications: Hydroxyurea, insulin, sulfonylureas, or medications prescribed specifically for the treatment of diagnosed diabetes
- •Vulnerable populations such as minors, prisoners, or pregnant women will not be enrolled in this study. Women who become pregnant will be excluded at that time.
- •Inability or unwillingness of subject to give informed consent
结局指标
主要结局
Change in weight
时间窗: During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years.
Change in number of pounds
Average fasting glucose
时间窗: During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years.
Daily fasting glucose, averaged periodically
次要结局
- Body composition(During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years.)
- Time in range(During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years.)
研究者
Stephanie Kim, M.D., MPH
Principal Investigator
Signos Inc