Metabolic Syndrome Clinical Trial
Official title:
Use of Continuous Glucose Monitoring in Non-Diabetic Population to Compliment Signos Mobile Health Platform: Comprehensive Weight Optimization Program and Customized Lifestyle Modifications
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.
Status | Recruiting |
Enrollment | 100000 |
Est. completion date | November 1, 2027 |
Est. primary completion date | November 1, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Signos | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Signos Inc |
United States,
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* Note: There are 51 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average fasting glucose | Daily fasting glucose, averaged periodically | During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years. | |
Primary | Change in weight | Change in number of pounds | During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years. | |
Secondary | Body composition | User input data including percentage of body fat or other measurements of 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. | |
Secondary | Time in range | percentage of time spent "in range" glucose level less than 140 or as determined by other parameters | During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years. |
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