Use of Continuous Glucose Monitoring in Non-Diabetic Population to Compliment Signos Mobile Health Platform

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Use of Continuous Glucose Monitoring in Non-Diabetic Population to Compliment Signos Mobile Health Platform: Comprehensive Weight Optimization Program and Customized Lifestyle Modifications

Conditions
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Weight Loss, Metabolic Syndrome, Pre-diabetes, Central Obesity, Glucose Intolerance, Metabolic Glucose Disorders

Intervention / Treatment
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* Device: Continuous Glucose Monitor Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open label single arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Signos digital health app and CGM<br>For all consented participants, the Signos app will use CGM data to provide recommendations customized to users for promoting general health and wellness. | Device: Continuous Glucose Monitor Device<br>* Continuous glucose monitoring automatically tracks blood glucose levels, also called blood sugar, throughout the day and night. You can see your glucose level anytime at a glance. You can also review how your glucose changes over a few hours or days to see trends. Seeing glucose levels in real time can help you make more informed decisions throughout the day about how to balance your food and physical activity.<br>* Other names: CGM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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health and wellness, excess adiposity