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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Signos digital health app and CGM | Experimental | For all consented participants, the Signos app will use CGM data to provide recommendations customized to users for promoting general health and wellness. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitor Device | Device | 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Signos | Palo Alto | California | 94306 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
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| 23467903 | Background | Adams OP. The impact of brief high-intensity exercise on blood glucose levels. Diabetes Metab Syndr Obes. 2013;6:113-22. doi: 10.2147/DMSO.S29222. Epub 2013 Feb 27. |
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Open label single arm study
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|
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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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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D024821 | Metabolic Syndrome |
| D018149 | Glucose Intolerance |
| D056128 | Obesity, Abdominal |
| D044882 | Glucose Metabolism Disorders |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006943 | Hyperglycemia |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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