Central Obesity, Glucose Intolerance, Metabolic Glucose Disorders, Metabolic Syndrome, Pre-diabetes, Weight Loss
Conditions
Keywords
health and wellness, excess adiposity
Brief summary
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
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.
Interventions
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.
Sponsors
Signos Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label single arm study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average fasting glucose | 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 |
| Change in weight | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | percentage of time spent in range glucose level less than 140 or as determined by other parameters |
| 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. | User input data including percentage of body fat or other measurements of body composition |
Countries
United States
Outcome results
None listed