Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05121844

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersAccepted
ConditionWeight Loss, Metabolic Syndrome, Pre-diabetes, Central Obesity, Glucose Intolerance, Metabolic Glucose Disorders

Full registry criteria

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

Treatments and study arms

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.

Primary outcomes

Average fasting glucoseDuring 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 weightDuring 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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Signos🇺🇸 Palo Alto, California, United States