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

Sponsored by Signos Inc

About this trial

Last updated a year ago

Study ID

195165

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Trial Timing

Started 4 years ago

What is this trial 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.

What are the participation requirements?

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

No

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

Locations

Location

Status

Recruiting