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

Signos

Status: Active, not recruiting

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

Treatments: Device: Continuous Glucose Monitor Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05121844

195165

Details and patient eligibility

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.

Full 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.

Enrollment: 31,187 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31,187 participants in 1 patient group

Signos digital health app and CGM

Experimental group

Description:

For all consented participants, the Signos app will use CGM data to provide recommendations customized to users for promoting general health and wellness.

Treatment:

Device: Continuous Glucose Monitor Device