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

Not Applicable

Recruiting

• Conditions: Pre-diabetes; Metabolic Syndrome; Glucose Intolerance; Weight Loss; Central Obesity; Metabolic Glucose Disorders
• Interventions: Device: Continuous Glucose Monitor Device

• Registration Number: NCT05121844
• Lead Sponsor: Signos Inc

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.

Study Timeline

• Study Start: 2021-11-02
• Study First Submitted: 2021-11-04
• Study First Submitted QC: 2021-11-04
• Study First Posted: 2021-11-16
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13
• Primary Completion: 2026-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Signos digital health app and CGM	Continuous Glucose Monitor Device	For all consented participants, the Signos app will use CGM data to provide recommendations customized to users for promoting general health and wellness.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Signos; 🇺🇸 Palo Alto, California, United States