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OpenTrials
Active, Not Recruiting

NCT Number: NCT05121844

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: CGM

Primary outcomes

  1. Average fasting glucose

    Time frame: 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

  2. Change in weight

    Time frame: 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 outcomes

  1. Body composition

    Time frame: 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

  2. Time in range

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Signos Inc

Industry

Registry information

Official study title

Use of Continuous Glucose Monitoring in Non-Diabetic Population to Compliment Signos Mobile Health Platform: Comprehensive Weight Optimization Program and Customized Lifestyle Modifications

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Nov 16, 2021
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.