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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05121844
• Other study ID #: 195165
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2021
• Est. completion date: November 1, 2027

Study information

• Verified date: May 2023
• Source: Signos Inc
• Contact: Study Administration
• Phone: 6502634502
• Email: clinicaltrials[@]signos.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: November 1, 2027
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Obesity
• Glucose Intolerance
• Glucose Metabolism Disorders
• Metabolic Glucose Disorders
• Metabolic Syndrome
• Obesity, Abdominal
• Pre-diabetes
• Prediabetic State
• Weight Loss

Intervention

Device:
• Continuous Glucose Monitor 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.

Locations

Country	Name	City	State
United States	Signos	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Signos Inc

Country where clinical trial is conducted

United States, 

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* Note: There are 51 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average fasting glucose	Daily fasting glucose, averaged periodically	During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years.
Primary	Change in weight	Change in number of pounds	During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years.
Secondary	Body composition	User input data including percentage of body fat or other measurements of 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.
Secondary	Time in range	percentage of time spent "in range" glucose level less than 140 or as determined by other parameters	During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years.