Use of Continuous Glucose Monitoring in Non-Diabetic Population to Compliment Signos Mobile Health Platform
NCT ID: NCT05121844
Last Updated: 2025-08-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
31187 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-11-02
Study Completion Date
2027-11-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Weight Loss
Metabolic Syndrome
Pre-diabetes
Central Obesity
Glucose Intolerance
Metabolic Glucose Disorders
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Open label single arm study
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Signos digital health app and CGM
For all consented participants, the Signos app will use CGM data to provide recommendations customized to users for promoting general health and wellness.
Group Type
EXPERIMENTAL
Continuous Glucose Monitor Device
Intervention Type
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.
Interventions
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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.
Intervention Type
DEVICE
Other Intervention Names
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CGM
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Signos Inc
INDUSTRY
Sponsor Role
lead
Responsible Party
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Stephanie Kim, M.D., MPH
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Signos
Palo Alto, California, United States
Site Status
Countries
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United States
References
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Other Identifiers
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195165
Identifier Type: -
Identifier Source: org_study_id
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