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

NCT05121844 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 195165
• Study Type: interventional
• Target: 31,187
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

health and wellness; excess adiposity

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• 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.

• 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.

Study Arms (1)

Signos digital health app and CGM

EXPERIMENTAL

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

Device: Continuous Glucose Monitor Device

Interventions

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.

Also known as: CGM

Signos digital health app and CGM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Signos Inc: lead

Study Sites (1)

Signos

Palo Alto, California, 94306, United States

Location

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MeSH Terms

Conditions

Weight Loss; Metabolic Syndrome; Glucose Intolerance; Obesity, Abdominal; Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia; Obesity; Overweight; Overnutrition; Nutrition Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open label single arm study

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 16, 2021
• Study Start: November 2, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)