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

May 16, 2023 updated by: Stephanie Kim, M.D., MPH, Signos Inc

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Study Population

Study population will include adults over the age of 18 who desire to lose weight or optimize body composition, who are generally healthy, who have a smartphone and ability to use it, and are willing to interact with a digital health application in pursuit of improved health.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • CGM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Signos Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2021

Primary Completion (Anticipated)

November 1, 2026

Study Completion (Anticipated)

November 1, 2027

Study Registration Dates

First Submitted

November 4, 2021

First Submitted That Met QC Criteria

November 4, 2021

First Posted (Actual)

November 16, 2021

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 195165

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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