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

Last updated: June 11, 2024
Sponsor: Signos Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Metabolic Syndrome

Diabetes (Pediatric)

Diabetes Prevention

Treatment

Continuous Glucose Monitor Device

Clinical Study ID

NCT05121844
195165
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years and above

  • Own a smartphone and be willing to install the Signos App to use the app, receivemessages or notifications, and input weight and other data.

  • Willingness to complete questionaries or other surveys

  • Able to speak and read English

Exclusion

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 previouslystruggled with disordered eating behaviors with current BMI less than 24

  • Medical conditions (e.g., such as seizure disorder) requiring a specific medicaldiet.

  • 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) thatwould preclude a subject from safely participating in dietary recommendations and/orphysical 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 diagnoseddiabetes

  • Vulnerable populations such as minors, prisoners, or pregnant women will not beenrolled in this study. Women who become pregnant will be excluded at that time.

  • Inability or unwillingness of subject to give informed consent

Study Design

Total Participants: 100000
Treatment Group(s): 1
Primary Treatment: Continuous Glucose Monitor Device
Phase:
Study Start date:
November 02, 2021
Estimated Completion Date:
November 01, 2027

Study 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.

Connect with a study center

  • Signos

    Burlingame, California 94010
    United States

    Site Not Available

  • Signos

    Palo Alto, California 94306
    United States

    Active - Recruiting

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