ACTIVE_NOT_RECRUITING

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

Conditions

Weight Loss Metabolic Syndrome Pre-diabetes Central Obesity Glucose Intolerance Metabolic Glucose Disorders health and wellness excess adiposity

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-11-02

Study Completion:2027-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05121844

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Locations (Sites)

Signos

Palo Alto, California, 94306

United States

Collaborators and Investigators

Sponsor: Signos Inc

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 Registration Dates

Study Start Date2021-11-02

Study Completion Date2027-11-01

Study Record Updates

Study Start Date2021-11-02

Study Completion Date2027-11-01

Terms related to this study

Keywords Provided by Researchers

health and wellness
excess adiposity

Additional Relevant MeSH Terms

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