Using continuous glucose monitoring to help non-diabetics with weight management
Use of Continuous Glucose Monitoring in Non-Diabetic Population to Compliment Signos Mobile Health Platform: Comprehensive Weight Optimization Program and Customized Lifestyle Modifications
This study is testing if using a continuous glucose monitor along with the Signos app can help people without diabetes lose weight and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Signos Inc Industry-sponsored |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT05121844 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the effectiveness of continuous glucose monitoring (CGM) in conjunction with the Signos mobile health platform to assist non-diabetic individuals in achieving their weight loss and wellness goals. Participants will use a CGM device to track glucose levels, while receiving targeted coaching and nutrition education through the Signos app. The study will enroll both existing and new users of the Signos platform, focusing on optimizing body weight and composition with minimal risk involved. The hypothesis is that CGM data will enhance behavioral changes related to diet and exercise, leading to improved health outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and above who are interested in weight management and own a smartphone capable of using the Signos app.
Not a fit: Patients with medical diagnoses of Type 1 or Type 2 diabetes, eating disorders, or certain chronic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide non-diabetic individuals with effective tools for weight management and improved metabolic health.
How similar studies have performed: Previous studies have shown that continuous glucose monitoring can assist in behavioral changes for individuals with obesity and diabetes, suggesting potential success for this novel application in a non-diabetic population.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Palo Alto, California
- Signos — Palo Alto, California, United States (Recruiting)
Study contacts
- Study coordinator: Study Administration
- Email: clinicaltrials@signos.com
- Phone: 6502634502
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.