Using continuous glucose monitoring to help manage weight in people with type 2 diabetes
Use of Signos mHealth Platform in Participants With Non-Insulin Dependent Type 2 Diabetes: Weight and Blood Glucose
This study tests if using a continuous glucose monitor along with a mobile app can help people with type 2 diabetes manage their weight better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Signos Inc Industry-sponsored |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT05874635 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the effectiveness of continuous glucose monitoring (CGM) combined with a mobile health application, Signos, to assist individuals with type 2 diabetes who are not using insulin in achieving their weight management goals. Participants will be enrolled to utilize the CGM device and the Signos app to track their glucose levels and receive personalized feedback to promote healthier eating and exercise habits. The study focuses on optimizing wellness and body composition through behavioral changes facilitated by technology. It is designed as a minimal risk intervention for eligible participants.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and above with a medical diagnosis of type 2 diabetes who are not using insulin and are willing to engage with mobile health technology.
Not a fit: Patients with type 1 diabetes, those currently using insulin, or individuals with severe hypoglycemia or eating disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved weight management and overall health for individuals with type 2 diabetes.
How similar studies have performed: Previous studies have shown that continuous glucose monitoring can lead to positive behavioral changes in diabetes management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Medical diagnosis of Type 2 Diabetes; determined by review of subject-provided most recent Hg A1c. * Subject is under current care of a primary care provider or specialist * Clearance by medical provider to participate in diet, physical activity, and lifestyle changes * 18 years and above * Own a smartphone and be willing to install the Signos App to personally receive text messages or have access to a web-based survey to self-report their weight. * Willingness to complete quality of life questionnaires or other in-app surveys. * Willingness to use CGM device * Able to speak and read English * Be a Signos mHealth (mobile/web-based) user Exclusion Criteria: * Medical diagnosis of Type 1 Diabetes * Type 2 Diabetes currently using insulin or most recent A1c ≥10% * Severe hypoglycemia \<54 mg/dl resulting in seizure or unconsciousness, or requiring assistance/EMS/hospitalization - within 3 months prior to enrollment * Current medical diagnosis of an eating disorder (such as anorexia nervosa or bulimia) * Medical conditions (e.g., such as seizure disorder) requiring a specific medical diet. * Inborn error of metabolism such as phenylketonuria (PKU), glycogen storage disease, fructose intolerance, Maple Sugar Urine Disease (MSUD). * 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: Clozapine, Hydroxyurea, or any form of insulin.
Where this trial is running
Palo Alto, California
- Signos — Palo Alto, California, United States (Recruiting)
Study contacts
- Principal investigator: Stephanie Kim, MD — Signos Inc
- 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.