Trials / Active Not Recruiting
Active Not RecruitingNCT05874635
Signos DM2 Empowerment Study (SIGNOS-CGM-EMPOWER-201-2022)
Use of Signos mHealth Platform in Participants With Non-Insulin Dependent Type 2 Diabetes: Weight and Blood Glucose
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20,000 (estimated)
- Sponsor
- Signos Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The use of continuous glucose monitoring (CGM) in earlier data has inspired behavioral changes leading to improved adherence to an exercise plan in individuals and eating habits in people with diabetes. Mobile health (mHealth) platforms provide satisfactory, easy-to-use tools to help participants in the pursuit of weight change goals. We hypothesize that the use of CGM data and the Signos mHealth platform will assist with weight control in a population of people with type 2 diabetes mellitus who are not using insulin.
Detailed description
The scope of this study is to enroll existing and new Signos non-insulin dependent type 2 diabetes mellitus 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.
Conditions
- Weight Loss
- Metabolic Syndrome
- Diabetes Mellitus, Type 2
- Central Obesity
- Insulin Resistance
- Glucose Intolerance
- Metabolic Glucose Disorders
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-05-11
- Primary completion
- 2028-05-10
- Completion
- 2029-05-10
- First posted
- 2023-05-25
- Last updated
- 2025-08-29
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05874635. Inclusion in this directory is not an endorsement.