Signos DM2 Empowerment Study (SIGNOS-CGM-EMPOWER-201-2022)
NCT05874635 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20000
Last updated 2025-08-29
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.
Conditions
- Weight Loss
- Metabolic Syndrome
- Diabetes Mellitus, Type 2
- Central Obesity
- Insulin Resistance
- Glucose Intolerance
- Metabolic Glucose Disorders
Interventions
- 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.
Sponsors & Collaborators
-
Signos Inc
lead INDUSTRY
Principal Investigators
-
Stephanie Kim, MD · Signos Inc
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-05-11
- Primary Completion
- 2028-05-10
- Completion
- 2029-05-10
- FDA Device
- Yes
Countries
- United States
Study Locations
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