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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05874635 on ClinicalTrials.gov