ROME GS System Study

Recruiting N/A Interventional Study
Diabetes Diabetes Melletus, Type 1 Diabetes Mellitus, Type 2
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
60 (estimated)
Sponsor
Senseonics, Inc. · Industry
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About This Trial

The purpose of this clinical investigation is to demonstrate that the proposed physical changes to the ROME GS Sensor do not have any adverse impact on safety and performance when compared to the Eversense 365 Sensor.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: Subjects meeting all of the following inclusion criteria will be included in this study: 1. Subjects ≥18 years of age 2. Clinically confirmed diagnosis of diabetes mellitus for ≥1 year 3. Subject has signed an informed consent form (ICF) and is willing to comply with protocol r…
Contacts

Maggie Lewis

667-218-3309

maggie.lewis@senseonics.com

CONTACT

Susan Huynh

301-407-2923

susan.huynh@senseonics.com

CONTACT