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.
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…
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