Actively Recruiting
ROME GS System Study
Led by Senseonics, Inc. · Updated on 2026-04-21
60
Participants Needed
4
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ROME GS System Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Clinical diagnosis of diabetes mellitus for at least 1 year
- Signed informed consent form and willingness to follow study requirements
You will not qualify if you...
- History of unexplained severe hypoglycemia causing loss of consciousness or seizures within 6 months
- History of diabetic ketoacidosis requiring emergency or hospital visit within 6 months
- Diagnosis of gastroparesis
- Female of childbearing potential who is pregnant, lactating, intends to become pregnant, or not using birth control
- Conditions preventing sensor placement, operation, removal, or transmitter use, including arm deformities or skin issues
- Symptomatic coronary artery disease, unstable angina, recent heart attack, stroke, uncontrolled high blood pressure, heart failure, or cardiac arrhythmia (except benign PACs/PVCs)
- Hematocrit less than 38% or greater than 60% at screening
- History of hepatitis B, hepatitis C, or HIV
- Current seizure disorder treatment without neurologist clearance
- History of adrenal insufficiency
- Current or likely need for immunosuppressants, chemotherapy, anticoagulants (except aspirin), topical glucocorticoids over sensor site only, or antibiotics for chronic infection
- Need or likely need for MRI
- Known allergy to topical/local anesthetics or glucocorticoids
- Any condition making participation unsafe or not in best interest, including psychiatric conditions or substance abuse
- Participation in another drug or device clinical trial within 2 weeks prior or intention during study
- Presence of active implanted devices (e.g., implantable defibrillator); passive devices allowed
- Use of FDA-approved Eversense CGM System not provided by study is not allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Headlands Research - AMCR Institute
Escondido, California, United States, 92025
Actively Recruiting
2
Flourish Research - Diablo Clinical Research
Walnut Creek, California, United States, 94598
Not Yet Recruiting
3
Flourish Research - San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
4
Rainier Clinical Research Center
Renton, Washington, United States, 98057
Actively Recruiting
Research Team
M
Maggie Lewis
CONTACT
S
Susan Huynh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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