🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT07518004
Recruiting Not applicable

ROME GS System Study

NCT07518004 · tracked via the Priya Life Science USA tracker
Sponsor
Senseonics, Inc.
Phase
Not applicable
Started
2026-02-12
Last updated
2026-04-21

Condition(s) studied

DiabetesDiabetes Melletus, Type 1Diabetes Mellitus, Type 2

Investigational drug(s) / intervention(s)

Continuous Glucose Monitoring System

Continuous Glucose Monitoring System: Eversense 365 Continuous Glucose Monitoring System and ROME GS System

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 requirements Exclusion Criteria: Subjects meeting any of the following exclusion criteria at the time of screening will be excluded from this study: 1. History of unexplained severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure 2. History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months 3. Subjects with gastroparesis 4. Female subjects of childbearing capacity (defined as of childbearing age and as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study. 5. A condition preventing or complicating the placement, operation or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition 6. Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient ischemic attack or stroke within 6 months; uncontrolled hypertension (systolic\>160 mm HG or diastolic \>100 mm Hg at time of screening); current congestive heart failure; history of cardiac arrhythmia (benign PACs and PVCs allowed). Subjects with asymptomatic coronary artery disease (e.g. CABG, stent placement or angioplasty) may participate if negative stress test within 1 year prior to screening and written clearance from Cardiologist documented. 7. Hematocrit \<38% or \>60% at screening 8. History of hepatitis B, hepatitis C, or HIV 9. Current treatment for a seizure disorder unless written clearance by neurologist to participate in study 10. History of adrenal insufficiency 11. Currently receiving (or likely to need during the study period): immunosuppressant therapy; chemotherapy; anticoagulant/antithrombotic therapy (excluding aspirin); topical glucocorticoids over sensor site only; antibiotics for chronic infection (e.g. osteomyelitis, endocarditis) 12. A condition requiring or likely to require magnetic resonance imaging (MRI) 13. Known topical or local anesthetic allergy 14. Known allergy to glucocorticoids 15. Any condition that in the investigator's opinion would make the subject unable to complete the study or would make it not in the subject's best interest to participate in the study. Conditions include but are not limited to psychiatric conditions, known current or recent alcohol abuse or drug abuse by subject history, a condition that may increase the risk of induced hypoglycemia or risk related to repeated blood testing. Investigator will supply rationale for exclusion 16. Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during study period 17. The presence of another active implanted device\* \*An example of an active implanted device includes but is not limited to an implantable defibrillator. Passive implantable devices are allowed. An example of a passive implantable device includes, but is not limited to, a cardiac stent. The use of commercial transcutaneous CGM devices (e.g. Dexcom G6/G7 CGM and Abbott Libre) are allowed and not exclusionary. Note that FDA-approved Eversense CGM System (not study provided) use will not be allowed.

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Headlands Research - AMCR Institute Escondido California Recruiting
Flourish Research - Diablo Clinical Research Walnut Creek California Not Yet Recruiting
Flourish Research - San Antonio San Antonio Texas Recruiting
Rainier Clinical Research Center Renton Washington Recruiting

More Senseonics, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07518004 on ClinicalTrials.gov ↗ ← All trials in the USA