ROME GS sensor comparison with Eversense 365 for continuous glucose monitoring

ROME GS System Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of the ROME GS System

This study will test whether the redesigned ROME GS glucose sensor is as safe and accurate as the Eversense 365 in adults with diabetes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Senseonics, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 4 sites (Escondido, California and 3 other locations)
• Trial ID: NCT07518004 on ClinicalTrials.gov

What this trial studies

This is a prospective, non-randomized, multi-center comparison of the ROME GS continuous glucose monitoring (CGM) system versus the Eversense 365 sensor. The trial will measure ROME GS glucose readings against a reference glucose analyzer to determine accuracy and will track device- and insertion/removal-related serious adverse events. Participants are adults with diabetes who undergo sensor insertion and follow-up visits at study sites. The goal is to show that the proposed physical changes to the ROME GS sensor do not adversely affect safety or performance compared with the existing Eversense 365 device.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18 years) with type 1 or type 2 diabetes diagnosed at least one year ago who can give informed consent and comply with study visits.

Not a fit: Patients with a recent history (past 6 months) of unexplained severe hypoglycemia or DKA, those with gastroparesis, and pregnant or lactating women of childbearing potential not using birth control are excluded and likely would not benefit from participation.

Why it matters

Potential benefit: If successful, patients could gain access to a redesigned ROME GS sensor option that matches the safety and accuracy of the Eversense 365.

How similar studies have performed: Longer-term implantable CGM systems such as the Eversense family have demonstrated accuracy and safety in prior studies, so this trial tests a modification of an established approach.

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 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.

Where this trial is running

Escondido, California and 3 other locations

• Headlands Research - AMCR Institute — Escondido, California, United States (Recruiting)
• Flourish Research - Diablo Clinical Research — Walnut Creek, California, United States (Not_yet_recruiting)
• Flourish Research - San Antonio — San Antonio, Texas, United States (Recruiting)
• Rainier Clinical Research Center — Renton, Washington, United States (Recruiting)

Study contacts

• Study coordinator: Maggie Lewis

Conditions Diabetes; Diabetes Melletus, Type 1; Diabetes Mellitus, Type 2