ROME GS System Study

April 16, 2026 updated by: Senseonics, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A prospective, non-randomized, multi-center evaluation of accuracy and safety of the ROME GS system. 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. The investigation will also determine the accuracy of the ROME GS Sytem measurements compored to a reference glucose analyzer. Additionally, the study will demonstrate the safety of the ROME GS System post-sensor insertion or removal and follow-up by measuring the incidence of device-related and insertion/removal procedure-related serious adverse events during the investigation.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Escondido, California, United States, 92025
      • Walnut Creek, California, United States, 94598
        • Not yet recruiting
        • Flourish Research - Diablo Clinical Research
        • Principal Investigator:
          • Mark Christiansen, MD
        • Contact:
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Flourish Research - San Antonio
        • Contact:
        • Principal Investigator:
          • Douglas Denham, DO
        • Contact:
    • Washington
      • Renton, Washington, United States, 98057
        • Recruiting
        • Rainier Clinical Research Center
        • Principal Investigator:
          • Frances Broyles, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Continuous Glucose Monitoring Device
Eversense 365 Continuous Glucose Monitoring System and ROME GS System
Device: Continuous Glucose Monitoring System
Eversense 365 Continuous Glucose Monitoring System and ROME GS System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean absolute relative difference (MARD) for paired sensor and reference measurements post-insertion.
Time Frame: 365 days post-insertion
To determine accuracy of the ROME GS System measurements compared to a reference glucose analyzer. The effectiveness measure will be mean absolute relative difference (MARD) for paired sensor and reference measurements post-insertion for reference glucose values from 40-400 mg/dL. Effectiveness measures will be evaluated descriptively. Neither inferential analysis nor hypothesis testing will be performed.
365 days post-insertion
Number of device-related or sensor insertion/removal procedure-related serious adverse events
Time Frame: 365 days post-insertion and follow-up
Incidence of device-related or sensor insertion/removal procedure-related serious adverse events in clinic and during home use post-sensor insertion or removal and follow-up.
365 days post-insertion and follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Senseonics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP-0049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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