DiabetesNCT07518004
ROME GS System Study
A study testing Continuous Glucose Monitoring System in people with Diabetes and Diabetes Melletus, Type 1, run by Senseonics, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Melletus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- Continuous Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 12 Feb 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects meeting all of the following inclusion criteria will be included in this study:
- Subjects ≥18 years of age
- Clinically confirmed diagnosis of diabetes mellitus for ≥1 year
- Subject has signed an informed consent form (ICF) and is willing to comply with protocol requirements
Who cannot join
- Subjects meeting any of the following exclusion criteria at the time of screening will be excluded from this study:
- History of unexplained severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure
- History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
- Subjects with gastroparesis
- 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.
- A condition preventing or complicating the placement, operation or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition
Show all 18Show fewer
- 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.
- Hematocrit <38% or >60% at screening
- History of hepatitis B, hepatitis C, or HIV
- Current treatment for a seizure disorder unless written clearance by neurologist to participate in study
- History of adrenal insufficiency
- 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)
- A condition requiring or likely to require magnetic resonance imaging (MRI)
- Known topical or local anesthetic allergy
- Known allergy to glucocorticoids
- 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
- Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during study period
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Headlands Research - AMCR Institute
Escondido, California, 92025
Jenine Yager Stone, PhD, MSN, FNP-C, 760-466-1520, jenine.yagerstone@headlandsresearchamcr.com
- Recruiting
Rainier Clinical Research Center
Renton, Washington, 98057
Tina Mitchell, 425-251-1720 ext. 313, tmitchell@rainier-research.com
Frances Broyles, MD
- Recruiting
Flourish Research - San Antonio
San Antonio, Texas, 78229
Shelbie Martin, 210-949-0122 ext. 161, smartin@flourishresearch.com
Sierra Wilson, 210-949-0122 ext. 208, swilson@cttexas.com
- Not yet recruiting
Flourish Research - Diablo Clinical Research
Walnut Creek, California, 94598
Catherine Morimoto, 925-930-7267, cmorimoto@flourishresearch.com
Mark Christiansen, MD
About this study
Official title: 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.
Read the 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.
- Being tested
- Continuous Glucose Monitoring System
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitoring SystemDevice
Eversense 365 Continuous Glucose Monitoring System and ROME GS System
| Study group | Role | What they receive |
|---|---|---|
| Continuous Glucose Monitoring Device | Experimental | Eversense 365 Continuous Glucose Monitoring System and ROME GS System Receives: Device: Continuous Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean absolute relative difference (MARD) for paired sensor and reference measurements 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.
Measured: 365 days post-insertion
Number of device-related or sensor insertion/removal procedure-related serious adverse events
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.
Measured: 365 days post-insertion and follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start12 Feb 2026
- Primary completionAug 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Senseonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518004
- Sponsor's protocol ID
- CTP-0049
- Status last verified
- Feb 2026
- First submitted
- 1 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROME GS System Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of the ROME GS System
- ClinicalTrials.gov ID
- NCT07518004
- Acronym / sponsor ID
- CTP-0049
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Senseonics, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous Glucose Monitoring Device | Experimental | Device: Continuous Glucose Monitoring SystemEversense 365 Continuous Glucose Monitoring System and ROME GS System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects ≥18 years of age
- Clinically confirmed diagnosis of diabetes mellitus for ≥1 year
- Subject has signed an informed consent form (ICF) and is willing to comply with protocol requirements
Key exclusion criteria (18 listed)
- Subjects meeting any of the following exclusion criteria at the time of screening will be excluded from this study:
- History of unexplained severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure
- History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
- Subjects with gastroparesis
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Glucose Monitoring SystemEversense 365 Continuous Glucose Monitoring System and ROME GS System | Device | Continuous Glucose Monitoring Device |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitoring System in people with Diabetes and Diabetes Melletus, Type 1, run by Senseonics, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maggie Lewis (667-218-3309, maggie.lewis@senseonics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean absolute relative difference (MARD) for paired sensor and reference measurements post-insertion. (time frame: 365 days post-insertion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.