RecruitingNot applicable

ROME GS System Study

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether physical changes to the ROME GS Sensor affect its safety or how well it works compared with the Eversense 365 Sensor. It is for adults who have had diabetes for at least 1 year.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • A health care provider confirmed that you have had diabetes for at least 1 year.
  • You have signed a consent form and are willing to follow the study rules.

Who can't join

  • In the past 6 months, you had unexplained low blood sugar that caused you to pass out or have a seizure, or diabetic ketoacidosis (dangerous acid buildup) that needed emergency or hospital care.
  • You have gastroparesis (slow stomach emptying), adrenal insufficiency (too little of certain hormones), or a history of hepatitis B, hepatitis C, or HIV. You are being treated for seizures without written approval from a brain and nerve doctor.
  • You can become pregnant and are pregnant, breastfeeding, planning pregnancy, or not using birth control during the study.
  • You have heart disease with symptoms, unstable chest pain, current heart failure, or a history of abnormal heart rhythms, except certain harmless extra beats. You had a heart attack, stroke, or mini-stroke within 6 months, or your blood pressure is above 160/100 at screening. Heart artery disease without symptoms requires a negative stress test within 1 year and written approval from a heart doctor.
  • Your hematocrit (the share of your blood made up of red blood cells) is below 38% or above 60%. You use or may need medicines that weaken the immune system, chemotherapy, blood-thinning medicines other than aspirin, steroid creams at the sensor site, or antibiotics for a long-term infection.
  • A condition makes placing, using, or removing the sensor or wearing the transmitter difficult. You need or may need an MRI scan, or you have an allergy to local numbing medicines or steroid medicines.
  • You have another active implanted device, such as an implanted heart shock device, or use an Eversense system not supplied by the study. Passive implants, such as heart stents, and commercial glucose sensors worn through the skin are allowed.
  • You joined another drug or device study within 2 weeks before screening or plan to join one during this study. The study doctor may also exclude you if a condition makes participation unsafe, not in your best interest, or unlikely to be completed.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (4)

CA

TX

WA