ROME GS sensor comparison with Eversense 365 for continuous glucose monitoring

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Headlands Research - AMCR Institute
  Escondido, California, United States Recruiting
• Flourish Research - San Antonio
  San Antonio, Texas, United States Recruiting
• Rainier Clinical Research Center
  Renton, Washington, United States Recruiting
• Flourish Research - Diablo Clinical Research
  Walnut Creek, California, United States Not yet recruiting

Study contacts

• Study coordinator: Maggie Lewis
• Email: maggie.lewis@senseonics.com
• Phone: 667-218-3309

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.