Continuous Glucose Monitoring for Diabetes

Recruiting at 3 trial locations

Overseen By Maggie Lewis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Senseonics, Inc.

Must not be taking: Immunosuppressants, Chemotherapy, Anticoagulants, others

Disqualifiers: Severe hypoglycemia, Gastroparesis, Coronary artery disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 365 days

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

Subjects must have signed an informed consent form (ICF) and be willing to comply with protocol requirements

I have had a confirmed diagnosis of diabetes for at least one year.

I am 18 years old or older.

Exclusion Criteria

I have had unexplained severe low blood sugar causing unconsciousness or seizures in the past 6 months.

I have had diabetic ketoacidosis needing ER care or hospitalization in the last 6 months.

History of adrenal insufficiency

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the ROME GS System and Eversense 365 Continuous Glucose Monitoring System

365 days

Follow-up

Participants are monitored for safety and effectiveness after sensor insertion or removal

365 days

What Are the Treatments Tested in This Trial?

Interventions

• ROME GS System

How Is the Trial Designed?

Group I: Continuous Glucose Monitoring Device Experimental Treatment 1 Intervention

Eversense 365 Continuous Glucose Monitoring System and ROME GS System

Who Is Running the Clinical Trial?

Senseonics, Inc.

Lead Sponsor

Trials

10

Recruited

2,000+