ROME GS System Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSenseonics, Inc.
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Continuous Glucose Monitoring System
DeviceEversense 365 Continuous Glucose Monitoring System and ROME GS System
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Continuous Glucose Monitoring DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
365 days post-insertion2
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.
Time frame
365 days post-insertion and follow-upSponsors and contacts
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Source ClinicalTrials.gov