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
Qualifiers
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
Treatments tested in this trial
- Continuous Glucose Monitoring System
Treatment groups
60 Participants
are divided into 1 treatment groupLocations
4Headlands Research - AMCR Institute92025, EscondidoCalifornia, United States
Flourish Research - Diablo Clinical Research94598, Walnut CreekCalifornia, United States
Flourish Research - San Antonio78229, San AntonioTexas, United States
Rainier Clinical Research Center98057, RentonWashington, United States
Sponsors and collaborators
Senseonics, Inc.
Lead sponsor
Source ClinicalTrials.gov