Abstract
Previously, the safety and accuracy of the Eversense continuous glucose monitoring (CGM) system were characterized in three pivotal trials among individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D) with a single 90- or 180-day sensor insertion–removal cycle. The Post-Market Clinical Follow-up (PMCF) registry is a prospective study evaluating the long-term safety and performance of the Eversense CGM system over multiple sensor insertion–removal cycles among adults with T1D and T2D. All patients who had a sensor subcutaneously implanted across 534 participating centers in Europe and South Africa from June 2016 to August 2018 were enrolled. Adverse events (AEs) were recorded at each visit and patients were instructed to inform their clinic if they experienced any AEs between visits. AEs were adjudicated for relatedness to the device, procedure, or drug (dexamethasone acetate). The primary safety endpoint was the rate of related serious adverse events (SAEs) through four sensor insertion–removal cycles. The registry enrolled 3023 patients. As of last follow-up, 5417 sensors had been inserted with a total of 1260 patient-years (PYs) of follow-up: 969 patients had used the system for at least 6 months and 173 patients had used the system for at least 1 year. No related SAEs were reported. The most frequently reported related AEs were sensor location site infection (0.96%; 2.46 events per 100 PYs), inability to remove the sensor upon first attempt (0.76%; 1.90 events per 100 PYs), and adhesive patch location site irritation (0.66%; 1.59 events per 100 PYs). One nonserious allergic reaction to lidocaine was reported, which resolved with administration of an antihistamine. The full intended sensor life was achieved by 91% of 90-day sensors and 75% of 180-day sensors. The PMCF registry provides real-world evidence that the Eversense CGM system is safe over multiple cycles of use.
Highlights
IntroductionThe fully implantable fluorescence-based Eversense continuous glucose monitoring (CGM) system was designed to address several of the limitations of traditional CGM systems
Continuous glucose monitoring (CGM) systems improve glycemic control and reduce the incidence and duration of hypoglycemia among patients with type 1 diabetes (T1D) and type 2 diabetes (T2D).[1,2,3,4] the uptake of traditional transcutaneous continuous glucose monitoring (CGM) systems has substantially increased in recent years, alternative solutions are needed to address the reasons why patients either do not start CGM or discontinue after the first year.[5,6,7]The fully implantable fluorescence-based Eversense CGM system was designed to address several of the limitations of traditional CGM systems
The safety and accuracy of the Eversense continuous glucose monitoring (CGM) system were characterized in three pivotal trials among individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D) with a single 90- or 180-day sensor insertion–removal cycle
Summary
The fully implantable fluorescence-based Eversense CGM system was designed to address several of the limitations of traditional CGM systems. Regulatory approval in Europe and the United States was based on three pivotal clinical studies, which evaluated the accuracy and safety of the system over a single insertion– removal cycle up to 180 days (PRECISE) or up to 90 days (PRECISE II and PRECISION). These studies enrolled 206 patients who had 335 sensor insertion–removal cycles and were followed for a cumulative total of 61 patient-years (PYs).[8,9,10]
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