A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II

Abstract

Background: Persistent use of real-time continuous glucose monitoring (CGM) improves diabetes control in individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D).Methods: PRECISE II was a nonrandomized, blinded, prospective, single-arm, multicenter study that evaluated the accuracy and safety of the implantable Eversense CGM system among adult participants with T1D and T2D (NCT02647905). The primary endpoint was the mean absolute relative difference (MARD) between paired Eversense and Yellow Springs Instrument (YSI) reference measurements through 90 days postinsertion for reference glucose values from 40 to 400 mg/dL. Additional endpoints included Clarke Error Grid analysis and sensor longevity. The primary safety endpoint was the incidence of device-related or sensor insertion/removal procedure-related serious adverse events (SAEs) through 90 days postinsertion.Results: Ninety participants received the CGM system. The overall MARD value against reference glucose values was 8.8% (95% confidence interval: 8.1%–9.3%), which was significantly lower than the prespecified 20% performance goal for accuracy (P < 0.0001). Ninety-three percent of CGM values were within 20/20% of reference values over the total glucose range of 40–400 mg/dL. Clarke Error Grid analysis showed 99.3% of samples in the clinically acceptable error zones A (92.8%) and B (6.5%). Ninety-one percent of sensors were functional through day 90. One related SAE (1.1%) occurred during the study for removal of a sensor.Conclusions: The PRECISE II trial demonstrated that the Eversense CGM system provided accurate glucose readings through the intended 90-day sensor life with a favorable safety profile.

ISPAD Clinical Practice Consensus Guidelines 2018: Diabetes technologies

“…In Europe, this sensor has been approved for up to 6‐months of wear, while in the United States it has been approved for up to 3‐month duration. Safety and accuracy (MARD = 11.1%) of this implantable system was demonstrated in a prospective multicenter pivotal trial, with a subsequent study demonstrating improved accuracy with a MARD of 8.8% . Implantable sensors may provide additional ease of use over standard transcutaneous CGM systems, since frequent sensor insertions through the skin are not needed.…”

“…Safety and accuracy (MARD = 11.1%) of this implantable system was demonstrated in a prospective multicenter pivotal trial, 138 with a subsequent study demonstrating improved accuracy with a MARD of 8.8%. 161 Implantable sensors may provide additional ease of use over standard transcutaneous CGM systems, since frequent sensor insertions through the skin are not needed. However, the need for implantation and removal through a minor in-clinic procedure by a trained health care professional is a significant limitation of the system, particularly in regards to its potential application in the pediatric population where there is no data available yet.…”

First assessment of the performance of an implantable continuous glucose monitoring system through 180 days in a primarily adolescent population with type 1 diabetes

“…Median sensor lifespan was 149 days (IQR 97‐180) with 82% functional through day 90 and 40% functional through day 180. The subsequent system generation included repositioning of the dexamethasone collar and updated software, and was studied in 90 adults with T1D and T2D through 90 days with a resultant MARD of 8.8% [for blood glucose (BG) 40 to 400 mg/dL] and a 15/15% metric of 86% . Ninety‐one per cent of sensors were functional through day 90.…”

“…[for blood glucose (BG) 40 to 400 mg/dL] and a 15/15% metric of 86%. 9 Ninety-one per cent of sensors were functional through day 90.…”

Surgical options for glycaemic control in Type 1 diabetes

“…The system requires calibration with capillary blood glucose every 12 hours. The mean absolute relative difference has been reported as 8.8% , suggesting better accuracy than the subcutaneous needle‐based sensors, which have a reported mean absolute relative difference of 9.0–13.6% .…”