Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial

Abstract

OBJECTIVEIt is known that continuous glucose monitoring (CGM) systems can lower mean glucose compared with episodic self-monitoring of blood glucose. Implantable CGM systems may provide additional benefits. RESEARCH DESIGN AND METHODSWe studied the Eversense (Senseonics Inc.) implantable CGM sensor in 71 participants aged 18 years and older with type 1 and type 2 diabetes in a 180-day multinational, multicenter pivotal trial. Participants used the CGM system at home and in the clinic. CGM accuracy was assessed during eight in-clinic visits with the mean absolute relative difference (MARD) for venous reference glucose values >4.2 mmol/L as the primary end point. Secondary end points included Clarke Error Grid Analysis and alarm performance. The primary safety outcome was device-related serious adverse events. This trial is registered with ClinicalTrials .gov, number NCT02154126. RESULTSThe MARD value against reference glucose values >4.2 mmol/L was 11.1% (95% CI 10.5, 11.7). Clarke Error Grid Analysis showed 99.2% of samples in the clinically acceptable error zones A and B. Eighty-one percent of hypoglycemic events were detected by the CGM system within 30 min. No device-related serious adverse events occurred during the study. CONCLUSIONSOur results indicate the safety and accuracy of this new type of implantable CGM system and support it as an alternative for transcutaneous CGM.People with diabetes frequently use fingerstick capillary glucose measurements to guide their dosing decisions (1). Continuous glucose monitoring (CGM) systems can provide glucose data in real time and reduce the need for fingerstick testing (2). Additionally, people with diabetes can receive temporal information, trend information, and alarms for impending hypoglycemic and hyperglycemic events (2). When used regularly, CGM can effectively lower mean glucose compared with fingerstick glucose measurements only (3). Unfortunately, wear time of current transcutaneous CGM is low in some populations, which might partially be explained

Continuous Glucose Monitoring: A Review of Recent Studies Demonstrating Improved Glycemic Outcomes

“…142 Several companies are developing prototypes of implantable sensors using a variety of techniques. We can expect continued rapid activity on that front, just as the percutaneous glucose sensors continue to improve.…”

Glucose monitoring in diabetes: from clinical studies to real‐world practice

“…Most CGM devices require calibration with capillary glucose testing, which can prove inconvenient and has the potential to affect accuracy if not conducted regularly . A recent addition to the range is the G6 CGM that does not require calibration, has high accuracy and the sensor lasts up to 10 days, although costs may limit widespread use …”

Wearable Continuous Glucose Monitoring Sensors: A Revolution in Diabetes Treatment

“…Several optical detection methods have been proposed in the literature, both for noninvasive detection, e.g., near infrared detection and Raman spectroscopy, and for implanted systems, which are instead fluorescence-based sensors [18,26]. This last category of optical sensing technique has been recently successfully applied by Senseonics (Senseonics, Inc., Germantown, MD, USA) to develop a fully implanted CGM system [22,53], the Eversense sensor, which provides real-time glucose measurements through the external coupled transmitter for an expected lifetime of six months [54]. Currently, the Eversense CGM is approved to be used in European countries only (CE mark received in 2016) with a lifetime of 90 days and an accuracy of 11.4% MARD [55].…”