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Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial
Kropff J, Choudhary P, Neupane S, Barnard K, Bain SC, Kapitza C, Forst T, Link M, Dehennis A, DeVries JH
Editorial comment by Sarah Cvach
Continuous Glucose Monitoring (CGM) has reached a certain level of use in the diabetes population. People with diabetes frequently use fingerstick capillary measurements to guide their dosing decisions. CGM systems provide glucose data in real time and detect hyper- and hypoglycaemic events and allow receiving trend information, which would not be known with fingerstick measurements alone. People with diabetes get temporal information from some systems which are able to alarm for hypo- or hyperglycaemic events. CGM systems on the one hand reduce the need for fingerstick testing and effectively lower mean glucose, but on the other hand the wear time of current transcutaneous CGM is low in some populations. Implantable CGM systems may provide additional ease of use over transcutaneous CGM.
The current study used Eversense, an implantable CGM sensor in 71 participants with type 1 and 2 diabetes in a 180-day multinational, multicentre, pivotal trial. CGM accuracy was assessed with the mean absolute relative difference (MARD) for venous reference glucose values >4.2mmol/L (75mg/dL) as the primary endpoint. Secondary endpoints included alarm performance and Clark Error Grid Analysis. The primary safety outcome was device-related serious adverse events.
The primary efficacy outcome over the study duration showed a MARD for reference samples >4.2mmol/L (75mg/dL) of 11.1%. Eighty-one percent of hypoglycaemic events were detected by the CGM system within 30 minutes. No device-related serious adverse events occurred during the study. Clarke Error Grid Analysis showed 99.2% of samples in the clinically acceptable error zones A and B.
A quality of life questionnaire indicated a high device acceptance: “Using the system helped minimize the burden of diabetes in my life” got a 90% rating of 5 or higher on the scoring range from 1–7.
Sensor survival at day 90 was estimated to be 82%. Median sensor lifetime is 149 days.
The results seem to indicate the safety and accuracy of this new type of implantable CGM system and support it as an alternative for current transcutaneous CGM.