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

• Published in: Diabetes care Vol. 40; no. 1; pp. 63 - 68
• Main Authors: Kropff, Jort, Choudhary, Pratik, Neupane, Sankalpa, Barnard, Katharine, Bain, Steve C, Kapitza, Christoph, Forst, Thomas, Link, Manuela, Dehennis, Andrew, DeVries, J Hans
• Format: Journal Article
• Language: English
• Published: United States American Diabetes Association 01.01.2017
• Subjects: Accuracy; Adult; Blood Glucose - analysis; Blood Glucose Self-Monitoring - instrumentation; Blood Glucose Self-Monitoring - methods; Clinical trials; Diabetes; Diabetes Mellitus, Type 1 - blood; Diabetes Mellitus, Type 1 - complications; Diabetes Mellitus, Type 1 - drug therapy; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - complications; Diabetes Mellitus, Type 2 - drug therapy; Female; Glucose; Humans; Hypoglycemia - diagnosis; Hypoglycemia - etiology; Hypoglycemic Agents - therapeutic use; Infusion Pumps, Implantable; Insulin Infusion Systems; Longevity; Male; Middle Aged; Monitoring systems; Prospective Studies; Reference Values; Reproducibility of Results; Transplants & implants
• ISSN: 0149-5992; 1935-5548
• DOI: 10.2337/dc16-1525

It 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. We 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. The 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. Our results indicate the safety and accuracy of this new type of implantable CGM system and support it as an alternative for transcutaneous CGM.