Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial.
Journal Article (Clinical Trial;Journal Article;Multicenter Study)
OBJECTIVE: 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. RESEARCH DESIGN AND METHODS: 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. RESULTS: 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. CONCLUSIONS: Our results indicate the safety and accuracy of this new type of implantable CGM system and support it as an alternative for transcutaneous CGM.
- Kropff, J; Choudhary, P; Neupane, S; Barnard, K; Bain, SC; Kapitza, C; Forst, T; Link, M; Dehennis, A; DeVries, JH
- January 2017
Volume / Issue
- 40 / 1
Start / End Page
- 63 - 68
Electronic International Standard Serial Number (EISSN)
Digital Object Identifier (DOI)
- United States