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- Title
Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial.
- Authors
Kropff, Jort; Choudhary, Pratik; Neupane, Sankalpa; Barnard, Katharine; Bain, Steve C.; Kapitza, Christoph; Forst, Thomas; Link, Manuela; Dehennis, Andrew; DeVries, J. Hans
- Abstract
<bold>Objective: </bold>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.<bold>Research Design and Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>Our results indicate the safety and accuracy of this new type of implantable CGM system and support it as an alternative for transcutaneous CGM.
- Subjects
GLUCOSE in the body; HYPOGLYCEMIC agents; HYPOGLYCEMIA; BLOOD sugar; TYPE 2 diabetes; BLOOD sugar analysis; TYPE 2 diabetes complications; BLOOD sugar monitoring; CLINICAL trials; COMPARATIVE studies; DRUG infusion pumps; INSULIN pumps; TYPE 1 diabetes; LONGEVITY; LONGITUDINAL method; RESEARCH methodology; MEDICAL cooperation; REFERENCE values; RESEARCH; RESEARCH evaluation; EVALUATION research; DISEASE complications; EQUIPMENT &; supplies; DIAGNOSIS
- Publication
Diabetes Care, 2017, Vol 40, Issue 1, p63
- ISSN
0149-5992
- Publication type
journal article
- DOI
10.2337/dc16-1525