>99 percent of samples in clinically acceptable error zones A and B in Clarke Error Grid Analysis
MONDAY, Nov. 14, 2016 (HealthDay News) — A new implantable continuous glucose monitoring (CGM) system seems to be safe and accurate for diabetes, according to a study published online Nov. 4 in Diabetes Care.
Jort Kropff, M.D., from the University of Amsterdam, and colleagues studied the Eversense implantable CGM sensor in 71 participants aged 18 years and older with type 1 and type 2 diabetes. Participants used the CGM system at home and in the clinic in a 180-day multinational-multicenter pivotal trail. During eight in-clinic visits, CGM accuracy was assessed with the primary end point of the mean absolute relative difference (MARD) for venous reference glucose values >4.2 mmol/L.
The researchers found that the MARD value against reference glucose values >4.2 mmol/L was 11.1 percent. Overall, 99.2 percent of samples were found to be in the clinically acceptable error zones A and B in Clarke Error Grid Analysis. The CGM system detected 81 percent of hypoglycemic events within 30 minutes. There were no device-related serious adverse events reported 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,” the authors write.
Several authors disclosed financial ties to pharmaceutical and medical device companies, including Senseonics, which manufactures Eversense.
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