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Senseonics Announces Results of the PROMISE Study Demonstrating Strong Accuracy of 180 Day CGM Sensor
-Overall MARD of 8.5%-9.1% during 180 Day Period GERMANTOWN, Md.--(BUSINESS WIRE)-- Senseonics Holdings, Inc. (NYSE-American: SENS), a medical technology
About this update from Senseonics Holdings, Inc.
[{"type":"text","content":"\n-Overall MARD of 8.5%-9.1% during 180 Day Period\n\n GERMANTOWN, Md.--(BUSINESS WIRE)--\nSenseonics Holdings, Inc. (NYSE-American: SENS), a medical technology company focused on the development and commercialization of the first and only long-term, implantable continuous glucose monitoring (CGM) system – the Eversense® CGM System – today announced the results of the PROMISE Study evaluating the accuracy and safety of the next generation Eversense CGM System for up to 180 days with reduced calibrations. The data was presented by Satish Garg, MD, Professor of Medicine at the Barbara Davis Center of the University of Colorado, Denver, and the study group Principal Investigator (PI), as an oral presentation at the 14th Annual ATTD Meeting. Results were presented for both the primary sensor and for a secondary sensor with modified chemistry (referred to as the SBA sensor) in a subset of study participants.\n\n“The value of CGM for patients with diabetes, especially those requiring insulin, is unquestioned,” said study PI, Dr. Satish Garg. “To enable more patients to utilize CGM, there needs to be choice in product features. The accuracy profile demonstrated by Eversense in the PROMISE Study validates the role that long-term implantable CGM systems can play in helping people manage their glucose levels.”\n\nStudy results:\n\n\nOverall mean absolute relative difference (MARD) against reference value was 9.1% for the primary sensor over 49,000 paired points and 8.5% for the SBA sensor over 12,000 paired points.\n\n\nThe percent sensor readings within 20 mg/dL or 20% of reference values (20/20% agreement rate) were as follows:\n\n\nAcross the full 40-400 mg/dL range, the agreement rate was 92.9% for the primary sensor and 93.9% for the SBA sensor.\n\n\nIn the hypoglycemic ranges of 40-60 mg/dL and 61-80 mg/dL, the agreement rates were 89.4% and 92.2% for the primary sensor and 96.5% and 96.8% for the SBA sensor, respectively.\n\n\n\n\nConfirmed hypoglycemic alert detection rate was 93% for primary sensor and 94% for the SBA sensor.\n\n\nThere were no related serious adverse events, all sensors were removed during the initial removal procedure and 1.1% of patients had a mild infection at the procedure site.\n\n\n“We are very pleased with the results of the PROMISE Study which demonstrate an excellent safety and accuracy profile for the ...