Senseonics strutted out some promising results from a clinical study of its Eversense system, a 180-day continuous glucose monitor sensor.
The Germantown, MD-based company showed off data from the PROMISE study during an oral presentation at the 14th Annual International Conference on Advanced Technologies and Treatments of Diabetes Meeting. The company said results were presented for both the primary sensor and for a secondary sensor with modified chemistry referred to as the SBA sensor.
In the study 181 patients at eight sites across the U.S. had a primary sensor inserted subcutaneously in their left upper arm; 43 of these participants also had the SBA sensor inserted in their right arm.
Participants underwent 10 clinic visits between days 1 to 180 to measure accuracy by comparing the sensor glucose values with the standard reference YSI glucose values obtained simultaneously. Subjects also underwent hypoglycemia and hyperglycemia challenges to assess performance over the glucose range of 40-400 mg/dL, the reporting range of the device.
Results show overall 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.
Other results show:
Across the full 40-400 mg/dL range, the agreement rate was 92.9% for the primary sensor and 93.9% for the SBA sensor.
In 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.
Confirmed hypoglycemic alert detection rate was 93% for primary sensor and 94% for the SBA sensor.
There 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.
“We are very pleased with the results of the PROMISE Study which demonstrate an excellent safety and accuracy profile for the 180-day sensor. This study was initiated December 2018 and we’re very grateful to the tireless Clinical Investigators and the devoted study subjects for participating in this important clinical trial,” said Tim Goodnow, PhD, President and CEO of Senseonics. “As we await hearing from the US and European regulatory agencies concerning our pre-market submissions of data from both the primary and the SBA sensors, we are pleased to continue to offer the Eversense CGM systems in both the US and Europe with our commercialization partner, Ascensia Diabetes Care.”