On Thurday June 3rd, Senseonics (SENS), a company that engages in the design, development, and commercialization of implantable continuous glucose monitoring system for people with diabetes, announced that it’s 180-day CGM system shows strong accuracy.
The study results are:
- 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.
- The percent sensor readings within 20 mg/dL or 20% of reference values (20/20% agreement rate) were as follows:
- 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. 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.
Tim Goodnow – CEO of Senseonics
Senseonics (SENS) rises 30% after hours
This is great news for Senseonics, this will only quicken FDA approval for their 180-day CGM System.
Senseonics is also planning on working on a 365-day system later this year.
