Medtronic kicks off pivotal trials for Guardian CGM, hybrid closed-loop pump
Medtronic announced at the American Diabetes Association 79th Scientific Sessions in San Francisco that it has initiated its pivotal trial for its next-generation Guardian continuous glucose monitoring sensor.
The multi-center, prospective trial will study the CGM sensor in up to 460 participants who have Type 1 or Type 2 diabetes and are ages two to 80 years old over a seven day period. Sensor location on the participants will be randomly assigned.
Medtronic’s CGM sensor is designed to improve accuracy and system performance while reducing sensor calibration and enhancing overall user experience.
“We are very excited about this next-generation CGM sensor as it is designed to require calibrations only on the first day of wear, reducing fingersticks by 95% over our current CGM,” Ali Dianaty, VP of research and development for the diabetes group at Medtronic, said in a press release. “We strongly believe calibration on the first day of wear is necessary to improve day one performance, which we know from physician and patient feedback is a challenge for all sensors. Our research shows this day one performance is critical for keeping patients safe in a hybrid closed loop, or Auto Mode, which we know from real-world experience delivers the optimal Time in Range for patients on insulin therapy.”