Medtronic Begins Pivotal Trial for Next-Gen Guardian CGM Sensor

Medtronic plc has initiated the company’s pivotal trial for its next-generation Guardian continuous glucose monitoring (CGM) sensor designed to improve accuracy and overall system performance, reduce sensor calibrations, and enhance overall user experience. The multi-center, prospective trial will study the next-generation CGM sensor in up to 460 participants with type 1 or type 2 diabetes aged two to 80 years old over the course of seven days. Study participants will be randomly assigned to sensor wear location and testing days and times.
 
“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 percent over our current CGM,” said Ali Dianaty, vice president of research & development for the Diabetes Group at Medtronic. “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 hybrid closed loop, or Auto Mode, which we know from real-world experience delivers the optimal Time in Range for patients on insulin therapy.”
 
“This is a very positive next step to enhancing the overall experience with Medtronic hybrid closed loop systems with enhanced sensors that really focus on the patient experience. It’s great to see that these advancements are being informed by robust real-world use of Medtronic therapies with an emphasis on ensuring that these important technologies are not only delivering best-in-class outcomes but also prioritizing ease of use,” said Dr. Bruce Bode, clinical associate professor at Emory University in the Department of Medicine and co-principal investigator of the study.
 
For more details, including enrollment information for the trial, please visit https://clinicaltrials.gov/ct2/show/NCT03966911