Irish medical technology firm Medtronic has commenced the pivotal study of its next-generation Guardian continuous glucose monitoring (CGM) sensor.
Image: Medtronic has started pivotal study of next-generation Guardian CGM sensor. Photo: courtesy of Medtronic.
Guardian study has been designed to enhance accuracy and overall system performance, reduce sensor calibrations and improve overall user experience.
The company will recruit up to 460 participants with type one or type two diabetes aged two to 80 years old in the multi-center and prospective trial.
Medtronic will randomly assign study participants to sensor wear location and testing days and times.
Medtronic diabetes group research and development vice president Ali Dianaty said: “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.
“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.”
The objective of the study is to show the performance of the Guardian CGM sensor with an advanced algorithm in subjects aged between two and years for the span of 170 hours (seven days).
According to the US National Library of Medicine’s ClinicalTrials.gov, the safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
The study co-principal investigator Dr Bruce Bode said: “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.”
The Guardian Connect CGM’s sensor can be worn up to seven days and a slim, discreet Bluetooth transmitter can be worn almost anywhere on the body.
CareLink personal therapy management software will automatically upload Guardian Connect CGM data, helping to make treatment plan with healthcare provider.
Guardian Connect CGM system will link with the Sugar.IQ smart diabetes assistant, which supercharges the system.
With over 90,000 employees, Medtronic serves physicians, hospitals and patients in over 150 countries.