Medtronic announced that it has initiated the company’s pivotal trial for its Guardian(TM) continuous glucose monitoring (CGM) sensor earlier last month.
The next-generation sensor is 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% over our current CGM,” said Ali Dianaty, vice president of research & development for the diabetes group at Medtronic in a statement.
“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,” he added.
For more details, including enrollment information for the trial, please visit: https://clinicaltrials.gov/ct2/show/NCT03966911
Featured image: Medtronic Guardian® REAL-Time System. Image courtesy: Medtronic.
- Medtronic. (2019, June 8). Medtronic Initiates Pivotal Trial for Next-Generation Guardian(TM) Continuous Glucose Monitoring Sensor. Retrieved June 27, 2019 from http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2400976