Fridley, Minnesota-based Medtronic presented new data from the study of MiniMed 780G with the no-calibration, non-adjunctive Guardian 4 sensor at the Advanced Technologies & Treatments for Diabetes (ATTD) Conference in Barcelona.
Data demonstrated sustained improvements in glycemic outcomes that met or exceeded consensus guideline recommendations of 70% time in range with less user interaction and fewer fingerstick calibrations, according to a news release.
Time in range registered at 72.8%, with adults averaging 76.3% and children between seven and 17 years old averaging 70.7%. No episodes of diabetic ketoacidosis (DKA) or severe hypoglycemia occurred, while the average time spent in advanced hybrid closed loop mode came in at more than 90% across all age groups.
Medtronic began the pivotal study of the advanced hybrid closed loop (AHCL) system in 2019 and the study concluded in 2021, at which point participants were offered the opportunity to stay on the product as part of the extended study phase. The extension covers 176 participants aged between seven and 75 years old.
Study participants did not have to calibrate their sensor at a minimum of twice per day due to the transition from the previous generation Guardian 3 sensor to the next-generation Guardian 4. Even with fewer calibrations, participants achieved glycemic targets similar to those observed in the trial of the AHCL system with Guardian 3, Medtronic said.
MiniMed 780G with Guardian 4 is available in more than 40 countries and is under review by the FDA for U.S. approval. However, earlier this year, CEO Geoff Martha said there was some uncertainty over approval timing for Medtronic’s next-generation platforms, including the MiniMed 780G insulin pump and Guardian 4 CGM sensor, as a result of a December 2021, FDA warning letter highlighting inadequacies in specific medical device quality system requirements at its diabetes business’ Northridge, California, facility.
