Medtronic has collected a European approval that allows it to combine its latest automated insulin pump with its newest glucose sensor for the first time.
The CE mark covers the MiniMed 780G pump and the Simplera Sync system, which the medtech giant describes as a disposable, all-in-one blood sugar sensor that takes less than 10 seconds to insert under the skin while requiring no fingersticks.
The company said it plans to begin making the package available in Europe, for people with diabetes aged 7 and up, through a limited release starting spring 2024, with phases of its commercial launch growing throughout the summer. Currently, the MiniMed 780G system can be used with Medtronic’s Guardian 4 sensor.
The company previously received a CE Mark last September for its Simplera CGM, used in connection with its InPen smart insulin pen; Medtronic said the updated Simplera Sync system is made to have a similar look and feel as its sibling while being designed to work better with the MiniMed’s dosing algorithms. The Simplera Sync sensor has not yet been approved in the U.S., while the Simplera CGM is under review by the FDA.
“A challenging aspect of living with diabetes is counting carbohydrates and dosing the right amount of insulin before consuming snacks and meals. Many people underestimate their carbs, which can lead to high blood sugars (hyperglycemia),” Robert Vigersky, chief medical officer of Medtronic’s diabetes division, said in a statement. “Prolonged hyperglycemia can lead to serious health problems impacting the eyes, major organs, and even cognitive function, which is particularly concerning in developing children.”
“With its responsive algorithm, the MiniMed 780G system can help people living with diabetes even when they occasionally forget to bolus or undercount their carbs,” Vigersky added. “The system takes on more of the work involved in diabetes management and helps alleviate mental burden.”
According to Medtronic, the MiniMed 780G checks glucose levels and adjusts its insulin delivery every five minutes. Previous studies of the hybrid closed-loop system, along with its meal-detection algorithm, have shown drops in HbA1C levels and gains in the amount of time spent in a healthy blood sugar range, including in children and teenagers with Type 1 diabetes.
“We’re incredibly proud that the MiniMed 780G system continues to be the most widely used automated insulin delivery system in Europe since we launched it in 2020. Real-world data on over 100,000 users on the system across many geographies and cultures shows that when using recommended settings the system is delivering an average time in range of nearly 80%, raising the bar on what ‘good’ looks like,” said Medtronic Diabetes President Que Dallara.
During Medtronic’s investor presentation at the J.P. Morgan Healthcare Conference in San Francisco, CEO Geoff Martha described the global tech-powered diabetes space—including automated insulin delivery systems, wearable patches and pumps—as a $6 billion-plus opportunity, and fast-growing share of users.
“The market for intensive-insulin patients is shifting from one that is primarily standalone CGM with multi-daily injections today, to one that is smart dosing,” Martha said.
“By the end of the decade, we believe smart dosing systems will be the technology used by the majority of the market,” he added. “No company is as well-positioned to go after this opportunity than Medtronic, given our insulin delivery devices including pumps and pens today, as well as a patch system that’s under development, in addition to our CGM sensors and leading algorithms.”
Martha also said that Medtronic has completed enrolling participants into a U.S. study for the Simplera Sync sensor, and plans to submit the device for FDA review in the first half of this year.