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FDA approves Enlite sensor for iPro2 CGM system
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The FDA has approved the Enlite sensor for use with Medtronic’s iPro2 Professional Continuous Glucose Monitoring system, a disposable glucose sensor that can be worn for up to 6 days.
The Enlite sensor is 69% smaller than the previous Medtronic sensor and requires a shorter start-up time, the company noted in a press release. The iPro2 system, approved by the FDA in 2011, includes a small data recorder that automatically records glucose information. The CGM system also includes an algorithm-based, one-page “Pattern Snapshot” report that identifies key problem areas.
"We fundamentally believe that to improve outcomes for people with diabetes, physicians need advanced insights to optimize therapy, and people with diabetes need to understand the context behind glucose fluctuations to drive behavior change," Laura Stoltenberg, vice president and general manager for nonintensive diabetes therapies at Medtronic, said in the release. "Our focus is to continuously enhance our professional CGM solutions and improve patient and physician experience by making the systems easier to use through advancements such as the Enlite sensor and our Pattern Snapshot report."
“Having 6 days of patient data permits robust pattern analysis for more accurate decision support," Robert Vigersky, MD, medical director of nonintensive diabetes therapies at Medtronic, said in the statement. "With the insights and reports provided through professional CGM, patients can be shown the factors that are driving glucose fluctuations, so together with their doctor they can develop a plan to improve glucose control."