Medtronic Gets FDA Approval of CGMs For Kids and Launches a New Guardian
Medtronic has received FDA approval for pediatric models of both of its REAL-Time continuous glucose monitors, the MiniMed Paradigm REAL-Time System and the Guardian REAL-Time System. Previously approved only for adults, both pediatric models will be appropriate for kids ages 7-17.
Medtronic’s also just released its new Guardian REAL-Time CGM, which has a rechargeable waterproof transmitter about a third the size of the previous one. It also comes with new software that integrates meter, logbook, and CGM data so that patients can see the effect of diet, exercise, medication, and lifestyle on their blood sugar.
According to Medtronic, clinical studies have shown that CGMs can shorten low blood sugar events and lower A1c’s by up to two percentage points. The company asserts that up to 60 percent of low blood glucose events are not detected by current glucose monitoring standards.
Medtronic believes, however, that wide insurance coverage for continuous glucose monitors is still a few years off. The company plans clinical studies to demonstrate the cost effectiveness of the technology, but expects it to take two or three years before there is widespread reimbursement for the monitor.