Continuous Sensors Approved for Children
Last year, the FDA approved Medtronic’s Guardian REAL-Time System, which reads glucose levels in the interstitial fluid every five minutes. But the device was only approved for adults 18 and over. Great news for any diabetic who can vote, but bad news for everyone else (and their parents).
But youth has now been served. On March 12, the FDA approved new REAL-Time (CGM) devices for children and adolescents ages seven to 17. Medtronic’s REAL-Time CGM will soon be available in specifically designed pediatric models of the MiniMed Paradigm REAL-Time System and Guardian REAL-Time System.
Steve Sabicer, a Medtronic spokesperson, says that CGM therapy combined with an insulin pump is the most aggressive and effective diabetes therapy available. “Parents will sleep better at night knowing that their children have added protection against dangerous high and low glucose levels,” Sabicer says. According to the company, Medtronic REAL-Time CGM therapy can reduce the duration of hypoglycemic events and can lower A1c levels by as much as two percentage points.
We bristle a little at the two points, since that wasn’t the average reduction, although some patients at very high A1c’s did see a reduction like this. We actually think it’s not all about A1c, as we have learned at meetings over the years and as Dr. Irl Hirsch told us in diaTribe #2 – it’s also about improving glycemic variability.
Of course, young patients will still face some of the same hurdles as their older counterparts. Insurers do not cover CGM therapy, so diabetics must pay out of pocket. What’s more, it remains to be seen how many grade-schoolers will want to wear a complicated sensor, which – like any new technology – requires time, patience, and trouble shooting. But at least the regulatory hurdle has been cleared.
Another hurdle for Medtronic had been the large size of the transmitter, but this also has seen vast improvement. We just discovered at Diabetes UK in Glasgow, Scotland, that the new mini-LINK transmitter has started shipping already!
CGM remains far from perfect, as we wrote in Test Drive in an earlier issue, but of course both pumps and blood glucose monitors took a long time to develop a big following; so as long as reimbursement emerges, we think CGM could still ultimately help many patients.
