FDA Approves Pediatric Use for Dexcom’s G4 Platinum CGM
By Adam Brown
On February 4, Dexcom announced FDA approval of the G4 Platinum CGM for children 2-17 years old in the United States. Dexcom’s G4 Platinum was previously approved in October 2012, but only for patients above 18 years old – learn more about the G4 Platinum in our test drive of the CGM here. It is great news to hear about more choices for children and teenagers interested in CGM, since the technology is so beneficial for avoiding hypoglycemia and improving time in range. The recently approved MiniMed 530G with Enlite CGM is only labeled for people 16 years and older, although patients 7-15 years old can use the Medtronic Paradigm Revel system with Sof-sensor.
The pediatric version of the G4 Platinum will have an identical sensor to the adult CGM, and the only difference will be two additional warning screens included for extra safety. Some younger patients may already use the G4 Platinum “off label,” but it can be difficult to receive access – providers are sometimes hesitant to prescribe off label and reimbursement is more challenging.
Last July, Dexcom also filed for FDA approval of the Dexcom Share remote monitoring system; a response is expected from the agency in the first half of 2014. The launch will hopefully occur sometime this year if all goes well. As a reminder, Share will use a cradle to send G4 Platinum CGM data and alerts to an app on up to five selected recipients’ smartphones. To learn more about how it works, please read our new now next here. The device should offer peace of mind to parents and caregivers, especially when children are at school and when loved ones are traveling alone. Dexcom’s first insulin pump integration – the Animas Vibe – is also currently under FDA review. A US launch could hopefully occur this year if no major regulatory roadblocks are encountered. –NL/AB
