GluBill and GluAnna interviewed Steve Pacelli, Executive Vice President of Strategy and Corporate Development at Dexcom, to get his perspective on the news about FDA approval for use of the G4 Platinum sensor on pediatric patients.

What will be the biggest benefit for families with children living with type 1 diabetes in using this newly approved product for pediatrics?

Dexcom: What is most exciting for us is that for the first time, we can have our clinical and sales team proactively call on pediatric endocrinologists and nurse educators about this product. Over 90 percent of children and adolescents see an endocrinologist, which makes targeting this product much easier. We can safely get the message out there to the entire family about the value of continuous glucose monitoring for children as young as age two. This access to continuous glucose monitoring is huge for parents, as they play such an instrumental role in their care.

What were the biggest challenges you faced in getting this product approved?

Dexcom: When it comes to the FDA approval process, what they are really looking at are data sets, not products. If the data sets are good enough, they approve it. The pivotal trial for the G4 Platinum in the adult population had much more rigorous requirements for participation with forced blood sugar fluctuation to measure accuracy and blood draws every 15 minutes. The pediatric trial was much less rigorous in terms of number and range of data points captured—additionally, we saw more parental involvement and a few outlier patients at a couple sites which skewed the data. This resulted in a data set that was not as robust as the adult data, resulting in an extended review by the FDA. For example, the alarms didn’t function as well in a few patients, and a number of lows weren’t detected by the CGM. And although we are still labeled as adjunctive to finger sticks, meaning a blood glucose meter is still used for treatment decisions, we agreed with the FDA to provide additional warnings regarding our threshold alarms as you may have seen in the new labeling released just days ago. We’ve learned a lot about how to best conduct a clinical trial in children and have shared much of our learning with the FDA, so we expect to be in a position to generate data more closely resembling our adult data in the future. Ultimately, the FDA wanted more time to understand the data set and work with us to formulate appropriate labeling for the pediatric product.

With the new pediatric indication are there any new features or differences than the current G4 Platinum sensor available for adults?

Dexcom: The system itself in terms of hardware, including the receiver and transmitter, and sensors, are exactly the same as the adult version of G4 Platinum. The only difference is the addition of two warnings displayed on the receiver screen when a new sensor session is started or the alert thresholds are changed, reminding users to use their blood glucose meter for treatment decisions and to not rely solely on CGM alarms for detection of hypoglycemia.

In some children, the amount of body site availability is limited. Can you explain the flexibility in site location this provides?

Dexcom: We added an additional site location on the upper buttocks area because we know kids are smaller and often skinnier, and this area tends to have more fatty tissue versus the abdomen.

Can you discuss the reimbursement process? What will be the expected cost and what is included with the initial order?

Dexcom: I’m not sure it makes a bit of difference. We know a number of doctors have written prescriptions for pediatric patients in the past, and we have had excellent success in securing reimbursement for these patients. We expect most policies will be formally on board with coverage at the age levels that have been approved.

The pediatric approval of your CGM system has been applauded by the diabetes community. What can we look forward to seeing from Dexcom in 2014?

Dexcom: We have lot to look forward to in 2014. The Dexcom Share is a docking station device where caregivers, such as parents or spouses, will have remote viewing opportunity of a patients glucose values, trend information and threshold alarms via their iPhone. We hope to gain FDA approval and release this product in mid-2014. Our hope is that the next generation of a sensor, the “Gen5,” will not only provide significant patient convenience by enabling transmission directly from the body to the patient’s smartphone, we expect to open up a world of remote monitoring capabilities with access to one’s data via an iPhone or other mobile devices. We hope to secure FDA approval and release this toward the end of 2015, as we are still working on the regulatory and technical approval process for this product. The ultimate goal for our future products is to reduce and eventually eliminate calibration through finger sticks and rely solely on sensor technology for glucose readings. Stay tuned!

Thank you, Steve, for taking the time to talk with us about this exciting development! For more information, you can read Dexcom’s Press release here.