Dexcom Share approved by FDA and Available Online Now - Paves Way for G5

Twitter summary: FDA approves Dexcom Share for remote monitoring of G4 Platinum CGM; data sent to 5 followers Apple devices

Today, the FDA approved Dexcom Share, a remote monitoring system for the Dexcom G4 Platinum CGM. The product allows CGM data to be sent to up to five designated followers’ Apple devices. The Share device costs $299, and is available for purchase on the Dexcom website (it begins shipping on Wednesday).  It does not require a prescription to receive. You can watch a neat video on the product here. Here’s how it works:

• The G4 Platinum receiver plugs into the Dexcom Share docking cradle.

• The Share cradle (plugged into a power outlet) both charges the receiver and transmits CGM data every five minutes to a nearby iPhone or iPod touch via Bluetooth.

• The Dexcom Share app on the nearby smartphone then receives the CGM data and sends it up to a secure internet server. Once there, the data can be shared with up to five followers’ Apple devices.

Patients are able to invite individuals to receive their CGM data by sending an invitation from the Share app on their iPhone or iPod Touch (Android is in development). Those invited can download a free app called ‘Dexcom Follow’. These followers are then able to receive alerts and notifications for high and low glucose levels, as well as to view CGM values and trends on demand. This is especially welcome news for parents and partners, who are often just as interested in the glucose numbers as patients themselves.  The notifications are completely programmable – e.g., a follower could choose not to be notified of a 200 mg/dl excursion after breakfast, but to get all hypoglycemia notifications. This is a dream for many who have relied on asking patients for data in the past – Share can help eliminate the challenging conversation, “What’s your number?!” The system could offer the most benefits at night, allowing parents and partners to know their loved one’s glucose levels every five minutes from another room, another state, or another country!

Perhaps most importantly, Dexcom Share paves the way for Dexcom’s exciting Gen 5 mobile system, which will send CGM data straight from a new on-body transmitter to a mobile app – no receiver cradle required. Gen 5 will use much of the same backend software architecture as Share, meaning the FDA review will ideally go much smoother. For context, the FDA review of Share took a lengthy 15 months. Dexcom plans to submit Gen 5 to the FDA in late 2014 or early 2015. 

Prior to the approval of Share, some patients in the Nightscout/CGM in the Cloud group have built do-it-yourself software/hardware to take Dexcom CGM data and send it the cloud and smartphones in real-time – see Kerri Sparling’s review here. Nightscout and Share do have some fundamental differences – level of setup, expense, FDA approval, etc. – but we think those points of difference are far less important than the overall message Share’s launch brings to the diabetes community: a new solution to help patients and caregivers monitor their glucose levels with more peace of mind. – NL/AB