A number of exciting and innovative diabetes products were introduced to the market in 2012, including a few new glucose meters, Abbott’s InsuLinx Blood Glucose Monitoring, the OneTouch Verio IQ, and the first iPhone compatible glucose meter, the iBGStar. This year also brought the first touchscreen insulin pump, Tandem’s t:slim, and the long anticipated improved continuous glucose monitoring system, the Dexcom G4, came to market in November.
Not all of the diabetes products that we expected to be available in 2012 made it to market, but we hope that some of them will be approved in 2013 and will soon after be available in the U.S.
Here are some of the diabetes products we’re hoping will become available in 2013:
Receiving FDA 501(k) clearance earlier this month, Insulet’s Next-Generation OmniPod System is comprised of a smaller pod and an updated personal diabetes manager (PDM). The new OmniPod insulin pump is more than one-third smaller and one-quarter lighter than the original model (34% smaller, 25% lighter and 16% slimmer), while maintaining the same 200-unit insulin reservoir capacity and easy-to-use features.
My impression upon seeing this new pod was that the slimness is its greatest advantage. The pod also has a new pink slide insert, which is visible through its top, which helps you verify that the cannula has deployed.
The new PDM has some enhanced functionalities, which are designed to improve the existing system. The PDM status screen now always shows details about your current insulin on board (IOB). Correction and meal boluses are used to calculate your IOB when the suggested bolus calculator is on. Another improvement in the next-generation OmniPod is the increased communication distance between the PDM and pod during regular use – up to 5 ft.
The FDA clearance means that Insulet can begin manufacturing and selling the new OmniPod in the U.S., so we can expect to see it during the first half of 2013.
The new pod (with the old PDM) has been available outside the U.S. since 2011.
Animas Vibe Insulin Pump and CGM System
Johnson&Johnson’s CGM-enabled Animas Vibe, has been available out side the U.S. since 2011, first using the old Dexcom 7 sensor and now available with the new Dexcom G4. Following the long awaited FDA approval of the Dexcom G4, there’s hope that the CGM-enabled Animas Vibe will finally make its way to the U.S.
For anyone not familiar with the CGM-enabled Vibe, it’s an insulin pump that combines state-of-the-art Dexcom G4 sensing technology with all the features of the Animas pump. The Vibe is durable and waterproof and has a color screen which, like the Dexcom G4, shows where your glucose is headed and how fast using color trend arrows and lines. The color-coded trend lines (blue, red, or green) indicate that glucose levels are low, high, or within the target range relative to the low and high alerts set in the pump. You can also customize alerts to tell you when you’re going high or low. The Vibe has a non-adjustable hypo safety alert set at 55 mg/dl.
We don’t know when this diabetes product will be available in the U.S. but when it is it will definitely give Medtronic a little competition.
Medtronic’s Enlite Sensor
Speaking of Medtronic, here is a long awaited diabetes product, which has been available outside the U.S. since 2011 and has been awaiting FDA approval.
According to Medtronic, Enlite combines greater comfort with improved glucose sensor performance in both overall accuracy and hypo detection.
The new sensor is 69% smaller than the current CGM sensor and is, according to Medtronic, much more accurate. The Enlite has a life span of 6 days bringing it into the range of the DexCom.
Abbott’s New Navigator 2 Continuous Glucose Meter
Another new product we can only hope will make it to the U.S. is the new Navigator 2 Continuous Glucose Meter by Abbott. After Abbott pulled the previous Navigator from the market following supply issues it is unknown if the company intends to introduce this new product to the U.S. We do, however, know that one U.S. study was completed although the results have not yet been published. The Navigator 2 has been launched discreetly in a few European countries.
The Navigator 2’s wireless receiver is 40% smaller than the original Navigator. It has an illuminated color display, which allows direct access to past, current and expected blood sugar trends.
The blood sugar levels are measured once a minute and the value shown on the Navigator 2’s screen (on the right) is an average of the last 10 one-minute measurements. The new Navigator 2, like the old one, also displays a trend arrow showing the direction in which blood sugar is heading.
The sensor of the Navigator 2 is smaller than the previous model, and works for up to 5 days, less than both the Dexcom G4 and the new Medtronic Enlite.
The Navigator 2’s transmitter has a 30 meter range which is almost 100 feet, meaning you can leave it in the next room and still stay in range. It also includes a built in glucose meter, which uses FreeStyle Lite strips.
Next Generation Tandem t:slim Integrated with Dexcom G4
One of the more exciting diabetes products to hit the market last year was Tandem’s t:slim insulin Pump.
Last year, before the t:slim was introduced, San Diego based companies Dexcom and Tandem signed an agreement which would allow Tandem to integrate Dexcom’s technology into next generation Tandem pumps. Does the recent FDA approval of the Dexcom G4 mean that we may soon be seeing something new out of San Diego?
Cellnovo Mobile Patch Pump
After receiving CE approval in 2011, we hoped to see the first mobile patch pump out (in Europe, at least) by now. The good news is that, Cellnovo, the UK-based company behind the system signed a production agreement, in October, with Flextronics Medical for the production of their intriguing mobile diabetes management system.
The Cellnovo mobile diabetes management system is comprised of two parts – handset and pump.
The slim, discreet patch pump has no buttons or a physical connection to a control unit and allows its user to choose where and how to wear it.
The pump is rechargeable and each system comes with two pumps and a recharging station so that there is always a Cellnovo pump primed and ready. Users can also choose to have long or very short infusion tubes, allowing the infusion site to be somewhere other than where the pump is worn.
The smartphone looking handset with a touch color screen, controls the pump wirelessly. It also has a built-in blood glucose monitor and a mobile data connection to the Cellnovo web portal. Mobile connectivity ensures that real-time information is available anytime and anywhere for patients, family and clinicians.
The handset runs a series of apps to help the user keep track of diet, insulin, blood glucose and exercise. Physical activity is even recorded automatically from a sensor in the pump.
We hope to see this pump on the market in 2013, at least in Europe. We don’t know when it will cross the Atlantic, but it is worth waiting for.
Dario Glucose Meter
The Dario Glucose Meter turns a smartphone into a blood glucose meter. This unique diabetes product is an integrated unit that includes a basic adapter designed to connect to the audio jack of a smartphone. When the adapter is connected, a measurement is transmitted to the smartphone, turning the phone into a glucose monitor. The Dario also includes a built-in lancing device loaded with disposable lancets and an integrated cartridge holding and dispensing 25 test strips.
For a closer look at the Dario click here.
The makers of Dario expect the device to receive the CE mark in early 2013 and it should be available in Europe soon after. Although the Dario has not been submitted to the FDA yet, they expect the Dario to be available in the U.S. in the near future.