Most of the diabetes products we thought would be introduced in 2013 did not make it to the U.S. market. We’re optimistic that some of those products will be available this year. Some, however, like Abbott’s Navigator 2 CGM, still seem far off.
The new technologies and treatments making their appearance in 2014 means it will be an exciting year in diabetes care and management. Everything from an insulin pump that promises to be the first step in the development of an artificial pancreas, to an expansion of drugs already available offer new ways to both type 1 and type 2 diabetics to take better control of their diabetes, and their lives.
Medtronic’s MiniMed 530G with Threshold Suspend
Following FDA approval in September 2013, Medtronic will introduce to the United States the first insulin pump that shuts off if a wearer’s blood sugar goes low (Threshold Suspend or Low Glucose Suspend). The MiniMed 530G automatically ceases delivering insulin to the wearer if the wearer’s blood sugar reaches a personally predetermined, preset level between 60 and 90. This is especially useful in avoiding nighttime low blood sugar episodes when a person might not be able to hear or respond to a threshold alarm. The pump shuts itself off for up to two hours, during which time boluses cannot be delivered, although basal insulin delivery can be restarted. Medtronic (and some reporters who cover the diabetes industry) are touting the 530G as one of the first steps in development of an artificial pancreas; a project that will undoubtedly take years to complete and bring to market, but is at least getting a boost in 2014.
Threshold Suspend has been available since 2012 on Medronic’s Minimed VEO insulin pump outside the U.S.
J&J’s Animas Vibe: Will We See it in the U.S. This Year?
After being approved in Europe in 2011 (first using the old Dexcom 7 sensor and now available with the new Dexcom G4), we had hoped to see the Animas Vibe in the U.S. following the approval of the Dexcom G4 CGM System.
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.
Johnson & Johnson submitted the Animas Vibe for FDA approval in April, 2013. So there is hope that this long awaited product will be available sometime in 2014.
The PaQ: An Insulin Pump for People with Type 2 Diabetes
The PaQ is an insulin pump designed for people with type 2 diabetes who might want to use insulin, but are deterred from the treatment option by the idea of taking multiple daily injections. Approved in Europe and awaiting regulatory approval in the United States, the small pump can be worn for up to three days. According to CeQur, the Switzerland-based company that makes the PaQ, the device holds up to 330 units of fast-acting insulin. This diabetes product has seven preset basal rates, push button bolus delivery, and can be worn in water to a depth up to six feet.
Novo Nordisk’s NovoPen Echo
Novo Nordisk is introducing the NovoPen Echo with a proprietary feature that not only records the time and dose amount when delivered, but also allows injections in half-unit increments. The pen is specially designed to appeal to children, and not only because it keep s a record of last doses that busy children might not recall. The pen is designed to be cool looking. It comes in red and blue but also has many “skins,” or graphically intense overlays available, giving kids a ton of changeable options to customize their pens to their personal tastes and preferences.
The NovoPen Echo was approved by the FDA in August 2013 and is expected to hit the U.S. market in early 2014. The NovoPen Echo is already available in Europe, Canada, and Israel.
Afrezza: An Ultra-Rapid-Acting Inhaled Insulin
The system delivers what the company calls an “ultra rapid-acting mealtime insulin therapy” to be taken in conjunction with food by either type 1 or type 2 diabetics. The inhalable powder is delivered in premeasured, single use cartridges by using a proprietary inhaler that fits comfortably into the palm of your hand.
MannKind resubmitted it’s New Drug Application to the FDA in October and the FDA is expected to finish its review of Afrezza by April 2014.
New SGL-2 and GLP-1 Treatments: Empagliflozin, Dulaglutide and Forxiga (Dapagliflozin)
New SGLT-2 and GLP-1 products from major pharmaceutical companies could signal a greater acceptance and higher use of such treatments in 2014.
The drug maker Eli Lilly is seeking approval for both an SGLT-2 inhibitor called Empagliflozin that works to remove glucose from the blood stream through the kidneys (of the same drug class as Johnson & Johnson’s Invokana), and the GLP-1 agonist Dulaglutide, which works to increase insulin production and sensitivity.
Likewise, partners AstraZeneca and Bristol-Myers Squibb have resubmitted an application for approval of the SGLT-2 Forxiga (Dapagliflozin) after providing the results of additional clinical trials to the Food and Drug Administration, as requested.
Forxiga (Dapagliflozin) was the first SGLT-2 to be approved outside the U.S. and is currently available in Europe and Australia.
Both these classes of treatment are intended for type 2 diabetics, although applications for type 1 diabetes are being explored.
Still Waiting for the Dario Glucose Meter
LabStyle Innovations’ Dario is an all-in-one system that can make managing your diabetes easier and more convenient. This was one of the diabetes products that really caught our eye last year. It’s not only a blood glucose meter with a built-in lancing device that includes a compartment storing up to 25 test strips, but it also interacts with your smartphone.
A breakaway section of the device connects to your smartphone via the headphone connection and you’re connected to a Dario app. Once connected, you just add blood to the test strip and, presto! The results then appear on your phone. From there at the touch of a button you can share the results with friends, family, medical professionals, and others. We expected this product to be available in 2013, but it is noe expected to be available in early 2014 in Europe, and LabStyle Innovations predicts the device will make its debut in the United States later in the year.
Read more on the Dario Glucose Meter.
ShugaTrak: An App For Sharing Blood Glucose Results
ShugaTrak is a new mobile app for people with diabetes that, at the start of 2014, is already available. When someone with diabetes checks blood glucose, ShugaTrak gets the reading from the meter using a Bluetooth adaptor, stores it in an online database, and transmits it to interested parties like family and friends in text messages and emails. This all happens immediately, and the person with diabetes doesn’t have to do anything beyond an ordinary blood glucose check. Shugatrak gives peace of mind to parents, spouses, and adult children of people with diabetes by informing them of their loved ones’ blood glucose readings when they are apart.