November is American Diabetes Month and the American Diabetes Association offers some sobering statistics. Nearly 26 million people in the US have diabetes, and as many as one in three adults will have diabetes by 2050.
The biggest recent news is not that actor Tom Hanks has been diagnosed with type 2 diabetes. It’s that there are many exciting new developments to treat people with this group of diseases.
At the end of September, Medtronic, Inc. received FDA approval of its MiniMed® 530G with Enlite®, a first-generation “artificial pancreas” system with Threshold Suspend automation. It is designed for those with type 1 diabetes. The device includes an insulin pump and a glucose sensor that stops insulin delivery when blood glucose reaches a preset level. Its sensor can be worn for six days.
There are currently several other “artificial pancreases” under development. The article on page 25 from ZMDI describes the development of a sensor and microchip to control a continuous glucose measurement device, this one with the ability to have the sensor implanted for up to six months.
In October, Tandem Diabetes Care, Inc., which developed an insulin device, t:slim, to treat diabetics, filed for an IPO. Tandem’s product, which looks like a smartphone, utilizes a miniaturized pumping mechanism that draws insulin from a flexible bag within the pump’s cartridge rather than using a syringe and plunger mechanism.
Israel’s Cnoga Medical Ltd. has developed a blood glucose monitor that uses optical sensors to measure changes in skin color instead of a pin prick to take a sample of blood. In addition to blood sugar levels, the device can monitor heartbeat, skin resistance, and the quality of skin collagen. This “noninvasive” device is available in Europe, but will likely require a clinical trial in the US before being marketed here. However, its technology has been FDA approved for other applications.
Labstyle Innovations Corp’s Dario seeks to not only transform a smartphone into a blood glucose meter, but also to simplify an entire diabetes kit into an all-in-one device that will fit in a pocket. The system uses a tiny meter that attaches to the headphone jack in a phone. Users load the app, check their sugar, and the meter transfers the results to the phone display, and sends the data as a PDF report. Dario was granted a CE mark and approved for sale in 32 countries across Europe in September.
Last but certainly not least, on September 23, the FDA issued final guidance for developers of medical applications that run on mobile devices, like smartphones and tablets, and perform the same functions as traditional medical devices. The FDA will focus its oversight on mobile medical apps that: “are intended to be used as an accessory to a regulated medical device… or transform a mobile platform into a regulated medical device,” like functioning as the “central command” for a glucose meter. Mobile medical apps that undergo FDA review will be assessed using the same standards and risk-based approach for other medical devices.
For diabetics, these are some sweet advances, indeed.
Beth G. Sisk