J&J's Animas will advance a second artificial pancreas trial
|The image illustrates components of Animas' artificial pancreas system, but not the final product--courtesy of Animas|
Johnson & Johnson's ($JNJ) Animas will advance a second feasibility study for its artificial pancreas system, after the system generated promising results from its first trial effort involving 13 adult patients with Type 1 diabetes.
"We hope to start the second study as soon as possible," Animas Chief Medical Officer Henry Anhalt told FierceMedicalDevices. "Since we have FDA approval [for the study], we anticipate starting in very short order."
As far as the company's initial feasibility study, those results were to be disclosed today at the annual American Diabetes Association Meeting in Philadelphia. In short, they learned that their device could safely and automatically predict an anticipated rise or fall in blood glucose levels, and then increase or decrease insulin levels accordingly. Doctors don't implant the device. Rather, the insulin pump, continuous glucose monitor and software that predicts blood glucose changes sits externally, connected by wire to a sensor that sits just under the skin.
So continues the race to develop an artificial pancreas system. Johnson & Johnson/Animas has an ongoing partnership with the Juvenile Diabetes Research Foundation (JDRF), but it's not the only game in town. Medtronic ($MDT), for example, recently signed its own partnership with the JDRF to boost the company's development of continuous glucose monitors for a competing artificial pancreas product. Toward that end, Medtronic recently filed a PMA application seeking FDA approval for an integrated insulin pump and continuous glucose monitor that would suspend insulin delivery if the sensor glucose value is equal to or lower than the threshold value. Animas gained its investigational device exemption in June of 2011 to begin the first of two planned feasibility studies for its closed-loop artificial pancreas system, and formed its initial partnership with the JDRF in January of 2010.
Anhalt wouldn't comment on Medtronic's effort, other than to note that it is a "reactive system" that stops insulin infusion when glucose levels hit a certain threshold. The Animas device is unique because it is predictive, he argued, predicting coming changes in glucose levels and adjusting insulin infusion proactively before the pump needs to be suspended altogether. This will help minimize patients' high and low blood sugar levels, he said.
Animas was in the news earlier this year over an FDA warning letter that cited the company for waiting several months, rather than the required 30-day timeframe, to report two incidents where patients using its insulin pumps had to be hospitalized.
- here's the release