Espicom View: The inconvenience of insulin pumps could make them fall out of favour with diabetes sufferers, while the constant recall of major products due to faults will not win potential patients' confidence. The development of alternative insulin delivery methods is an extremely competitive market; a number of key players are racing to develop artificial pancreas for the delivery of insulin, which has been touted as a potential cure for diabetes. If success is achieved in the development and eventual approval of an artificial pancreas, not only would the rewards be gargantuan, but development of infusion pump technology could significantly slow, overshadowed by a new so-called diabetes cure.
Johnson & Johnson has recalled yet another of its medical devices from the market. The FDA has issued a Class I recall of the 2020 insulin infusion pump, manufactured by J&J's Animas unit between 1st March 2012 and 30th November 2012, due to a component issue that may trigger the pumps to sound a false alarm or warning related to one of the following: "loss of prime", "occlusion", or "no cartridge detected". These alarms may prompt the user to complete the rewind, load and prime sequence to clear this alarm. Failure to follow the pump's safety instructions and disconnect the infusion set from the patient body before the "rewind, load and prime" steps can lead to unintended delivery of insulin, placing the patient in danger of potential serious health risks, such as hypoglycaemia.
The Animas 2020 insulin pump also has a software limitation that will impact the ability of the pump to function past 31st December 2015. After this date, the pump will no longer deliver insulin and will generate a "call service alarm". Animas 2020 joins the growing list of recently-recalled J&J products, including the OneTouch Verio1Q blood glucose meter, Prolift vaginal mesh for the treatment of a collapsed pelvic floor, the DePuy Orthopaedics ASR hip replacement system, and a component of the LPS revision knee system.
However, this time, J&J is not alone. A number of insulin pumps from different manufacturers have been the subject of FDA recalls in recent times. In March, Espicom reported that Symbios Medical Products' GOPump elastomeric infusion pump kit containing Dual GOPump, part number 510076, became the subject of an urgent Class I recall. The recall of the faulty part was due the possibility of the flow restrictor bead becoming displaced from its fitting, which may permit solutions to flow at a higher rate than intended. Additionally, January saw the recall of Medtronic's SynchroMed II and EL implantable infusion pumps due to a motor pump stall fault.
Furthermore, at the end of March, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued a recall of CareFusion's Alaris GP volumetric infusion pump in the UK, due to a risk of embolisation caused by the pump producing small air bubbles that are too small to trigger either the 50 to 500mcL air-in-line alarm set by the user, or the 1mL over a rolling 15 minutes alarm.
As well as this latest MHRA recall, CareFusion has had repeated run-ins with the FDA concerning the recall of certain Alaris pump models. In August 2012, Espicom reported that Alaris pump model 8100, a part used with the Alaris electronic infusion pump system, was Class I recalled by the FDA, after CareFusion received reports of customers experiencing motor stalls during infusion with the pump module. Furthermore, in August 2010, the company recalled approximately 17,000 Alaris PC model 8015 pumps, a recall that the FDA also a classified as Class I.
According to Espicom data, insulin pumps make up nearly 14 per cent, or around US$1.8 billion, of the global diabetes therapy device market, which, according to Espicom internal estimates, was worth US$12.4 billion in 2011 (latest available data). However, amid the infusion pump recall frenzy, many device manufactures are turning to the research and development of a new product, an artificial pancreas, which some industry specialists have commented could be the closest therapy to a cure for diabetes, if effective. An artificial pancreas is an innovative device that automatically monitors blood glucose and provides appropriate insulin doses in people with diabetes who use insulin.
While systems that can both continuously monitor glucose levels and administer insulin are available, fully closed-loop artificial pancreas systems remain in development. With a closed-loop system, a continuous glucose monitor (CGM) measures blood glucose levels and transmits them to an insulin pump. The pump includes computer algorithms that automatically calculate the necessary amount of insulin based on the CGM's readings and delivers the right amount of insulin to the patient. If the device senses blood sugar levels are getting high, it would automatically administer insulin. If glucose levels are becoming too low, the device would cut off or reduce the insulin supply to avoid hypoglycaemia.
The key benefit of the technology is the improvement in diabetes control gained from a system that can constantly not only detect, but respond to, changes in glucose levels. For the patient, it would also eliminate the need to calculate insulin doses and respond to the many alarms created by stand-alone CGMs, as well as the fear of hypoglycaemia that can lead to a reluctance to comply with more intensive insulin therapy regimes.
First-generation artificial pancreas products currently use two commercially-available insulin pumps and CGMs, and the main developments in this area are centered around the computer algorithms that control the devices. Going one step further, it is envisioned that algorithms could be developed that not only respond to changes in glucose levels, but predict them. The aim would be to completely eliminate fluctuations in glucose levels, leading to ultimate diabetes control and providing diabetes patients with a true artificial pancreas.
The FDA fully backs the development of such devices; the Agency is helping advance development by prioritising the review of research protocol studies, providing clear guidelines to industry, setting performance and safety standards, fostering discussions between government and private researchers, sponsoring public forums and finding ways to shorten study and review time. Major companies currently developing and competing for approval of their own pipeline artificial pancreas products include Animas (J&J), Medtronic and Becton Dickinson.