A step ahead in the race for an artificial pancreas
Soon specialists will be able to provide their patients with an artificial pancreas that brings the promise of automated administration of insulin when monitored glucose levels are too high. A European consortium has created a device that goes a step further, and could provide Europe with a competitive edge on this new market. If there is one obsession people with diabetes need to learn to live with, it’s certainly that of their glucose level. The internet is overflowing with articles containing advice on how to best regulate it, yet the real solution that will put their minds at ease is still nowhere to be found. Instead, they have to maintain a healthy diet, do physical exercise and, when the diet isn’t enough, use a glucose-level meter or continuous monitor and injections or an insulin pump to eliminate any surplus. The only light at the end of the tunnel is the artificial pancreas, a technology that — when finally commercialised — would help them to automatically regulate their glucose levels. The EU-backed PCDIAB (A Portable Bihormonal Closed Loop for Diabetes) project is one of the most promising scientific ventures to create such an artificial pancreas and bring it to patients. Launched in 2011, the project has just been granted a nine-month extension by the European Commission in light of the clear potential of this new device. Unlike other upcoming artificial pancreases, PCDIAB’s is a bihormonal solution able to both raise and bring down glucose levels depending on information relayed by its sensors. Dr J. Hans DeVries, coordinator of the project, told us about the device’s potential and his future plans to bring it to market. What are the benefits of PCDIAB’s artificial pancreas for patients? Patients with Type 1 diabetes have to determine many times per day the appropriate dose for their insulin injections. To do so, they not only have to monitor their blood glucose concentration with finger pricks, but also have to consider the influence of meals, exercise, stress and several other factors on their glucose level. Maintaining glucose levels in the normal range is essential for preventing diabetes-related complications. However, getting glucose levels to reach the target using insulin therapy is limited by the occurrence of hypoglycaemic episodes. Therefore, guideline targets for glucose control are notoriously difficult to attain for a substantial proportion of patients. With an artificial pancreas, the glucose control can be automated to achieve near-normal glucose control and avoidance of hypoglycaemia. It alleviates the burden of self-management. Glucose changes, including those following meals and exercise, are corrected without patient intervention. Is it easy to use? In the first clinical trial, patients found the device easy to use. Appropriate interaction with the device is required to keep it functioning properly. The user interface will be further developed using the feedback from these trial patients to make it more intuitive, so that it will be suitable for all kinds of patients. How does this compare to current practices and technologies? There are two notable points here. The first is that in comparison to other ‘insulin only’ artificial pancreas projects, PCDIAB uses both glucagon (to increase glucose if needed) and insulin (to lower glucose). The use of two hormones opens the way for a fully reactive device. Secondly, as compared to existing technology on the market, that is, insulin pumps and continuous glucose monitors which are managed by the patient, the artificial pancreas takes over this control from the patient. What were the main challenges you faced in the development of PCDIAB’s artificial pancreas? There are two main challenges. The first was the assembly of a miniaturised device, integrating two pumps, one for insulin and one for glucagon, together with two sensors and essential software implemented twice, once as a safety backup. This has now been completed, but took us longer than we hoped. The second challenge is to find a manufacturer for a stable glucagon solution or analogue. We are actively collaborating with companies with that capability, but this will take several years. One of your objectives was to provide Europe with a competitive edge in the field. Three years after the project started, would you say you succeeded? It seems that there will be only a few European companies able to bring an artificial pancreas to the market. Recently, the Juvenile Diabetes Research Foundation, a US-based foundation which is the largest funder of Type 1 diabetes solutions worldwide, listed companies with potential to bring artificial pancreas systems to the market. It showed two large US companies and one large EU company, two medium US companies, two small US companies and one small EU company, the latter being Inreda, the manufacturing partner in our PCDIAB project. So I would say that we should be able to succeed. Now that the project has reached its initial end date, do you have any plans for further developing this technology? We are very happy that a nine-month extension was recently approved by the Commission. We certainly intend to bring a product to the market after the project, within a few years. PCDIAB Coordinated by the Academic Medical Center in the Netherlands. Funded under FP7-HEALTH. Project website
Countries
Netherlands