After last week’s US approval of Medtronic’s MiniMed 530G system, the concept of the artificial pancreas – a device that could take over from a type 1 diabetes patient’s failing native organ – is again under the spotlight.
While the 530G is a useful advance, it is just the first step in a long process (Medtronic claims artificial pancreas win but tech is limited, September 30, 2013). EP Vantage’s research shows that a true artificial pancreas is still several years away, and when it does arrive it will almost certainly be the result of a collaboration between smaller, more specialist companies.
Potential to improve lives
The JDRF, a New York-based charity formerly called the Juvenile Diabetes Research Foundation, has laid out six iterations of technology it believes will appear, with the final step representing a true artificial pancreas. The group is working with several medtech companies to help bring this about.
Dr Aaron Kowalski, head of the JDRF’s artificial pancreas programme, tells EP Vantage that Medtronic’s device, which can stop insulin delivery when a patient’s blood sugar gets too low, is a crucial advance. “One of the biggest barriers to people with type 1 diabetes achieving better glucose levels is hypoglycaemia. There are a number of other steps that need to be taken but in terms of getting the ball rolling, it’s a very important first step.”
Dr Kowalski adds: "This system is not an artificial pancreas per se yet, but if the cessation of insulin delivery could save that person’s life, that’s a huge thing.”
Step 2 on the JDRF’s roadmap is a system that can predict when a patient is heading towards hypoglycaemia and stop the insulin before the state is reached. Medtronic’s follow-up device to the 530G, the MiniMed 640G, is designed to do this. It is expected to reach Europe early next year (see table), but no date is yet set for US introduction.
Step 3 is where things get interesting. The JDRF is partnering with Johnson & Johnson’s Animas unit on the development of an insulin pump capable of avoiding both hypo- and hyperglycaemia. Called, sensibly enough, the Hypoglycemia/hyperglycemia minimizer (HHM), it could allow full insulin dosing, rather than simply suspending delivery.
“The approach that Animas has been studying is, instead of trying to restore perfect blood sugar levels, perhaps we could just lop off the highs and lows,” Dr Kowalski says. “The Animas system starts to dose insulin automatically, and that’s what we’re trying to drive towards, because the potential to improve lives is huge.”
Animas’s pump must of course be coupled with a blood glucose sensor, and here a third partner comes in: San Diego’s Dexcom.
“The key enabling technology to any of these closed-loop artificial pancreas systems is having an exquisite sensor, and we have the sensor of choice,” Dexcom’s executive vice-president, Steven Pacelli, tells EP Vantage. “Management of diabetes is not straightforward, but in essence what you’re trying to do is maintain the patient in the target zone without having blood sugar too high or too low.”
“The [Medtronic] system doesn’t control the delivery of insulin,” he says, whereas the HHM “can deliver more insulin if blood sugar is rising or less if blood sugar is going to be low”.
Asked when the HHM could reach market, Dr Kowalski said it could be close, though he cautioned that it may not be soon, as automatic insulin dosing will be tricky to get past the FDA. “A couple of things are affecting [approval], and one is the regulatory pathway. This is something that we’re pushing on and we have significant and robust proof-of-concept data. We want this as quickly as possible, and the JDRF is going to launch a major initiative to push it faster because we think there’s such potential here.”
The good news is that once this third-phase device is approved, subsequent advances should be more rapid. “The big step is getting regulatory agreement to dose insulin. I hope that we’ll see that particularly in Europe in the not-too-distant future,” Dr Kowalski says. “That will catalyse a massive amount for work because the upside is so big.”
The ideal device, according to the JDRF, would deliver not only insulin, but other hormones such as glucagon or amylin, to regulate blood sugar more precisely. The charity is also collaborating with Tandem Diabetes Care on the development of a dual-chamber pump.
“Ultimately we want to see a multi-hormone system mechanically replicating what the pancreas has lost in diabetes. That takes a little more work. Glucagon is the yang to the yin of insulin, and we are doing studies with glucagon that are working fantastically,” Dr Kowalski says.
Dexcom is providing the sensor for this project, too. “In order to be a complete closed loop system you would have to have a second chamber,” Mr Pacelli says. “To truly automate this thing, you have to have some means to bring the patient back from a low blood sugar state.”
This project could satisfy the requirements of step 6 on the JDRF’s plan, making it a true artificial pancreas. But it has required quite an imaginative leap on Tandem’s part, Dr Kowalski says. “The challenge for device manufacturers is there’s not a good market opportunity today for multi-chamber pumps. Tandem was willing to take a risk and say ‘maybe we can get out ahead of the curve’. That would facilitate a much more advanced artificial pancreas in the future.”
As with any new device, cost is the watchword for both regulators and payers. If an artificial pancreas is to succeed, pricing will be vital, as will obtaining proof that the cost of the system can be recouped elsewhere.
“In this era of cost-cutting in healthcare, the question is, if they build these highly complicated automated system, whether there’s enough dollars in the healthcare system to support them,” Mr Pacelli says. “The system isn’t looking for new technology that provides more convenient outcomes for the patient – they’re going to have to show that patients do better on these technologies than with what is otherwise available at a lower cost.”
By contrast, Dr Kowalski believes that artificial pancreas devices will not be much more expensive than a current pump plus a sensor, and could meet cost-effectiveness standards. “Here we have a technology that holds the potential to be incredibly cost-effective. You will be able to significantly lower A1c levels and hypoglycaemia events in a broad group of people. That will mean significant cost savings. And Medtronic is not pricing their [new device] in the US any differently to their current pump system.”
If the artificial pancreas systems do take off in the treatment of type 1 diabetes there is potential for them to cross over to the much bigger type 2 market. “It comes down to cost-benefit,” Dr Kowalski says. “Currently, type 2 adults think pulling out an insulin pen is easier, so the benefit [of an artificial pancreas] doesn’t outweigh the cost.
“But there’s a huge population who have similar challenges to type 1 people and who could benefit from better tools. It absolutely is applicable – the question is, would people use it? I personally believe, yes.” He adds that continuous glucose monitors were initially seen as suitable only for type 1 patients, but are now used in type 2 as well.
A true artificial pancreas is unlikely to reach market before 2017. But, as Dr Kowalski says, “Why wait for the perfect system? If you wait for perfection you’ll miss out on the incremental benefits that are very meaningful to people.”
|Commercial artificial pancreas projects|
|Device name||Pump manufacturer||Sensor manufacturer||JDRF Artificial Pancreas Project Stage||Worldwide status|
|MiniMed 530G||Medtronic||Medtronic||1||Approved in Europe in 2011 and US in Q3 2013|
|MiniMed 640G||Medtronic||Medtronic||2||European approval expected in Q1 2014|
|Hypoglycemia/ hyperglycemia minimizer||Johnson & Johnson/JDRF||Dexcom||3||Unknown|
|Dual-chamber pump system||Tandem Diabetes Care/JDRF||Dexcom||6||Unknown|