Nothing Artificial about this pancreas

Nothing Artificial about this pancreas

Diabetic Investor is always fascinated by the quest to develop an artificial pancreas; this is after all is the ultimate piece of diabetes technology. Even better it sounds so cool as people conjure up images of patients with diabetes living a “normal” life. No more monitoring glucose, counting carbs or worrying about hypoglycemia. This many believe is the Holy Grail of diabetes management.

Just yesterday Diabetic Investor came across a Reuters story entitled; “Artificial pancreas works in 11 patients –study”. The article states; “A test run of an “artificial pancreas” that monitors blood sugar and delivers both insulin and regulatory hormone called glucagon helped patients achieve near-normal blood sugar levels for more than 24 hours, U.S. researchers said on Wednesday.

The system — made up of a glucose monitor, two pumps and a laptop — is designed to better mimic the body’s natural mechanism of controlling both high and low blood sugar.” (Diabetic Investor added the highlighting.)

The story notes that the study was published in the journal Science Translational Medicine. Looking up this study Diabetic Investor found the following diagram of how this artificial pancreas is set up. (Please see the attachment.)

Now Diabetic Investor is all for helping patients better manage their diabetes and there is no question that Type 1 patients in particular can use all the help they can get, but does anyone realistically see a patient using such a device. Just how many patients would be willing to use such a complex system, never mind the fact the most patients hate carrying around all the various components for existing pump therapy options let alone adding the additional burden of schlepping around a computer, three pumps and a rather bulky continuous glucose monitoring device.

Even if all the components can be miniaturized and instead of using a single chamber pump use a dual chamber pump, so one chamber would deliver insulin and the other glucagon, this is still a machine and as we have seen recently we can’t even get a simple glucose monitor to be accurate what leads anyone to believe someone can develop an artificial pancreas that works reliably 100% of the time. While it may seem like a minor point to those dedicated engineers and scientists who are working on this project, if this system fails just once it could kill the person using it. Diabetic Investor may not be the sharpest tact in the box but death is a fairly serious adverse event, one even the FDA might notice.

Diabetic Investor doesn’t mean to halt innovation and actually believes some good may come out of this effort, so let’s give everyone the benefit of the doubt and assume for one moment that such a system makes it all the way through the FDA and actually onto the market. Please explain to Diabetic Investor who is going to pay for and support such a device. Conventional insulin pumps already cost $8,000 or more, add in supply costs and that’s another $2,500 per year. We can only imagine what a true closed loop system would cost as besides the pump and pump supplies, you have to add in the CGM component. (By the way has anyone bothered to pay attention to what’s happening with Navigator these days?)

There are days when Diabetic Investor honestly believes the people working on this project also believe a non-invasive glucose monitor would forever change glucose monitoring. As if magically patients who have never understood what these numbers mean or how to use them would all of sudden embrace monitoring because it was done without a blood draw.

Getting back to the artificial pancreas did we mention that training a patient on such a complex system just might take more than a few hours? Diabetic Investor encourages readers to look through the FDA’s MAUDE database and read some the adverse event reports related to insulin pumps. Please pay particular attention to the ones that state the patient was attached to their pump while they were priming the pump and ask how pump companies who can’t even train patients on the basics of pump therapy will be able to train patients to use a much more complex system like an artificial pancreas.

Diabetic Investor contrary to what some may believe is not two sandwiches shy of a picnic basket. We understand pump therapy very well and further understand the business dynamics of running a pump company. While we may not have an advanced science or engineering degree it doesn’t take a genius to figure out that the quest to develop an artificial pancreas will be a long and expensive process. The real question here is will it be worth it when, or should say if, this system ever gets here. Diabetic Investor would like to be around to find out the answer to this question but given the many hurdles that lie ahead its likely we’ll be waiting a long, long time.