November 14 is an important day for the estimated 366 million people globally who have been affected by diabetes. Since 1991 World Diabetes Day has served to raise global awareness about diabetes, a condition that affects nearly 26 Americans alone (according to the American Diabetes Association) and will affect roughly 522 million people globally by 2030 according to predictions by the International Diabetes Federation (IDF).
The majority of individuals have type 2 diabetes which has shown to be manageable by lifestyle changes including exercise and diet. However the less common, but more dangerous, type 1 diabetes has not been linked to lifestyle or diet. Type 1 patients are required to monitor their blood sugar levels constantly and require insulin injections sometimes multiple times a day. The pharmaceutical industry's stake in this is pretty clear with the plethora of blood glucose-regulating drugs on the market. But one shouldn't ignore the device industry's contribution toward treating, and potentially curing, this condition. While no one can argue that innovation won't be the next big step toward treating type 1 diabetes (discovering insulin itself was considered an innovation at one point), the question looms as to how close we really are to any significant strides.
|The Paradigm Veo is Medtronic's entry into the artificial pancreas market.
Today FDA has released the final offical draft guidance for an artificial pancreas which "allows for a range of scientifically valid study designs, allowing flexibility that will encourage innovation in technologies for people with type 1 diabetes while ensuring thorough evaluation of such systems before they can be prescribed by doctors." In a press release Jeffrey Brewer
, president and CEO of JDRF, a global organization focused on type 1 diabetes research and organizers of the Artificial Pancreas Project
, said,"This FDA guidance is an important milestone in improving lives of people with type 1 diabetes. JDRF commends the FDA for its scientific leadership in the area of artificial pancreas systems, which have the potential to be the most revolutionary advance in treating type 1 diabetes since the discovery of insulin."
The artificial pancreas, several versions of which are currently being developed, presents a sort of holy grail in the fight against type 1 diabetes (the causes of which are still not fully understood). While other versions that use gene therapy and bioengineering are being developed, on the medical device end the artificial pancreas takes the form of an insulin pump under a closed loop control that utilizes real-time data from a blood glucose sensor to regulate insulin levels. Device giant Medtronic has been the biggest name in this arena since it submitted its Paradigm Veo
insulin pump for FDA approval in June. If approved, the device will offer patients 24/7 monitoring of their blood sugar levels and will even be able to help prevent severe hypoglycemia by suspending insulin delivery when glucose levels are too low.
This week also saw an announcement by JDRF that it has provided grant funding to associate professor Jenny Gunton from Sydney's Garvan Institute of Medical Research and Dr. Nigel Greenwood, founder of the technology company NeuroTech Research. The goal of their project is to test a prototype of an artificial pancreas alongside artificially intelligent software developed by NeuroTech. If the software is able to successfully learn to monitor and treat patients it presents a potentially great leap forward in developing an artificial pancreas. In a statement to MedicalXpress
Gunton said the ultimate aim to to have “glucose monitoring and insulin administration in the same machine – with very smart pump software keeping people's blood glucose normal." He continues, "The technology we just tested is revolutionary for a whole lot of mathematical reasons – but the point is that it forecasts a completely new approach to programming insulin pumps, with the results from this preliminary grant being extremely impressive."
However there's always a gap between innovation and implementation and while patients wait for FDA to approve the next innovative product, others are dealing with the reality that devices may not be doing enough or even be the most effective means of treating diabetes. A study
published in the November 2012 issue of The Annals of Thoracic Surgery has shown that diabetes patients who undergo bypass surgery for coronary artery disease (a leading cause of death in diabetic patients) have a better long-term survival rate than those who received stents instead. While encouraging in the sense that it points to better patient care, study results like these also show a potential shortfall in medical devices for treating diabetes. While a big leap forward will certainly point the way the question becomes not about the need for innovation but the speed at which it can get here.
What are your thoughts on the state of medical devices in treating diabetes? Share you thoughts/comments with us!
-Chris Wiltz is the Assistant Editor at MD+DI