Medtronic just announced FDA approval of its MiniMed 530G insulin pump with low-glucose suspend, the first step toward a full-blown artificial pancreas. How’s that for thrilling news?
I just got off a conference call with Nancy Katz, Medtronic’s vice president of consumer marketing and Mark O’Donnell, its vice president of regulatory affairs. They were clearly ecstatic, and I and the other patient advocates on the call were as well: this is an enormous first step toward the approval of a closed-loop system, the much longed for artificial pancreas that would so greatly improve patients’ lives.
In case you aren’t up on the latest in the world of insulin pumps, here’s the background: as of today, America’s insulin pumps do not make any decisions of their own. Some include “bolus wizard” features that use a patient’s self-determined insulin-to-carb ratios and sensitivity factors to calculate a suggested insulin dose, but the pump does not administer insulin until a patient tells it to. Likewise, if your blood sugar is low, today’s pumps do not stop delivering basal or bolus insulin unless the patient intervenes. While some pumps can display CGM data on their screens, the pump also doesn’t take any action on that information. All dosing and suspension is the patient’s responsibility.
As of today, part of that statement is no longer true: the MiniMed 530G system is the first pump in America to be approved for what’s known as “low glucose suspend.” This means that if your CGM or compatible blood glucose meter says that your blood sugar hits a preset level for hypoglycemia — which the 530G allows you to set anywhere between 60 mg/dl and 90 mg/dl — and you don’t respond to its warnings, it will suspend basal insulin delivery until you intervene.
The benefit to this is obvious: if your blood glucose is already low, adding more insulin can make a dangerous situation worse. It’s easy to imagine situations (say, overnight) where shutting off insulin delivery could prevent a medical emergency. As such, it’s been frustrating that the Minimed Veo pump — which has low-glucose suspend — has been available in Europe since 2009. But now, thanks to the FDA — which I’ve repeatedly heard described as being extremely committed to getting new diabetes technologies to market in as timely a fashion as it can — we are one step closer to the goal of a fully closed system. What’s more, and as an indication of its commitment to this area of development, the FDA itself came up with a new product device classification for the system: “artificial pancreas device system, threshold suspend,” a word choice that to me gives a heartening sense of where the FDA anticipates technology is heading.
Along with the new pump, Medtronic also got approval for its new Enlite CGM sensors. These new sensors are approved for up to six days of wear (as opposed to three) and have a 31 percent improvement in accuracy over the current generation (as well as 38 percent shorter in length and 69 percent shorter in sensor size [not transmitter]).
At the moment the FDA approval is only for people ages 16 and up, but Medtronic is filing for pediatric approval, as well as approval for it to be integrated with its MySentry system. Its retail price will be $7,350 but Medtronic anticipates that most people with insurance coverage will pay between $500 and $1200 out of pocket; there also will be a program to help current MiniMed pump users to upgrade to the new system at a discount. (For updates, you can check Medtronic Diabetes’ website, its Loop Blog, or follow it on Twitter.)
As the Medtronic folks readily admitted, this is not actually an artificial pancreas in any real sense of the word, despite the FDA classification — as Katz put it, “it’s a first step in a journey.” The system isn’t predictive, for example, meaning that it only shuts off insulin delivery once you’ve already reached your self-defined threshold of a low. (The fact that you can set your “low” at 90 mg/dl would seem to me to provide a possible workaround, but a real predictive system will actually make decisions based on how fast your blood glucose is dropping. That sort of system is already in the works.) And of course, this system won’t proactively give you any insulin boluses; it just suspends insulin delivery.
But nonetheless. I remember speaking with JDRF’s Aaron Kowalski in January of 2010 about the Artificial Pancreas Project; he said that the goal was to get a system to the commercial market within the next four years. And despite the fact that this is only a first step in a long road, I have to admit that when I got the press release, it brought tears to my eyes. Thank you to Medtronic, the FDA, and everyone else working to make the dream of a closed loop system one step closer to reality.
Here’s a link to the Medtronic press release. (They’re taking orders for the new system now, though it won’t ship for a while, until Medtronic feels it’s adequately trained healthcare providers and salespeople about how to use it.)
The other patient advocates and I on the call agreed on the importance of expressing to the FDA how much patients appreciate its commitment to bringing new diabetes technologies to market as quickly as safety will allow. If you’d like to send a message to the FDA, please leave a note in the comments section below and I’ll forward it to the relevant people.