Man, I wish there were times that I didn’t have to work. Don’t get me wrong; I love my job and get a lot of satisfaction from the work that I do and from being with my coworkers. The MathWorks is a great company, and I wouldn’t want to work anywhere else. But sometimes it would be nice if I could just take the day off to attend or follow one of the diabetes events that people discuss on Twitter as it happens: EASD, FDA meetings, Epatcon, ADA scientific sessions, and so on.
Today it was the FDA and NIH’s public workshop on the artificial pancreas project (APP). From the little bits of the live webcast that I heard during lunch, the project is engaged in numerous clinical trials at several locations using multiple different technologies. It would seem that there’s also a lot of room for debate between the doctors, researchers, and FDA regulators about how to interpret the results of the trials and what the standards for safety and efficacy really are.
So many things seem so promising. Some pumps can predict low blood glucose and then suspend background insulin delivery, preventing hypoglycemia from occurring. Other solutions involve a “closed loop” between the insulin pump and the continuous glucose monitor (CGM), constantly adjusting the amount of insulin delivery in response to changing levels of blood sugar. Stopping lows is one thing; preventing highs seems much more difficult.
Everybody said the right things: a solution should prevent lows, minimize the intensity and duration of post-meal blood glucose spikes, be easy to use by people with diabetes, and make our lives better. Of course, for the doctors and regulators, making our lives better means reducing the number of complications and the risk of death from hypoglycemia. Those are important, but I think that most of us with diabetes think that “making our lives better” involves feeling like we have a greater degree of influence over our blood glucose, making our daily choices and actions easier.
But I was surprised by how much disagreement there was between the doctors on the research and regulatory sides. How many hours of in-clinic trials do you need to do before you can start out-patient trials? How much can your rely on software and hardware simulation (“in silica” v. “in vivo”)? If CGMs are reliable enough to use in the project, why aren’t they reliable enough to gather the data needed to validate the research findings? What level of higher blood glucose is acceptable if a pump prevents 90+% of all lows? Can you look at outcomes instead of just A1c numbers?
Those are all great questions, but answering them to the FDA’s satisfaction is going to take a lot of time. It’s good that the FDA purports to take an impartial look at the technology, free from conflicts of interest. But in my mind, they seem like they’re really dragging their feet when it comes to patient-operated technology. It’s hard for me to see so many promising technologies and wonder how long we’re going to have to wait before the products are available on the market. Patricia Beaston, one of the regulators, was very skeptical of integrating medical devices with mobile devices. (It’s enough to make someone like me say things like, “We don’t need your stinking FDA approval.”)
The variability — one might say “inaccuracy” — of CGM sensors and blood glucose meters seems to be the limiting factor in the current technology. The algorithms appear fairly robust, but the data they receive is frequently suspect. As one of the speakers said, the CGM sensors are quite accurate near the calibration points, but not so much as you get farther away. (Those less accurate zones seem likely to be the ones where critical decisions about insulin delivery need to happen.) I wish the FDA would apply the same amount of scrutiny and rigor to existing sensors and monitors that they’re applying to the rest of the artificial pancreas project.
Expect to see some more thoughts on the APP here in the coming days.