For the first time ever, FDA has approved an artificial pancreas. The MiniMed 670G system is "the first hybrid closed loop system in the world" according to Medtronic. This means that it monitors the wearer's insulin levels and adjusts and administers the medication doses as needed, with some input from the patient (i.e.: bolus, or insulin dosing at meals).
Or, as more delightfully and theatrically put by Craig Idlebrook at Insulation Nation: "Ladies and gentlemen, the future is now...The FDA released a press release that matter-of-factly announced what once sounded like science fiction has now become science. Mark it down that on September 28, 2016, the first artificial pancreas system gained approval for commercial sale in the United States." Indeed! Medical devices bringing science fiction to life: just one more reason to love them.
The 670G is essentially an insulin pump that also monitors glucose levels, and is for patients ages 14 years and older who have Type I diabetes. (Clinical trials are currently being conducted for younger patients, according to Insulin Nation.) The device brings a fully automated system one step closer to reality, and allows patients and their doctors to decide on the level of automation that works for them. Not only that but, significantly, this is a smart system that learns and adapts to the patient's needs, which means it requires less valuable time and adjustment from the wearer and thus improved quality of life. Again, it's more than just an insulin pump: it's an artificial pancreas.
Medtronic's press release explains in some detail: "The MiniMed 670G system features our most advanced algorithm to date – SmartGuard HCL – which simplifies and improves diabetes management through a smart algorithm that enables greater glucose control with reduced user input. Through SmartGuard HCL, the system builds on Medtronic’s industry leading algorithms to offer therapy customization so people with diabetes and providers can choose from increasing levels of automation that best fit their diabetes management needs.
Driven by the SmartGuard HCL, the system delivers a variable rate of insulin 24 hours a day based on the personalized needs of the individual, maximizing the time glucose levels are within the target range. It is designed to learn what an individual’s insulin needs are and to take action to minimize both high and low glucose levels. As a result, the system requires minimal input – users only need to enter mealtime carbohydrates, accept bolus correction recommendations, and periodically calibrate the sensor."
This novel device is truly on the cutting edge of technology, and it's so exciting to see it approved. FDA's recent approval was granted sooner than expected and as such, the MiniMed 670G is scheduled to ship in Spring of 2017–earlier than the company had originally anticipated. Once again, Med Device Monday is reminding me why I do what I do!
Better yet, as Craig Idlebrook again so nicely put it, "Here we could give you a lot of carefully crafted quotes from the press releases from Medtronic and the FDA, but none of the words would do justice to the raw emotion people who have fought for years for such a system will feel with this news. For every parent who Google-searched desperately for a better treatment option in the aftermath of a child’s scary low; to every Type 1 activist who pushed the FDA to move faster; to every Type 1 hacker who would not wait and decided to code a DIY artificial pancreas just to show it’s possible, this is a moment of bittersweet victory."