On a February morning in 1962, astronaut John Glenn was launched into space to orbit the earth. The world watched in wonder, imagining what could be next. Man could walk on the moon; space travel could – and would – become real. The future seemed so bright and open. And it was.
Yesterday, the diabetes world had a similar experience as Medtronic won approval for the very first “Artificial Pancreas” in the United States. Like that earth orbit, this launch is just a beginning. And like that world of watchers in 1962, the diabetes community is filled with hope, wonder, and joy.
Before we go into details: a checkpoint from JDRF CEO Derek Rapp, who spoke to JDRF leaders on a call Wednesday afternoon: “Our work is not done. Today is a great day, but we’ve got more work to do.”
JDRF had reason to celebrate: it was at a board table just a decade ago that then international board member – and now Bigfoot Founder – Jeffrey Brewer gave his own call to action. Acknowledging the long road ahead until a cure, Brewer challenged JDRF to expedite the road to better tools, specifically to what came to be called the “artificial pancreas.” Rapp commended Brewer today and said he’d be calling to personally thank him.
So where are we? Medtronic has won USA FDA approval to market their Medtronic MiniMed 670G hybrid closed-loop system, a “hybrid pump”. In doing this, the FDA became the first regulator in the world to approve a commercial version of this technology. It is approved for people 14 and up, and Medtronic has plans for trials to win approval for children under that age in the near future as well. Of course, as has been the case as pumps and CGMS come to the market, patients can work with their physicians to get approval “off label” for those younger ages.
JDRF Chief Mission Officer Aaron Kowalski, who has headed up this push, said today that Medtronic is hoping to have the system on the market by the spring of 2017, and that they do not expect the price point to be much different than their current system, the 630G.
Why is this a big deal? Because, put simply, this has paved the way for similar products – by many companies – to win approval as well.
Rapp said that without JDRF, this would never have happened. “Make no mistake: This day would not have happened were it not for JDRF. The name on the product might not say JDRF, but our work went into making this a reality.”
That work started years ago when JDRF funded the first trial at Yale to prove an algorithm could work in such a system. They went on to fund more trials and also to push the FDA toward approval. The JDRF push to prioritize AP project moved the products toward the top of a very long list at the FDA a number of years ago.
“This is an epic day,” Kowalski said. “To see it happen after over a decade of work is amazing”
The hybrid system requires the user to still do mealtime boluses. But, it also turns off when it detects lowering blood sugars, and ramps up insulin doses when it detects a trend toward high. The system will use the new Medtronic pump body, a 4th generation sensor (Not the current Medtronic sensor) and a control algorithm to automate basal insulin delivery to maximize the time glucose levels are in a healthy range throughout the day and night. Previous systems stop insulin in response to existing or predicted low sensor glucose values; hybrid closed-loop systems combine user-delivered pre-meal boluses with automatic insulin delivery.
JDRF is working harder now, Kowalski said, with a goal of access for all for all such products, and to continue pushing other products toward market as well.
“This is not the end of the game,” Kowalski, who estimates that JDRF’s work and funding accelerated this process by five to seven years, said. “We want other systems, competition and ultimately, a cure. Ultimately, we want to completely eliminate the need for this system with a cure.”
The Medtronic system won’t be the end all, nor will it be the only one available. But the FDA approval, imagined at a table by Jeffrey Brewer only a decade ago, is reality. And just like that orbit of earth, it could very well be a most remarkable beginning.