10/4/2016 – 9:47 p.m. – This story has been updated with new information.
During a webinar held shortly after the FDA announced approval for the Medtronic 670G, JDRF chief mission officer Dr. Aaron Kowalski discussed why he believes the pump system merits the label of an artificial pancreas.
“When you start dosing insulin automatically, that is the first artificial pancreas,” Dr. Kowalski said.
JDRF, along with the Helmsley Charitable Trust and the National Institutes of Health’s Special Diabetes Program, spearheaded the philanthropic giving to fund research into artificial pancreas development. In a separate press release, JDRF stated it gave more than $116 million towards artificial pancreas research in the past decade. Now, Dr. Kowalski said, Medtronic has released an artificial pancreas system, and every other major pump company is working on artificial pancreas technology, as well.
There has been vocal criticism among some in the Type 1 diabetes community that the 670G is not automated enough to be considered an artificial pancreas. For example, users of the pump system will still have to bolus for meals. Dr. Kowalski said that there is still more work to be done on developing the technology and insulin formulations to make a fully automated artificial pancreas possible. The 670G should be seen as a step toward full automation.
“The hybrid closed loop (system) is on the road to a fully automated artificial pancreas,” he said.
A chief hurdle toward full automation is that the insulin currently on the market is not fast-absorbing enough for the bolus corrections needed in an automated system. Neither Dr. Kowalski nor anyone at JDRF answered a question posed by Insulin Nation, during the forum and on Twitter, of why insulin companies failed to develop the insulin formulation necessary for such a system during a time of record profits from high insulin prices.
The 670G will be available for commercial sale in Spring 2017 for use in people with Type 1 diabetes who are 14 and older. Off-label, doctors can prescribe the device to children ages 13 and younger, as well. Medtronic is currently conducting clinical trials of the 670G for pediatric use.
In the meantime, Dr. Kowalski said, JDRF will be working to ensure that the 670G, and other future artificial pancreas systems, are covered by insurance and Medicare.
You can listen to the webinar here: https://www2.jdrf.org/site/Donation2?18761.donation=form1&df_id=18761&s_src=jdrf.org&s_subsrc=homeBanner
Update: Dr. Kowalski responded by email to Insulin Nation’s query about why there isn’t an insulin available that could handle automatic bolus adjustments in an artificial pancreas system. Here is a passage from that response:
“We have been working on a number of approaches to speed up insulin action and have spent millions of dollars on research in this area over the past decade. It’s hard. Insulin delivered through the skin does not work fast like insulin made in your pancreas, which gets in the blood quickly. This is compounded by the fact that insulin coming through your skin can’t anticipate you eating like your brain does. And, insulin through the skin doesn’t reach your liver quickly, while that’s the first place insulin acts after the pancreas.
There are two broad ways to tackle this – new insulin molecules and new means of delivery. We’ve supported multiple versions of each. Novo Nordisk has a faster insulin in the pipeline and there is Afrezza, but beyond that we are working hard to deliver better solutions.”
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