Updates from www.DiaTribe.org
Lots of news and updates are flooding the blogs regarding the artificial pancreas. It is exciting (albeit not a cure).
At a recent Carb DM Bay Area Diabetes Summit, three experts on automated insulin delivery (aka, “artificial pancreas,” “AP,” or “closed loop” systems) discussed the current state of the field, what patients can expect with “first-generation” systems, working with the FDA, and future innovation. The power-packed panel included leading closed-loop researcher Dr. Bruce Buckingham (Stanford), Medtronic Diabetes’ Chief Medical Officer Dr. Fran Kaufman, Bigfoot Biomedical’s Director of Clinical Innovation Jen Block, and moderator Howard Look (Tidepool). According to DiaTribe, here are the key points (read in detail: http://tinyurl.com/hcw7vec):
- Medtronic has completed a pivotal trial for their hybrid closed loop system, and hopes to sell it at a relatively comparable price to the cost of a separate CGM and pump system. According to Dr. Kaufman, the biggest concern is who’s going to pay for it and what’s the cost going to be. Medtronic’s investment is huge (tens of millions of dollars on trials plus the FDA submission report which will be tens of thousands of pages long!). Launch hope: April 2017
- Dr. Buckingham said the FDA has “accelerated tremendously” on automated insulin delivery, which he attributed to the power of the patient advocacy community. One area of FDA uncertainty, however, is the approval process for next-generation improvements: what can companies update on their own without a long FDA process, and what will require more in depth review?
There are a couple companies out there working on stable glucagon.
- Bi-Hormonal Closed Loop Systems: “Nobody has ever gotten glucagon every day in these quantities. It adds a complexity that we don’t feel is warranted.” And, “Until we have more experience with use, glucagon may be better for next-generation systems.” In other words, expect the first generation of an AP to be a single hormone, insulin-only system.
In other Closed Loop News:
- A disposable Asante pump connected to a Bigfoot reusable closed-loop controller (with NO screen or buttons);
- Bluetooth connected to a Dexcom G5 CGM;
- Bluetooth connected to a smartphone app that functions as the system’s user interface; and
- A paired Bluetooth glucose meter for CGM calibration.
The key difference from other closed-loop devices is that users will only interact with the smartphone app, which will function as a “window” to the automated insulin delivery system. Read more: http://tinyurl.com/zhsew88
Dr. Ed Damiano of the Bionic Pancreas team announced the launch of “beta Bionics”, a new “public benefit corporation” to commercialize the team’s fully integrated iLet Bionic Pancreas. Lilly has invested $5 milion in Beta Bionics. Beta Bionics will take the Bionic Pancreas platform developed in the academic research setting, integrate it into a single medical device (the iLet), and obtain FDA approval to bring it to people with type 1 diabetes.
As for the timeline: a small study later this year to make sure the iLet works like the previous research platform (a “bridging study”), followed by a large pivotal study in mid-2017 testing both insulin + glucagon and insulin-only versions of the automated system. The hope is still to launch the Bionic Pancreas with insulin-only first, with a potential FDA approval in late 2018. The iLet device is designed to function with just the insulin chamber operating, and glucagon could easily be added later once a stable version is approved.
Read more: http://tinyurl.com/zp348jg