Bionic Pancreas Updates: Possible Launch with Insulin Alone, with Glucagon to be Added Later
By Adam Brown
By Adam Brown
Pivotal trial to start in early 2017. What does glucagon add to automated insulin delivery?
What’s the latest on Drs. Ed Damiano and Steven Russell’s automated insulin+glucagon Bionic Pancreas? See the updates below, which came in a fascinating debate at the recent diabetes tech conference, ATTD. For context, this automated system controls blood glucose using CGM readings every five minutes, a mathematical algorithm, and pumps dosing insulin and glucagon. Right now the Bionic Pancreas is in the research phase, though the team has built an integrated system (iLet) expected to enter a pivotal trial in early 2017.
1. We saw the first data from insulin-only tests of the Bionic Pancreas at Stanford (no glucagon), which showed similar efficacy to other automated insulin delivery systems: an average glucose of approximately 154-159 mg/dl (depending on the target glucose), with just ~1-3% of the time spent <70 mg/dl. A separate study at Mass General directly compared the insulin-only vs. insulin+glucagon Bionic Pancreas, showing similar average glucose and rates of hypoglycemia with a target glucose of 130 mg/dl – the addition of glucagon was only 5 mg/dl better on average and 0.3% better on time spent in hypoglycemia. The real advantage of adding glucagon may come once the system targets lower glucose values (e.g., 100 mg/dl), and data is not yet available for the insulin-only version.
Thus far, an insulin-only version of the Bionic Pancreas works, and it does have some advantages relative to other automated systems: the set-up only requires weight information (prior insulin or glucose data is not needed), it rapidly adapts to insulin requirements and different meals, and it requires no carb counting (users just enter if it’s a large, typical, or small meal). We certainly love the idea of no carb counting!
Participants in the Stanford study had varied experiences testing the insulin-only Bionic Pancreas for a week, but 12 of the 13 patients said they would take the system home as is. This was a highly positive finding, since most of these patients were doing well on their own, and the research system is very clunky: two separate Tandem pumps, an iPhone brick connected to the Dexcom receiver, and daily glucagon changes (the ultimate vision is for a fully integrated product, the iLet; see below). Some participants said the insulin-only Bionic Pancreas was “amazing,” though others felt it “made them go too high.” Many participants liked not having to carb count (a big plus of the Bionic Pancreas), and many experienced Bluetooth connectivity issues with the research platform.
2. The Bionic Pancreas dual-chamber iLet device may be released as an insulin-only product to start, which could come to market six months to a year before an insulin+glucagon system. At the very earliest, that means an insulin-only Bionic Pancreas could launch in late 2018. Though we’ve known since last year that the Bionic Pancreas pivotal trial (early 2017) would include an insulin-only arm, this was the first mention at a conference that the team might pursue insulin-only first, giving patients the option to add glucagon once it is approved later. Drs. Ed Damiano and Steven Russell have long been advocates of a dual-hormone approach, and we’re glad to see them thinking about ways to get the Bionic Pancreas to patients sooner.
An approved stable glucagon is one of the key roadblocks to getting the insulin+glucagon Bionic Pancreas approved, and Dr. Russell said there are now two stable, pumpable glucagons in development: one from Xeris (in development for several years), and a newer candidate from Zealand. The pivotal trial will hopefully include one of these glucagons, though the FDA would also have to approve a chronic indication to use glucagon in the Bionic Pancreas – no small task.
3. The Bionic Pancreas pivotal trial is still expected to start in early 2017, testing the dual-chamber iLet pump with Dexcom CGM (both insulin-only and insulin+glucagon versions). It’s not clear how the academic team behind the Bionic Pancreas will bring the iLet to market, though we assume the system could come to market as soon as 2018 or 2019, putting it a year or two behind Medtronic’s MiniMed 670G (expected to launch by April 2017).