Welcome to the age of the artificial pancreas – sort of. True, Medtronic’s MiniMed 670G has become the first device to automatically administer insulin to gain FDA approval, and some months ahead of schedule at that. But patients must still administer mealtime boluses manually, and the calibration required for the blood glucose sensor is still fairly onerous.
The 670G is thus what diabetes experts refer to as a hybrid closed-loop system: it is a hybrid of automatic and manual. A true closed-loop device, where manual insulin delivery is eliminated, is still some way away. But Medtronic is certainly ahead of the pack, leaving competitors including Tandem Diabetes and Insulet behind (see table).
Artificial pancreas systems consist of a continuous glucose monitor (CGM) linked to an insulin pump, and employ software to detect and correct low blood sugar without any intervention from the patient.
It is fair to say Medtronic has won the artificial pancreas race. But its problems are far from over: while patients are likely to be eager for a system that lifts some of the burden of dealing with their condition, payers are likely to be less keen. If it is to convince insurers Medtronic will have to prove that by better controlling blood sugar the 670G, which costs around $7,500, works out cheaper than the current low-tech standard (Medtronic gets closer to an artificial pancreas, June 14, 2016).
Most type 1 diabetics currently use very cheap finger-stick blood glucose testing and disposable insulin syringes. The CMS seems to believe this technology works well enough: Medicare does not cover CGMs, and only pays for insulin pumps for a small minority of patients with certain comorbidities.
Perhaps the argument most likely to loosen the purse strings rests on the 670G’s utility in children. It is approved for type 1 diabetes patients over the age of 14 and Medtronic is testing it in patients aged seven and up. Getting payers on board might take time.
Up and coming
If it will take Medtronic a few years to build decent sales of an artificial pancreas, it will take other groups longer still.
A significant milestone will occur when the NIH-funded international diabetes closed loop trial reports data next year. Conducted under the auspices of the Mayo Clinic, the study is enrolling 240 patients with type 1 diabetes and will assess various artificial pancreas systems which use an algorithm called inControl developed by start-up TypeZero. Companies providing other technology to be used I the study include DexCom, Tandem Diabetes and Cellnovo.
Insulet has also gone down the collaboration route with its OmniPod pump. It will link this with Dexcom’s CGM technology and software developed by Mode AGC.
Californian start-up Bigfoot Biomedical, which has possibly the most pleasing logo in medtech, aims to file its Smartloop system with the FDA in 2017. To that end has begun a 50-patient US trials for the Smartloop device, which again incorporates Dexcom sensor technology.
Another young company is working on a more sophisticated technology than all of the others. iLet, a so-called bionic pancreas under development by Beta Bionics, is intended to deliver both insulin and glucagon, which would theoretically enable it to guard against high blood sugar crises as well as hypoglycaemia.
A crowdfunded spinout from Boston University, Beta Bionics intends to start a small trial this year followed by a pivotal study starting in the second quarter of 2017. It hopes that the pivotal trial will enrol at least 600 patients aged 13 and older, and that the data will enable a PMA application to the FDA for the insulin-only and bihormonal configurations of the device in 2017 and 2019, respectively.
These would be incredibly ambitious plans even for an established company. Beta Bionics is to be commended for trying, but it is hard to see how it can fund the trial when its funding so far seems to amount to $6m.
Companies including Roche and Johnson & Johnson have made noises about developing an artificial pancreas in the past, but these efforts seem to have dried up in recent years, leaving Medtronic the sole big-cap group interested. It will have the market to itself for a good few years, but will still has a difficult case to make for reimbursement. Perhaps, if it does persuade payers, the newer groups will be able to find success too.
|Selected artificial pancreas programmes|
|Medtronic||MiniMed 670G plus Enlite 3 CGM||Approved in US September 29, 2016|
|Medtronic||MiniMed 630G plus Enlite sensor||Approved in US August 10, 2016|
|Medtronic||MiniMed 530G plus Enlite sensor||Approved in US September 26, 2013|
|Tandem Diabetes/ DexCom/TypeZero||Tandem's t:slim pump plus DexCom CGM, incorporating TypeZero’s algorithms||Currently in the 240-patient international diabetes closed loop trial (NCT02844517); data expected early 2017|
|Cellnovo/DexCom/ TypeZero||Cellnovo’s e-connected insulin patch pump plus DexCom CGM, incorporating TypeZero’s algorithms||Currently in the 240-patient international diabetes closed loop trial (NCT02844517); data expected early 2017|
|Insulet||OmniPod plus DexCom CGM and an algorithm licensed from Mode AGC||Feasibility study of prototype underway. US clinical trials expected in 2016|
|Bigfoot Biomedical||Type 1 Diabetes Management System||50-patient phase I trial underway (NCT02849288); FDA submission expected in 2017|
|Beta Bionics||iLet Bionic Pancreas||Pivotal trial including include insulin-only and insulin+glucagon arms to start in 2017. Insulin-only FDA submission expected in 2017.|