Last year Tandem Diabetes Care (NASDAQ:TNDM) and Dexcom (NASDAQ:DXCM) suffered as patients waited for Medtronic’s (NYSE:MDT) artificial pancreas-type device, the Minimed 670G, to go on sale. They may soon receive a leg up from the National Institutes of Health, which has just begun pivotal studies of sensor-pump combos including technology from these beleaguered groups.
It will take a year or so for data to emerge on Tandem and Dexcom’s technology – a year in which Medtronic will have the US market to itself. And the industry leader is also in on the NIH action, having obtained funding for a pivotal trial of a next-generation device.
The Knights of NIH
The NIH, via its National Institute of Diabetes and Digestive and Kidney Diseases unit, is funding four projects. Two are academic: a US/UK study of a smartphone-enabled system overseen by the University of Cambridge, and a US-based study of a “bionic pancreas” designed to deliver both insulin and glucagon.
The other projects involve industry. The NIH has kicked in $12.7m for the six-month International Diabetes Closed-Loop (IDCL) trial, testing a system integrating a Tandem insulin pump and Dexcom G5 blood glucose sensor with a smartphone running Typezero’s inControl closed loop algorithm.
This system is intended to predict high and low blood sugar levels and adjust insulin delivery accordingly throughout the day, while allowing the user to manually bolus for meals. Ascensia Diabetes Care is also involved in the IDCL trial, which aims to prove that the system can improve a range of diabetes metrics when compared with the use of an insulin pump plus a continuous glucose monitor and glucometer.
A second study, also covered by the $12.7m NIH grant, will follow on from this. The Enhanced Control-to-Range Trial (ECTR) will follow 180 patients who complete IDCL for a further six months to test a different control algorithm. Previously the companies have said that these trials will form the basis of a regulatory submission by Tandem.
As befits the first company to get a product that can just about be called an artificial pancreas on the market, Medtronic is one step ahead. A study due to start in December will compare its approved device, the Minimed 670G, to a next-generation system, the 690G. This is intended to further improve glucose control, particularly around mealtimes. The NIH is funding this study to the tune of $6.9m.
The study will randomize 100 patients to either the 670G or the 690G for three months. Following a month-long washout period the patients will then cross over to the opposite arm for another three months.
With a completion date of late 2019, and bearing in mind the whiplash-fast approval of the 670G, the trial could allow the 690G on to the market in 2020 (US medtech approvals dip, January 25, 2017).
According to the NIH, as well as assessing safety and efficacy the trials will look at user-friendliness, the physical and emotional health of participants and the cost of the devices. Perhaps this last factor is being examined with an eye to reimbursement; the willingness of payers to foot the bill for these devices is as yet untested – the 670G has not yet been launched.
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