The grinding to a halt of a pivotal trial of a new technology is rarely a good sign. The insulin pump developer Insulet, however, not only managed to get the study of its Omnipod 5 artificial pancreas back up and running after addressing a software glitch, but has now posted highly competitive data in type 1 diabetes.
The device employs Dexcom’s G6 blood glucose sensor with Insulet’s latest-generation pump technology to deliver insulin with minimal input from the patient. And it appears to be as good as or better than rival technologies from Medtronic and Tandem Diabetes Care.
The pivotal trial of the Omnipod 5, which was then called the Omnipod Horizon, was halted a year ago. For once Covid-19 was not to blame; instead the company said it needed to correct a software anomaly. The study restarted three months later.
Having recruited 241 patients aged between 6 and 70, this is the largest hybrid closed loop pivotal study to date, according to Stifel analysts.
The data, presented on Saturday at the Endo 2021 meeting, suggest that Insulet’s device might be particularly competitive in the traditionally hard to control paediatric population.
After using the Omnipod 5 for three months, the children posted impressive gains in their time in the healthy blood sugar range of 70-180mg/dl. Notably, the performance looked better than that achieved in pivotal trials of competing closed-loop systems from Medtronic and Tandem.
It must be stressed that the data come from separate clinical trials, with slightly different age criteria and different treatment durations, rather than one direct head-to-head comparison.
Results with the Omnipod 5 in the older age group are arguably not quite as impressive, though they are certainly still competitive. Again, the data come from different trials. All these datasets concern patients aged between 14 and 70 or 71, except the data on Minimed 670G, Medtronic’s current-generation closed-loop system, which is from a trial in adults aged 22-75.
On several measures Insulet’s technology looks better than Minimed 670G. More worryingly for the world’s largest medtech group, the Omnipod 5 also appears to beat the 780G, which Medtronic is expected to launch in the US in the next few months. No pivotal paediatric data on the 780G have yet been released.
But in the adult population Tandem, a much smaller group than either Medtronic or Insulet, might be the winner. Its t:slim X2 device also uses the Dexcom G6 sensor, as well as an algorithm called Control-IQ to determine the right amount of insulin to deliver. This is a relatively old product, having launched in the US in 2019.
Insulet plans a limited launch for the Omnipod 5 during the first half of 2021, meaning that it will go on sale at roughly the same time as Medtronic’s new contender. The data might favour Insulet, but Medtronic’s commercial muscle will be hard for the smaller group to overcome.
A further twist might follow. Insulet is also looking at developing a version of the Omnipod 5 using Abbott’s hugely popular FreeStyle Libre 2 continuous glucose monitor in place of Dexcom’s G6. If and when data on this emerge the calculation for type 1 diabetics could change all over again.