This weekend’s data on the latest iteration of Medtronic’s artificial pancreas look good enough to secure US approval. The question is whether the MiniMed 780G controls patients’ blood sugar as well as rival technologies, and could thus allow Medtronic to slow the decline of its market share.
And today’s US market clearance of the long-awaited next generation of Abbott’s continuous glucose monitor ups the ante. The FreeStyle Libre 2 is one of the most effective blood sugar sensors available and also one of the cheapest, and could soon be available as part of a closed-loop system with Insulet’s Omnipod 5 insulin pump, impressive data on which also emerged on Friday.
Medtronic’s 780G was CE marked last week, but must still prove its worth to the US regulator. In the pivotal trial, data from which were presented at the virtual annual meeting of the American Diabetes Association on Friday, the device allowed type 1 diabetes patients’ blood sugar levels to remain in the safe range of 70-180mg/dl 75% of the time.
The trial had no control group, but all study subjects had previously been using either Medtronic’s earlier version of the system, the MiniMed 670G, or a different sensor-augmented pump. Comparing patient’s achievements at the end of the study with their baseline stats gives an indication of sorts of the 780G’s performance.
The patients did improve; unfortunately many of the improvements were marginal. Perhaps the most positive finding was that the amount of time the participants were happy to leave their device in auto mode jumped from 33% to 95%. In the pivotal trial of the 670G this was 87%, though likely lower in real life. Stifel analysts say this is a critical improvement over the 670G.
|Minimed 780G pivotal data|
|Time in range||68.8%||74.5%|
|Time in auto mode||33.4%||94.8%|
|Time in hypoglycaemia||4.1%||2.8%|
|Time in hyperglycaemia||34.1%||27.7%|
|Source: ADA 2020 Presentation.|
The time in range is better than seen with some other artificial pancreas technologies, but not by much. The combination of Tandem Diabetes Care’s t:slim X2 insulin pump with Dexcom’s G6 continuous glucose monitor kept patients in range 71% of the time. And this system does not require patients to test their blood sugar with daily fingersticks for calibration, whereas Medtronic’s system requires maybe four or five of these each day.
Another rival technology whose performance must be considered is Insulet’s Omnipod 5. Formerly called the Omnipod Horizon, this insulin pump is intended to work with glucose sensors from Abbott and Dexcom – including the former’s newly available Freestyle Libre 2 (Collaborative diabetes tech on the Horizon, February 20, 2020).
The pivotal trial of the Omnipod 5 was halted in March to allow Insulet to correct a flaw in the software that could have caused the system to deliver the wrong quantity of insulin, though at the time no adverse events had been reported due to this issue. The trial resumed just over a week ago and ought to report towards the end of this year.
The ADA data come from a small, single-arm study. In 18 adults, time in range improved from 66% at baseline to 73%; in the 18 children in the trial this jumped from 51% at baseline to 65%. Patients had the device in auto mode 97% of the time, which Stifel analysts called “very impressive”.
Better and cheaper
If Insulet’s system can repeat this kind of performance in its pivotal trial approval, a planned launch in the first half of next year, is all but assured. Following that, a combination closed-loop system incorporating Abbott’s CGM is intended to follow.
The first version of the Freestyle Libre is the bestselling CGM in the US thanks in large part to its relative cheapness. Abbott said today that the Libre 2 will be sold at the same price as its forerunner, preserving this advantage, but it also has potentially best-in-class accuracy, and a paediatric indication. This label could meaningfully expand Abbott’s market in the US when the device is launched in late summer.
By the time any an artificial pancreas incorporating Omnipod 5 and Libre 2 reaches market, the 780G will likely have already been on sale for a year or more. Medtronic must make the most of this, because on current showing it does not have the technological edge.