Beta Bionics and the promise of autonomy
A simpler diabetes tech is in the offing, but some patients are yet to be convinced that a device knows best.
The publication of pivotal data on Beta Bionics’ iLet last month positions the insulin delivery device for US approval. The product beat standard care in the study, and this is particularly notable since the control arm included patients on hybrid closed-loop systems, the sophisticated devices nicknamed artificial pancreases.
Should approval follow the US market could see a step-change in the kind of technology available to type 1 diabetics. The system’s USP is its near-total autonomy. “You can’t override the insulin dosing decision,” as Edward Damiano, the company’s founder and executive chair, puts it. However, some patients might not be thrilled with the idea of giving up control.
The iLet is an aggressively simple device. It connects to Dexcom’s G6 continuous glucose monitor, and all the user has to do to set it up is enter their bodyweight. At mealtimes they tell the system whether they are eating breakfast, lunch or dinner, and whether they are eating more, less, or the same amount as usual – and that’s it.
The trial compared the iLet with whatever insulin delivery technique the patients were already using – daily injections, an insulin pump or an artificial pancreas. Nearly a third of the subjects in the control group used an artificial pancreas – 19% used Tandem Diabetes Care’s t:slim X2 insulin pump with its Control-IQ technology, and 11% the MiniMed 670G or 770G, both from Medtronic.
The data show Beta Bionics’ device handily beating the standard care arm on blood glucose control measures, putting approval well within the company’s reach. An FDA submission has already been made, with the group hoping for approval “soon”.
Tricky comparison
But how does the system stack up against the available, and perhaps soon to be available, products? The table below includes data from the iLet’s pivotal trial and from the pivotal trials of the approved insulin pumps from Tandem and Insulet. These, like iLet, work with glucose monitors from other developers.
Many industry watchers will consider a different device as the most interesting comparator for the iLet: the hotly anticipated MiniMed 780G from Medtronic. This uses Medtronic’s own glucose sensor, and is therefore the latest iteration of the only closed-loop system in which all the components are made by the same group. Its pivotal trial reported in 2020, and like the iLet it is awaiting FDA approval.
| Cross-trial comparison of pivotal data on selected insulin delivery tech | ||||||
|---|---|---|---|---|---|---|
| Trial | NCT04200313 | NCT03959423 | NCT03563313 | NCT04196140 | ||
| Device | iLet (Beta Bionics) |
Control (standard care) | Minimed 780G (Medtronic) | t:slim X2 (Tandem) | Control (pump + sensor) |
Omnipod 5 (Insulet) |
| Status | Awaiting US approval | Awaiting US approval | Approved in the US | Approved in the US | ||
| CfB in average A1C (% points) | -0.6 | 0.0 | -0.5 | -0.3 | 0.0 | -0.4 |
| CfB in time in blood glucose range: | ||||||
| Target: 70-180mg/dl (%) |
14.0 | 3.0 | 5.7 | 10.0 | 0.0 | 9.3 |
| <54mg/dl (%) | -0.1 | 0.0 | -0.3 | -0.6 | -0.2 | -0.1 |
| <70mg/dl (%) | 0.3 | 0.4 | -1.0 | -2.0 | -0.6 | -0.9 |
| >180mg/dl (%) | -13.0 | -3.0 | -4.8 | -9.0 | 0.0 | -7.7 |
| >250mg/dl (%) | -7.5 | -2.9 | -1.6 | - | - | -4.3 |
| CfB = change from baseline. There was no control group in 780G or Omnipod 5 trials. Source: NEJM 1 and 2; ADA 2020; FDA. | ||||||
Comparing across different trials is always somewhat fraught, but Mr Damiano makes the point that this comparison is particularly invidious. Most obviously, Medtronic’s pivotal trial did not have a control arm.
“We actually looked at baseline-adjusted differences compared to control. You can’t do that without an intervention arm,” Mr Damiano says.
He adds that the performance of these techs, especially hybrid systems, depend greatly on the user’s skill. “Looking at how the absolute time in range, or A1c change, is so dependent on socioeconomic factors, demographic factors, glycaemic factors at baseline, that it’s really dubious to compare across trials.”
He insists that the control arm in iLet’s pivotal trial is a more apt comparison, adding that it was “the only study with a direct head-to-head comparison of the iLet with a hybrid system”. However, since the trial did not specifically split out the outcomes of the closed-loop population from those of the injection and pump users also in the control arm, this is not a perfect comparison either.
Room for one more
This may not matter too much for Beta Bionics from a competition perspective. The company does not anticipate taking share from the artificial pancreas developers.
“A big part of our uptake, we’re hoping, will be from people on injection therapy,” says Mr Damiano. Injection users that switched to the iLet system in the pivotal trial had, he says, greater reductions in glycated haemoglobin than those who had previously used pumps or hybrid closed loop devices.
This is because people who are used to controlling their own sugar levels by making their own insulin dosing decisions find it hard to cede control to the iLet, Mr Damiano says. In other words, Beta Bionics believes that most pump and closed-loop users are likely to stay on their current therapy, rather than switching to the iLet.
For now it is over to the FDA. Approval of Medtronic’s 780G has been in the works for some time, having been delayed by a warning letter following an inspection of its diabetes headquarters in December 2021. Medtronic hopes to get its approval in the first half of next year, which means the 780G might hit the market at a similar time to the iLet. Their respective sales trajectories will be watched with interest.
