Tandem’s Basal-IQ Gets FDA Interoperable Designation
The FDA designated Tandem’s Basal-IQ as an ‘interoperable automated glycemic controller’ and this will expand ‘user choice’
Tandem’s Basal-IQ technology received the FDA’s interoperable automated glycemic controller designation (iAGC) which allows this tech to be paired with different pumps and CGM systems to create an automated insulin dosing (AID) system.
This is the second piece of tech from Tandem to receive such designation. In December of 2019, Tandem’s Control-IQ also received iAGC status.
To understand what is so important about these interoperable designations, you need to understand the different types of “i” designations and how they will benefit users.
In contrast to Control-IQ, which works to fully automate insulin delivery for the user, Basal-IQ simply works on the lower end of the BG spectrum.
Basal-IQ is similar to Medtronic’s SmartGuard in this regard. It is a technology that works to reduce hypoglycemia by suspending insulin delivery through an insulin pump anytime a low is predicted based on the values from a connected CGM.
Specifically for Basal-IQ, if BG levels are predicted to drop below 80 mg/dL within 30 minutes or current levels drop below 70 mg/dL, it instructs the pump to suspend insulin delivery until blood sugars begin to rise.
Right now, this tech is available to be used with the Tandem t:slim X2 insulin pump and the Dexcom G6 CGM.
But, with the new interoperable designation, the Basal-IQ algorithm can now be used with other “i” designated pumps and CGMs without the need for additional FDA approval.
An Interoperable Future?
At this point, there are few interoperable designated devices on the market. But, as this designation is expanded to more and more products, users will gain the ability to mix and match devices to create their own customizable AID systems based on the devices they like best.
But before we dive too deep into the potential benefits of this new designation, lets first look at the three different categories of “i” products that current diabetes tech can fit into.
Interoperable Automated Glycemic Controller (iAGC)
iAGCs, or iControllers, are algorithms used to process values from a CGM and turn them into commands for an insulin pump to follow. This type of tech is the basis for all AID systems.
While multiple companies have developed or are in the stages of developing these types of algorithms, Control-IQ and Basal-IQ are the only ones currently approved to be used with other “i” pumps and CGMs beyond the devices they were originally packaged with.
Tidepool, a non-profit organization, is currently in the process of developing an open-source algorithm and will also be seeking this special FDA designation.
Alternate Control Enabled (ACE) Insulin Pump
Before a pump can be used with an iAGC or CGM that was not part of it’s original makeup, it must first receive the Alternate Control Enabled (ACE) designation. Once it has this designation, the pump can be used with different components to create a customizable AID system without the need for further FDA approval.
The only pump, so far, to receive this ACE designation is Tandem’s t:slim X2
Interoperable Continuous Glucose Monitor (iCGM)
The last piece of the AID puzzle is the CGM. As you can probably guess by now, interoperable CGMs, or iCGMs, are continuous glucose monitors that can be used alone or in combination with different pump types and algorithms to create an AID system.
Currently, the Dexcom G6 is the only CGM with this iCGM designation.
Why Interoperable Designations are Important?
To understand why these designations are so beneficial to the diabetic community, we have to look at an AID system that lacks the type of flexibility the “i” designation was created to build.
Old School Approach
Medtronic was the first company to develop a fully functional AID algorithm capable of taking readings from a CGM and turning them into commands for an insulin pump to follow. This powerful new tool allowed users to take a step back from their diabetes management. They no longer had to set their own basal rates or work as hard to prevent highs or lows between meals.
Medtronic’s algorithm works exclusively with its MiniMed 670g system. As promising as the tech is, that exclusivity is where this product falls short.
Anyone interested in using the Medtronic hybrid-closed loop system has to use Medtronic’s pump and CGM as well.
While the Medtronic pump has had many problems of its own, including a recent recall due to a reservoir ring malfunction, it is the CGM that truly discourages many T1Ds from purchasing the product.
Unlike the new Dexcom CGM, the Medtronic CGM requires multiple daily calibrations. It also has a shorter sensor life and is less accurate overall than the G6.
Better User-Friendly Approach
Many users would prefer to use the Medtronic AID system if it used the Dexcom G6 CGM. Other people would likely prefer a different pump, like the Tandem t:slim X2 or Insulet’s tubeless Omnipod. Unfortunately, this kind of mixing and matching is not available with the Medtronic AID system.
It is only possible with devices that have been designated as interoperable.
At the moment, only Tandem’s algorithms and t:slim X2 pump and the Dexcom G6 CGM have interoperable designations and can be mixed and matched this way.
Insulet’s Omnipod has announced its own AID based on a partnership with Dexcom. We expect they will seek ACE designation in the next 18 months.
While this doesn’t provide a lot of choices at the moment, things will be different in a few years after companies like Tidepool and Abbott add their tech to the interoperable smorgasbord. And if Medtronic and Insulet get on board, the options for AID customization could truly become endless.