BREAKING NEWS from Tandem Diabetes

FDA authorizes first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customize their individual diabetes management device system

For Immediate Release: December 13, 2019

The U.S. Food and Drug Administration today authorized marketing of the Tandem Diabetes Care Control-IQ Technology, an interoperable automated glycemic controller device that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM). This is the first such controller that can be used with other diabetes devices that are also designed to be integrated into a customizable diabetes management system for automated insulin delivery. This FDA authorization paves the way for iCGMs and ACE pumps to be used with an interoperable automated glycemic controller as a complete automated insulin dosing (AID) system. AID systems typically consist of a pump, CGM and software to control the system of compatible devices.

“Today’s action continues the agency’s ongoing efforts to work with the diabetes community to help ensure the safety and efficacy of innovative and customizable diabetes management systems that may help patients better tailor their treatments to their individual needs,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “The marketing authorization of this first stand-alone interoperable automated glycemic controller also allows substantially equivalent controller technologies that are developed for diabetes in the future to go through the 510(k) review process, helping to promote timely patient access to innovative technologies that can improve their care and quality of life.”

Diabetes impairs the body’s ability to make or properly use the blood glucose-regulating hormone insulin and impacts nearly 10% of Americans. In type 1 diabetes, once known as juvenile diabetes, the patient’s pancreas produces little or no insulin. Five percent of patients with diabetes have type 1 diabetes. The Control-IQ Technology controller is a new type of glycemic controller that when used as a system with compatible iCGMs and ACE pumps can be used by patients with type 1 diabetes to automatically increase, decrease and suspend delivery of basal insulin to the patient based on insulin delivery history, iCGM readings and predicted glucose values. The controller can also automatically deliver a specific amount of insulin when the glucose value is predicted to exceed a predefined amount. Other software to automatically control insulin delivery has previously been approved by the FDA as part of a single, predefined diabetes management system (as a class III, high-risk device). The Control-IQ Technology controller, which is designed to communicate with other compatible diabetes device components that are also designed to be integrated into a modular system, was reviewed through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

The FDA reviewed data from a clinical trial of the Control-IQ Technology controller that included 168 participants with type 1 diabetes. Patients were randomized to use either the Control-IQ Technology controller installed on a Tandem t:slim X2 insulin pump, or a CGM and insulin pump without the Control-IQ Technology controller. The study demonstrated that the controller determines and commands safe and effective insulin delivery from a compatible ACE pump based on iCGM readings, with limited user intervention outside of mealtimes. The FDA also assessed the ability of the controller to communicate with all parts of the system with appropriate reliability, cybersecurity and fail-safe modes.

Even though the system has been assessed for reliability, incorrect and inappropriate calculation, and command, delay of insulin delivery can still occur. Other risks associated with use of the interoperable controller can include incorrect insulin delivery as a result of loss of communication between connected devices, or from exploitation of cybersecurity vulnerabilities. These associated risks can lead to low blood glucose (hypoglycemia) or high blood glucose (hyperglycemia, including diabetic ketoacidosis).

Along with this authorization, the FDA is establishing criteria, called special controls, which outline specific regulatory requirements that, when met along with general controls, provide a reasonable assurance of device safety and effectiveness for devices of this type. For this device, those controls include requirements related to reliability, device interoperability, cybersecurity, and clinical relevance. With the authorization of the interoperable Control-IQ Technology controller and the establishment of these special controls, the FDA has created a new regulatory classification for this type of device, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

The FDA granted marketing authorization of the Control-IQ Technology controller to Tandem Diabetes Care Inc.

https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-interoperable-automated-insulin-dosing-controller-designed-allow-more-choices

8 Likes

And now we wait for ‘the email’.

I wonder if Tandem’s servers will be overrun with users trying to upgrade?

They send out the email, so they control the ‘flow’ for updates.

:clap::clap::clap:

.
https://www.tandemdiabetes.com/products/tandem-device-updater/control-iq
On their website about Control-IQ

No action is required at this time

If you are an in-warranty t:slim X2 insulin pump user in the United States, you will soon have the option to update your pump software to Control-IQ technology at no cost* from home using your personal computer. In the next few weeks, you will receive an email with instructions on how to start the process.

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I’m personally a little hesitant to upgrade because the control point (112) is higher than my current manual target. I love the fact that it takes a lot of the manual intervention out of the process. I’m on the fence right now.

As I understand it, once you upgrade, there’s no going back. You can turn-off Control-IQ and use the pump manually, but the Basal-IQ feature (which I love) is no longer available. I understand they are working on a downgrade path, but who knows when that will be available. For now its one way only,

I think I’ll wait a bit and see what others say once they have experience using it.

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I understand and agree with your reticence.
I have a strong feeling that we will be able to get around the control point of 112 by adjusting our basals, sensitivity, boluses, etc.
I know this is a guess on my part, but I think we can take back some control of this on how we act.
And when we don’t act, it already has set parameters to stay within.

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I am with @Paytone. Basal-IQ is much more attractive than Control-IQ. I would not use Control-IQ because the lowest target is too high for me. I am an OmniPod DIY Loop user. Even that I have total freedom with all parameters, I ended up emulating Basal-IQ.

Unfortunetly I think we’re stuck with 112 until Dexcom is more accurate. Why for me the majority of time it has good accuracy there are times it it way,off. Too much risk for the FDA.

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I’m excited, and cautious too. I keep my targets pretty low also, and will be curious to see how much flexibility we can create (to maintain the numbers we can get manually), while still benefitting from the automated features. I love the Basal IQ and while I often do override it (at meals, etc), it has definitely improved my sleep and my life overall.
:star_struck:

I understand them being cautious.
You can see the trend already though, Medtronic is already lowering their targets for the new 780.

Also, the Control IQ will have two settings, daytime and nightime which has a tighter tolerance.

I personally set my target for 85. And I imagine that if I still bolus for 85, I should still be able to keep myself in the same basic range I am now.
Also, by setting my carb ratio, or IOB timing to different settings, I think we could potentially get he Control IQ to work more in our favor. This is just guessing, but going by how a lot of these things are written, code wise, I think it would be possible.

I really wish it would allow for Control IQ, and to be able to turn it off and just use Basal-IQ. I would do that upgrade immediately. Basal IQ works GREAT for me, and I know many others.

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The way it’s described, it sounds like the Control-IQ might decrease your basal if you were to go under 112… So even if you could correct to 80, you might drift up over time.

I’m also looking forward to seeing some real-world reviews.

My conspiracy theory: The FDA figured out that with Basal-IQ people set their basal rate artificially high which could be dangerous in case of a sensor problem.

That is what I did, and it worked GREAT!
Of course I understand my own risks are exactly that, MY OWN.
Not sure how those numbers will be able to be skewed on the new programming.

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I couldn’t be happier. I have been waiting for this day for quite a while. I am sure you can accomplish tighter control with a DIY solution, but for the majority of us who can’t or won’t go DIY, this is a MAJOR step forward.

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Yeah thinking I’ll sit on the sidelines for awhile and see what the initial reviews look like.

Regardless I’m excited to see this.

@Hammer, how long did it take you to come up with the ‘high basal rate’ mode? 30 seconds? Me too. I cannot understand why the FDA didn’t see this coming?

One way to defeat Control-IQ is to mis-calibrate the sensor. Calibrate the Dexcom G6 so that it reads 112.5 when BG is 85.