People who live with diabetes make more than 180 additional decisions every day. A seemingly simple decision around eating lunch becomes a string of questions: What’s my glucose? When did I last eat? Should I take insulin? How much should I take? How soon should I take it? How much is already working in my body?
On top of these decisions are bigger decisions about which therapies we will use to manage our diabetes: Insulin pumps, syringes, apps, drugs, insulin pens, automated systems. All complicated by how these therapies can work together. I want to use CGM C and Pump Q with Software A, but Pump Q works only with Meter B, and neither can upload to Software A. Software A is only for CGM A and Pump R. My insurance will pay for only Pump X and Meter B, which don’t actually work together. It’s maddening. And it just adds to the decision burden we already feel as people with diabetes.
Enter the concept of interoperability. Tidepool has been talking with you about interoperability since our founding, but we recognize that it may not mean the same thing to everyone.
What does interoperability mean?
Imagine a world where you can decide which devices you want to use because they’re the devices:
- You think will help make your life better, or
- That will help put diabetes in the background so you can get back to living.
What if you choose what you want to use to manage your diabetes and it just works?
That’s what we had in mind in 2013 when we first formed to build the Tidepool platform. Today, you can upload over 50 supported insulin pumps, CGMs (continuous glucose monitors), meters, and digital health apps into one place and see your data. Tidepool has worked to bridge the gap of the How so you can get back to your Why.
Since so many of us on the team have a personal connection to diabetes though, we recognize that there’s a lot of What left. You still live with the many challenges of diabetes that these extraordinary pieces of technology have yet to fix. As the diabetes device industry continues to innovate, Tidepool has taken a leading role in helping to define how we can all make devices work better together. We have worked closely with FDA as they defined three new regulatory pathways for the pieces that make up automated insulin dosing technology.
In 2018, iCGM became the first interoperable component designation. iCGM stands for “integrated continuous glucose monitor.” When a CGM system meets FDA’s criteria for accuracy and safety for dosing insulin, it can receive an “iCGM” designation. Both Dexcom and Abbott have CGM systems that have met these criteria today.
2. ACE Pumps
ACE stands for “alternate controller-enabled.” This pathway was made available by FDA in 2019. An insulin pump with an “ACE” designation means that the pump has been designed to work safely with multiple algorithms that adjust insulin. When companies build an ACE pump, they build a pump with the potential to communicate with other pieces of the puzzle.
To be an ACE pump, a company has to be more transparent about how the pump performed in clinical trials and provide information on how the pump communicates, logs data, and on how accurately it measures and delivers insulin. Both Insulet and Tandem have pumps labeled with the ACE distinction.
This year, in 2020, the third and final piece of the automated insulin delivery system puzzle fell into place with the new iAGC pathway. iAGC stands for “interoperable automated glycemic controller.” A controller is a piece of software with an algorithm (computing logic) to adjust insulin delivery based on glucose. This controller software might be embedded in the insulin pump itself, run from a separate handheld device, or even live inside a smartphone app.
To receive clearance as an iAGC, a company’s software has to be designed to communicate with other compatible diabetes device components — like a pump and a CGM. There’s an approval process for the software itself, separate from the insulin pump or the CGM. Companies have to show FDA that the software meets some of the same rigorous standards for safety, labeling, and user training that a piece of physical hardware has to meet.
That’s where Tidepool Loop fits in. The iAGC pathway is what we are pursuing with the software for our Tidepool Loop app (currently in development). The work we’ve been engaged in for the past year and a half has been to help ensure our success when we hand the app over for review for this designation. And we’re delighted to have you along for the journey!
The path forward for interoperability
Imagine a world where anyone with diabetes and a smartphone can access the latest innovations coming from medtech. A world with the flexibility to choose the component pieces that you have the greatest access to. Or the components that you believe reduce the burden of your own diabetes management. That’s the promise of interoperability.
With your support today, Tidepool can continue to pave the way forward for diabetes technology to offer you more personal choice, more connection, and less frustration. With a gift of any size, you will be a part of bringing Tidepool’s vision to life in a way that can help more people, in more circumstances, by delivering our world-class software at no charge to users.