Interoperable devices ensure that the rapid pace of innovation directly benefits individuals with diabetes. By fostering flexibility, accessibility, and affordability, it removes barriers to advanced care. The resulting plug-and-play systems empower users to adopt the latest technologies without being left behind, enabling a future where managing diabetes is more straightforward, more effective, and more personalized than ever before.
Introducing Bluetooth Low Energy (BLE) in 2010 marked a turning point for electronic device communication. BLE enabled secure, energy-efficient data transfer over longer distances, transforming diabetes technology by allowing seamless communication between key components like continuous glucose monitors (CGMs), insulin pumps, and algorithms. Like King Harald “Bluetooth” Gormsson united Denmark in the 10th century, BLE has unified diabetes devices into connected systems.
Breakthrough T1D (formerly JDRF) launched the Open Protocols Initiative (OPI) in 2017 to advance interoperability. This initiative aims to establish “plug-and-play” compatibility among Automated Insulin Delivery (AID) components, offering users greater flexibility and access to cutting-edge technology.
Regulatory Milestones
In March 2018, the Dexcom G6 became the first interoperable Continuous Glucose Monitor (iCGM) to receive FDA designation. Meeting rigorous accuracy standards and featuring factory calibration, the G6 eliminated the need for mandatory fingersticks while sharing real-time glucose data with compatible iPumps and iAlgorithms via BLE. Users could share data with up to 10 individuals and receive Siri voice updates, emphasizing the device’s user-centric design.
In February 2019, the Tandem t:slim X2 insulin pump received the FDA’s ACE (Alternate Controller Enabled) designation, becoming the first interoperable insulin pump (iPump). ACE-designated pumps ensure accurate insulin delivery, robust cybersecurity, and seamless communication with iCGMs and iAlgorithms.
By December 2019, Tandem achieved another breakthrough when its Control-IQ software received FDA clearance as the first iController. Combined with the Dexcom G6 iCGM and t:slim X2 iPump, the Control-IQ iAlgorithm created the first fully interoperable AID system, setting a new standard for plug-and-play diabetes management.
The Benefits of Interoperability
The FDA’s clear regulatory framework has empowered manufacturers to innovate rapidly, knowing new devices will integrate seamlessly with existing systems. This progress benefits users in several key ways:
- Extended Device Lifespan: Software updates enable older devices to remain compatible with new technologies, reducing waste and costs.
- Lower Financial Barriers: Users can adopt new CGMs, pumps, or algorithms without overhauling their entire system.
- Simplified Access: Streamlined insurance approvals and reduced clinical research burdens have made advanced technology more accessible.
For example, a user with an older insulin pump can now download updates to connect with a newly released iCGM, or manufacturers can introduce new algorithms that integrate seamlessly into existing devices.
As of December 2024, the U.S. Food and Drug Administration (FDA) has approved several interoperable devices for diabetes management, enhancing flexibility and personalization in treatment. Below is a categorized list of these devices:
Interoperable Continuous Glucose Monitors (iCGMs):
- Dexcom G6: Authorized in March 2018, the Dexcom G6 was the first iCGM approved by the FDA. It provides real-time glucose readings and integrates seamlessly with compatible insulin pumps and algorithms.
- Dexcom G7: Building upon the G6, the Dexcom G7 offers enhanced features and maintains interoperability with various diabetes management systems.
- Eversense E3: An implantable CGM that lasts up to six months, offering continuous glucose monitoring with integration capabilities.
- Eversense 365: Recently cleared by the FDA, this implantable CGM can last up to a year and provides extended continuous glucose monitoring.
Interoperable Insulin Pumps (ACE Pumps):
- Tandem t:slim X2 Insulin Pump: In February 2019, this device became the first insulin pump to receive the FDA’s Alternate Controller Enabled (ACE) designation, ensuring compatibility with various CGMs and AID algorithms.
- Tandem Mobi Insulin Pump: The FDA cleared the Tandem Mobi in July 2023. It is an ACE-designated pump designed for interoperability with compatible CGMs and dosing algorithms.
- Omnipod 5: A tubeless, wearable insulin pump system that integrates with compatible CGMs and algorithms for automated insulin delivery.
Interoperable Automated Insulin Dosing (AID) Algorithms:
- Control-IQ Technology: Developed by Tandem Diabetes Care, this algorithm received FDA clearance in December 2019. It automates insulin delivery adjustments based on CGM readings and is designed to work with interoperable devices.
- Tidepool Loop: An open-source AID algorithm that received FDA clearance, designed to integrate with various interoperable pumps and CGMs, offering users customizable diabetes management options. After receiving FDA approval, Tidepool Loop partnered with the Sequel Medtech Twiist insulin pump to create a new AID system.
Interoperable Controllers:
- Tandem t:slim X2 with Control-IQ: This system combines the t:slim X2 insulin pump with the Control-IQ algorithm, functioning as an interoperable controller to automate insulin dosing.
- Omnipod 5 System: This system combines the Omnipod 5 insulin pump with integrated algorithms to serve as an interoperable controller for automated insulin delivery.
These FDA-approved interoperable devices give individuals with diabetes greater flexibility in customizing their management systems. They allow for the integration of preferred components to suit personal needs and preferences.