The Food and Drug Administration (FDA) today authorized an algorithm that enables the second artificial pancreas system: The Control-IQ™ advanced hybrid closed loop technology.
For now, the algorithm can be used with Tandem’s t:slim X2™ insulin pump and Dexcom’s G6 continuous glucose monitor (CGM). Though this is not the first algorithm approved for an artificial pancreas system, it is the first algorithm authorized as an interoperable automated glycemic controller, which means the algorithm could be a component of any open protocol, or interoperable, artificial pancreas system. Formerly, there was only one FDA approved artificial pancreas system on the market: The Medtronic 670G, approved in 2016.
Enabling open systems is a priority for Breakthrough T1D—meaning that insulin pump, a CGM and an algorithm can “talk” to each other, regardless of the manufacturer. This gives the T1D community more choice and flexibility to select the technology that works best for them.
Breakthrough T1D has been a leader in the development of artificial pancreas systems for 15 years, since starting the Breakthrough T1D Artificial Pancreas Project in 2005 and the Breakthrough T1D Artificial Pancreas Consortium, which have dramatically accelerated progress by bringing academic researchers, government agencies, industry and the Helmsley Charitable Trust together to pursue artificial pancreas technology.
Through these efforts, Breakthrough T1D developed a roadmap for artificial pancreas development with increasingly advanced versions of the device. Manufacturers embraced the roadmap to guide their own research and development programs.
- Breakthrough T1D has funded over $110 million to date in artificial pancreas research.
- As testing new artificial pancreas technology in people with T1D can be challenging, Breakthrough T1D partnered with the FDA to create a regulatory pathway for approval and commercialization of this technology, leading to the 2012 FDA guidance for artificial pancreas systems. Industry experts have said Breakthrough T1D’s involvement cut five years off the approval process for the Medtronic 670G artificial pancreas system in 2016, the first approved system.
- Breakthrough T1D continues to advocate with private and government insurers for choice and affordability of all treatments and technology for people with T1D. In particular, Breakthrough T1D calls upon United Healthcare to lift its restrictions on insulin pump coverage, which currently prevents its members with T1D from accessing technology like that authorized by FDA today.
Data for the submission to FDA came from the International Diabetes Closed Loop Protocol-3 (iDCL) trial, a six-month closed loop study, funded by the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) with funds from the Special Diabetes Program (SDP). The clinical trial, with 168 participants ages 14+, which was recently published in the New England Journal of Medicine, met all of its primary and secondary endpoints, including time-in-range and HbA1c, with no fingerpricks and no severe low blood sugar events—a dangerous event for people with T1D, which, if not caught early, can lead to seizures, coma or, in extreme cases, death.
This important development is also a testament to the importance of the Special Diabetes Program (SDP), which has been renewed by Congress numerous times thanks to leadership by Breakthrough T1D.
The Special Diabetes Program (SDP) is up for renewal, so if you haven’t done so already, please sign up to be an advocate, and encourage friends and family to do the same. You’ll receive timely updates and actions you can take to turn Type One into Type None.
This is the latest example of how Breakthrough T1D research and advocacy work together to make T1D management better and safer. This is a win for the T1D community, and provides people with T1D another option to improve daily blood-sugar management, until cures are found.
