Control-IQ software for insulin pumps approved by the FDA; other tech in pipeline.
The new software, “Control-IQ,” approved by the FDA, can automate insulin dosing and is a significant change for insulin pumps. The FDA approved Control IQ through the De Novo pathway after a review that lasted a little less than five months. The De Novo pathway is designed for “medical technologies that can be adequately regulated as Class I or II devices with general and special controls, but for which no predicate device exists.”
The approval of Control-IQ created the third and final category required for a complete automated insulin dosing system. This was following the FDA designation of Dexcom’s G6 CGM (Continuous Glucose Monitor) as an integrated continuous glucose monitor, and of Tandem’s t:slim X2 insulin pump as an alternate controller enabled pump.
When Tandem’s Control-IQ algorithm was approved under the De Novo pathway, it was authorized for use in patients with diabetes who were older than 14 years old. However, the company plans to file a regulatory submission this quarter, which would allow Control-IQ to be used in patients as young as six years old.
Tandem had doubled its volume to over 362 million for 2019 and shipped more than 73,000 insulin pumps. Tandem stated that the company currently has nearly 2% of the U.S. insulin pump market and predict that sales will reach up to $465 million in 2020, with growth forecasted between 24% and 28%.
The ability to administer bolus doses of insulin via a smartphone is a “number one feature that people desire,” according to Tandem CEO John Sheridan. The company plans an FDA filing this summer for an innovative mobile app that would allow for remote bolus dosing. The FDA submission has been “a bit of uncharted territory as there is not a commercial precedent for mobile control from an insulin pump using an unrestricted mobile device.” This makes the FDA approval timing challenging to predict, but the remote bolus feature via smartphone app is estimated to be available in the latter half of this year.
Furthermore, Tandem plans a future FDA submission of a smaller insulin pump named t:sport. This submission will be in two filings since patients who use the pump will have to decide whether to activate the device via their smartphones or another separate handheld device. Presently, the company plans to prioritize the different handheld devices and file for it this summer. They plan to submit a file for complete control through a mobile app later. The new pump is not scheduled to launch until the submissions above are approved by the FDA, though they are aiming for the first half of 2021.
Stiff competition may rear its head in the form of Tandem’s competitor: Insulet, which has intentions of bringing its automated insulin delivery system to the 2020 market if everything does go according to plan. The major continuous glucose monitoring device manufacturers Dexcom and Abbott, have both delineated plans to integrate their devices with Insulet’s system which is called Horizon. The Control-IQ algorithm already currently works with Dexcom’s G6 Continuous Glucose Monitor.
- Tandem annual revenue doubled to $362 million and the company shipped over 73,000 pumps in 2019.
- The CEO of Tandem states that the ability for patients to administer bolus doses of insulin via phone is a priority feature that people desire.
- Tandem has filed submissions for an automated insulin dosing system but faces stiff competition in the form of Insulet’s Horizon system.
Rachal, Maria. “Tandem Shapes FDA Strategy for New Insulin Pump Features.” MedTech Dive, Tandem Diabetes, 25 Feb. 2020, www.medtechdive.com/news/tandem-reworks-fda-strategy-for-new-insulin-pump-features/572846/.
Mit Suthar, PharmD. Candidate, LECOM School of Pharmacy