Tandem’s Control-IQ Hybrid Closed Loop Approved by the FDA
Updated 6/17/20: Tandem Diabetes Care announced that Control-IQ has been approved by the U.S. Food and Drug Administration (FDA) for pediatric use in children ages 6 and older.
Updated 1/15/20: Tandem Diabetes Care announced the commercial launch of the t:slim X2 with Control-IQ technology on January 15. Read the full press release.
On Dec 13, 2019, the FDA announced the approval of the Control-IQ Hybrid Closed Loop System from Tandem Diabetes Care. The approval of the Control-IQ system as a “controller” represents the first-ever approval of an interoperable algorithm for use in an automated insulin dosing (AID) system.
The Control-IQ technology was built with the t:slim X2 insulin pump and Dexcom G6 continuous glucose monitor working together with help from Control-IQ’s groundbreaking algorithm. Features of the algorithm include automated insulin correction boluses for high blood sugars in addition to basal rate modulation, a dedicated hypoglycemia safety system (like that of Basal-IQ), and gradually intensified control overnight to reach 6.1-6.7 mmol/L110-120 mg/dL by morning. The system is designed to gradually improve time-in-range. No other hybrid closed loop has offered automatic correction boluses or been able to bypass finger stick calibrations.
The FDA approval is notable in that it is the first approval of an interoperable hybrid-closed loop system, allowing patients to use multiple devices in concert with each other to manage their blood glucose levels. In this case the Tandem t:slim X2 insulin pump—which has received designation as an alternate controller-enabled insulin pump (ACE pump)—is working with an integrated continuous glucose monitor (iCGM), the Dexcom G6.
Similar to Basal-IQ, the Control-IQ algorithm will be offered in the form of a free software update—current Tandem pump users will not need to purchase a new device to run Control-IQ. Anyone who purchases a Tandem pump in the United States before the end of 2020 will also receive the free update.
“With this clearance, we will be launching the most advanced automated insulin dosing system commercially available in the world today,” said John Sheridan, president and CEO of Tandem Diabetes Care. “This is a testament to our commitment to improving the lives of people with diabetes by offering simple-to-use products that deliver superior performance.”
According to a press release from Tandem, the Control-IQ update is expected to be available by the end of January 2020, and new pumps with Control-IQ technology will begin shipping to customers in the same timeframe. Control-IQ is intended for patients ages 6 and older.
Editor’s Note: This article has been updated to reflect that as of June 17. 2020 Control-IQ has been approved by the FDA for pediatric use, after an initial indication of ages 14 and older.
Control-IQ technology should not be used by anyone under the age of six years old. It should also not be used in patients who require less than 10 units of insulin per day or who weigh less than 55 pounds.
“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.”
Positive study results presented at ADA 2019 boded well for approval and early predictions saw Control-IQ being approved by the end of the year as a result. Trial users saw their time-in-range increase by 11% (up to 71%), translating to an additional two and a half hours every day spent between 3.9-10.0 mmol/L70-180 mg/dL. User A1Cs also saw an average decrease from 7.4% at the outset of the trial to 7.06% by the end. Participants also saw less time overall in hyperglycemia and hypoglycemia than their non-loop counterparts.
JDRF President and CEO Aaron J. Kowalski, Ph.D, weighed in on the significance of this approval, saying “As part of our mission to improve the lives of those affected by type 1 diabetes (T1D), JDRF has been a leader in artificial pancreas (AP) research for more than 15 years and partnered with the FDA to establish regulatory pathways to ensure AP technology gets into the hands of people with T1D as quickly as possible… Until we find cures, we are continuing to support the development of new technologies and treatments to improve blood sugar management so people with T1D can live healthier and more manageable lives.”
Control-IQ builds on the Basal-IQ algorithm which was approved by the FDA last summer. Basal-IQ is a predictive low blood glucose suspend feature, which uses data from the Dexcom G6 Continuous Glucose Monitor (CGM) to predict what blood sugars will be, suspend insulin delivery when low blood glucose is predicted, and then automatically resumes insulin delivery once blood glucose levels begin to rise.
Tandem is currently in the recruitment phase of a pediatric trial for Control-IQ and anticipates FDA approval for use in pediatrics (6 to 13 years) by the end of Summer 2020.
Check out Beyond Type 1’s initial impressions on this breaking news below!
For additional information on Control-IQ, visit Tandem’s Website here.
This story is developing and will be updated as more information becomes available.
