The anomaly, according to Tandem, relates to how the company’s t:slim X2 insulin pump with Control-IQ technology handles continuous glucose monitoring data under undisclosed conditions. The company reported that the anomaly could impact the system’s prediction of future blood glucose values and automated insulin delivery.
The problem has not resulted in any reported adverse events, Tandem noted, but use of the Control-IQ software feature will be temporarily halted until the software update is available.
Roughly 120 out of 168 trial participants have finished the 6-month study and have been enrolled in the 3-month extension. The pediatric arm of the study will kick off once the updated software is available, Tandem added.
The company said it’s in talks with the study investigators to determine if the software update will impact the clinical or regulatory strategy for the t:slim X2 insulin pump with Control-IQ tech.
“A primary reason for a larger pivotal clinical trial is to identify and resolve infrequent anomalies like this that may not appear in smaller studies. Being able to address this now helps us to offer a more robust product for our customers at launch,” president & CEO John Sheridan said in prepared remarks.
“Our ability to quickly develop and provide trial participants a remote software update is another example of the revolutionary power of our Tandem Device Updater, and our Company’s nimble research and development capabilities. We continue to prepare for the launch of our Control-IQ technology in the second half of this year, subject to successful completion of the study and FDA review,” Sheridan added.
Last month, Tandem beat estimates on Wall Street with its fourth-quarter and full-year financial results. The company also announced plans to shuffle its C-suite, with former CEO Kim Blickenstaff becoming executive chairman and Sheridan assuming the corner office.