The company anticipates that the software update will be available to study sites before the end of March.

“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,” said John Sheridan, president and chief executive officer.

“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.”

The anomaly relates to how the t:slim X2 insulin pump with Control-IQ technology handles continuous glucose monitoring (CGM) data under specific conditions, which could then impact the system’s prediction of future blood glucose values and automated insulin delivery.

Manifestations of this anomaly are rare and have not resulted in any reportable adverse events; however, due to an increased risk of hypoglycemia, use of the Control-IQ software feature in the IDCL study will be temporarily suspended until the software update is available.

The Company is currently in discussions with the IDCL study investigators to evaluate any impact of the software update to the clinical or regulatory strategy for the t:slim X2 insulin pump with Control-IQ technology. Currently, approximately 120 out of 168 trial participants have completed the 6-month DCLP3 study. Individuals who complete the 6-month study period are then enrolled in a 3-month extension to the primary study.

The Company has notified other clinical trial sponsors using Control-IQ technology of the anomaly and that a software update will be made available. The DCLP5 study, which is the pediatric arm of the IDCL study, will commence following availability of the updated software.

Source: Company Press Release