Tandem Diabetes Care is tackling an anomaly it found during a clinical trial of its Control-IQ technology with a software update. The San Diego-based company said the software update will be available to study sites before the end of this month.
Tandem said 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. The company said that 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 firm said that nearly 120 out of the 168 patients have completed the 6-month study and have been enrolled in a 3-month extension. Tandem said that once the updated software is available, a pediatric arm for the clinical trial will begin.
“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,” John Sheridan, president and CEO of Tandem said in a release. “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 software update follows on the heels of Tandem receiving FDA approval for its t:slim X2 insulin pump in February. Through the approval, the agency created a new device category – Alternate Controller Enabled Infusion Pumps (ACE Pumps).
During Tandem’s 4Q18 earnings call held in February, Kim Blickenstaff its president and CEO spoke to the importance of the ACE Pumps Category going forward.
“Being the first to achieve this designation, further establishes the role we've taken as the key innovator in the insulin pump industry, having launched the first touch screen pump in the U.S.,” Blickenstaff said according to a Transcript from Seeking Alpha. “The first pump capable of remote feature updates; the first pump approved as iCGM compatible; and now the first in this new interoperable pump category.”