The study is the first of 3 in the International Diabetes Closed Loop trial, funded by the National Institute of Health.
Sue Brown, MD
Tandem Diabetes Care, Inc. reported that a successful pilot study was completed on the company’s t:slim X2 Insulin Pump, utilizing a hybrid closed-loop system that utilizes algorithms from TypeZero Technologies and Dexcom's G6 continuous glucose monitoring.
The study is the first of 3 in the International Diabetes Closed Loop (IDCL) trial, funded by the National Institute of Health (NIH). It was a 36- to 48-hour study with 5 participants at the University of Virginia.
The second of the 3 studies, which will be last 2 weeks, is currently enrolling patients at 7 clinical sites and is expected to begin in early 2018.
“We have enjoyed introducing patients to this latest advancement in technology, featuring an easy-to-use system and an algorithm with a successful track record in past clinical trials of improving blood glucose control while simultaneously decreasing hypoglycemia,” Sue Brown, MD, an associate professor at the Center for Diabetes Technology at the University of Virginia and the endocrinologist in charge of the IDCL trials that utilize the embedded technology, said in a statement. “This study was an exciting step forward in closed-loop technology for people with diabetes.”
The IDCL trial began near the end of 2016, and will include close to 360 adults with type 1 diabetes in total. A premarket approval submission is expected to be given to the US Food and Drug Administration (FDA) upon the completion of the trio of trials.
“The first successful use of the commercial version of our hybrid closed-loop system is a huge step forward, and the speed of the development cycle for this product has been impressive for our industry,” Kim Blickenstaff, MBA, president and CEO of Tandem Diabetes Care, said in a statement. “We look forward to starting the pivotal study later this year and continue to prepare for a launch in the first half of 2019, subject to FDA approval.”
The system is the second featuring a closed-loop system, following the September 2016 approval of the MiniMed 670G Insulin Pump System by the FDA, produced by Medtronic. The t:slim X2 pump does, however, offer a touchscreen, and is the only closed-loop system to do so.
TypeZero’s algorithms that are featured in the system have been involved in more than 30 clinical trials including almost 500 participants, according to Tandem Diabetes Care. Dexcom’s executive vice president of strategy and corporate development, Steve Pacelli, JD, noted the importance of the sensor accuracy in the system.
According to Tandem Diabetes Care, the device is also 38% smaller than Medtronic’s 630G and 670G pump systems, and 28% smaller than the 530G. It measures 3.13 inches long, 0.6 inches wide, and 2 inches tall. The pump, which also offers a pairable smartphone app, allows for software updates at no-cost, as soon as they are cleared by the FDA.