Reduced Time in Hypoglycemia Demonstrated in Tandem’s Trial for the t:slim X2 Pump with Predictive Low Glucose Suspend

Tandem Diabetes Care®, Inc., a medical device company and manufacturer of the only touchscreen insulin pumps available in the US, announced positive results from a pivotal study of the t:slim X2™ Insulin Pump with Basal-IQ technology, a predictive low glucose suspend (PLGS) feature. Data showed that the system achieved the primary outcome of reducing time spent in hypoglycemia compared to sensor-augmented pump therapy alone. Details from the study are being presented at the 11^th Annual Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Vienna, Austria by Dr. Bruce Buckingham, Professor of Pediatric Endocrinology at Stanford University, and principal investigator of the PROLOG (PLGS for Reduction Of LOw Glucose) trial.

The t:slim X2 Insulin Pump with Basal-IQ technology utilizes Dexcom G5® Mobile Continuous Glucose Monitoring (CGM) sensor values to suspend insulin delivery when low blood glucose is predicted and automatically resume insulin delivery when glucose levels begin to rise. Use of the system during a 3-week period at home reduced the number of sensor glucose readings below 70 mg/dL by 31 percent compared to the control period using a standard CGM-integrated t:slim X2 Pump without automated insulin suspension. Importantly, this marked reduction of time spent in low glucose was accomplished without any increase in the rate of hyperglycemia.

“Tandem’s t:slim X2 Insulin Pump with Basal-IQ proved easy to use, reduced time spent in hypoglycemia and improved time in range. These results are especially impressive given the study participants started out very well controlled, with a mean hemoglobin A1c of 7.3 percent. Participants also reported a high level of confidence using the system without a significant training burden to get started,” said Dr. Greg Forlenza, principal investigator for the Barbra Davis Center study site. “With increased availability and patient use of automated insulin delivery systems, we expect to see improvements in short term complications such as hypoglycemia, and a decrease in patients’ daily burden of diabetes and long-term complications.”

“Reducing the risk of hypoglycemia has been the most requested feature of automated insulin delivery in our market research, due to the severity of the complications when left untreated. The data from this study supports our mission to improve the lives of people with diabetes through new innovations, such as the t:slim X2 Pump with Basal-IQ technology,” said Kim Blickenstaff, president and CEO of Tandem Diabetes Care. “These results will support a PMA submission that we are on track to submit this quarter, and we continue to prepare for a launch in summer of 2018, pending FDA review and approval.”

The PROLOG study was a multi-center, randomized crossover clinical trial comparing two 3-week periods of at-home insulin pump use, one period using the t:slim X2 Pump with PLGS, and another period using a standard CGM-integrated t:slim X2 Pump without automated insulin suspension. The study included 103 participants with type 1 diabetes age 6 to 72 at four research centers across the United States and was coordinated by the Jaeb Center for Health Research in Tampa, Florida. The mean A1C of participants entering the study was 7.3 percent, with the majority already using a pump (83%) and/or CGM (84%). The primary endpoint of the study was to demonstrate a reduction in the percentage of CGM values below 70 mg/dL when using Tandem’s PLGS feature.

Tandem Diabetes Care, Inc. is a medical device company dedicated to improving the lives of people with diabetes through relentless innovation and revolutionary customer experience. The Company takes an innovative, user-centric approach to the design, development and commercialization of products for people with diabetes who use insulin. Tandem manufactures and sells the t:slim X2™ Insulin Pump, the only pump capable of remote feature updates using a personal computer, now available with Dexcom G5® Mobile CGM integration, and the t:flex® Insulin Pump, the first pump designed for people with greater insulin requirements. Tandem is based in San Diego, California.

Tandem Diabetes Care and t:flex are registered trademarks, and t:slim X2 is a trademark of Tandem Diabetes Care, Inc. Dexcom and Dexcom G5 are registered trademarks of Dexcom, Inc. All other trademarks are the property of their respective owners.