Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, today 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 today at the 11th 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 OfLOw 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."
About the PROLOG Study
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.
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc. (www.tandemdiabetes.com) 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.
Forward Looking Statement
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. These forward-looking statements relate to, among other things, whether the data from the PROLOG study will be adequate to support a future regulatory filing by Tandem, the anticipated timing of a PMA submission for the t:slim X2 with BASAL-IQ and the planned launch of t:slim X2 with BASAL-IQ in the summer of 2018. These statements are subject to numerous risks and uncertainties, including the risk that the data from the PROLOG study may not be adequate to support a future regulatory approval of the t:slim X2 with BASAL-IQ, that the approval of the t:slim X2 with BASAL-IQ may not occur when expected or that Tandem may encounter other challenges that may delay the commercial launch of t:slim X2 with BASAL-IQ, as well as other risks identified in Tandem's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, respectively, and other documents that we file with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Tandem undertakes no obligation to update or review any forward-looking statement in this press release because of new information, future events or other factors.
Tandem Diabetes Care
Steve Sabicer, 714-907-6264
Susan Morrison, 858-366-6900 x7005