SAN DIEGO--(BUSINESS WIRE)--Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, today presented results from a Human Factors study conducted to validate the safety of the user interface of a predictive low glucose suspend (PLGS) feature as part of the t:slim X2™ Insulin Pump. The study included users ages 6 and up (N=53), with and without experience using an insulin pump or continuous glucose monitoring (CGM). The study demonstrated a 99 percent success rate among study participants who performed a series of critical tasks using the PLGS system after initial training. Out of 530 tasks performed, only seven task failures were observed, none of which were related to safety. These data were presented today during a poster session at the 2017 Diabetes Technology Meeting (DTM) in Bethesda, Maryland.
“This study demonstrates that the t:slim X2 System with PLGS requires minimal training and is easy to use, even for people without pump or CGM experience,” said Betsy Dokken, PhD, Director of Clinical Affairs at Tandem Diabetes Care. “We believe that the high success rate and minimal errors observed in this study highlight the importance of human factors research in insulin pump development, particularly with the introduction of automated insulin delivery algorithms.”
The study was conducted at four independent research centers in the United States. Training consisted of live one-hour sessions on the t:slim X2 Pump and the Dexcom G5 Mobile CGM System with a break in between. These were waived for current Tandem and Dexcom users, or were shortened for those with previous pump and/or CGM experience. Participants then took a 45-minute computer-based training module on the PLGS feature. Following a one-hour break, they were asked to complete 10 critical tasks on the device in a simulated environment in order to uncover and identify errors and difficulties. Parents were permitted to help children. Interactions were observed and scored by a researcher seated in a separate observation room. Successful performance required completion of the task without any observed errors or assistance from the study moderator. Pass/fail scoring was completed according to pre-set criteria.
Data from a feasibility study on Tandem’s PLGS system was presented this summer at the 77th Scientific Sessions of the American Diabetes Association. A pivotal trial is currently underway and anticipated to be complete by the end of 2017. The Company is preparing to launch its t:slim X2 Pump with PLGS in the summer of 2018, subject to future U.S. Food and Drug Administration review and approval.
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, and the t:flex® Insulin Pump, the first pump designed for people with greater insulin requirements. Tandem is based in San Diego, California.
Forward Looking Statement
This press release includes forward-looking statements relating to the Company’s t:slim X2® Insulin Pump featuring a predictive low glucose suspend, including the conclusions from research studies on the ease of use of the pump, the effectiveness of training and the anticipated completion of the Company’s pivotal trial for the PLGS system. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including risks that (i) current and past results of research studies may not be indicative of results of future research studies or of actual user experience, (ii) the Company may experience unanticipated delays in the completion of the pivotal trial for the PLGS system or the results of the pivotal trial may not be adequate to support a future regulatory submission and approval of the t:slim X2 with PLGS system, and (iii) the launch of the t:slim X2 with PLGS may be delayed due to the uncertainty generally associated with the regulatory review process. Forward looking statements are also subject to other risks and uncertainties, including those identified in the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as well as other documents that the Company files with the Securities and Exchange Commission. Investors 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 any forward-looking statement in this press release.
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Tandem Diabetes Care and t:flex are registered trademarks, and t:slim X2 and t:simulator are trademarks 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.