Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps with continuous glucose monitoring (CGM) integration, today announced its launch of the t:slim X2™ Insulin Pump with Basal-IQ™ Technology, a predictive low glucose suspend (PLGS) feature designed to help reduce the frequency and duration of low glucose events (hypoglycemia). It is integrated with the Dexcom G6® CGM System, which requires no fingersticks for calibration or diabetes treatment decisions.1,2 The Company has begun sending emails with update instructions to all in-warranty t:slim X2 users in the United States, who have the option to add the new feature free of charge via remote software update.3 t:slim X2 Pumps pre-loaded with Basal-IQ Technology are expected to begin shipping to new customers by the end of August.
Tandem's Basal-IQ algorithm is designed to look 30 minutes into the future to predict where glucose levels are heading. The device suspends insulin delivery when low glucose is predicted, then automatically resumes insulin delivery once glucose levels begin to rise. In the pivotal clinical study, use of the t:slim X2 Pump with Basal-IQ Technology demonstrated a 31 percent relative reduction in time spent below 70 mg/dL, with no rebound hyperglycemia compared to a CGM-enabled insulin pump without the feature. The system received high usability scores in the study, with 93 percent of participants indicating that the system was easy to use, and 97 percent indicating that they felt confident using the system.4
"This launch marks the achievement of our goal to offer people with diabetes a simple-to-use automated insulin delivery feature that can reduce time spent low without adding significant burden to the pump therapy experience," said Kim Blickenstaff, president and CEO of Tandem Diabetes Care. "Our ability to provide remote software updates, allowing in-warranty t:slim X2 Pump users the ability to add Basal-IQ Technology to their current pumps using a personal computer, is unparalleled in the industry and further differentiates the t:slim X2 Insulin Pump from other devices on the market."
Update Instructions for In-warranty t:slim X2 Pump Users
No action is required at this time. Individual emails are being sent to all in-warranty t:slim X2 Pump users in the United States with information on how to start the update process. Emails are being sent out in batches, with all users anticipated to have received the information by the end of August. The Basal-IQ feature update will require a new prescription and completion of a 45-minute online training module, all of which will be coordinated through a simple-to-use online portal. Internet and computer access are required for pump updates. Basal-IQ Technology is only compatible with the Dexcom G6® CGM System. t:slim X2 Pump users who have Dexcom G5® Mobile CGM supplies they plan to use may want to postpone this update until they are ready to switch to the new Dexcom G6 CGM System. More information about the update process and system requirements is available at www.tandemdiabetes.com/X2update.
Free Basal-IQ Technology Demo App
Tandem's free t:simulator™ App lets users experience the touchscreen interface of the t:slim X2 Insulin Pump with Basal-IQ Technology directly on a mobile device. For more information and to download the app, visit http://www.tandemdiabetes.com/tsimulator.