Tandem Diabetes Care Announces FDA Approval of t:slim G4 Insulin Pump with CGM Integration

Tandem Diabetes Care®, Inc. TNDM today announced U.S. Food and Drug Administration approval of the t:slim G4™ Insulin Pump, the first and only touch-screen pump with continuous glucose monitoring (CGM) integration, for use by people 12 years of age or older who use insulin. It combines features of the t:slim® Insulin Pump and Dexcom G4® PLATINUM CGM System, devices that have consistently ranked #1 in independent surveys1, into a single device that is simple to use. The t:slim G4 Pump is the only pump that conveniently displays CGM graphs and trend information with current insulin delivery activity together on the home screen to help make informed treatment decisions. Orders for the t:slim G4 Insulin Pump can be placed now with shipments expected to begin in October 2015. "The t:slim G4 Pump combines our intuitive touch-screen interface and bright color display with Dexcom's CGM technology, giving the diabetes community a powerful new tool to help simplify therapy management," said Kim Blickenstaff, President and Chief Executive Officer of Tandem Diabetes Care. "CGM integration has been one of the most requested features since the launch of the t:slim Pump. The addition of t:slim G4 to our product family allows us to address a wider variety of diabetes management needs through the broadest range of insulin pump options available from one company." "The integration of Tandem's touch-screen interface and Dexcom's G4 PLATINUM CGM product could prove to be a powerful combination for people with diabetes," said Kupper Wintergerst, MD, pediatric endocrinologist at the University of Louisville and director of the Wendy L. Novak Diabetes Care Center in Louisville, KY. "It's great to have another integrated option for my patients, particularly one with an age indication for people as young as 12 years old." "We believe the t:slim G4 Pump's touch screen technology and simple user interface are a great combination for Dexcom G4 PLATINUM CGM integration," said Steve Pacelli, EVP, Strategy and Corporate Development at Dexcom. "CGM-integration is key to future automated insulin delivery technology, and we are pleased to be working with a company like Tandem who is continuously innovating to make diabetes technology simpler to use for people with diabetes." The t:slim G4 Pump is the newest addition to the Company's family of products, which includes the t:slim® and t:flex™ Insulin Pumps. Each pump in the portfolio features a touch-screen with a streamlined, user-friendly interface. This provides people rapid access to frequently used features while eliminating the need for excessive scrolling and button pressing, making these features simple to learn and simple to use. Each Tandem product utilizes modern technology, such as a built-in rechargeable battery and micro-USB port for convenient charging and fast data transfers. They also feature the Company's Micro-Delivery® technology that allows for basal delivery every 5 minutes in increments as small as 0.001 unit. The t:slim G4 and t:slim Pumps are the slimmest and smallest durable insulin pumps on the market, yet still hold up to 300 units of insulin, and the t:flex offers similar size benefits while holding up to 480 units of insulin. The t:slim G4 Pump can operate as a stand-alone insulin pump without CGM, or be paired with a Dexcom G4 PLATINUM sensor. When paired with a sensor, the CGM component of the pump closely mimics the interface of the Dexcom system, tracking glucose continuously and displaying color-coded graphs and arrows directly on the Pump's home screen2. The system also allows users to program personalized information, such as glucose targets and alerts, and has an alarm feature to notify the user if glucose levels rise or fall to dangerous levels.