Tandem Diabetes Launches New Version of Insulin Pump in U.S.

Tandem Diabetes Care Inc., an insulin delivery and diabetes technology company, today announced its commercial launch of the t:slim X2 insulin pump with Control-IQ technology, an advanced hybrid-closed loop feature designed to help increase time in range (70-180 mg/dL)¹. It is the first and only system cleared to deliver automatic correction boluses in addition to adjusting insulin to help prevent high and low blood sugar. The system integrates with Dexcom G6 continuous glucose monitoring (CGM), which requires no fingersticks for calibration or diabetes treatment decisions.^2,3,4 The Company will soon begin 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. t:slim X2 pumps pre-loaded with Control-IQ technology are now shipping to new customers.
 
The t:slim X2 insulin pump with Control-IQ technology uses CGM values, in conjunction with other variables such as insulin on board, to predict sensor glucose levels 30 minutes ahead and adjust insulin delivery accordingly. If glucose values are predicted to drop below 112.5 mg/dL, basal insulin delivery is reduced, and when predicted to be below 70 mg/dL, basal insulin delivery is stopped. If glucose values are predicted to be above 160 mg/dL in the next 30 minutes, basal insulin will be increased. If glucose values are predicted to be above 180 mg/dL, Control-IQ technology calculates a correction bolus with a target of 110 mg/dL, and delivers 60 percent of that value up to once an hour as needed. Control-IQ technology also offers optional settings for sleep and exercise that will change treatment values to better match the different physiologic needs during these activities.
 
“Control-IQ technology has been described by study participants and investigators as ‘life-changing,’ ‘easy to use,’ and ‘a new standard of care in insulin therapy management,’ which is incredible feedback as we commence this commercial launch and begin bringing its benefits to more people with diabetes,” said John Sheridan, president and CEO. “We began processing orders earlier this month and are excited about the opportunity this launch presents for 2020. As these new customers move through the insurance verification process it will provide us with valuable trend information that will be used in setting our financial guidance for the year.”
 
References
¹ As measured by CGM
² If glucose alerts and CGM readings do not match symptoms or expectations or if taking over the recommended maximum dosage amount of 1000mg of acetaminophen every 6 hours, use a blood glucose meter to make diabetes treatment decisions.
³ Dexcom G6 CGM sold separately
⁴ The Dexcom G6 CGM transmitter can only be paired with one medical device (either a Dexcom receiver or t:slim X2 pump) and one consumer device (phone or tablet) at the same time.