Tandem Diabetes Care’s t:slim X2 Insulin Pump with Basal-IQ Technology Wins FDA Nod

Tandem Diabetes Care Inc., a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, announced U.S. Food and Drug Administration (FDA) approval 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). This is the first automated insulin delivery system approved for use by children as young as 6 years old, and the first insulin pump designated as compatible with integrated continuous glucose monitoring (iCGM) devices. The Company plans to launch its new product with Dexcom G6 continuous glucose monitoring (CGM) integration, which requires no fingersticks for calibration or diabetes treatment decisions and was the first CGM device to receive the iCGM designation from the FDA earlier this year.^1,2,3 Tandem expects the t:slim X2 Pump with Basal-IQ technology to be available in August 2018, and all in-warranty t:slim X2 users in the United States will have the option to add the new feature free of charge via remote software update.⁴
 
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. Use of the t:slim X2 Pump with Basal-IQ technology in the pivotal clinical study 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.
 
“Hypoglycemia can be a significant source of fear for people who use insulin and is a major cause of hospitalizations for people with diabetes,” said Dr. Greg Forlenza, Assistant Professor of Pediatrics at the Barbara Davis Center, and one of the principal investigators in the PROLOG (PLGS for Reduction of Low Glucose) trial. “Basal-IQ technology proved very effective in the clinical trial at reducing time spent in hypoglycemia and improving time in range. The system was also simple to learn and use, so the training burden was minimal for the clinics and study participants compared to other automated insulin delivery systems.”
 
“The t:slim X2 Pump with Basal-IQ technology was designed to predict and help prevent time spent low using best-in-class CGM technology,” said Kim Blickenstaff, president and CEO of Tandem Diabetes Care. “As the first company to launch a touchscreen insulin pump capable of remote feature updates, and now the first to have a pump approved with iCGM compatibility, we are delivering new innovation to our customers at a pace that is unprecedented in our industry, furthering our mission to help improve the lives of people with diabetes.”
 
Benefits of the new Basal-IQ predictive low glucose suspend feature include:
 

• Predicts and helps prevent lows—Using CGM values, the Basal-IQ feature looks ahead 30 minutes and suspends insulin when glucose is predicted to drop below 80 mg/dL or if glucose is currently below 70 mg/dL and falling. The system resumes insulin once glucose values start to rise.
• No fingersticks—With Dexcom G6 CGM integration, the Basal-IQ feature works with no fingersticks required for mealtime dosing or calibration.¹ Other benefits of the Dexcom G6 CGM include an extended 10-day wear, acetaminophen blocking⁵, and the ability to share real-time CGM data with up to 5 followers.⁶
• Works silently in the background—No additional alerts or alarms are required to use Basal-IQ technology compared to standard CGM-enabled pumps. Users can choose whether or not to receive alerts when insulin is suspended and resumed based on their personal preference.
• No complicated modes to manage—The Basal-IQ feature has no complicated settings to manage and operates without constant input or interaction. The user only has to decide whether they want the feature on or off.

 
References
¹ 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.
² Dexcom G6 CGM sold separately
³ 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.
⁴ A new prescription and additional training are required for this software update.
⁵ Dexcom G6 CGM readings can be used to make diabetes treatment decisions when taking up to a maximum acetaminophen dose of 1,000mg every 6 hours. Taking a higher dose may affect the G6 readings.
⁶ Separate Follow App required.