Automated Insulin Delivery System Receives FDA Approval

The system’s algorithm predicts glucose levels 30 minutes in advance and adjusts insulin delivery to reduce hypoglycemic events.

Tandem Diabetes Care, Inc. announced US Food and Drug Administration (FDA) approval of the t:slim X2 Insulin Pump with Basal-IQ technology, the first automated insulin delivery system approved for use by patients as young as 6 years old with diabetes.

The system’s predictive low glucose suspend (PLGS) feature is designed to reduce the occurrence and length of hypoglycemic events.

“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 Greg Forlenza, MD, 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.

The Basal-IQ algorithm predicts where glucose level trends are heading up to 30 minutes into the future. The device withholds insulin when glucose is predicted to drop below 80 mg/dL or when glucose is below 70 mg/dL and dropping, and automatically resumes treatment when glucose levels increase.

“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.”

Results from the PROLOG (PLGS for Reduction of Low Glucose) trial, a randomized crossover study, showed that use of the Basal-IQ technology reduced incidents of glucose readings below 70 mg/dL by 31% compared to the control period when patients used a standard CGM-integrated t:slim X2 Pump without automated insulin suspension.

The study included 103 patients with type 1 diabetes from age 6 to 72 at 4 US research centers. Participants “overwhelmingly” called the system easy to learn and use.

“Basal-IQ technology proved very effective in the clinical trial at reducing time spent in hypoglycemia and improving time in range,” said Forlenza. “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 company expects the t:slim X2 Pump with Basal-IQ technology will be available in August 2018. Additionally, in-warranty t:slim X2 users in the United State will be eligible to update the software and add the new Basal-IQ feature for free.