FDA Okays New Insulin Delivery System That Cuts Low Glucose

Miriam E. Tucker

June 22, 2018

The US Food and Drug Administration (FDA) has approved a second insulin-delivery system that suspends delivery of insulin in anticipation of hypoglycemia.

The t:slim X2 Insulin Pump with Basal-IQ technology (Tandem Diabetes Care) is the first automated insulin delivery system approved for use in children down to 6 years of age. It is also the first to team an insulin pump with the Dexcom G6, the first integrated continuous glucose monitoring (iCGM) device. The Dexcom G6 was approved in March 2018. The t:slim is also compatible with the Dexcom G5 CGM.

Like the Medtronic MiniMed 670G hybrid closed-loop insulin delivery system, which has also just been approved for use in children aged 7 to 13 years, the new t:slim system includes a "predictive low glucose suspend" feature that predicts and helps prevent hypoglycemia.

The new Basal-IQ feature in t:slim uses CGM trend information to anticipate glucose levels 30 minutes in advance and suspends insulin delivery when glucose levels are predicted to dip below 80 mg/dL or if the current level is below 70 mg/dL and dropping. The system restarts insulin delivery when glucose levels begin to rise.  

MiniMed 670G, which has also been dubbed the artificial pancreas, and t:slim are the first examples of automated insulin delivery systems that make up the new so-called "clever insulin delivery systems" being developed for people with diabetes. MiniMed 670G is the more sophisticated device because it also responds to hyperglycemia and cuts off insulin supply when glucose is too high, rather than just too low, as is the case with the t:slim.

This category also includes a number of smart insulin pens and needles in development, which many believe will be more widely used in the long-run because far more patients with diabetes use pens to deliver insulin rather than pumps worldwide.

FDA Approval Based on PROLOG Trial

"Hypoglycemia can be a significant source of fear for people who use insulin and is a major cause of hospitalizations for people with diabetes...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," said Gregory P. Forlenza, MD, of the Barbara Davis Center for Diabetes, Aurora, Colorado, in a press release issued by Tandem.

Forlenza was an investigator in the pivotal Predictive Low Glucose Suspend for Reduction of Low Glucose (PROLOG) study, a 6-week, 4-center randomized crossover trial, for which the main results were presented in February 2018 at the Advanced Technologies and Treatment for Diabetes conference. A total of 103 patients with type 1 diabetes aged 6 to 72 years wore the t:slim X2 pump with and without the Basal-IQ low glucose suspend feature for 3 weeks each. Use of the system with the Basal-IQ feature resulted in 31% fewer blood glucose readings below 70 mg/dL compared with the control period, without increased hyperglycemia. 

PROLOG investigators will present more data showing "exceptional usability" of the system in a late-breaking poster on Monday at the American Diabetes Association (ADA) 2018 Scientific Sessions in Orlando.

In early July, Tandem's free t:simulator App will be updated so that users can experience the touchscreen interface of the t:slim X2 pump with the Basal-IQ technology directly on their mobile devices.

And tentatively starting in August 2018, all in-warranty t:slim X2 pump users in the United States will be able to add the Basal-IQ feature free of charge via a software update using a personal computer. The update will require a new prescription, and users will need to complete a 45-minute online training session. Patients must have Internet and computer access to receive the updates.

Information about the requirements and update process are available here.

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