FDA Approves Basal-IQ Predictive Low Suspend for the t:slim X2 Pump from Tandem

TODAY, Tandem announced FDA approval of the Basal-IQ™ technology, a predictive low glucose suspend (PLGS) feature designed to help reduce the frequency and duration of low blood glucose events for the t:slim X2™ Insulin Pump. The technology has been approved for children as young as 6 years old. Basal-IQ will roll out at the same time as the Dexcom G6® continuous glucose monitoring (CGM) integration. 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.

The Basal-IQ algorithm uses data from the Dexcom G6 CGM to predict what blood sugars will be 30 minutes in the future. The device suspends insulin delivery when low blood glucose is predicted, then automatically resumes insulin delivery once blood glucose levels begin to rise. In clinical trials, use of the t:slim X2 Pump with Basal-IQ technology demonstrated a 31 percent relative reduction in time spent below 3.9 mmol/L70 mg/dL, with no rebound hyperglycemia compared to a CGM-enabled insulin pump without the feature.

The Basal-IQ rollout is the first step from Tandem towards their more complete hybrid closed-loop system, which will be called Control-IQ. This is the first FDA approval of a pump algorithm integrating with the Dexcom G6, on the heel’s of it’s “interoperability” approval this spring.

From Tandem’s press release:

Benefits of the New Basal-IQ Predictive Low Glucose Suspend Feature

Predicts and helps prevent lows – Using CGM values, the Basal-IQ feature looks ahead 30 minutes and suspends insulin when blood glucose is predicted to drop below 4.4 mmol/L80 mg/dL or if blood glucose is currently below 3.9 mmol/L70 mg/dL and falling. The system resumes insulin once blood 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 five 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.

Read the full press release from Tandem Diabetes Care here.