Tandem Diabetes won FDA approval for its t:slim X2 insulin pump with Basal-IQ, a technology that prevents hypoglycemia. Basal-IQ, known as a predictive low glucose suspend (PLGS) feature, monitors a number of parameters and prevents insulin delivery when there’s a high chance that would result in a low glucose event.
The system can be used by diabetics six years and older, and thanks to compatibility with the Dexcom G6 continuous glucometer that can be used for days at a time, the process is close to completely automatic. The Dexcom G6 does not require calibration, so finger pricks can be a thing of the past, and the entire process of sugar control left to the paired devices.
The t:slim X2 with Basal-IQ should be available in the U.S. in August and existing users of the t:slim X2 will be able to simply download the Basal-IQ feature for free to their devices.
From the official announcement:
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.”
Flashbacks: t:slim X2 Insulin Pump with Dexcom G5 CGM Connectivity Cleared in EU…; Tandem t:slim G4 Insulin Pump with Dexcom CGM Integration Approved by FDA…; Tandem t:slim Insulin Pump Gets FDA Clearance…
Product page: t:slim X2 Insulin Pump…
Via: Tandem Diabetes…
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