Hybrid Closed Loop Insulin System Keeps Diabetics in Check

SmartGuard HCL learns an individual's insulin pattern by analyzing data directly from the Guardian Sensor, and therefore requires only minimal input. Patients therefore need only to enter mealtime carbohydrates, accept bolus correction recommendations, and periodically calibrate the sensor.

A recent study that compared the MiniMed 670G system to an open-loop system--i.e., an insulin pump and continuous glucose monitor (CGM), without automation—showed that patients spending three months on the MiniMed 670G saw an average 0.5% reduction in A1c, a 40% decline in time spent in dangerous hypoglycemia (under 50 mg/dl); and an 11% decline in time spent over 180 mg/dl. The overall result was an 8% improvement in time-in-range (71-180 mg/dl). The MiniMed 670G system is a product of Medtronic (Dublin, Ireland), and has been approved by the U.S. Food and Drug Administration (FDA).

“The FDA approval of the world's first hybrid closed loop system is a culmination of many years of hard work and close collaboration with the clinical and patient communities to generate the body of evidence needed to advance this technology for those living with diabetes,” said Francine Kaufman, MD, chief medical officer of the Diabetes Group at Medtronic. “We appreciate the unprecedented speed by which the agency approved our PMA submission to help bring this advanced insulin pump therapy so quickly to U.S. patients living with this challenging disease.”

“With SmartGuard HCL, the ability to automate basal insulin dosing 24 hours a day is a much-anticipated advancement in the diabetes community for the profound impact it may have on managing diabetes, particularly for minimizing glucose variability and maximizing time in the target range,” said Richard Bergenstal, MD, executive director of the Park Nicollet International Diabetes Center (Minneapolis, MN, USA). “The data from the pivotal trial were compelling and I am confident that this therapy will be well-received by both the clinical and patient community.”

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