First FDA Approval of Closed-Loop Insulin Pump


Medtronic’s MiniMed 670G system was recently approved by the FDA – this marks the first-ever FDA approval of a hybrid closed-loop insulin delivery system.  Medtronic explains that the system uses a computer algorithm in combination with a wearable glucose monitor that automatically measures glucose levels every five minutes after which it automatically administers any insulin needed by the patient.  While the system does not completely automate insulin management—users still have to enter mealtime carbohydrates and must periodically calibrate the sensor, among other tasks—nevertheless, Lori Laffel, an endocrinologist at Harvard University’s Joslin Diabetes Center, says that the approval was a “big step forward.”

According to Medtronic, the MiniMed 670G system features Medtronic’s SmartGuard HCL algorithm and new Guardian Sensor 3, which can be worn continuously for up to seven days.  The system is approved for the treatment of type 1 diabetes in individuals fourteen years of age or older and provides continuous delivery of basal insulin (at rates selectable by the user) and administers insulin boluses (in amounts that can also be adjusted by the user).  According to the U.S. Centers for Disease Control and Prevention, approximately 5% of people with diabetes have type 1 diabetes, which is also commonly referred to as “juvenile diabetes.”

Richard M. Bergenstal, M.D., the principal investigator of the pivotal study and executive director of the Park Nicollet International Diabetes Center in Minneapolis, states:

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.

Following Medtronic’s recent approval, experts and analysts have also opined on what future insulin delivery systems could provide.  For example, Aaron Kowalski, PChief Mission Officer and Vice President of Research at JDRF, an organization dedicated to type 1 diabetes research, states:

This is a fantastic step forward, but we are not done, JDRF will continue supporting other artificial pancreas advancements and advocating for broad access to this life-changing technology.  Next generation systems are in the pipeline that could provide even better outcomes with less burden.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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