By Sysy Morales on September 28th, 2016
The FDA approved Medtronic’s 670G insulin pump system, featuring automatic adjustment of insulin levels based on data from a continuous glucose meter. This is a semi- closed loop system because although it automatically adjusts your insulin dose every 5-minutes, the user must still manually bolus insulin at mealtimes or announce exercise.
According to the FDA, “The MiniMed 670G System includes SmartGuard technology, which can be programmed to automatically adjust delivery of basal insulin based on Continuous Glucose Monitor sensor glucose values, and can suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values.”
This means that the continuous glucose monitor sensor will communicate to the device any low blood sugar levels below a user defined point and the device will stop any insulin delivery to the user.
Safe, Effective, and Reduces Blood Sugar Variability
The results of Medtronic’s pivotal study were recently announced and the device was deemed safe and effective. At the ADA conference, Medtronic reported the data from its studies used in the FDA submission.
DiaTribe reported that A1c levels were reduced by .5 percent. Also, the data showed that the percentage of time below 70 mg/dL declined 44 percent and the amount of time below 50 mg/dL declined 40 percent. There was also “An 11% decline in time spent over 180 mg/dl and an 8% improvement in time-in-range (71-180 mg/dl).”
Diabetes Daily recently featured DiaTribe’s interview with Josh Airth, a 17-year old trial patient of the closed-loop system. When asked what the best part of using the device was, he said, “Overall, if you think of a diabetic’s blood glucose (on a graph) going up and dropping, going up and dropping, etc. – the pump with the Enlite 3 sensor took those numbers and tightened the margins horizontally and vertically. It led to fewer highs and lows, and also made them shorter – the CGM graph looked more like rolling waves and not a cardiac monitor. Within the three and a half days that I was using the closed loop portion, my blood glucose didn’t go above 210 or below 60.”
More About the Medtronic MiniMed 670G System
The FDA states “The Medtronic MiniMed 670G System consists of the following devices: MiniMed 670G Pump, the Guardian Link (3) Transmitter, the Guardian Sensor (3), One-Press Serter, and the Contour NEXT Link 2.4 Glucose Meter. The system requires a prescription.”
It is important to note: the 670G is considered a “hybrid-closed loop,” as a user still needs to bolus for meals and notify the system of exercise. Otherwise, it mostly takes care of insulin dosing in the background, which is particularly valuable at night.
Who Can Use the Medtronic 670G?
The FDA states the Minimed 670G/Enlite 3 is intended for the management of type 1 diabetes in those age 14 or older.
The FDA also issued an important note about very young users. “Medtronic performed an evaluation of the 670G closed loop system and determined that it may not be safe for use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore this device should not be used in anyone under the age of 7 years old. This device should also not be used in patients who require less than a total daily insulin dose of 8 units per day because the device requires a minimum of 8 units per day to operate safely.”
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