Those who want to use the Medtronic pump with a different CGM like the Dexcom G4 or Navigator would order the Revel 523 or 723 pumps that are identical to the 530G other than its display of the Enlite CGM.
These coverages, however, can be used for the pump by itself.Also, for those who would just would like to switch from the Medtronic uses the Artificial Pancreas classification for the 530G pump/CGM system, but many bloggers and writers have pointed out that this is misleading. What’s more, and as an indication of its commitment to this area of development, the FDA itself came up with a new product device classification for the system: “artificial pancreas device system, threshold suspend,” a word choice that to me gives a heartening sense of where the FDA anticipates technology is heading.
Written by Amy Tenderich — Updated on June 1, 2018. Along with the new pump, Medtronic also got approval for its new Enlite CGM sensors. Some include “bolus wizard” features that use a patient’s self-determined insulin-to-carb ratios and sensitivity factors to calculate a suggested insulin dose, but the pump does not administer insulin until a patient tells it to. I just got off a conference call with Nancy Katz, Medtronic’s vice president of consumer marketing and Mark O’Donnell, its vice president of regulatory affairs. They were clearly ecstatic, and I and the other patient advocates on the call were as well: this is an enormous first step toward the approval of a closed-loop system, the much longed for artificial pancreas that would so greatly improve patients’ lives.In case you aren’t up on the latest in the world of insulin pumps, here’s the background: as of today, America’s insulin pumps do not make any decisions of their own. After months of waiting, I finally received the world’s first hybrid closed loop system, the Minimed 670G system. This review is my opinion of the pump, both positive and negative.
Product Details Medtronic just announced FDA approval of its MiniMed 530G insulin pump with low-glucose suspend, the first step toward a full-blown artificial pancreas. MiniMed™ 630G system is approved for ages 14 years or older with Guardian™ Sensor 3 and MiniMed™ 530G system is approved for ages 16 years or older with Enlite™ sensor. I got a Minimed 506 pump in 1998 and have been a fan of the Minimed/Medtronic pumps since.
The 530G is the first system in the United States that can automatically stop insulin delivery if the CGM's glucose value falls to a preset level (60-90 mg/dl) AND the wearer doesn't respond to the Threshold Suspend Alarm. We have almost lost him a few times over the years with low blood sugar. But nonetheless.
This functionality puts the device in the newly created OZO: Artificial Pancreas Device Classification created by the U.S. Food and Drug Administration.The FDA approved the Medtronic MiniMed 530G insulin pump with its display of the Enlite continuous glucose monitor in September, 2013. The low threshold can be set between 60 and 90 mg/dL.
Medtronic Minimed 530G Insulin Pump with CGM - Review. Her work has been featured in publications including The Best American Science Writing, The New York Times, Popular Science, The Los Angeles Times, The San Francisco Chronicle, The Washington Post Magazine, Salon, Slate, Men’s Journal, Health Magazine, The Oprah Magazine, and Outside, among others. Likewise, if your blood sugar is low, today’s pumps do not stop delivering basal or bolus insulin unless the patient intervenes. Medtronic advises against calibration when two down or up arrows are shown on the pump screen.The retail cost is $7,350 for the pump/CGM system.