The long awaited announcement came from Medtronic today, that the low blood glucose suspend pump has been approved for the marketplace. This is a huge piece of good news for all who use an insulin pump!
Five years ago, I wrote about Medtronic’s new pump available in Europe, called the VEO. But the FDA held skepticism that the pump would ultimately be safe. In a lengthy clinical trial process, Medtronic hunkered down and maintained reaching every endpoint the FDA put before them. The sensors for the CGM were a main sticking point, and the FDA needed reassurance that the 2-hour shutoff would not create damaging hyperglycemia.
Almost one third of all us living with type 1 diabetes use a continuous glucose monitor (CGM), and as better sensors continue to come on the market, the CGM will be in higher demand. We also know that for the artificial pancreas to breathe life, the data that the sensors generate becomes an intricate part of the device’s deliver of insulin.
The new pump is called the MiniMed 530G with Enlite and is the first system approved under the new product classification “OZO: Artificial Pancreas Device System, Threshold Suspend,” created by the US Food and Drug Administration. Threshold Suspend automation automatically stops the delivery of insulin if glucose levels reach between 60-90 mg/dl. Once the threshold is met, the MiniMed 530G system will first alert wearer with an alarm. If the individual is sleeping, unconscious, or otherwise unable to react, the system will suspend all insulin delivery for two hours. Insulin delivery can be resumed at any time.
Enlite is the new sensor. The Enlite is smaller than it’s predecessors, Sof-sensor and glucose sensor and 31% more accurate with a 93.2% hypo detection rate. The sensors will also last up to six days, another improvement from their 3-day Sof-sensor.
The future is here. It's integrated and looking alarming beautiful!