Developing an artificial pancreas is the Holy Grail for diabetes patients.
This week, Medtronic announced that it was inching closer to this becoming a reality by proving the efficacy of its MiniMed Paradigm System featuring Low Glucose Suspend (LGS) automation in a landmark clinical study. This pump with a sensor has the ability to automatically suspend the delivery of insulin when a low glucose threshold is met, explained Dr. Scott Lee, global medical director at Medtronic Diabetes, in a phone interview Thursday.
“For the first time, the pump is actually listening to the sensor glucose values and when the glucose reaches a certain threshold, the pump suspends after alarming,” Lee said.
Currently, pumps approved in the U.S. set off an alarm to alert the patient when the sensor detects low glucose levels, but it does not suspend the insulin delivery.
In the U.S. clinical trial, the MiniMed Paradigm System featuring Low Glucose Suspend (LGS) automation demonstrated a 19 percent reduction in time that patients spent below the low glucose threshold, compared to conventional pump therapy.
The maximum amount of time for which the insulin delivery is suspended is two hours, Lee said. This is especially helpful during the overnight hours when a patient is sleeping and thereby most vulnerable to low glucose levels, he said.
The Automation to Simulate Pancreatic Insulin Response (ASPIRE) study proved that diabetics using the MiniMed Paradigm System featuring Low Glucose Suspend (LGS) automation spent less time below 70 mg/dL — the low glucose value at which insulin was suspended. Further, the study group’s average drop in blood glucose values remained higher compared to patients using conventional insulin pumps and the suspension did not result in high blood sugar.
The next step will be to prove that the product meets its end points in another study where the device will be worn by patients at home, Lee said. That is different from the first phase of the ASPIRE trial where patients were observed in the clinic.
But Medtronic is already working on the next innovation on the road to developing an artificial pancreas.
“The next major innovation that we hope to see even within the next year is predictive low glucose system,” Lee said. “The pump would be so smart that it would predict (a low glucose-level event) even before the low glucose level is met and the pump would suspend.”