In its latest step toward the long-term goal of creating an artificial pancreas for diabetes patients, Medtronic researchers this weekend are unveiling positive data from a pivotal trial of an insulin pump designed to automatically control glucose levels with limited input from patients.
At the American Diabetes Association annual meeting in New Orleans, researchers are scheduled to present data showing that the experimental Medtronic MiniMed 670G insulin pump kept 124 type 1 diabetes patients within the desired blood-sugar range for three months without any incidents of severe hypoglycemia, diabetic ketoacidosis, or severe device-related complications.
The device also increased the time spent in the desired range, and decreased incidents of having glucose go too high or too low, which can be unhealthy and dangerous.
Medtronic executives have already said that they plan to use the data from the trial in an application sometime this month to the Food and Drug Administration for commercial approval of the 670G system. The 670G is seen as the fourth step in a six-stage process to develop an almost-completely automatic "closed loop" insulin-delivery system. Work toward that goal began in the 1990s.
"The concept of a closed loop has been the dream, if you will, for a very long time," said Ben Andrew, an analyst at William Blair who has tracked diabetes technology for decades. "It's actually technically feasible today. The trick is to make it safe and reliable. And that is a very big step, even from where we are."
Type 1 diabetes happens when a person's pancreas can't produce the insulin the body needs to break down blood sugar (also called glucose) into energy. That forces the person to test glucose readings regularly and take insulin manually or with an automatic pump throughout the day.
According to an abstract of the final data from Medtronic's pivotal study of unsupervised type 1 patients using its 670G "hybrid closed loop" system, the patients were kept within the desired ranges for blood sugars 73.4 percent of the time. The same patients using a pump with less automation remained in-range 67.8 percent of the time.
The benefit was more pronounced at nighttime. Between 10 p.m. and 7 a.m., the patients using the 670G hybrid closed loop system were within range 76.4 percent of the time, compared with 67 percent with the less-advanced insulin pump system, the abstract shows.