Medtronic announced that it has enrolled its first patients for a trial to test an insulin pump which predicts which way your blood sugar levels are trending, and takes action if it detects a rapid downward trend. If the new predictive pump design does well in trials and receives FDA approval, it would mark a significant step in the development of an artificial pancreas.
According to Medtronic senior spokeswoman Pamela Reese, the experimental pump design measures the rate of change in blood sugar levels, and then take action if it detects a dangerous trend. The algorithms behind what is being called Predictive Low Glucose Management (PLGM) technology are designed to behave like a continuous glucose monitor that can show trending arrows for blood sugar levels.
This new technology is a progression from Medtronic’s groundbreaking 530g pump, which was the first commercial pump to automatically suspend insulin delivery once a continuous glucose monitor detected that a threshold of low blood sugar levels had been reached. With the 530g design, the pump automatically suspends insulin delivery for 2 hours when a predetermined low number has been reached. With this new design being tested, the pump can take action before that low level is hit, and then resume insulin delivery when sensors say it’s safe.
“This is the first system to act on rate of change,” Reese says. “PLGM will (then) resume insulin delivery after those glucose levels recover.”
This new technology is not being groomed to fit existing Medtronic pumps, Reese says. Rather, the study will use a new pump design, the 640g, along with a new continuous glucose monitor. The monitor being used in the trial is designed to be 80% lighter than the Enlite sensor that is currently paired with the 530g.
“This technology would be for what comes next,” she says.
The trials will take place in 8 medical facilities around the US, and involve 84 participants in inpatient treatment. The goals of the trial is to prove that the technology is safe and will prevent bouts of hypoglycemia. If the technology works as hoped, it may also head off rebound cases of diabetic ketoacidosis, which can occur as insulin therapy is suspended to deal with hypoglycemia, says Reese. The future economic viability of this technology depends on the results of this trial, she says.
“There have been feasibility studies, but this is the pivotal trial,” she says. “This is a major step for us.”
The predictive technology currently is only designed to ward off lows, but it is part of Medtronic’s effort to create, and commercialize, the technological pieces that would make up an artificial pancreas pump. This past year, the company successfully launched the 530g, the first with low-glucose suspend, in the US. It also is selling the Medtronic Duo, an interconnected pump and continuous glucose monitor system, in Europe.
So far, however, the company has not moved publically on the final piece of the artificial pancreas puzzle: creating a pump that can also incorporate glucagon delivery. Tandem, another pump maker, has been active in working with researchers to develop dual-chambered pump technology that can deliver both insulin and glucagon.
To learn more about Medtronic’s pump trial, you can visit the enrollment page at http://www.clinicaltrials.gov/
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