In September 2016, the U.S. Food and Drug Administration (FDA) approved new technology that will automatically regulate basal insulin for people with type 1 diabetes, but it’s important to know exactly what this breakthrough technology will and won’t do.
What it is
Despite commonly being called an “artificial pancreas,” the Medtronic MiniMed 670G hybrid closed looped system is not a synthetic organ and does not perform all the same functions as a normal human pancreas.
The system includes a continuous glucose monitor (CGM) sensor that attaches to the body to measure glucose levels under the skin, an insulin pump, and an infusion patch connected to the pump with a catheter that delivers insulin, according to the FDA.
These three pieces of technology will work together to fully automate basal insulin delivery, but the system is not completely closed looped, or automated, because it still requires some input from the user—this is why it comes with the “hybrid” tag.
Right now, it is only intended for people with type 1 diabetes who are 14 years or older.
How it works
The system monitors glucose levels every five minutes and then automatically administers or withholds basal insulin based on its readings.
Because the system only manages basal insulin, also known as background or baseline insulin, users will still need to manually bolus insulin to counter carbohydrate consumption at meals. The user will also have to notify the system of exercise.
“It should not be called an artificial pancreas, but rather a highly improved insulin pump,” Chris Clement, who has type 1 diabetes, said. “I see this more as a phase of development toward a true artificial pancreas.”
Even though it doesn’t take care of everything like a normal pancreas would, this technology represents a major step forward in diabetes management.
“We have all these pieces of technology that we use constantly every day to make decisions on delivering insulin, but none of them talk to each other in a way that is reducing the burden of diabetes management,” Clement said. “This technology will improve blood sugar trends by default because it is able to use the same data we are already looking at and use it properly and automatically.”
But just how beneficial will this new technology be to people with type 1 diabetes? That depends on who you ask.
Some, like registered nurse and PWD Jewels Doskicz, are extremely optimistic about this new technology and its potential benefits.
“This is the single best tool I have seen in the past 30 years living with type 1 diabetes,” she said. “It is so exciting.”
Jessica Gibbons, CDE, reminds us that this technology will not completely remove the onus from the users.
“This is not an artificial pancreas, in that you still have to bolus for food correctly, you still have to figure out what exercise and stress will do to your body, and you still need an accurate sensor to dose with,” she said.
Having that accurate sensor is a big concern, especially because using the new technology will require that you use the Enlite CGM made by Medtronic.
“There are concerns about Medtronic’s CGM not being as accurate as Dexcom’s,” Clement said. “I have heard of plenty of experiences from peers via social media that say this is a concern.”
A comparison of CGMs by DiabetesLab did find that Medtronic’s sensors are statistically less accurate than Dexcom’s. Having inaccurate readings would essentially nullify any benefits of the new system.
Dexcom is working to develop its own artificial pancreas technology, but for the time being Medtronic is the only option.
“I do hope that all of these device makers will move toward opening up integration with each other,” Clement said. “I would love to use my Dexcom and connect it with whichever device I choose.”
The FDA approved this technology after evaluating a clinical trial of 123 participants. The clinical trial showed that the device is safe for use in people 14 years of age and older with type 1 diabetes. No serious adverse events, diabetic ketoacidosis (DKA), or severe hypoglycemia (low glucose levels) were reported during the study.
Study participants lowered their A1c by an average of 0.5% (from 7.4% to 6.9%) over the course of the 90-day trial. Additionally, use of this closed-loop system reduced time spent in a low-blood-sugar range (less than 70 mg/dl) by 44% and time spent over 180 mg/dl by 11% (as compared to a two-week period where participants used the same devices in an open-loop set up).
The approval timeline was faster than even Medtronic expected. Approval came 109 days after Medtronic submitted thousands of pages of documents and was seven months earlier than expected, according to DiabetesMine.
As part of this approval, the FDA is requiring a post-market study to better understand how the device performs in real-world settings.
“The really significant thing is that the FDA has approved a device that allows CGM data to make programmatic insulin dosing decisions,” Clement said. “That is a crucial element of an artificial pancreas."
The MiniMed 670G is not expected to be available until spring 2017.
What are your thoughts about this new technology? Let us know what you think by commenting below.