Tuesday , March 28 2017
Home / Resources / Articles / FDA Approves First Artificial Pancreas

FDA Approves First Artificial Pancreas

Device automatically monitors blood glucose levels and delivers insulin when appropriate for people age 14 years and older who have type 1 diabetes.

Medtronic’s MiniMed 670G hybrid closed looped system, which is often referred to as an “artificial pancreas,” automatically administers or withholds insulin in response to blood glucose measurements, which it takes every five minutes. It is the first FDA-approved device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes. This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin.

The system is made up of a sensor that measures blood glucose under the skin; an insulin pump; an infusion patch that delivers insulin from the pump via a catheter inserted into the skin and a computer chip that uses data to optimize insulin delivery by the minute.

The FDA evaluated data for the device from a clinical trial that involved 123 participants with type 1 diabetes. The results showed that the system significantly reduced the average blood glucose level over three months, with the most improvement seen among people who had the highest blood glucose levels at baseline.

The photo you see here is the Biostator, an artificial pancreas closed-loop IV insulin and glucose delivery system from 1979, which cost 50,000 dollars a month to rent.  It was used to manage patients through surgery in the OR. You can see what was accomplished over the last 37 years.  The current research over just the next 5-10 years will make improvements that previously took 37 years to make.

As part of the approval, the FDA needs a post-market study to assess how the system performs in real-world scenarios. So far, the device has only been approved for use by people age 14 yearsBiostator and older, but Medtronic is now carrying out further research to assess how safe and effective the system is for children ages 7 to 13 years.

The MiniMed 670G hybrid closed-looped system, often referred to as an “artificial pancreas,” is intended to adjust insulin levels with little or no input from the user. It works by measuring glucose levels every five minutes and automatically administering or withholding insulin. The system includes a sensor that attaches to the body to measure glucose levels under the skin; an insulin pump worn on the body; and an infusion patch connected to the pump with a catheter that delivers insulin. While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate (meal) consumption.

The clinical trial included an initial two-week period where the system’s hybrid closed loop was not used followed by a three-month study during which trial participants used the system’s hybrid closed loop feature as frequently as possible. This 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.

Risks associated with use of the system may include hypoglycemia, hyperglycemia, as well as skin irritation or redness around the device’s infusion patch. This version of this device is unsafe for use in children 6 years of age or younger and in patients who require less than eight units of insulin per day.

As part of this approval, the FDA is requiring a post-market study to better understand how the device performs in real-world settings. While the device is being approved today for use in people 14 years of age and older with type 1 diabetes, Medtronic is currently performing clinical studies to evaluate the safety and effectiveness of the device in children 7-13 years old who have diabetes.

Derek Rapp, chief executive officer of the Juvenile Diabetes Research Foundation, which has spent $116 million on research in the artificial pancreas field added that, “This device will mean peace of mind, in knowing a person will be in normal blood sugar range a great majority of the time.”

Rapp, who has a college-age son with type 1 diabetes, said his son as a child had to be awakened many times each evening so his finger could be pricked for a blood sample, to ensure his blood sugar level was in an acceptable range. If too low, his son would be given fruit juice or a snack. If too high, he would be given insulin.” “It is a major news event that a system of this kind has been approved – the first time a pump will administer insulin as a result of information it receives from a sensor,” Rapp said.

The Medtronic system is a big step for patients, but the Holy Grail would be a completely automatic artificial pancreas that does not need any intervention, including for meals or exercise. Such a product is probably at least five years away from development.

Although Medtronic has not announced a price for the MiniMed 670G, It is estimated it may cost $5,000 to $8,000, with the annual cost of disposable sensors another few thousand dollars.

Analysts said the FDA approved the device six months sooner than expected. However, it will not be available until the spring of 2017.

Practice Pearls:

  • The MiniMed 670G still requires some intervention, including adjusting bolus for meals or exercise
  • Risks associated with use of the system may include hypoglycemia, hyperglycemia, as well as skin irritation or redness around the device’s infusion patch.
  • This is just the first step in this type of technology. Watch for major improvements from other companies also working on this type of technology.

Watch for an upcoming interview with Dr. Richard Bergenstal , executive Director of the International Diabetes Center.  He was the principal investigator for the Closed Loop Technology that the FDA just approved.