Medtronic Gets FDA Approval for Artificial Pancreas System with Automatic Shut-Off

Medtronic Inc. has received U.S. Food and Drug Administration (FDA) approval for the first artificial pancreas that shuts itself off when a patient’s blood sugar levels get dangerously low.

The device, called the MiniMed 530G, combines an insulin pump with a sensor that halts insulin delivery for two hours if a patient’s blood sugar falls below preset levels. It’s a step toward a fully automatic artificial pancreas that adjusts insulin delivery continuously as glucose levels change.

The pancreas produces the hormone insulin, which converts blood sugar to energy. Type 1 diabetes occurs when insulin-releasing beta cells in the pancreas are destroyed. Patients repeatedly test their glucose levels throughout the day, then inject insulin to control blood sugar. The Medtronic system is an advance over existing machines that sound an alarm to wake sleeping patients when their blood sugar gets too low.

Medtronic’s system is the first in the United States that can automatically stop insulin delivery when sensor glucose values reach a preset level and when the patient doesn’t respond to what the company calls a “Threshold Suspend” alarm. The MiniMed 530G system also incorporates the new Enlite sensor, which the company says has a 31 percent improvement in overall accuracy from the previous generation.

“The diabetes community has eagerly awaited approval of this system that stops insulin delivery when sensor glucose values fall below a predetermined threshold,” said Richard M. Bergenstal, M.D., executive director of the International Diabetes Center at Park Nicollet Health Services in Minneapolis, Minn., and Clinical Professor for the Department of Medicine at the University of Minnesota. “We are hopeful that advances such as this and improvements in the accuracy of continuous glucose sensors will help people with diabetes strive for better control of their diabetes.”

“We’re excited to bring yet another important ‘first’ to the United States. The MiniMed 530G with Enlite can help people gain better control of their diabetes versus multiple daily injections,” said Katie Szyman, president of the Diabetes business at Medtronic. “We are committed to advancing closed loop algorithms, continuous glucose monitoring and insulin delivery technologies to bring new artificial pancreas systems to market.”

The Enlite sensor delivers better comfort and reliable continuous glucose monitoring accuracy, company officials claim.  In addition to the 31 percent improvement in overall accuracy, the Enlite sensor detects up to 93 percent of hypoglycemia episodes when predictive and threshold alerts are on, according to the company. The Enlite sensor is also 69 percent smaller than the previous Medtronic sensor, to deliver improved comfort in using continuous glucose monitoring. Enlite provides a simpler sensor insertion process with a hidden-introducer needle.

The MiniMed 530G system was approved for use by people with diabetes ages 16 and older. Medtronic will conduct a post-approval study including children ages two and older. The Enlite sensor can be worn for six days.

Before the devices can be sold, as a condition of approval and in addition to the post-approval study, Medtronic will engage in direct patient follow-up and will make certain manufacturing changes. These actions are the result of product approval requirement by the FDA and an accompanying warning letter issued to Medtronic on Sept. 19. Medtronic officials report that they already have addressed many of the observations noted in the warning letter and will resolve the remaining observations as quickly as possible.

Medtronic will begin ramping up production immediately to prepare for a launch of the MiniMed 530G in the next several weeks.

The MiniMed 530G system is the first system approved under the new product classification, “OZO: Artificial Pancreas Device System, Threshold Suspend,” created by the FDA. Threshold Suspend automation automatically stops the delivery of insulin if glucose levels reach a threshold, which can be set by a healthcare provider between 60-90 mg/dL. Once the threshold is met, the MiniMed 530G system will first alert the wearer with an alarm. If the individual is sleeping, unconscious or otherwise unable to react, the system will suspend all insulin delivery for two hours. Insulin delivery can be resumed at any time.

When Medtronic develops a next generation product for diabetes control, it will be designed to fully replicate the function of the pancreas by automatically monitoring glucose levels and delivering appropriate insulin to people with Type 1 diabetes. This future “fully automated artificial pancreas” will truly require minimal to no interaction by the patient user.