FDA Approves New Smart Insulin Pump

The US Food and Drug Administration (FDA) has approved the first insulin pump that can analyze information from a blood glucose monitor to adjust basal insulin dose sizes in patients older than 13 with type 1 diabetes.

Some have called Medtronics MiniMed 670G an "artificial pancreas." The device is not that. It still requires user intervention. That said, it requires less intervention than any of the devices that have come before it.

Insulin pumps typically deliver the hormone at a constant rate that is set by users, who periodically check their glucose levels and adjust insulin dosing as needed. Even in Manual Mode, the 670 G keeps track of its continuous glucose monitor and automatically suspends insulin delivery when glucose levels fall too low. When glucose levels rise above the threshold once again, the device resumes insulin delivery.

In Auto Mode, however, the 670G takes considerably more control over the entire process. The device continuously adjusts the amount of insulin it delivers from 1 minute to the next based upon readings from the continuous glucose monitor. The goal is to keep glucose levels as steady as possible.

If all goes well, the only time the user must intervene in the insulin delivery process is at mealtimes, which require a manual insulin infusion matched to the size and makeup of the meal.

“The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases — especially those that require day-to-day maintenance and ongoing attention,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, speaking in an announcement from the FDA. “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 670G’s approval hinges on data from a clinical trial in 123 patients with type 1 diabetes. For the first 2 weeks of the trial, patients did not use the systems technology for automating insulin delivery. During the 3 months after that, they used the technology as often as possible. No serious adverse events, diabetic ketoacidosis (DKA) or severe hypoglycemia (low glucose levels) were reported during the study.

The FDA is requiring Dublin-based Medtronic to conduct a post-market study that will provide data about the devices performance in real-world settings. Medtronic is also performing trials to evaluate the device in children aged 7 to 13 years. It is assumed to be unsafe for use by children younger than that and by patients who require less than 8 units of insulin per day.

The FDA approval came months before most observers were expecting any action on Medtronic’s application, and the FDA seems particularly proud of the efficiency of the testing and review process.

“As part of our commitment to improving diabetes care, the FDA worked interactively with Medtronic from the earliest stages of development to assist in making this technology available to people with type 1 diabetes as quickly as possible,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “We encourage companies to work closely with the agency to ensure scientifically sound, highly efficient clinical study designs, helping to expedite the FDA’s evaluation and subsequent approval of novel devices that can make a difference for patients.”

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