The ‘Artificial Pancreas’ Has Arrived

FDA approval of the first closed-loop insulin delivery system is exciting for both physicians and patients. What does this mean for the future?

“This is a revolutionary day for the treatment of diabetes. We’ve been long awaiting the artificial pancreas, and it’s exciting to see it.” – Robert Courgi, MD, endocrinologist, as quoted on CNN

The “artificial pancreas” will be available soon. When I wrote the draft of this month’s column just a few days ago, that first sentence was still a question. I had to quickly reopen and revise the version I had saved and sent to my editor, because on September 28, 2016, the US Food and Drug Administration (FDA) approved the first closed-loop insulin delivery system — the MiniMed 670G from Medtronic — for use in those aged 14 years or older, with type 1 diabetes.1 While basal insulin will be largely automatically adjusted, patients will still need to manually enter bolus doses.

What’s next? Watch for larger studies of use of this device in real-world settings, and of its use in children aged 7 to 13. The company expects this will be on the market in spring 2017.

With pivotal clinical trials that started this year and in 2017, along with launches slated for late next year and 2018, many other questions abound. Currently, it is estimated that approximately 30% of the individuals with type 1 diabetes in the United States are insulin pump users, and approximately 10% to 15% use a continuous glucose monitor (CGM). The name of this integrated system comes from the pairing of a CGM with an insulin pump, and a small device that stores the control algorithm. This algorithm orchestrates the delivery of insulin in response to real-time glucose levels detected by the CGM, and can potentially automatically determine and deliver insulin via a pump (hybrid closed-loop insulin pump), which contrasts with a sensor-augmented insulin pump (a CGM that is paired with a standard pump).

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While such a device has been garnering headlines the last few years, in journal articles and conference presentations, the concept is far from new. Charles Weller, MD, was the first to study semi-continuous glucose monitoring in 1960. Four years later, Arnold Kadish, MD, introduced the first portable insulin pump. The initial commercial closed-loop device, the Biostator, was actually an intravascular machine. Challenges with the dearth of devices that were compatible with this route, coupled with concerns for infection, led to a shift to the subcutaneous route, beginning 2 decades later, in the 1990s.