The company's announcement notably does not use the term "artificial pancreas," although the technology is a considerably more significant advance from the 530G threshold suspend device of 2013. When the description "artificial pancreas" was attached to that product, the term was met with howls of protest from the type 1 diabetes community.
The FDA today approved Medtronic’s MiniMed 670G, the world’s first hybrid closed loop insulin delivery system, which is designed to automatically deliver basal insulin doses while monitoring glucose levels in those aged 14 years or older who have type 1 diabetes (T1D).
While the FDA press release referred to the technological advance as an “artificial pancreas,” the announcement from Medtronic notably did not. The company withstood an uproar back in 2013 when the term "artificial pancreas" appeared in announcements of its 530G threshold suspend system, which technically fell under FDA’s category for the technology. The description was lampooned in the T1D community as far short of the ultimate goal.
Results from the pivotal trial for the MiniMed 670G system, which involved 123 adults and adolescents, gained considerable attention in June at the 76th Scientific Sessions of the American Diabetes Association. Those using the closed, automated system spent considerably less time with low blood glucose and had improved glycated hemoglobin (A1C), compared with a 2-week “open loop” phase, when they used an insulin pump with a continuous glucose monitor (CGM) but not automation. Findings with the 670G from the trial included:
· A 44% decline in time spent with blood glucose below 70 mg/dL
· A 40% decline in time spent with dangerous hypoglycemia (below 50 mg/dL)
· A 0.5% reduction in A1C, from a baseline of 7.4% to 6.9%
· No serious adverse events, diabetic ketoacidosis, or severe hypoglycemia were reported.
“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 Albert Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health, FDA Center for Devices and Radiological Health.
"The FDA approval of the world's first hybrid closed loop system is a culmination of many years of hard work and close collaboration with the clinical and patient communities to generate the body of evidence needed to advance this technology for those living with diabetes," said Francine Kaufman, MD, chief medical officer for Medtronic's Diabetes Group. She said the company appreciated "the unprecedented speed" with with FDA handled the submission, which would allow enable the company to get the new product to patients as quickly as possible.
“The data from the pivotal trial were compelling and I am confident that this therapy will be well-received by both the clinical and patient community,” said Richard M. Bergenstal, MD, principal investigator and executive director for the Park Nicollet International Diabetes Center in Minneapolis.
“This significant milestone represents an important step forward in the management of type 1 diabetes and will improve the quality of life for those living with this chronic disease,” said Derek Papp, president and CEO of JDRF, which has funded research to advance artificial pancreas technology.
"We are very encouraged by the speed in which this groundbreaking technology was approved by the FDA, and we are proud of the role JDRF played in achieving this exciting breakthrough. Medtronic and JDRF are committed to ensuring appropriate patient access to this therapy."
In its statement, FDA said it will require a postmarketing study to gather real-world data. Medtronic is currently studying the device in patients who are 7 to 13 years old. It is not considered safe for children under age 6 who need less than 8 units of insulin per day.
The system features Medtronic’s SmartGuard HCL, which the company describes as method of allowing patients to choose “increasing levels of automation to best fit their diabetes management needs.” There is also a 7-day sensor specifically approved to work with the automated system.
In a statement, Medtronic said it plans to make the system available in spring 2017 to allow time to work through payer coverage, manufacturing, and market issues.