Artificial Pancreas Approved by FDA

670g-image-5// by Emily Goldman

ANYONE WHO’S EXPERIENCED TYPE 1 DIABETES (T1D)—those with the disease, their relatives or friends—understands that many aspects of the illness lay beyond their control. From blood sugar highs and lows to faulty insulin calculations and the fear of deadly low blood sugar during the night, those with T1D know their share of stress. In October the Food and Drug Administration (FDA) approved a system set to be released in Spring 2017 that would drastically improve the lives of those age 14 and older dealing with the disease. Researchers have configured a device that bridges the gap between continuous glucose monitors (CGMs)—devices that measure sugar levels between the layers of the skin to give the wearer continuous blood sugar updates—and insulin pumps.

According to Medtronic, the biotech firm behind the newly FDA-approved technology, the 670G insulin pump uses sensors and a controlled algorithm to automatically give the wearer insulin after using readings pulled from the CGM to calculate the proper dose of insulin in a hybrid closed-loop system. In effect, it is the first-ever artificial pancreas.

“This technology automates the dosing of insulin so that people can effectively manage their blood sugar levels continuously, throughout the day and night. In addition to improving glucose control, artificial pancreas systems have the potential to dramatically reduce the burden that people with T1D live with every day,” says Dr. Aaron Kowalski, chief mission officer for the Juvenile Diabetes Research Fund (JDRF). “While it’s not a cure, the extra sleep, the better blood glucose levels and the reduced stress allow people with T1D to feel better overall while thinking about it less, and that’s a big step forward.”

The road to FDA approval for the Medtronic’s 670G insulin pump proved difficult. After taking a decade to make, and with more than $116 million contributed by JDRF toward research, the artificial pancreas caused anxiety for many due to the technology being the first of its kind.

According to Kowalski, the FDA did not explicitly say what trial data would be required for approval.

The entire process involved researchers, Congress and regulators to back the new technology and embrace the idea of a system that would take over the process of regulating blood sugar in those with T1D. “Initially, risk-averse device makers were hesitant about the concept of a computer controlling insulin delivery because an error could be lethal, and we needed to convince them that this was a problem worth solving,” says Kowalski.

“Then, we needed to help that idea come to fruition. We also lobbied the FDA to issue a roadmap outlining what companies would need to do in order for an artificial pancreas device to be approved.”

According to JDRF, companies such as Animas, Tandem and Bigfoot Biomedical all publicly stated that they are developing closed-loop systems. Dr. Larry Fox, medical director of the Northeast Florida pediatric diabetes center, is a proponent for the new technology. He believes the Medtronic system should greatly impact how patients manage their T1D, and maybe even Type 2 Diabetes in the future—if it is approved to do so.

However, Fox explains that pump therapy may not be the best option for every diabetic. “Like insulin pump therapy and continuous glucose monitoring in general, the 670G may not be for everyone. For now, the 670G is only approved for children at least 14 years old,” he says. “If the patient and family are right for the 670G, I see no reason why it cannot be prescribed once it becomes commercially available in spring of next year.”

The FDA’s approval of the Medtronic system means more than easier management for those with diabetes. By earning FDA approval of the new  technology, many experts are hopeful that it signals quicker approval for other devices and practices in the future.

“For adolescents using the device, it should help improve diabetes control and decrease risk of mild, moderate and maybe even severe hypoglycemia,” says Fox. “Parents fear hypoglycemia and sometimes this limits achievement of excellent diabetes control. Using the 670G, parents can worry less about hypoglycemia, especially overnight.”