Communication, Breaking Down Walls, and a Huge Step Forward for People with Type 1 Diabetes

Posted on December 5, 2017 by FDA Voice

By: Courtney Lias, Ph.D., and Stayce Beck, Ph.D., M.P.H.

At FDA’s Center for Devices and Radiological Health (CDRH) we recognize that medical innovators with a novel technology can get lost in navigating the regulatory landscape if there is no well-worn path to follow.

Without such guideposts, even well-intentioned scientists and businesses can make incorrect assumptions that can cost a lot of time and money, such as assuming FDA only will accept certain types of rigidly-defined data. Such assumptions inevitably delay patient access to important devices.

We’ve learned that to promote innovation we must break down walls and open lines of communication, an approach we used with great success recently in approving an automated insulin dosing system, commonly known as an “artificial pancreas” device.

Example of an Artificial Pancreas System
1. Glucose Sensor & Transmitter: Detects person’s blood glucose level and transmits that information to the glucose monitor and insulin pump.
2. Control Algorithm: Calculates dose and sends instructions to the insulin pump. This software can run on any number of devices, including directly on the insulin pump, or remotely from a laptop computer or a smart phone.
3. Continuous Glucose Monitor & Insulin Pump: Displays the person’s blood glucose levels and, based on calculations made by the control algorithm, administers the correct dose of insulin.
4. It is necessary to periodically calibrate the Continuous Glucose Monitor (3.) using a Blood Glucose Device.

Several FDA guidance documents and approvals had already laid the groundwork for the device, approved in 2016. But in years past, the diabetes and medical device communities commonly believed that FDA would never approve a device that does all of the thinking about when and how much insulin should be used without human input.

Companies had assumed that FDA would take an overly cautious approach to the study and development of this type of device which would delay its availability for U.S. patients.

To correct these assumptions and open a line of communication between FDA and the diabetes community, we developed a proactive approach with patients, their caregivers, device developers, academia, and the many doctors and scientists who have devoted their careers to developing automated insulin dosing systems.

Starting in 2012, FDA’s artificial pancreas team worked to better understand the daily struggles of living with type 1 diabetes by reaching out to patients and their caregivers. We heard from parents of young children with diabetes who often had to wake up multiple times every night to check their children’s blood sugar to ensure that it had not gone too high or too low in a way that can be dangerous.

These parents were worried that their children might not wake up the next day, and were willing to use a device that would help, even if that device is not perfect. These parents and patients provided valuable insight into the risks they were willing to take and helped us understand that even if this device increases risks in certain areas, it might decrease them in others. Some were willing to accept a slight increase in risk of long-term health effect due to high blood sugar, if the device provided greater assurance that their child would make it through each night safely.

We also developed productive relationships with key academic investigators and thought leaders who knew they could call us up and talk about any issues or concerns they might have about the required clinical trials, their design, or the trials themselves.

Much early stage work had already occurred that laid the foundation for an artificial pancreas, including the previous clearance of insulin pumps made by several manufacturers, approvals of interactive glucose monitors that transmit blood glucose readings to the pump, and the development of investigational algorithms that determine insulin doses based on blood sugar readings and other considerations, such as carbohydrate intake.

Courtney Lias, Ph.D., (left) Director, Division of Chemistry and Toxicology Devices; and Stayce Beck, Ph.D., Chief of the Diabetes Diagnostics Branch, at CDRH. Lias, Beck, and the center’s Artificial Pancreas team received the 2017 Samuel J. Heyman Service to America Medal for Management Excellence for developing the first hybrid closed loop system to treat type 1 diabetes three years earlier than expected.

FDA’s artificial pancreas team met monthly for three years prior to approval with the manufacturer, Medtronic, to develop an efficient study design to evaluate their “closed looped system,” a significant step toward a truly artificial pancreas device. That least burdensome clinical research approach balanced pre-market and post-market data collection by allowing Medtronic to do a small, focused pre-market study to support approval of the device, followed by a larger post-market study to gather additional real-world information about use of the device.

We understood their device design and their clinical study approach before they even started the process of developing a medical device for market.

These meetings and relationships helped the artificial pancreas team understand the challenges and questions faced by all involved. It also gave the FDA team an opportunity to provide input on what factors would be critical during review of the product.

The results speak for themselves. FDA’s approval of Medtronic’s Minimed 670G hybrid closed loop system, the first FDA-approved device intended to automatically monitor glucose and provide appropriate basal insulin doses in people with type 1 diabetes came three years earlier than anticipated by the company and was a first-in-the-world approval.

We know that this effort is only the tip of the iceberg; much more work remains to be completed. FDA continues to engage the diabetes community, academic investigators, and industry to advance this and other novel device technologies. In the diabetes community, the walls are coming down, and we are excited to see the advances for patients that will result.

Courtney Lias, Ph.D., is Director, Division of Chemistry and Toxicology Devices, at the Center for Devices and Radiological Health; Stayce Beck, Ph.D., is Chief of the Diabetes Diagnostics Branch at the center. Lias, Beck, and the CDRH Artificial Pancreas team were awarded the 2017 Samuel J. Heyman Service to America Medal for Management Excellence for their work in the approval of Medtronic’s Minimed 670G hybrid system.