At Medgadget we love artificial organs, from kidneys to hearts to skin. The pancreas is no exception. We recently had the opportunity to speak with Medtronic Diabetes’ Chief Medical Officer and VP of Global, Clinical, and Health Affairs, Dr. Francine Kaufman, about the most recent step that Medtronic has taken towards developing a fully-functional artificial pancreas.
Shiv Gaglani, Medgadget: Can you describe how the artificial pancreas works?
Dr. Francine Kaufman: A fully automated “artificial pancreas” is a system that closely mimics the insulin delivery of a working pancreas using advanced technology that continuously monitors glucose levels and automatically adjusts insulin delivery with minimal or no patient interaction.
Medtronic’s new MiniMed 530G with Enlite is a critical step toward the development of a fully automated artificial pancreas system. It is the first device system approved by the FDA under its “Artificial Pancreas Device System with Threshold Suspend” category. Threshold Suspend is a key feature of the MiniMed 530G. It temporarily stops insulin delivery when sensor glucose levels reach a preset threshold and if the patient is unable to respond to the Threshold Suspend alarm. This is a first critical step because it’s the first time an insulin pump automatically intervenes based on a sensor glucose value. Before Threshold Suspend, the many people with diabetes who use insulin pumps and continuous glucose monitoring have always had to manually stop the constant rate of insulin delivery that’s programmed into the pump, which is not always possible if they are asleep, unconscious or otherwise unable to react.
Medgadget: What is the timeframe for deployment of this device?
Dr. Kaufman: A fully automated artificial pancreas will not be ready for several years. However, MiniMed 530G with Enlite – an important first step – is available now and we have additional iterative steps toward a fully automated system in various stages of development. Examples of future steps include predictive low glucose management and an overnight closed loop system (where the system would be fully automated, but only in the overnight setting).
Medgadget: Are there any security concerns related to the artificial pancreas?
Dr. Kaufman: Medtronic takes device security and any threat to patient safety seriously. Medtronic is actively engaged with security research firms and regularly conducts and uses independent assessments to improve the security of our systems. We continuously monitor the security of our devices and if new vulnerabilities are revealed, Medtronic will assess whether additional security measures can be implemented without compromising the therapy that the device is designed to deliver to patients.
Medgadget: What are all of the use cases (e.g. Type 1 diabetes only or Type 2 as well)?
Dr. Kaufman: MiniMed 530G with Enlite is intended for use by people with diabetes who require insulin and who are 16 years of age or older. So, it can be used by anyone with type 1 as well as those with type 2 who require insulin (and of course if his/her doctor prescribes it and they use it under the direction of a healthcare professional). While it’s too early to determine the use cases for a future fully automated artificial pancreas, our intent is that it would also be for people with type 1 and people with type 2 who require insulin.
Medgadget: What is your background in medical technology/innovation?
Dr. Kaufman: In addition to my role at Medtronic, I’m an attending pediatric endocrinologist at Children’s Hospital of Los Angeles. I’m also a Past President of the American Diabetes Association and Distinguished Professor Emerita of Pediatrics and Communications at the Keck School of Medicine and the Annenberg School of Communications at the University of Southern California. I have a long career caring for patients, advocating for patients and their families, trying to find ways to help them understand and manage their diabetes, and conducting research to find ways to prevent, manage and (ultimately) cure diabetes.
One of the reasons that I decided to join Medtronic a few years ago is that we as a company have 30+ year history of innovation in diabetes technology. The first insulin pump we brought to market was back in 1983. Since then, we’ve developed the first CGM device for physician use, the first (and only FDA approved) integrated insulin pump and continuous glucose monitoring system and now the first and only system with Threshold Suspend Automation.
Technology innovation combined with the clinical work necessary to demonstrate the safety and effectiveness of that technology is the key to our success. As Chief Medical Officer, I have the opportunity to lead that clinical research in partnership with leading research institutions and investigators around the world. It’s exciting to work together to study the many steps toward an artificial pancreas that are currently in development – from closed loop algorithms to advanced sensor technology – with the goal of bringing these advancements to market in order to help people better manage their diabetes.
Product page: MiniMed 530G…