Frequently Asked Questions on the Artificial Pancreas Project
- What specific roles will each of the partners in this project play?
- How exactly will this system work?
- Is this an artificial pancreas?
- Will this system help improve glucose control?
- Who will supply the CGM for this system?
- Who is developing the computer program (algorithm) for this system?
- Can people specifically earmark donations to JDRF to this project?
- Why do people with diabetes want an artificial pancreas?
- What do you mean when you say this is a first generation artificial pancreas?
- Why did you choose to work with Animas?
- Are other pump and CGM companies interested in developing artificial pancreas systems?
- Will this involve clinical trials, and can I get involved?
- Approximately how much will the new system cost when it is available. Do you expect insurance to cover it?
- What kind of regulatory approvals will this system need?
Animas (a Johnson & Johnson company that manufactures insulin delivery systems) will be responsible for the overall delivery of the objective of this partnership: a first-generation artificial pancreas system. JDRF, which was the catalyst for the project, will provide funding, sit on a steering committee with Animas overseeing the project, and facilitate collaboration with the JDRF Artificial Pancreas Consortium for further computer software development and clinical trials.
This first-generation system will use a CGM device and an insulin pump. The wearer will still need to manually instruct the pump to deliver insulin at times, such as around meals, and adjust insulin delivery rates based on activity, illness and other variables. But the system would “treat to range,” that is, try to keep blood sugar within a set range between, for example, 80 mg/dL and 180mg/dL by automatically increasing insulin delivery when it senses blood glucose going above the high end of the range, and slowing down or turning off insulin delivery when it sensed blood glucose levels moving below the low end of the range.
Animas will determine the program to be used, either developing its own, or perhaps licensing software developed by researchers in JDRF’s Artificial Pancreas Consortium.
The near-term impact on quality of life that even a partially automated artificial pancreas system can have is huge. And people with type 1 diabetes understand that. As a result, many people really do want an artificial pancreas system. Both our own research experience, and that of the multiple partners we have worked with in industry and academia over the past few years tells us that. But our work on an artificial pancreas has in no way precluded us from continuing to focus on cures for diabetes and its complications. The majority of our research funding goes to what would be traditionally thought of as “cures,” while other research we fund will have a shorter-term impact, keeping people healthy until a cure is found.
JDRF has been working with a range of device manufacturers throughout the course of our research with CGM and an artificial pancreas. Animas obviously has the technical expertise to be an integral part of this project. They have a significant presence in diabetes, and a track record in bringing products and systems to market. Many people use Animas pumps today. Animas also shares JDRF’s commitment to and excitement about the prospects of developing a closed loop artificial pancreas in a relatively short timeframe, to significantly benefit people with diabetes in managing their disease on a day-to-day basis. Our hope and belief is that additional companies will follow J&J’s lead and begin development of their own versions of an artificial pancreas system and JDRF remains interested and will continue to work towards partnering with other companies to accelerate the development of multiple diabetes management device systems..
We have talked with a range of companies about an artificial pancreas system, and have been actively working with all of them to varying degrees on different aspects of CGM and artificial pancreas research. This project is one that has come to a point in time where we are able to announce a specific partnership and objectives. It is not the culmination of our efforts, but a great development in what we envision as a stream of research, products, and technologies that will be announced over a period of time. Other companies have looked at similar projects and products, and we anticipate that they will continue to do so. We are and will be collaborating with as many of these companies as possible to realize the vision of fully automated artificial pancreas systems.
Yes, there most certainly will be human clinical trials to test the first-generation artificial pancreas system developed through this partnership. As we get closer to that point, we will provide information through the JDRF website, and JDRF’s Clinical Trials Connection online trials service.
Approximately how much will the new system cost when it is available. Do you expect insurance to cover it?
With several years of development and testing ahead, it is difficult to say how much a first-generation artificial pancreas system will cost when they become available publicly. But JDRF’s Artificial Pancreas Project includes a significant effort to ensure the products are safe and also have accelerated regulatory approval as well as insurance coverage for the systems. JDRF’s track record in expanding the coverage for CGM devices over the past year, based on the findings on the success of the devices in improving diabetes control from its CGM Clinical Trials, is excellent. Today, most major insurers cover CGM devices in full or in part.