Frequently Asked Questions on the Artificial Pancreas Project

What specific roles will each of the partners in this project play?

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.

How exactly will this system work?

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. 

Is this an artificial pancreas?

This is a first-generation system.  It will be partially automated, coordinating an insulin pump with a continuous glucose monitor (CGM). The CGM will continuously read glucose levels and transmit those readings to an insulin pump, which delivers insulin through a small tube or patch on the body.  The pump will house a sophisticated computer program that would automatically calculate the necessary amount of insulin, based on the CGM’s glucose readings, and deliver insulin if blood glucose is too high.  It will slow or stop insulin delivery if it detects the blood sugar level is going too low.  This partial automation will allow for improved safety while delivering significant clinical benefit.  In essence, it will perform a similar function as the human pancreas by controlling insulin delivery dependent on glucose levels in the blood.  So while not yet a fully automated system, it represents a significant step forward in diabetes management, and could provide immediate benefits in terms of blood  sugar control, while minimizing dangerous highs and lows.

Will this system help improve glucose control?

The computer software that will run this system is still being developed, which makes it difficult to predict what the outcomes of using this system will be, but we believe even this first-generation system will help many more people with diabetes achieve target A1c’s of 7% or lower currently do so today.  Most important, we believe it will do that with far fewer low blood sugar problems.

Who will supply the CGM for this system?

DexCom will supply the CGM for this first generation system, through an arrangement with Animas.

Who is developing the computer program (algorithm) for this system?

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. 

Can people specifically earmark donations to JDRF to this project?

Absolutely.  Your local JDRF chapter can do that – or you can visit the JDRF website,

Why do people with diabetes want an artificial pancreas?

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.

What do you mean when you say this is a first generation artificial pancreas?

This is a first-generation, partially automated system.  So while not yet a fully automated system, this “hypoglycemia-hyperglycemia minimizer” system would represent a significant step forward in diabetes management, and could provide immediate benefits in terms of blood sugar control, while minimizing dangerous highs and lows. Even so, this system will have benefits for people as soon as it can be successfully developed, in helping them manage their diabetes better, and avoid highs and lows.  That in and of itself is a huge step forward in diabetes care.  But you’re right, this is not a fully automated artificial pancreas, and we are working to ensure that people understand that.  It is a great beginning, but it is just the first step on the path towards the development of an artificial pancreas system.

Why did you choose to work with Animas?

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..

Are other pump and CGM companies interested in developing artificial pancreas 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.

Will this involve clinical trials, and can I get involved?

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.

What kind of regulatory approvals will this system need?

This first-generation artificial pancreas system will need to be demonstrated to be safety and effective and approved by the U.S. Food and Drug Administration (FDA) through what is known as the Premarket Approval, or PMA, process.  The time frame for this process and the testing that will be necessary for approval are subject to a wide range of variables.  However, the goal of an artificial pancreas has been embraced by the U.S. Food and Drug Administration, which along with  JDRF and NIH, brought together scientists, regulators, industry, and patients for scientific workshops on the subject in 2005 and 2008; the FDA has designated an artificial pancreas as one of its “critical path” initiatives.