By James S. Hirsch and Kelly L. Close*
Diabetes Close Up
February 2006, No. 56

Continuous glucose sensing, perhaps the hottest area in diabetes technology research today, is getting a boost from the powerful Juvenile Diabetes Research Foundation (JDRF).

The JDRF has announced that it will spend up to $6.5 million for research on continuous sensors specifically and a "closed loop" system generally, which would tie sensors to insulin delivery in a partially or completely automated fashion. Such an "artificial pancreas," which would rely on computer algorithms to calculate insulin doses, has long been a goal of researchers. It has also been one of the JDRF's six "therapeutic goals." But recent advances in the continuous sensors, one of which is already available in select markets, persuaded the JDRF to launch its current initiative.

"We believe that continuous sensors can improve glucose control in virtually every person with diabetes," said Aaron Kowalski, JDRF's director of strategic research projects. The appeal is obvious: the sensors, inserted in the body, deliver real-time glucose data to a monitor, not only providing current readings but also trend lines so patients know if their blood sugars are rising or falling.

The artificial pancreas, if ever achieved, would have an even more profound impact by removing the potential for human error in administrating the correct dose of insulin.

The importance of the JDRF's commitment cannot be overstated. The organization is a fundraising juggernaut - it's now in the midst of a $1 billion global fundraising campaign - and a lobbying heavyweight; its efforts, for example, helped pass California Proposition 71 for stem cell research, and its advocacy has significantly contributed to NIH funding for diabetes.

The speed with which the JDRF is moving on its Artificial Pancreas Project is impressive. Researchers are encouraged to check information out now since the letters of intent are due shortly, with the final applications due April 15 and funding beginning as early as mid-June. Information about the applications for this initiative can be found on the homepage of its website (http://www.jdrf.org/). The organization wants to fund clinical trials that will demonstrate the effectiveness of continuous sensors in improving glycemic control. Such evidence could be used not only to facilitate regulatory approval but also to persuade insurers to cover the devices as a way to reduce costly complications. The JDRF also wants to fund researchers explicitly working on closing the loop. This could be, according to Dr. Kowalski, "a bridge to a biological cure" because maintaining normal blood glucose levels are central to such goals as beta cell regeneration or cellular transplants. On the path to the artificial pancreas, the primary other barriers are solid algorithms and a way for counterregulatory hormones to be part of the technology; we understand the JDRF looks to fund research on all these fronts.

The JDRF's renewed interest in continuous sensors arose last year when Jeffrey Brewer, one of its board members whose son has diabetes, attained a prescription to buy Medtronic's Guardian, the only sensor with FDA approval. Problem was, the sensor was unavailable. So the board asked the organization why that was the case and what could be done to make this technology more widely available. JDRF's work followed. The FDA is currently reviewing two other sensors in addition to having approved the Guardian RT last summer - Abbott's Navigator and Dexcom's STS, both of which have "fast track" status - and Kowalski said the JDRF hopes other companies join the fray as well. Said Brewer, "I am thrilled that the JDRF has moved so quickly on this important initiative. Continuous sensing holds tremendous power to improve patients' health in the short- and long-term and to raise patients' quality of life, and research on this front is absolutely critical to creation of the artificial pancreas. This is an inspired example of how the JDRF's support and advocacy can accelerate research, and I look forward to seeing the fruits of this important work."

Even if the continuous sensors are refined, reimbursement for the devices as well as for providers' time to help analyze data remains a problem. As things now stand, relatively few doctors and nurses have the time or expertise to assess the log records of individual glucose readings. The JDRF will be lobbying for reimbursement reform, urging public and private payors to increase compensation for providers - we believe that the successful creation of a thriving market hinges on reimbursement, and we are extremely hopeful about JDRF's efforts on this front.  Editor's note: JDRF is a client of Close Concerns.

*Kelly L. Close is the founder and a principle of Close Concerns, Inc., a consulting firm devoted to diabetes research. Kelly and her team publish a monthly newsletter following research trends for executives, doctors, and nurses called Diabetes Close Up. Kelly has had type 1 since she was a teenager and was profiled in a recent issue of Countdown, with her 18-month-old daughter, Coco. Close Concerns has worked with JDRF since 2003. 

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Diabetes Close Up is a newsletter highlighting notable information and events in the diabetes industry. This newsletter is put forth as an unbiased commentary on the industry and is not meant to serve as a recommendation to buy or sell (or hold!) any stocks. Companies in which Close Concerns writers have stock and/or that are current or past clients of Close Concerns include Abbott, Animas, Amylin, Johnson & Johnson, Medtronic, Roche, and Sanofi-Aventis, and a number of small, private companies. Non-profit companies that are clients of Close Concerns include JDRF. If you have any suggestions or comments regarding content, please contact info@closeconcerns.com. If you would like to subscribe to DCU, please contact subscribe@closeconcerns.com. More information and disclosures found on our website http://www.closeconcerns.com/.