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World Diabetes Day (WDD) is celebrated every year on November 14, in more than 160 countries and territories. The WDD campaign is led by the International Diabetes Federation to engage millions of people worldwide in diabetes advocacy and awareness.

The WDD logo is the blue circle, signifying the unity of the global diabetes community. This is why worldwide on November 14 participating organizations shine blue spotlights on recognizable landmarks in their cities, and hold gatherings, workshops, and events.

This year several Bay Area diabetes organizations partnered with JDRF to light up Union Square, and tried to break the Guinness World Record for largest number of people simultaneously hula hooping. Of course, we used lit-up blue hula hoops! Over 200 hoopers turned out for the event and we could verify 103 simultaneous hoopers, just a few short of breaking the World Record!

Check out upcoming diabetes-related activities at events.jdrfbayarea.org

Washington, D.C. — The JDRF today said it is encouraged that the Food and Drug Administration (FDA) has issued a draft guidance which appears to lay a foundation for accelerating the development and availability of artificial pancreas technology (AP) that will improve the lives of millions of Americans living with type 1 diabetes (T1D).

“Our initial review of the draft AP guidance indicates that the FDA has been responsive and listened to the recommendations of leading clinicians and researchers in the type 1 diabetes field,” said Jeffrey Brewer, President and CEO of JDRF. “It also appears that the draft guidance lays out a rapid timetable to move from inpatient trials to outpatient trials to prove the AP’s safety and efficacy, and if that turns out to be the case it is good news.”

Artificial pancreas technologies have the potential to be the most revolutionary advance in treating T1D since the discovery of insulin. They will allow the millions of Americans with T1D to maintain tighter control of blood glucose levels, thus significantly reducing the risk of both high blood sugar (hyperglycemia), which can cause long-term complications including heart disease, blindness and stroke, and low blood sugar (hypoglycemia), which can be life-threatening. It would also free them from much of the daily burden of managing the disease.

In 2006, the FDA added artificial pancreas technology to its Critical Path list, making a commitment to advance these systems. The draft guidance is the first step to getting the technology to those in dire need.

“To be sure, we have a ways to go before AP technologies are available to patients but this draft guidance suggests that Commissioner Hamburg and the FDA are committed to fostering innovation and being a global leader in bringing life-saving technologies for T1D patients to the U.S market,” said Brewer. “In the next few weeks, we will review the draft guidance in detail and provide detailed comments to the FDA so that the final guidance unmistakably lays out the pathway to put AP technologies in patient’s hands as soon as possible. In the end, that is what this is all about.”

About the Artificial Pancreas

The artificial pancreas (AP) is an external device which people with T1D could use to do what their bodies cannot-control both high and low blood sugar around the clock. It works by combining a continuous glucose monitor (CGM) and an insulin pump with sophisticated computer software to provide automatically the right amount of insulin at the right time.

One of JDRF’s top priorities is the development of the AP. JDRF-funded studies have shown greatly improved clinical outcomes from early trials of prototype AP systems. FDA’s guidance on artificial pancreas systems will allow for these systems to be further developed, tested in outpatient pivotal trials, and eventually approved for people with T1D.

An overwhelming amount of support from researchers, clinicians, policymakers, and patients called on the FDA to advance the development of an AP. Over 100,000 people in the diabetes community signed JDRF’s petition which urged the FDA to adopt clear guidance, and leading clinical organizations specializing in diabetes care urged the FDA to ensure that the development of an artificial pancreas is not delayed by unnecessary regulatory roadblocks. Furthermore, Congress demonstrated vast support for a reasonable and timely guidance from FDA, with 252 Representatives and 62 Senators having urged the FDA to act in the best interest of type 1 diabetes patients.

About JDRF

JDRF is the leading global organization focused on type 1 diabetes (T1D) research. Driven by passionate, grassroots volunteers connected to children, adolescents, and adults with this disease, JDRF is now the largest charitable supporter of T1D research. The goal of JDRF research is to improve the lives of every person affected by T1D by accelerating progress on the most promising opportunities for curing, better treating, and preventing T1D. JDRF collaborates with a wide spectrum of partners who share this goal. Since its founding in 1970, JDRF has awarded more than $1.6 billion to diabetes research. Past JDRF efforts have helped to significantly advance the care of people with this disease, and have expanded the critical scientific understanding of T1D. JDRF will not rest until T1D is fully conquered. More than 80 percent of JDRF’s expenditures directly support research and research-related education.

For more information, please visit www.jdrf.org.

By Jeffrey Brewer, JDRF President & CEO

I’m pleased to share the news that on Thursday, December 1, the U.S. Food and Drug Administration (FDA) issued artificial pancreas (AP) draft guidance. While the draft guidance is still under review, our initial analysis suggests that it affirmatively addresses many of JDRF’s key issues, and, in so doing, it appears to lay a foundation for accelerating the development and availability of AP technologies that will improve the lives of millions of Americans living with type 1 diabetes (T1D).

But there is more to the story. The fact is that this encouraging outcome probably would not have happened without the contributions of JDRF, our community, and our allies. In fact, it is fair to say that without JDRF, there might not have been any guidance at all, or at least not in 2011. And that is a good place to start the story.

By 2010, it was clear that JDRF-funded research in academic, hospital settings showed that prototype AP systems could greatly improve glucose control, and with encouragement from JDRF, companies had committed to developing commercial products for people with T1D. But there was no defined regulatory pathway for AP outpatient studies or product review, nor were there any immediate plans for the FDA to develop these clinical guidelines, which threatened to greatly slow the research and development process. So JDRF decided to play a leadership role to short-circuit potential bureaucratic delays, and to ensure that the FDA had the most current, state-of-the-art scientific thinking on the AP.

In July 2010, JDRF convened a panel of leading clinicians and researchers to make recommendations to the FDA about the key clinical questions for AP studies, which were presented at a public meeting that November. In early 2011, JDRF incorporated those recommendations into a guidance document that we proposed to the FDA. At the same time, we intensified our efforts by making issuance of AP guidelines a key “ask” of the advocates at our annual Government Day in March. Their efforts, and the efforts of countless JDRF volunteers across the country, resulted in more than 250 House members and more than 60 U.S. senators sending letters to the FDA calling on the agency to produce timely AP guidance that takes into account the recommendations of leading experts. In these highly partisan times, securing such broad bipartisan support for this goal was truly remarkable.

We continued our efforts at Children’s Congress in June, where, at a Senate hearing on June 22, the FDA committed to releasing AP draft guidance by December 1. It soon became apparent that simply seeing the FDA issue guidance would not be enough. Indeed, when the FDA released unreasonable, highly problematic low-glucose suspend (LGS) system guidance—guidance covering a system that was already available and in use in more than 40 countries around the world—JDRF’s team recognized the very real risk that the AP guidance might be similarly flawed, setting back the development of AP systems by years.

Once again, we mobilized and increased our efforts. JDRF chancellor Pam Sagan testified at a House hearing on medical device regulation on July 20, when she highlighted the need for timely access to innovative, life-saving technologies to help better manage diabetes, citing LGS systems as a key example. In August, we launched our Promise to Remember Me Campaign, in which our volunteers held 250 meetings with members of Congress in communities across the country by the end of November to enlist them to encourage FDA action.

After Labor Day, we began a more intense campaign to encourage the FDA to not only issue AP guidelines by December 1, but to issue guidelines that, unlike the LGS ones, would not throw up unnecessary obstacles to the development of these systems. Of course, the centerpiece of these efforts was substantive, solutions-oriented engagement with the FDA’s scientific and device center teams. To their credit, members of the FDA staff not only were open to dialogue with JDRF’s AP team and the clinical community, they genuinely listened to our concerns.

Beyond this interaction with the FDA, some of our activities were visible, such as the letter from leading diabetes clinical organizations (AACE, ADA, AADE, Endocrine Society), the powerful full-page newspaper ads in The New York Times and The Washington Post, and the Capitol Hill press conference; and others were less visible, such as our ongoing outreach to key Congressional supporters, who directly communicated to the FDA how important it was to get the AP guidance right. Then there was our online petition, which so many of you signed, a petition that was eventually delivered to the FDA with more than 100,000 signatures gathered in five weeks’ time.

Which brings us back to Thursday’s announcement by the FDA.

The AP draft guidance clearly indicates that the FDA has worked hard to produce reasonable guidelines for artificial pancreas systems. The guidance appears to provide a rapid timetable to move from inpatient trials to outpatient trials, and its flexible requirements allow for clinical development in a manner that will advance AP trials while ensuring their safety and effectiveness. For this, the FDA deserves great credit. Furthermore, this draft guidance suggests that Commissioner Margaret Hamburg and the FDA are committed to fostering innovation and being a global leader in bringing life-saving technologies for people with T1D to the U.S. market.

We are still studying the details of this highly technical, 60+-page draft guidance. We know there will be issues and further considerations that we will want to address; we know there will be more dialogue with the FDA before final guidance is completed. But we also know that without the involvement of the clinical community; without the contributions of so many of our volunteers who testified, wrote op-eds and letters to the editor, signed petitions, and more; without the commitment of our Hill allies such as Diabetes Caucus co-chairs Susan Collins, Jeanne Shaheen, Diana DeGette, and Ed Whitfield; without the outpouring of signers to the petition; without our successful efforts to raise the profile of this issue in the FDA, the Congress, the White House, and the T1D community; without a regulatory agency with committed professionals pushing forward an innovative agenda; and without the extraordinary commitment and cooperation of so many JDRF staffers and departments, we would not be as close as we are to seeing this revolutionary technology reach the hands of people with T1D.

Thank you for your continued dedication.

People with diabetes will help change the lives for others with diabetes in need as they do something in unison – exercise. Every time someone participates in the Big Blue Test and shares the experience on BigBlueTest.org, a donation of life-saving supplies will be made on their behalf to someone with diabetes in need.

The Big Blue Test, a diabetes awareness program started by the nonprofit Diabetes Hands Foundation, takes place every November leading up to World Diabetes Day on Nov. 14. The campaign reinforces the importance of exercise in managing diabetes. People with diabetes are encouraged to do the Big Blue Test any day between November 1 and November 14 at midnight Pacific Time, by testing their blood sugar, getting active, testing again, and sharing the results online at bigbluetest.org.

The website aggregates all of the data collected live. In the last two years, just 14 minutes of exercise decreased participants’ blood sugar level between 15 and 20 percent.

Learn more at www.bigbluetest.org

On World Diabetes Day, I’ve realized something about this column I’ve been writing.

You, reader, might have realized it too.

When I write “Lessons Earned,” there is a sameness to the posts.  I find that sameness interesting.  And . . . significant.

The first similarity is a matter of style. When I write Eight Times to remember that people Mean Well when really We Want to Whack Them or My Mother, My Mother-in-law and Myself  or—whoa! here I go again! The thing is, whenever I  write about T1D, I immediately want to use the stylistic trope of a series of three poignant details.

What’s significant about this style is that I never have to look hard for three details. My mind fills with five or seven or ten examples I could share about how horrible this disease is, how hard it is on our family, and how much it weighs on my wise and uncomplaining boy. I cull through these to find the examples that illustrate my point most powerfully. When I go back to re-write preliminary drafts, new examples flood in and I replace original details with others that seem even more poignant or more moving or a better way to encompass a broader scope.

What’s interesting–and terrible–is that there is so much to say!

It’s fascinating that T1D is rich enough, painful enough, to supply so many instances of the way our lives are changed—for better and for worse—by this disease.

There is a second aspect of sameness in the writing of “Lessons Earned.”

At the end of almost every post, I speak to how grateful I am that Will is all right. We have come SO FAR since the discovery of insulin in 1921. We have sensitive and accurate blood glucose meters, hypoglycemia-sensing dogs, insulin pumps, continuous glucose monitors and other aids that make the management of this disease far easier than it was even five years ago. For that, I keep repeating to myself—and to you—that despite our family’s near-daily T1D-related obstacles, we are incredibly fortunate.

Almost always, then, after affirming our good fortune, I find myself circling back to the fact that this disease is complex and difficult. Every single day. Given the immense hurdles that must be cleared in order to bring to market a glucose repsonsive insulin, an artificial pancreas, a T1D vaccine, or other means of preventing, better treating, and curing this disease, I am awed by the complexity of T1D.

Sisters of boys who have T1D. And who would like the disease to go away.

Again and again I find myself writing the same idea in different words:  No kid, no adult, no family should have to live with type 1.

I don’t usually ask readers to take action. My strong sense is that people living with T1D are forced to take enough action every single day.

If you’re reading this, however, you’re already on the JDRF website.  You’re halfway toward the action I urge you to take.

I would like the endings of these columns to be different.

I would like Will’s life and the lives of the millions of people like him, to be different.

Here’s my call to action: Let’s continue to work together, with JDRF, all of us, now, to find a cure.

Take a look around the website!

Become an advocate!

Support the Walk to Cure Diabetes either by donating to a team or by starting your own virtual team!

Watch the special World Diabetes Day broadcast today at 12:30 p.m. PST with Jeffrey Brewer!

Attend an event—chances are I’ll be there, come introduce yourself!

Come to Union Square this evening at 5 to hear inspirational talks and music, to partake in kids’ arts and crafts, to enjoy refreshments and even to break a Guinness World Record!

Come to the annual Silicon Valley Summit this Friday morning in Palo Alto and I will make room for you at my table!

Donate even a small amount of money.

Sign the petition for the artificial pancreas project.

Work with JDRF.

And finally, the third similarity about “Lessons Earned”: the handful of posts that end with one heartfelt line in italics:

Because we need to find a cure for type 1 diabetes.

Please join us as JDRF, the Stanford School of Medicine and BayBio host a conversation among stakeholders to consider constructive means to improve the FDA approval process, which has become a serious impediment to investment in US medical device and biotech companies and for those companies to market products and therapies in the US.

Moderator:

Mark Fischer-Colbrie, President and CEO, Labcyte Inc.

Panelists include:

Emory Anderson, President and CEO, Intuity Medical
Michael J. Billig, Co-Founder and CEO, Experien Group
Dr. Bruce Buckingham, Professor, Stanford School of Medicine
John F. Maroney, General Partner, Delphi Ventures
Michelle Rohrer, Vice President Regulatory Affairs, Genentech

Friday, November 18, 2011

Registration: 8:00 a.m.
Program: 8:30 a.m. to 10:30 a.m.

Four Seasons Silicon Valley
2050 University Avenue
East Palo Alto, California

Ticket Information:

Individual Ticket − $100
Table Sponsorship (10 seats) − $1,500

For all sponsorship and ticket inquiries, please contact Caroline Kinsey at 415.597.6314 or ckinsey@jdrf.org.

Sponsored by:

For federal income tax purposes, the amount the IRS considers deductible is the difference between the cost of your ticket and the fair market value of all goods and services JDRF will provide each person attending the Annual Silicon Valley Summit which is $60 per guest. JDRF Tax ID #23-1907729.

Last week JDRF ran a large advertisement in The New York Times and in The Washington Post.  The ad shows a photograph a young girl.  Below her are the words: “Piper has type 1 diabetes.  One in twenty people like Piper will die from low blood sugar.”

Understandably, the T1D community was shaken.

Predictably, people who live with T1D called the ad “painful,” “sensational,” “unnecessary.”

The ad is painful.

Low blood sugar is the immediate danger with T1D.  For most of us, it’s the scariest part of the disease.

Low blood sugar is why people have worked so hard to train dogs who can sense hypoglycemia.

It’s why all of the jacket pockets and glove boxes and purses and backpacks in the Chisholm family have smarties and glucotabs and starbursts and why, when I glance down to check these items, I dread the moment when we need one of those things and it’s not available immediately.

The very real threat of hypoglycemia is why CGM’s are made to alarm and why our doctors suggest 2 a.m. blood glucose checks and it’s why I was so very relieved when a participant in one of last week’s many email exchanges about the ad made the point that 1 in 20 people dying from low blood sugar also means that 95% of people with this disease won’t.

Still, the advertisement is disconcerting.

It’s disconcerting and unsettling, but not sensational.

The statistic JDRF chose was the product of many studies by many researchers:  P.E. Cryer, T. Deckert, and W. M. G. Turnbridge as well as the Diabetes Control and Complications Trial, the very large, ground-breaking study run from 1983-1993.  These studies conclude that the number of deaths from hypoglycemia are between 2% to 10%.

Therefore, 1 in 20, or 5%, or the statistic JDRF chose to publicize, is actually a conservative estimate.

The ad is unsettling and frightening but it is not unnecessary.

As soon as the ad came out, my friend Mark wrote, in response to the alarm, about the four times his son has suffered severe hypoglycemia and how very scary each of those incidents was.

My friend Shelly, mother of a three and a five year old, wrote about almost having died of hypoglycemia but for a “good Samaritan” who recognized her symptoms and came to her aid.  Shelly, when her husband is traveling, goes to bed with her blood glucose purposely high because of the “gruesome” specter of the severe hypoglycemic nighttime “event” that might leave her children “fending for themselves for days until her husband returns.”

Aaron Kowalski, Ph.D. and Research Director for JDRF, said:

“JDRF did not publish this ad to raise money. We ran this ad to tell the FDA that lives can be improved and even saved. We ran it because we want the FDA to understand that tools do exist to do this! JDRF-funded research has shown that predictive algorithms can minimize hypo by up to 80%. We can prevent many of these deaths. It is unacceptable to JDRF and it should be unacceptable to you that the United States is pretty much the only country in the world that hasn’t approved the Medtronic Veo pump that suspends insulin delivery when a person is low and non-responsive. This ad says to the FDA that they must get this guidance right.”

One in twenty is terrible.

But JDRF ran the advertisement with the express purpose of getting the FDA to approve technology—like the Medtronic VEO—that could LOWER THAT NUMBER.

JDRF and the T1D community need to create a sense of urgency.

We need even more of what the advertisement created:  a public outcry.

We need to recognize facts in ways that are not overblown or exaggerated but that will spur people to action.

We need to sign the petition urging the FDA to accelerate its review of the artificial pancreas (do so HERE! It takes two seconds!).

We need to educate the public and advocate for change and reimbursement and better treatments.

We need to fund research for new drugs and for the safer, more accurate, more impactful devices that will better treat this disease.

We need the regulatory agencies in this country to allow people to use them.

In Just 23 Days, Over 100,000 Individuals Sign Petition for the FDA to Advance, Not Delay, the Development of an Artificial Pancreas

Washington, D.C. – U.S. Senators, clinical experts, and people with type 1 diabetes (T1D) today urged the Food and Drug Administration (FDA) to issue clear and reasonable guidance on the artificial pancreas (AP) that avoids unnecessary delays in development and delivery of a medical technology and improves the lives of millions of Americans living with this disease. Over 100,000 people have signed a petition to the FDA calling for swift action.

“The FDA has a real opportunity not only to foster innovation but also to help diabetes patients in the United States by issuing the draft guidance on time and by taking into serious account the scientific consensus on the safest and most rapid way forward,” said Senator Susan Collins (R-ME). “The FDA guidance must truly lead to accelerated development and eventual regulatory approval of this key breakthrough technology which will ensure that those with type 1 diabetes can maintain better blood glucose control. Just last week in Italy and France, results from an outpatient trial for the artificial pancreas were announced. We need this innovation here in America.”

“Many of us in Congress care deeply about type 1 diabetes, and know how life changing this technology could be for the millions of children and adults living with diabetes,” said Senator Jeanne Shaheen (D-NH). “The FDA has promised to issue guidance for research by the end of this year. For the good of those families dealing with this disease, the FDA must honor that commitment.”

The guidance is expected by December 1. Clinical experts say that the AP is the most revolutionary development in diabetes care since the discovery of insulin.

Collins and Shaheen, the Senate Diabetes Caucus Co-Chairs, were joined at a press conference by 11-year-old Caitlin Ryan, from Washington, D.C., who has T1D.

Additionally, at the press conference a petition of over 100,000 signatures urging the FDA to issue guidance by December 1 was unveiled. The signatures came from Americans across the country, including tens of thousands who live with T1D every day. The petition signers called on the FDA to “adopt outside clinical recommendations allowing short term in-hospital evaluation of artificial pancreas systems followed by outpatient trials no more than three months long.”

The petition was posted on JDRF’s website on October 3. In just over 20 days since its launch it has garnered over 100,000 signatures.

Last week in a letter sent to FDA Commissioner Margaret Hamburg, Sens. Collins and Shaheen advised the FDA to consider seriously the recent recommendations put forth by leading clinical organizations suggesting that the final AP guidance avoid the shortcomings of the recently proposed guidance for Low Glucose Suspend Systems, an AP precursor technology.

“The artificial pancreas is a life saving and game changing device for kids and adults living with type 1 diabetes,” said Jeffrey Brewer, President and CEO of JDRF. “Research has demonstrated the dramatic impact the artificial pancreas would have – saving lives, transforming quality of life for people with type 1 diabetes and reducing preventable medical complications. However, if the FDA fails to issue guidance that adopts recommendations from leading clinical experts, patient access will inevitably be delayed and even prevented entirely. This is an opportunity for the FDA to demonstrate its commitment to meeting its goal of closing the agency’s regulatory science gap.”

On October 17, the American Diabetes Association, the American Association of Diabetes Educators, the Endocrine Society and the American Association of Clinical Endocrinologists sent a letter to FDA Commissioner Hamburg urging the FDA not to repeat the shortcomings of the Low Glucose Suspend decision. The letter stated, “The artificial pancreas has the potential to have more impact on diabetes care and patient health than any development since the discovery of insulin.”

Specifically, the clinical organizations called on the FDA to ensure that the AP guidance contains the following critical elements:

1. A firm commitment to use continuous glucose monitor (CGM) data in evaluation of artificial pancreas systems
2. Reasonable study progression
3. Flexibility with respect to endpoints, patient population, and safety elements
4. Policies to encourage system improvements

JDRF, the leading patient group for type 1 diabetes adults, children, and families applauded the letter.

About the Artificial Pancreas

The artificial pancreas (AP) is an external device which people with T1D could use to do what their bodies cannot-control both high and low blood sugar around the clock. It works by combining a continuous glucose monitor (CGM) and an insulin pump with sophisticated computer software to provide automatically the right amount of insulin at the right time.

One of JDRF’s top priorities is the development of the AP. JDRF funded studies have shown greatly improved clinical outcomes from early clinical trials of prototype AP systems. In order for AP systems to be further developed, tested in outpatient pivotal trials, and approved for people with T1D, the FDA needs to provide clear and reasonable artificial pancreas guidance.

About JDRF

JDRF is the leading global organization focused on type 1 diabetes (T1D) research. Driven by passionate, grassroots volunteers connected to children, adolescents, and adults with this disease, JDRF is the largest charitable supporter of T1D research. The goal of JDRF is to improve the lives of every person affected by T1D by accelerating progress on the most promising opportunities for curing, better treating, and preventing T1D. JDRF collaborates with a wide spectrum of partners who share this goal. Since its founding in 1970, JDRF has awarded more than $1.5 billion to T1D research. More than 80 percent of JDRF’s expenditures directly support research and research-related education. Past JDRF research efforts have helped to significantly improve the care of people with this disease, and have expanded the critical scientific understanding of T1D. JDRF will not rest until T1D is fully conquered.

JDRF-Funded Researchers Report Success with First Automated Real-World Study in Type 1 Diabetes Patients; JDRF Applauds Recent FDA Approval to Conduct Low-Glucose Suspend Device Clinical Trial at Home

Pivotal advances toward the development of an artificial pancreas were announced today, furthering the prospect of bringing this innovative and life-saving device to market.

For the first time ever, patients were able to control their diabetes using an artificial pancreas system in a real-life setting, JDRF-funded researchers in Europe announced today at a press conference in Montpellier, France. The study took place in France and Italy. JDRF applauds this major step forward in the field of artificial pancreas research and in diabetes care because of how this work could transform the lives of millions of people with type 1 diabetes (T1D).

In parallel experiments performed at Montpellier University Hospital in France (led by professor Eric Renard and professor Jacques Bringer), and at the Universities of Padova and Pavia in Italy (led by Drs. Claudio Cobelli and Daniela Bruttomesso), two patients with T1D attained near-normal glucose levels after spending one night outside of a hospital while their diabetes was automatically managed by a prototype artificial pancreas system. The patients were able to eat a meal at a restaurant and spend one night at a hotel while using the device.

“This marks a day that has been long awaited by people with type 1 diabetes, and we congratulate the researchers for this important achievement,” said Jeffrey Brewer, president and CEO of JDRF. “We are now bounds closer to the realization of the first generation of an artificial pancreas that will truly revolutionize diabetes care.”

These studies represent the first outpatient trials using an approach developed by the JDRF-supported International Artificial Pancreas Study Group, an international research consortium including teams from Montpellier University Hospital, the Universities of Padova and Pavia (Italy), and the Universities of Virginia in Charlottesville and of California in Santa Barbara (USA). Eight more patients enrolled in the trial will begin outpatient testing in the coming weeks in Montpellier, France and in Padova, Italy.

The research team used already approved insulin pumps (OmniPod) and continuous glucose monitors (DexCom), which were controlled by a hand-held device created at the University of Virginia by a team led by Dr. Boris Kovatchev and Patrick Keith-Hynes and monitored by the investigators at all times to ensure safety.

People with T1D are burdened with constantly having to determine the right amount of insulin to dose at the right time, multiple times every day. Yet even with diligent monitoring, a significant portion of the day is still spent with either high or low blood sugar, placing them at risk for devastating complications.

“Today, there are no fully-automated insulin delivery systems available on the market, and that’s why JDRF has made accelerating the development and delivery of these technologies a priority,” said Dr. Aaron Kowalski, assistant vice president of treatment therapies at JDRF. “Today’s announcement is incredibly exciting and shows us that the first generation of an artificial pancreas is no longer a dream. Now we need a regulatory pathway that will enable us to make it a reality.”

The report coincides with a major effort in the United States to ensure a clear and reasonable regulatory pathway for similar studies, and ultimately for artificial pancreas systems to be approved and made available by the Food & Drug Administration (FDA). The FDA committed to publishing guidance on artificial pancreas systems by December 1, 2011, but the speed with which an artificial pancreas reaches patients in the United States will be determined by whether the agency issues this guidance on time and adopts recommendations from leading clinical experts.

In a letter recently sent to FDA Commissioner Margaret Hamburg and leading members of Congress, the American Association of Clinical Endocrinologists, American Association of Diabetes Educators, American Diabetes Association, and the Endocrine Society told the FDA that the artificial pancreas guidance should adopt recommendations from JDRF, urging the agency to issue guidance that will allow researchers, scientists, and manufacturers to finally move forward with the next phase of outpatient clinical trials.

The advancement of an artificial pancreas is a top priority for the T1D community. A petition already signed by tens of thousands of T1D families and advocates urges the FDA to provide clear and reasonable guidelines for outpatient testing by December 1. The advancement of this life-saving technology relies on the FDA’s timely action.

“Today’s news is an incredible step forward,” said Mr. Brewer. “But to be truly meaningful, people with diabetes must have the opportunity to benefit from research breakthroughs such as these. I hope we will be able to conduct innovative trials like these here in the U.S. soon, and we urge the FDA to demonstrate its commitment to innovative science and provide the opportunity for United States-based researchers who are part of the JDRF Artificial Pancreas Consortium to participate in this important research.”

JDRF Applauds Medtronic on FDA Approval of Low-Glucose Suspend (LGS) Device Trial

Medtronic, Inc. today announced FDA approval of its Investigational Device Exemption (IDE) to conduct an in-home clinical trial of the company’s MiniMed Paradigm LGS system for its ASPIRE study. The FDA approval of Medtronic’s IDE marks the first time that an in-home trial of an artificial pancreas technology is approved in the U.S.

“JDRF and others have been urging FDA to create a more clear and reasonable path for low glucose suspend pumps in the United States,” added Kowalski. “While long overdue, we commend Medtronic for their commitment and persistence to our patients in the United Stands and we are pleased that FDA has agreed to let this promising technology move forward into outpatient trials.”

JDRF recently submitted comments to the FDA on its draft guidance for the testing and approval of an LGS system. An LGS system is a version of an insulin pump which suspends insulin delivery when a monitor indicates a person with diabetes has or is projected to have dangerously low glucose levels. These systems are the first step toward an artificial pancreas, a device that could transform the lives of individuals with T1D.

“People with diabetes not only need to achieve better glucose control, but they also need to prevent life-threatening complications. Nighttime is a particularly dangerous time for a person with diabetes, because an individual’s blood sugar level can drop while they are sleeping, unaware that their levels are too low and unable to do anything about it, leading to seizures, coma, and unfortunately sometimes even death,” noted Kowalski.

The in-home trial of LGS systems will be the second phase of the ASPIRE (Automation to Simulate Pancreatic Insulin REsponse) study, following the completion of the in-patient clinical study. ASPIRE is a multi-center, randomized, pivotal in-home study being conducted at multiple investigational centers to determine the safety and efficacy of the Low Glucose Suspend feature in the sensor-augmented MiniMed Paradigm insulin pump.

The Diabetes Heroes initiative launched by Roche features a selection of important diabetes activists they refer to as ‘Torchbearers.’

The Torchbearer page with the most Likes by World Diabetes Day, November 14, 2011, will have $10,000 donated to the JDRF Chapter in their area.

Luckily for JDRF Bay Area, three of the most influential and inspirational Torchbearers are here in the Bay Area!

How to Help

Pleases visit the Torchbearer pages of Kelly Close, Manny Hernandez, and Amy Tenderich and click the Facebook Like button on each to show your support!

If you are not familiar with Amy, Kelly, and Manny’s work, we suggest you watch the video interviews on their respective pages.