The News:

Stanford University and the FDA announced a collaboration on January 12 that will lead to more efficient and effective methods of establishing the safety and efficacy of medications and devices.  This will, presumably, lead to the acceleration of devices–such as the artificial pancreas–to market.

What This Means for the T1D Community:

Whether you plan to drive hard to get yourself a first-generation AP or whether you think you’ll be content to continue injecting insulin until the technology has developed further, the notion of an artificial pancreas should be exciting.

Most importantly, this should be meaningful because a closed-loop system in which a continuous glucose monitor tells an insulin pump how to dose, means better–and far easier–management of T1D.

For this parent of a kid with type 1, the announcement is particularly meaningful.  I have been lucky enough to get to know Dr. Bruce Buckingham, who happens to be at Stanford, and who happens to be one of the leading developers of the AP and who has been instrumental in the acceleration of the AP through the FDA, and I believe that Dr. Buckingham is more than capable of getting this product working well and into our hands.

This is yet another sign of cooperation between the FDA and the academic centers where important device innovations are being made. It’s also another example of the impact JDRF’s grassroots efforts have had in terms of making our voices heard by the government.  This is good news, indeed!

If You Want to Read More:

Story on Stanford’s website >

Washington, D.C. — The JDRF today said it is encouraged that the Food and Drug Administration (FDA) has issued a draft guidance which appears to lay a foundation for accelerating the development and availability of artificial pancreas technology (AP) that will improve the lives of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 “It also appears that the draft guidance lays out a rapid timetable to move from inpatient trials to outpatient trials to prove the AP’s safety and efficacy, and if that turns out to be the case it is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.

The News:

The FDA released a Guidance Document yesterday, December 1, that promises to accelerate the testing and potential approval of the Artificial Pancreas.

What this means for the T1D Community:

I have had December first on my calendar for months now.

Two weeks ago at the Silicon Valley Summit, I gained an even better sense of the crucial nature of the FDA Guidance Document we were awaiting.

The fact is that the Medtronic VEO–a low glucose suspend insulin pump that can be thought of as a step toward a product like the Artificial Pancreas–is available in 40 countries across the globe but not the United States because the FDA has not approved the system.

The fact is that if the FDA doesn’t quickly approve life-changing products like the AP, then components of it–continuous glucose monitors and insulin pumps–will not be developed and improved in this country because no markets for them will exist.

If this becomes the case, important innovations in the United States will not proceed and people with T1D will never have access to them.

I googled “FDA Artificial Pancreas” at least a dozen times yesterday.

Late in the afternoon, an email from Hasan Shah of JDRF Advocacy landed in my inbox.  I was extremely pleased to learn that the FDA has come through with this important guidance.

According to Jeffrey Brewer, JDRF President and CEO: “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. 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.”

Good news indeed!

Before December first, the FDA felt like an adversary of researchers and JDRF and individuals with T1D.  Through the tremendous effort of JDRF–whose 110,000+ advocates signed a persuasive petition and whose media campaign drew significant attention and whose dialogue with senators and congressmen have meant great governmental support–we made our concerns and priorities very clear and the FDA responded just as we hoped they would.

With the Guidance Document, we feel more aligned.

I, for one, am more convinced than ever that we are closer to bringing a product to market that is thought to be as revolutionary for T1D as the discovery of insulin.

John Lipp, Executive Director of JDRF Bay Area said that yesterday was “a very good day.”  I couldn’t agree more.

If You Want to Read More:

From the FDA website

JDRF Press Release

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 News:

Two important studies showed that use of a continuous glucose monitor (CGM) helps reduce Hemoglobin A1c, the blood test ideally taken every three months to indicate how well a person is managing his or her T1D.  Because a lower HbA1c is correlated with fewer complications, everyone with T1D would like his or her A1c to be as low as possible.

Use of CGM, according to two important studies, can help do just that.

The first of these studies, published in The New England Journal of Medicine in September, 2008, reported that the use of a CGM, worn at least six days per week, effectively lowered HbA1c in adults.

Diabetes Care then stated in September, 2011 that CGM use was helpful at all ages in lowering A1c’s.  In addition, better control was achieved with fewer incidents of dangerous hypoglycemic (low blood sugar) events.

What this means for the T1D community:

These studies are a big deal.

Each is large (322 and 451 patients, respectively) and randomized, with multiple participating medical facilities.

Their findings are significant enough to have convinced this mother of a thirteen-year old with T1D to have finally ordered up a CGM. The idea of a sensor and receiver that gives you continuous readings of blood glucose levels is appealing.  The idea that this device reveals TRENDS in blood sugar, instead of a discrete number, is even more appealing.  The idea that a CGM would ALARM when blood glucose rises too high or falls too low seems to good to be true.

These studies show that the positive aspects of CGM’s are real and significant.

More reading reveals, however, that CGM use–as with all things T1D–is imperfect.  Studies show that a CGM is most effective when patients work closely with diabetes educators or other professionals, which means more appointments or phone calls or emails for families already busy managing their disease.  Users are annoyed at false alarms.  CGM’s require another site on the body where another device sits. The 10-15 minute lag in reported blood sugars (taken from interstitial fluid, not blood) means information must be considered carefully.

These studies, though, along with other literature, mean that CGM’s–because they allow for tighter control of T1D–ought to be considered.

The use of new technologies is important not only for the success of an individual’s management of the disease, but also because the development of new technologies leads to more “cure-like treatments,” such as the artificial pancreas, and even, in some cases, toward the cure itself.

One can hope that, just as insulin pumps have become more common, that the use of CGM’s will follow suit.  With continued use by the T1D population, advancements will continue to be made in both pump and CGM design.

JDRF has worked hard—in funding research, in lobbying the government for approval of devices and medications, by seeing that health insurance companies will reimburse patients adequately—to advance these exciting technologies.

The use of insulin pumps together with continuous glucose monitors has been called “the bridge to the cure.”  If you haven’t already, you might just want to give some thought to climbing on that bridge.

The News:

The Mayo Clinic published an article in June, 2010 about dogs who can sense hypoglycemia in people with T1D.

Watch the video of Gregg and his service dog, Trajan, in the side column of this page.

With their acute sense of smell, these dogs can tell when their owners are approaching dangerously low blood sugar levels before the owners can.  Not only do these creatures know, but they will then alert their owner so that person can treat the hypoglycemia before it becomes dangerous.

What it means for the T1D community:

We have yet another tool to consider—one that won’t prick or stick or cause pain of any sort.

We love our Fiddy, but he barely responds to, "Sit!" "Sense hypoglycemia!"might not be within his reach.

Clearly a service dog is not for every family.  Four out of five Chisholms would love nothing more than another dog to add to our pack of two.  One of us—and it’s not me, and it’s not the kids—thinks our yard is too small and there’s not enough room at the foot of the bed and there’s plenty of barking.

Because nighttime hypoglycemia is especially scary for parents, I told a JDRF friend recently that when thirteen-year-old Will heads off to college one day, “he’s going with a dog!”

Jack laughed.  He said, “When Will goes off to college, he’ll go with an artificial pancreas.”

Clearly, an artificial pancreas would be more effective in managing diabetes than any new “best friend.”  Until the AP is available, though, I love the idea of a canine buddy to sleep on Will’s bed, pawing at him when the smell of Will’s breath alerts the dog that the boy’s becoming hypoglycemic.

Of course, Will’s CGM (when he wears it!) alarms and wakes him just as the dog would.

And guess what.

Even though my kids swore up and down that they would feed and brush and play with our dogs, there are days when I’m happy really that no one has to walk a continuous glucose monitor.

If you want to read more:

http://www.mayoclinic.com/health/diabetes-service-dogs/MY01338

http://www.dogs4diabetics.com/aboutus/aboutus.html

http://www.medicalnewstoday.com/releases/97981.php

This OpEd is published in the San Francisco Chronicle. Read Pam’s entire OpEd here. Pam also testified before Congress on this topic. Read a transcript of her testimony here.

For more than 20 years, my daughter Piper has lived with the constant, frightening, deceptive and malicious disease called type 1 diabetes. Piper has always been prone to the kind of hypoglycemic – low blood sugar – life-threatening attacks that come on hard, fast and without warning. She almost drowned as a youngster after becoming unconscious from low blood sugar. In college, she went into hypoglycemia while she slept and didn’t wake up in the morning. Fortunately, she was discovered and emergency care saved her life.

Unfortunately, the Food and Drug Administration has been dragging its feet on technologies that could revolutionize diabetes care and make these kinds of episodes a thing of the past. Key trials are on hold and it looks to be years more before these proven, life-saving technologies are available for patients in the United States. Meanwhile, kids are dying.

Every hour of every day, individuals with type 1 diabetes have to balance insulin, food and activity to try to prevent low and high blood sugars, and the devastating and costly complications: seizures, comas, kidney failure, heart disease, blindness and amputations. The human cost is incalculable; the economic cost isn’t: Diabetes costs our nation more than $174 billion a year and $1 in $3 of Medicare spending goes to care for people with diabetes.

Read more: http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2011/07/26/ED7H1KEPU9.DTL#ixzz1TKfWkQhV

Pam Sagan is Vice President of Government Relations for JDRF Bay Area’s Executive Board.

Thanks to our friends at DiabetesMine.com for recording this video with JDRF’s Dr. Sanjoy Dutta, Director of Glucose Control Therapies.

In another key step forward on the road to an artificial pancreas, JDRF has launched a research program to speed the development of faster-acting insulin.

Through the initiative, JDRF is funding investigators at leading academic institutions to test novel insulin formulations and delivery systems. The goal is to develop faster-acting insulin for use in an artificial pancreas system – which will automate blood sugar control by connecting a continuous glucose monitor to an insulin pump, via a sophisticated computer program. Faster-acting insulin would enable the artificial pancreas to more closely mimic a human pancreas in sensing blood sugar and secreting insulin in response.

“A key to making an artificial pancreas system significantly better than current methods to manage diabetes is to mirror as much as possible how the human pancreas works,” said Dr. Sanjoy Dutta, Director of JDRF’s Insulin Initiative.

Studies have shown that in people without diabetes, insulin is released and acts almost instantaneously. But even the fast-acting insulins currently available take more than 30 minutes to reach the bloodstream, and more than 90 minutes to reach peak effectiveness.

One way to speed up insulin action is to reformulate the molecule. JDRF will fund Dr. Bruce Buckingham of Stanford University to test such an insulin that is currently in development at Connecticut-based Biodel, Inc. JDRF will also fund Dr. W. Kenneth Ward of Oregon Health Sciences University to perform artificial pancreas experiments with the insulin.

Another way to speed insulin action may be to improve the route of delivery. Currently, insulin is delivered under the surface of the skin; this contributes to the slow action compared to insulin made in the pancreas. JDRF will provide grant funding to Dr. Howard Zisser at the Sansum Diabetes Research Institute to conduct studies there with a rapid-acting insulin being developed by California’s MannKind Corporation.

JDRF recently announced a collaboration with BD (Becton, Dickinson and Company) to develop a microneedle-based delivery system. In addition, JDRF will fund the testing of two new devices also aimed at providing the mechanical means to achieve faster insulin action.

The JDRF Insulin Initiative is another component in the Artificial Pancreas Project, which is focused on developing an artificial pancreas to give people with type 1 diabetes tighter blood glucose control – and reduce their risk for complications. With JDRF funding, numerous clinical trials have demonstrated that early-generation artificial pancreas systems enable people to better control diabetes and lower the risk of dangerous low blood sugar emergencies in people with type 1 diabetes.

Although the focus of the JDRF Insulin Initiative is accelerating the development and commercial availability of artificial pancreas systems, Dr. Dutta also noted that new faster-acting insulin would also have significant benefits for people with all types of diabetes who might choose not to use an artificial pancreas to manage their disease.

For more information about progress toward developing an artificial pancreas, please visit www.artificialpancreasproject.com.