Dr. Boris Kovatchev leads an international diabetes research team at UVA. Read more about the team and the financial supporters who are helping make it happen. A special “Thank You” to Fred and Susan Russell of The Banting Foundation.
Boris P. Kovatchev, Ph.D, and I show off the AP after my afternoon walk. Dr. Boris is the Director of the UVA Center for Diabetes Technology and the person who is building the ” brain ” or algorithm that makes the AP possible.
Have Artificial Pancreas; Will Travel.
Dr. Daniel Chernavvsky, Clinical Research Coordinator, and I display the AP as the 24-hour clinical trial ends March 15. I did NOT want to give it back to him. I’m sure he was watching me closely, LOL.
That’s the word today from Daniel Cherñavvsky, MD, CRC with the University of Virginia Health System. “Yes, we completed the trial in Santa Barbara and the following article published in Diabetesmine.com talks about it.,” Dr. Daniel tells me. “We are ready to do the trial overseas” in France and Italy next.
Yes! The AP outpatient trial was done with participants in California in April and provided more details and data. For Daniel, the next stop on the road trip is to bring the technology to his research colleagues in France and Italy. This is all building toward home trials — yes, home trials in the real world in 2014 — by PWDs ( persons with diabetes) while being closely monitored by doctors and researchers via remote technology!
Here is a brief excerpt from the Diabetesmine.com article.
“This is all very exciting! Although when you think about it, 48 hours is a pretty short timeframe to get a realistic read on any PWD’s ongoing patterns of glucose swings. I wondered how realistic the algorithm patterns were…
“We’re just dipping our toes in the stream right now,” Dr. Howard Zisser said. “We’re going with our ‘best guess’ until we can do week-long studies.” Meanwhile, patient Jim wasn’t complaining a bit over 48 hours of long-awaited freedom. “It’s soooo nice — I don’t have to do anything!” he crooned, with his eyes all a’twinkle. Dr. Zisser just grinned. “We’re learning and developing things along the way,” he said. “It’s like the space program. We’re going to the moon, and along the way we get Tang, and who knows what other innovations that come out of the process?”
Local TV Station Covers My Clinical Trial At UVA — Adds A Human Element To Complex Topic
First, my apologies to followers or readers of We R the Cure — I’ve owed you a follow up to my experience wearing the actual Artificial Pancreas in a clinical trial at UVA since late March. Here is part 2.
Before leaving UVa and giving back the AP, I pose with a few of the team members who watched over me and conducted the outpatient trial. L to R: my nurse, Crystal Leathers, computer engineer Benton MIze, and Stacey Anderson, MD.
Second, the headline of this post could have been written by thousands of Americans who are living with Type 1 diabetes and keeping ” Hope Alive ” that a solution like the AP is coming. Of course, solutions and “cures” have been promised by doctors, researchers, fundraisers and good-hearted volunteers for decades. I don’t believe in the tooth fairy either.
So rather than bore you with my prediction of when the AP will be built, approved and commercially available, I suggest you Google or Bing the topic and take a deep dive into the facts and the promises surrounding ” WHEN ?”
Here are some of the things I learned from my 24 hour period with Dr. Boris Kovatchev and his amazingly talented team of doctors, nurses, researchers and technology pioneers at the UVA Center of Diabetes Technology in Charlottesville, VA. Hopefully, you’ll see something here that gives you a dose of optimism for our future. A future filled with less daily stress and better diabetic health.
I’ve got renewed hope and excitement about the AP. How long before we’re all able to wear one? I’m hoping for three to five years. It’s going to take
AP SmartPhone shows Flat Line 167 mg/dl of awesome glucose control after dinner and prior to bedtime on March 14, 2013.
more time, brains, private sector investment and more research dollars to make this a reality. As many Type 1 Ds or Diabetes Online Community members have said before me: ” the solution is coming; it’s my job to keep myself in the best possible shape — to closely monitor and control my sugar levels — so I’ll be healthy enough to benefit from the AP when it arrives.”
It’s not a cure for diabetes. That’s still our goal. But, the AP ship is sailing on the horizon and is about to dock. I want to be ready when our ship finally comes in.
OK, so the headline might be a little bit over the top. My apologies. However, I was wearing the ” Future ” of high tech diabetes self-management, and it was amazing, incredible and a breath of fresh air.
I was blessed to actually plug in and wear the Artificial Pancreas in a human clinical trial at UVa on March 14 and 15. The AP is not exactly like clicking the Arc Reactor into your chest, but the two devices are similar. It is a new, high-tech device that brings the promise of: better health; less daily stress for you and your family, and the powerful hope of fewer long-term medical complications from diabetes such as blindness, heart attacks, strokes and amputations.
For 24 wonderful hours, I felt like Iron Man — without the cool cars, the ability to fly, the Malibu mansion or the lifestyle of Robert Downey, Jr. But the experience was still “Super Hero-like” for someone like me who has battled the ” Super Villan” Type 1D for 14 years and been unable to achieve consistent glucose control. The AP is not a cure for diabetes, but it does offer a solution or pathway to better health outcomes for the 3 million Americans living with Type 1 diabetes.
After missing an opportunity to participate in the last AP trial, this time I passed the FDA’s strict health screening ( done May 11) and was invited by the research team at the UVA Center for Diabetes Technology to participate in a shortened outpatient trial. Recently, the UVA team successfully completed a 48-hour pilot study with 5 individuals — to prove that a ” wearable AP is feasible and safe; therefore its continued testing and refinement for outpatient use is warranted,” according to Boris P. Kovatchev, Ph.D., the lead investigator and Director of the center.
In the prior study, the AP participants led a ” normal ” life and were able to eat and sleep without the constant finger pricks and mental burden of ” how’s my sugar doing now?” Check out Tom Brobson’s video story of his UVa trial experience. This was the first out-patient study done in the United States.
As a follow-up to this clinical trial, my one-person study was not designed to test the AP algorithm or to determine if the software worked. We know the AP works — and it worked again for me in this trial! The UVa team called me for a ” dry run” test to see if a new hardware solution — a fix to provide an uninterrupted source of power to the AP and the CGM — would prevent the battery ” burn out” that happened during the previous trials. This is where ” BRICK 1 ” comes in. The researchers designed a new power and communication system to be combined within one unit. The good news: the ” Brick” designed appeared to work exactly as the researchers expected during my 24-hour test, providing consistent data reporting with no gaps!
The team put the AP SmartPhone, CGM, Bluetooth wireless communication equipment all together in ” Brick 1″ — this is what I carried with me and how I communicated with my insulin pump. And instead of staying put in a hospital or hotel room, I was able to carry the AP/CGM Brick with me as I walked to dinner at the College Inn on ” The Corner” across from campus and again for lunch on Friday. As Dr. Boris joked with the local NBC TV reporter, “this is the first time ever anyone with the artificial pancreas has been outside walking in a parking lot.” One small step for man, one giant leap for AP research!
Dr. Boris, Dr. Daniel and Benton Mize, the computer engineer working on the AP design, said the Federal Drug Administration (FDA) — which is regulating and monitoring all human clinical trials performed in Charlottesville and the 4 other AP consortium universities in the USA, France and Italy — needs clinical proof the technology works and that patients in non-hospital trials will be safe from low glucose episodes. The technology must give researchers uninterrupted remote monitoring capability of participants on a 24/7 basis when AP home trials start in 2014.
My bottom line — the AP worked as advertised. I was involved in determining my meal boluses and counting my carbs ( the control factor). The AP was able to operate in ” safe mode ” while I slept and ” closed loop” mode while I ate dinner or exercised. It essentially acted like a normal pancreas does providing sugar control automatically. The CGMs and the AP monitored my sugar every 5 minutes and adjusted by basal rates ( baseline insulin dose) up or down to help me achieve the best possible glucose control with the least amount of work.
And thanks to the AP and the awesome team at UVa, I had the freedom to go to bed and sleep all night with no 2 am lows. I maintained a Flat Line sugar reading overnight and woke up the same — and that’s a “Super Hero” result and the promise of a bright future for everyone living with Type 1 diabetes.
Next post: I’ll add a few more observations from my clinical trial; Dr. Daniel’s trip to the University of California for a new outpatient clinical trial with the AP and “BRICK 1″; and Dr. Boris’ talks with manufacturers to get better quality technology for the AP.
JDRF today called the Food and Drug Administration’s (FDA) final artificial pancreas guidance a milestone in advancing better treatments for people with type 1 diabetes (T1D)-one of JDRF’s key goals.
Artificial Pancreas Closed Loop System
The final FDA guidance issued Friday provides, for the first time, researchers and industry with a clear and reasonable roadmap of the FDA’s expectations for conducting human studies of artificial pancreas systems, and for their approval for marketing to people with diabetes.
JDRF first proposed draft guidance to the FDA in March 2011, after convening an expert panel of clinician researchers to assess the best ways to measure safety and effectiveness of artificial pancreas systems. JDRF then led an extensive scientific and patient advocacy campaign to encourage the FDA to adopt its recommendations. JDRF provided extensive comments on the FDA’s draft guidance, released in December 2011. The FDA’s final guidance incorporates nearly all of the recommendations made by JDRF and the clinical community.
“This FDA guidance is an important milestone in improving lives of people with type 1 diabetes,” said Jeffrey Brewer, president and CEO of JDRF. ”JDRF commends the FDA for its scientific leadership in the area of artificial pancreas systems, which have the potential to be the most revolutionary advance in treating type 1 diabetes since the discovery of insulin. Until we can cure this disease, we have an obligation to reduce the daily burden of managing it and enable people with the disease to live healthier lives.”
Today’s technologies for managing T1D leave millions exposed to substantial risks of blood sugar levels that are either too high or too low, despite their best efforts to maintain tight control of their diabetes. These extreme blood sugar levels can have serious consequences. High blood sugar levels (hyperglycemia) can cause long-term complications including heart disease, blindness, and stroke, and low blood sugar levels (hypoglycemia) can be life-threatening.
The FDA’s final guidance allows for a range of scientifically valid study designs, allowing flexibility that will encourage innovation in technologies for people with T1D while ensuring thorough evaluation of such systems before they can be prescribed by doctors. For example, the guidance recognizes “time in range” as a potential endpoint to use in artificial pancreas studies, as well as other measures of glucose control. It allows sponsors the ability to propose statistical measures of efficacy tailored for their systems, and accepts the use of continuous glucose monitoring (CGM) data in evaluating artificial pancreas systems.
For more information contact: William Sorensen, JDRF, 212-479-7558; wsorensen@jdrf.org
The future of improved diabetes control is coming fast; it’s kinda like the small light at the end of the tunnel. The light is a freight train carrying the Artificial Pancreas Closed Loop solution currently being tested and in trials at the Center for Diabetes Technology at the University of Virginia and 4 other leading universities in the world.
One of the possible “brains” that will safely power the Artificial Pancreas Closed Loop system via an ordinary “smart phone.” Once in use, the quality of life and health improvements will be amazing for Persons With Diabetes (PWD).
With Full Disclosure and Much Credit — Here is a recent Podcast done by my friend, Tony Rose, who is a veteran contributor to the Diabetes Online Community (DOC), a fellow PWD and someone I called when I was starting Werthecure.com this year.
“In this episode of the Blogging Diabetes Podcast I talk to Lesley Berchtold about her history with diabetes and more recently, her in and out patient trial at UVA for the Artificial Pancreas. It was an eye opening interview that I certainly learned a lot from and appreciate Lesley talking about her experiences,” Tony blogged earlier this month.
If you’ve got feedback, comments on the APP or wish to “blog” about something in this space — let me know. It’s an open forum for Type 1 diabetes, research and clinical solutions and for the people who are living and thriving with this chronic disease. We R the Cure.
Next Month: How to react positively to a bad A1c report.
My quest for the Holy Grail — wearing the closed-loop, artificial pancreas technology at UVA — hit a small speed bump on the road this week. My search results: U.S. Food and Drug Administration’s health guidelines 1, Mike Anderson clinical trial participant 0.
When it is ready, the AP Algorithm will run on any SmartPhone and fit in your pocket.
Last Monday, I made a new pilgrimage on I-64 West to Charlottesville to take my health screen, step 1 of my hoped-for-admittance into a Mother’s Day weekend outpatient trial at the UVA Center for Diabetes Technology. If I passed the screen I would be rewarded with 2 overnight stays in an economy hotel adjacent to the university and the opportunity to actually “Wear” a working prototype of the closed loop artificial pancreas technology!
At the heart of the system is a novel hand-held device developed by a UVA research team, led by Patrick Keith-Hynes, PhD, and Boris Kovatchev, PhD. The device uses a “smart” algorithm that automatically delivers insulin and regulates a person’s blood sugar levels — taking much of the burden of constant monitoring off the patient. Inside the normal looking droid phone would be the “brain,” that would be smart enough to take over my glucose management for 24 hours and achieve nearly perfect control without my assistance. In this hospital test, a “straight line” means life NOT death for Type 1 diabetics. To say I was excited to see the APP in action, would be the understatement of the year.
To make a long story fit into a blogger’s attention span, however, I did not pass the FDA-required screen because my Hematocrit came back with a score of 39.5. The FDA minimum threshold for acceptance — 40.0.
Yes, I missed it by “that” much. So, I wondered, am I sick if I couldn’t score a 40? And why is my Hematocrit costing me a date with the APP? Hematocrit is a blood test that measures the percentage of the volume of whole blood that is made up of red blood cells. This measurement depends on the number of red blood cells and the size of red blood cells. Normal results vary, but in general are as follows:
Normal value ranges vary slightly among different laboratories, and you should always consult with your doctor on lab results before making changes to diet.
When Daniel Cherñavvsky, MD, called me with my UVA lab results I could not believe it. However, this was not a score that could be “managed” or “finessed” or worked around, Dr. Danny said. The FDA requirements are in place for the health and safety of clinical trial participants like me. The “irony is,” I’ve passed this same Hematocrit screen twice before and participated safely in two clinical trials where blood was drawn continuously for 12 hours! The new outpatient AP trial is only taking blood via finger sticks, so, I’m confident I’m “Iron Man” enough for this new study.
The good news about the bad new is that the May trial is the “proof of concept,” the first of what should be many more outpatient clinical trials in the coming months at UVA and four other universities in the USA and Europe.
So, I’ve got some work to do in the coming months if I wish to qualify.
I wonder if that’s how all great explorers prepared for their quest? So check back here very soon for a real-time, live blog report of the closed-loop AP in action. The future is coming thanks to the awesome team at UVa. Together, We R the Cure.
Editor’s Note: Dr. Boris Kovatchev of the University of Virginia gave this NEWS FLASH to a sell-out crowd attending the annual JDRF Gala held March 17th at The Jefferson Hotel in Richmond. Later, Dr. Kovatchev told me that his Center for Diabetes Technology team expects to start screening potential trial participants in late April. The “outpatient” trials will be conducted in a Charlottesville area hotel located in close proximity to the UVA Medical Center. This is NOT — THE CURE. But the APP is advanced technology that will — hopefully within 3 years — be available to help Type 1D Americans achieve better glucose control, better A1cs and better health — while we ALL keep working on regeneration, autoimmune research and PREVENTION of this chronic disease! — Mike Anderson
The Center for Diabetes Technology Team at UVA is part of a worldwide Artificial Pancreas Consortium working to bring a safe and high-tech Closed Loop System to Americans with Type 1 diabetes in the next few years!
NEW YORK, March 19, 2012 — JDRF applauds the recent approval by the U.S. Food and Drug Administration (FDA) of the first outpatient artificial pancreas trial in the United States, marking a critical development in the effort by JDRF and its allies to bring this innovative and lifesaving diabetes technology to people with type 1 diabetes (T1D).
The JDRF-funded study will test an artificial pancreas (AP) system’s ability to function outside of a hospital setting, and is similar to the current outpatient trials being conducted in Europe.
The study is part of the first outpatient trials using an approach developed by the JDRF-supported Artificial Pancreas Consortium, an international research group including teams from Montpellier University Hospital (France), the Universities of Padova and Pavia (Italy), and the Universities of Virginia in Charlottesville and of California in Santa Barbara (USA).
“We commend the FDA for its leadership and this concrete step in meeting its commitment to accelerate the development of artificial pancreas systems. These technologies could truly transform the lives of those living with type 1 diabetes, enabling them to live longer and healthier lives, and preventing some of the personal and financial toll diabetes places on our nation,” said Aaron Kowalski, Ph.D., assistant vice president of treatment therapies for JDRF. “While this is a small feasibility study, this is a major step forward in the field of artificial pancreas research and we congratulate the researchers and the FDA on this important milestone.”
The approval of this milestone study follows a major 18-month long effort by JDRF and allies to ensure a clear and reasonable regulatory pathway for outpatient artificial pancreas studies, and ultimately for AP systems to be approved and made available by the FDA. JDRF-funded studies have shown improved clinical outcomes from early trials of prototype AP systems. In early 2011, JDRF proposed guidance to the FDA, based on recommendations from an external expert panel. In the following months, over 100,000 people in the diabetes community signed JDRF’s petition, and numerous leading clinical organizations, as well as over 60 Senators and 250 Representatives joined JDRF in urging FDA to act. The FDA met its promised deadline and released draft guidance for AP systems on December 1, 2011.
JDRF recently completed an evaluation of the draft FDA AP guidance, and submitted comments to FDA on March 3rd. JDRF believes that the draft contains many positive elements that will encourage research and development of artificial pancreas technologies and lead to their eventual availability in the U.S.
“While there were some areas of concern in the guidance, we have begun a dialogue with FDA about these issues, and we will continue to urge the agency to revise these in the guidance before it is finalized so that we will continue to see more outpatient trials approved, and people with diabetes will ultimately have access to these lifesaving technologies as soon as possible,” added Kowalski. JDRF’s comments can be read here.
Contact:
Joana Casas, 212.479.7560, mcasas@jdrf.org
BETHESDA, MD — Imagine my surprise and excitement when a leading Type 1 diabetes researcher, Dr. Desmond Schatz of the University of Florida, unofficially promoted our “We R The Cure” blog site during the recent JDRF Type 1 Diabetes Research Summit on Feb. 18. Let’s roll the audio tape:
Juan Dominguez-Bendala, Ph. D, of the Diabetes Research Institute, opened the JDRF Summit with a keynote presentation on "The Hope and Promise of Stem Cells and Cell Therapies." Photo courtesy of JDRF Capitol Chapter.
“We do not have enough people participating in research studies,” Dr. Schatz told several hundred Type 1D enthusiasts in his opening statements. “My goal is to give you hope, to inspire hope, and to push you to get involved. Without U, there can be no cure.” Almost on cue, an outburst of applause came from the adjacent ballroom where young children with Type 1 diabetes were playing and having fun while their parents attended the JDRF Summit.
Dr. Schatz heard the applause and laughed. “I am here to make it clear, that the status quo (in Type 1 research) is unacceptable!” And again, the children cheered right on cue.
Dr. Schatz and his audience enjoyed the perfect timing, and I cheered, too. I could not believe my “good fortune.” I knew the JDRF Summit would be a unique opportunity for education and dialogue with prominent researchers in the Type 1 diabetes field. I also knew it would be a great chance to talk with friends and allies gathered in Bethesda. However, I was NOT expecting to get a free endorsement for “We R The Cure” from one of the researchers! (Of course, I’m joking. For the record — I did not pay him; However, I did thank Dr. Schatz later for pushing for more trial participants).
In the coming days, we’ll post some specific comments and follow up observations from what we learned at the Summit. In the meantime, here’s a link to all of the Summit presentations — without any edits — from the amazing professionals and lay people who spoke at the Summit.
A special thanks to Summit Presenting Sponsor, Johnson & Johnson, and the Capitol Chapter of JDRF for putting together such an amazing and educational event for us. Thank You! Read more about the Summit from the Diabetes Online Community (DOC) on Twitter, using #jdrfsummit.
