Tag Archives: artificial pancreas

How Much Longer Before An Artificial Pancreas Is Available To All? More Questions Than Answers

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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.

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.

  1. Dr. Boris said he’s having ongoing talks with insulin pump companies, smartphone technology providers and other manufacturers. His message is: the AP worldwide consortium needs better high tech equipment — to get the AP prototype to the finish line faster. If the human clinical trials continue to meet and surpass expectations, there is an expectation that manufacturers will remain fully engaged.
  2. Attachments. I was wearing a 3 ring circus of “stuff” during my AP clinical trial: A) basic Tandem t:slim insulin pump, B) Two, yes 2, Dexcom 4 CGMs, and C) A Sony droid smartphone and CGM receiver with a “brain” — an algorithm designed to react to my blood sugar readings every 5 minutes and make adjustments if needed to keep my levels as close to ” a control or flat line” reading. Being a human pin cushion is the downside of participating in a diabetes human clinical trial. In the future, the technology must evolve so Type 1 Ds will feel more like ” IRON MAN ” — wearing the coolest technology — and less like ” FRANKENSTEIN” with bolts in my neck.  Despite the tubing, monitors and fanny pack, I did not look like the patients who wore their insulin pump strapped to their back like a Jet Pack in the early days of diabetes research.
  3. Attachments, Part 2. The good news is : The smartphone and CGM  technology is working and all happens via Wi-Fi and Bluetooth. Very Cool. Very Exciting. You can carry it with you and walk without an IV or extension cord when you go out for lunch and dinner.  I felt kinda like a lab rat walking free. That is what the AP offers Type 1′s –  a dose of freedom from diabetes management.
  4. The new power/hardware design appeared to work well in my trial. Next step for the UVA team: Repeat the software and hardware clinical trials performed at UVA at the University of California at Santa Barbara in May with 5 participants. If it works well there then the next step is to take the AP prototype to the consortium partners in France and Italy and repeat the same trials overseas.
  5. Gather the research evidence from all of the 2013 trials and present it to the FDA and others who are involved in the AP project. Report the findings and set up the 2014 human clinical trial test agenda:  AP home trials. Yes, home trials with remote 24/7 monitoring of patients who are wearing the AP prototype as they go about their normal daily routines ” OUTSIDE ” of the research hospital settings.
  6. Finally, as I was wearing the AP for 24 hours — Dr. Boris and his research team was montoring my glucouse control from the hotel room adjoining my room, or from their UVA office on Main Street or — better yet — from their laptop while sitting in the Atlanta airport waiting for a flight back to Charlottesville. The device is capable of 24/7 remote monitoring access. Amazing.

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

Artificial Pancrease SmartPhone

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.

Another Eyewitness Testimony; Lesley Berchtold Tells About Her UVA APP Trial — She Is the Cure, Too!

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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.

Artificial Pancreas Mobile Technology

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.

Hematocrit-ically Incorrect: My Quest Continues For The Diabetes Holy Grail — The Closed Loop AP

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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.

Artificial Pancreas Inside SmartPhone Prototype

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:

  • Male: 40.7 – 50.3%
  • Female: 36.1 – 44.3%

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.

  • Eat more red meat. Eat more leafy green vegetables.
  • Check with my Endo and start taking a low-dose, slow release iron supplement once a day.
  • Exercise as much as possible, drinks lots of water and get more rest.

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.

FDA Grants Approval For First Outpatient Artificial Pancreas Trials In The USA; A Long Overdue Step Forward!

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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

UVA Researchers Start Outpatient AP Closed Loop Human Trials

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

Behind The Scenes Of A Closed Loop AP Clinical Trial; Guest Blogger Abby Bayer Shares Her Personal Story

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Abby Bayer and I have never met, but we have a lot in common. We’re both PWDs, DOCs and T1Ds. Say what?

Abby Bayer smiles during her Closed Loop AP clinical trial in Boston last December.

As I enter my second month as the “CEO and Chief-Bottle-Washer” at We R the Cure.com, I am now a new member of the Diabetes Online Community (DOC), basically a growing family of advocates and social media amateurs who blog, share personal stories and strive to help themselves and other PWDs ( Persons With Diabetes) — not MWDs (Mice With Diabetes). In the DOC, connecting with fellow T1Ds who are traveling the same “highs and lows” road is the “Glue-cose” that holds us all together. Forgive me, I couldn’t resist the corny joke.

Anyhow, back to my new friend, Abby. She recently blogged a two-part series on her participation in an Artificial Pancreas Closed Loop Clinical Trial in Boston. Abby is a Cure Seeker. She is giving her time, her talent and — her blood — in search of real solutions. That’s why I started this blog — to showcase the Cure Seekers and report on the human clinical trials that need more humans, according to Dr. Desmond Schatz, Medical Director of the Diabetes Center of Excellence at the University of Florida.  Together, We R the Cure, but we need more trial participants like Abby.

Read Abby’s two-part story on the SixUntilMe blog. You Rock Abby!

Editor’s Note: My sincere thanks and appreciation go to Abby and Kerri Morrone Sparling, the founder/editor of SixUntilMe — the amazingly awesome blog for Type 1Ds and the people who know us and love us. Thanks for giving me permission to share SUM editorial content on my blog!  Ironically, Abby and I were both diagnosed with Type 1 diabetes in 1998.

Next Post — We R the Cure bloggers will report on the news coming from the JDRF Research Summit held Feb. 18 in Bethesda, MD. Here’s a hint: Dr. Schatz wants to cure humans with T1D not just mice.

U.Va.’s Artificial Pancreas Trials Producing “Real-World” Success for Diabetes Patients

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The development of an artificial pancreas is coming. This year, U.Va. researchers expect to begin a new phase of human clinical trials testing the closed-loop system outside of a hospital setting. A test in the real world with real Type 1D people like me.

The UVA Artificial Pancreas Research Team

A blurry photo of a very "sharp" group of docs. Dr. Boris Kovatchev, center-right, Director of U.Va.'s Center for Diabetes Technology, and members of the Artificial Pancreas research team, gather with me in the summer of 2010. These are my favorite Wahoos!

This past December I was driving to Charlottesville for a new health screening,  tied to my third clinical trial in the AP research project, when I got the classic “Good News, Bad News” phone call from U.Va. The Bad News: My new trial — “Pramlintide Combined with Model Predictive Control Algorithm” with Open and Closed Loop randomization — was being postponed. I would not be needed today.

The Good News: Successful AP clinical trials in outpatient settings in Europe were paving the way for next step trials in the United States! So instead of wasting my blood, sweat and tears in another inpatient trial,  I am on the short list — fingers and toes are still crossed –  of participants who will participate in unique, closely monitored trials using the Droid-like artificial pancreas device! (Hit the link below to read article and hear audio interview with U.Va.’s lead researcher Dr. Boris Kovatchev, courtesy of U.Va’s Health System News Service.)

These studies are the next critical step in ensuring that an artificial pancreas is safe and effective for all patients and will meet all FDA requirements. More than 300 Members of Congress, including Virginia Senators Mark Warner and Jim Webb, and organizations representing 6,000 clinical endocrinologists, and thousands of academic researchers and medical professionals urged the FDA to move forward at the end of 2011.

Hopefully, we’re now on a faster track that leads to rapid commercial development of the real deal — not just a fancy laboratory device. It’s time to climb the next mountain. And soon, very soon, the more than 3 million Americans who are living and coping with this chronic disease — and cheating destiny daily — will be able to show off their digital life-saving AP devices and say, “Diabetes, There’s an App for that!”

U.Va.’s Artificial Pancreas a Real-World Success for Diabetes Patients.

Discovery of Insulin: It’s not a cure, but it sure beats death

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This blog is dedicated to a future of high tech products, better treatment solutions and, one day, real cures for persons living with autoimmune disorders like Type 1 diabetes. Before we can look forward, we need to stop and pay our respect to two Canadians and their laboratory dogs!

This month marks the 90th anniversary of the discovery of insulin by Canadian scientists Fred Banting and Charles Best.

As a person with Type 1 diabetes, I owe these men and many other scientists my life. Actually, about 4 million people living today are in debt to these trailblazers.

Fred Banting and Charles Best Discover Insulin

Canadian Scientists Fred Banting and Charles Best Discovered Insulin in 1922. Photo courtesy University of Toronto.

Although it is true — Insulin is not a cure for Type 1 diabetes — imagine the starvation deaths  suffered before the discovery of insulin in 1922. In fact, my favorite diabetes book, “Cheating Destiny,” writer James S. Hirsch tells the horror stories of children and adults living a “disgusting and painful” death from diabetes. In the early 1900s, doctors knew that sugar worsened the condition of diabetic patients and that the most effective treatment was to put the patients on very strict diets where sugar intake was limited.  At best, this treatment would buy patients a few extra years, but it never saved them. In some cases, the diets even caused patients to die of starvation.

“The Greek physician Aretaeus of Cappadocia offered the first accurate account of diabetes in the first century A.D., noting the distinctively gruesome fashion in which some patients withered away. He called their demise, the ‘melting down of the flesh and limbs into urine. Life is disgusting and painful.’ Diabetes’ signature symptom was polyuria or excessive urine. When blood sugar levels rise, the body draws water from its tissues to purge the sugar through its urine.”

This is why children and adults may lose 50% or more of their body weight in the initial weeks of the autoimmune disorder hitting. Your body is, basically, releasing excess sugar AND the food you need to stay alive. In my case, I lost 16-17 pounds in about 4 to 6 weeks before I finally dragged myself to Dr. G. V. Puster for my diagnosis! I made many rushed trips — running at full speed — to get to a bath room. And hoping that I would not wet my pants. It was a hit-or-miss race. Ugh. Fun times.

So, let’s celebrate the discovery of insulin. One of the most revolutionary moments in medicine. Though it took some time to work out proper dosages and to develop manufacturing processes to make enough insulin of consistent strength and purity, the introduction of insulin seemed literally like a miracle. One year the disease was an automatic death sentence; the next, people — even children — had hopes of living full and productive lives even with the disease. Wellcome's insulin Ad in 1923

Now, we stand on the water’s edge. Waiting for the next miracle. If you want to participate in miracles, then you need to get involved in a human clinical trial. Miracles like the artificial pancreas, beta cell regeneration and smart insulin are sitting on the horizon. So don’t wait on the shoreline. Jump in. Become a “research dog.”

Coming up next week, I’ll post details on how to find and enroll in a clinical trial.

Prototype AP “Apps” In Action @ UVA

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A Droid Cell Phone -- Running AP system with Red, Yellow, Green Traffic Lights

Dr. Patrick Keith-Hynes (University of Virginia, Charlottesville, VA) and Dr. Claudio Cobelli (University of Padova, Padova, Italy) led the first of two artificial pancreas demonstrations at the 2011 Diabetes Technology Conference*. Their research team has developed a way to wirelessly connect a Dexcom Seven Plus CGM, an Insulet OmniPod pump, and an Android cell phone application that runs the system. (We note that the system is still a prototype and is designed for research, not commercial use. Still, it was cool to see, and it helped us get a sense of what upcoming commercialized devices might look like).

The home screen of the UVA research app features a traffic light icon that shows people whether their glucose is in the target range (green light), slightly too high or low (yellow light), or in more dangerous territory (red light) – a quick, intuitive, and cool-sounding way for someone to get a sense of things with one look at the phone. People can also tell the system when they are about to start exercising and they can manually dial in mealtime boluses (this is an example of a hybrid artificial pancreas, which provides automated basal glucose control but still requires mealtime dosing of insulin).

On a positive note, the system is designed to work with a variety of different insulin pumps, CGM sensors, or software algorithms. Thus it can be widely used by researchers around the world. So far the system has been tested twice outside the hospital, once in Italy and once in France, and overall it performed well both times.

Article Reprinted from DiaTribe Blog Dec. 2011 following annual technology conference in San Francisco, CA.

Hello World! Cures Needed For Auto Immune Diseases

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Yes, my “unemployed” pancreas and I are headed back to the University of Virginia in 2012 to participate in the Artificial Pancreas human clinical trials supported by the National Institutes of Health (NIH). Since we’re both sitting around and not working today, it seems like we ought to get active again and donate our parts to science.

Soon I will go to Charlottesville for my health screening and prepare for my hospital admittance. I will let you know when I go back in. I will be in the hospital for about 24 hours — two or three separate overnight visits. I am really excited about participating in Phase III of the landmark trial. We can’t get an artificial pancreas or the technology to market without some human guinea pigs. That’s me. Oink, Oink.

This blog is dedicated to the patients, doctors, nurses, researchers and big thinkers who are actively pushing research forward – in our search for solutions & cures for persons living with auto immune diseases such as type 1 diabetes and certain forms of cancer — such as liver cancer — that are tied indirectly to weakened immune systems or a virus attack. If you’re ready to learn more or join a clinical trial, check back here often for news and information. Or simply click on Clinical Trials to get started.

What is a clinical trial?

Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. ClinicalTrials.gov includes both interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.

Why participate in a clinical trial?

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.