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?”
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.
News We Can Use, March 4 via PRNewsWire
When it is ready, the AP Algorithm will run on any SmartPhone and fit in your pocket.
– LifeScan, Inc. announced today that the OneTouch® Verio®Sync Blood Glucose Monitoring System has received clearance from the US Food & Drug Administration (FDA). It is the first meter to automatically send blood glucose results wirelessly via Bluetooth technology to an iPhone, iPad or iPod touch using the OneTouch® Reveal™ mobile app.
“For so many people, their iPhone, iPad or iPod touch have become a tool of choice to help organize and take charge of their daily lives,” said Ty Lee , Vice President of Marketing, representing the products of LifeScan, Inc. & Animas Corp. “For people with diabetes, the new OneTouch® Verio®Sync System will enable them to use their iOS device to view and share their blood glucose results wirelessly, in much the same way they rely on them in other areas of their lives.”
Through the OneTouch® Reveal™ mobile app, users will be able to view a variety of personalized information directly on their iPhone, iPad or iPod touch including a 14-day summary of blood sugar test results, simple visuals showing the percentage of test results within target range, and then share that information via email or text with their care providers, family or friends.
People with diabetes interested in learning more are encouraged to visit www.OneTouch.com where they can sign up to receive email updates on availability and special introductory offers for the OneTouch® Verio®Sync System.
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
November is National Marrow Awareness Month, and it’s the perfect time for you to consider becoming a donor. Volunteers are needed to become marrow donors and to join the National Marrow Donor Registry.
VCU Massey Cancer Center
Research at VCU Massey Cancer Center in Richmond is discovering new therapies for blood cancers, including vast improvements in the bone marrow transplant process that have led to safer transplants and have made transplants possible for more patients.
Patients with diseases such as hematologic malignancies (blood cancers) like leukemias, lymphomas and multiple myeloma sometimes need a bone marrow transplant (BMT). Bone marrow is the spongy material that is found inside the bones. In the marrow are stem cells. In some transplants, the patient’s own stem cells are harvested (removed from the blood) and given back to the patient after the patient receives high doses of chemotherapy and occasionally radiation therapy. In other cases, however, the patient needs to have a donor provide the stem cells. The donor can be a relative (related donor) or someone unknown to the patient (unrelated donor).
Seventy percent of bone marrow patients do not have a matching donor in their family. So the more volunteers in the Registry, the greater the chance of finding a matching donor, and the more patients who can be offered the potential for longer, healthier lives.
Article content courtesy of VCU Massey Cancer Center
This is a cool idea! Zip the Cure is a unique fundraising opportunity through JDRF for the ultimate reward: a cure for type 1 diabetes (T1D) and its complications. Originally created by 17-year-old Monica Oxenreiter from Pittsburgh, PA, Zip the Cure (ZTC) allows you to “sponsor” a zip code in the U.S. for just $50. The money goes to JDRF to fund type 1 diabetes research to cure, treat, and prevent T1D.
Here’s how it works:
• To sponsor a zip code go to zipthecure.com and use the search to find your zip code. If it’s already sponsored, you can choose another one close to you, or maybe the zip code of your child’s school; where you were born, or where your grandparents or relative lives. You can sponsor any zip code anywhere you desire!
• Each zip code costs $50 to sponsor. Imagine if we sponsored all the zip codes in the United States – that would be more than $2 million to support JDRF!
• There is no limit to the number of zip codes you can sponsor.
• You can name your sponsored zip code in honor of someone, in memory of a loved one or for yourself.
• You will “own” your zip code through the end of the calendar year. On January 1st, the map resets.
Let’s try and sponsor all the zip codes in our area. For any questions please visit zipthecure.com.
Diabetes Hands Foundation Announces Winners Seeds Micro-Grant
DHF announced August 1 the nine innovative diabetes advocacy projects selected to receive DHF Seeds grant funding for 2012. Each of these projects, aimed at connecting, educating or empowering people touched by diabetes, will receive US$2000.
“Our goal is to support promising projects and help advocates through grants that assist them in taking their projects to the next level,” explains Manny Hernandez, president and founder of the Diabetes Hands Foundation. Here is a complete list of the recipients of the 2012 DHF Seeds grant.
Category: Connect
College Diabetes Network Chapter Toolkit
CollegeDiabetesNetwork.org
The College Diabetes Network (CDN) is a student-led network aimed at empowering college students with Type 1 diabetes through peer support and access to information. CDN will use the grant to help build chapters faster and more effectivley on 45 campuses nationwide by publishing and distributing a hands-on chapter leadership toolkit.
World Diabetes Day Postcard Exchange
www.wddpe.com
Led by diabetes advocate, blogger, and art therapist Lee Ann Thill, the World Diabetes Day Postcard Exchange marks World Diabetes Day (November 14th) by coordinating the exchange of homemade postcards that promote healing through creativity, connection, and activism. The DHF Seeds grant will be used to underwrite the work and supplies needed to manage this international event.
You Can Do This Project
YouCanDoThisProject.com
Created by diabetes advocate, blogger, and cartoonist Kim Vlasnik, You Can Do This has, to-date, broadcast videos from over 90 people. Each person tells his or her own diabetes story and encourages others living with diabetes that they too “Can Do This.” The DHF Seeds grant will be used to broaden participation in this ongoing online project that connects people touched by diabetes.
Category: Educate
Drinking with Diabetes
www.YDMV.net and www.theBetesNOW.com
The Drinking with Diabetes guide is aimed at fostering healthful choices and a dialog about alcohol and diabetes between students and their families. This guide will discuss the health implications of drinking alcohol for college students living with diabetes. And it will help students make better choices. The DHF Seeds grant will be used to support the production and distribution of this guide.
LIFT – Levántate!
www.LiftForTeens.org
LIFT – Levántate! is focused on engaging low-income and at-risk youth and adults in managing diabetes with diet and exercise. The DHF Seeds grant will be used to extend bilingual family support for people with diabetes in low-income communities.
The Sweet Lowdown – Broom Street Theater
BSTOnline.org
The Sweet Lowdown, a live theater production, will use music and dance to demonstrate the science of how diabetes works and as a powerful way to educate people and destroy myths about diabetes. The DHF Seeds grant will be used to develop and produce this play at the nation’s oldest thriving experimental community theater—The Broom Street Theater in Madison, WI.
Category: Empower
Riding on Insulin, UK
www.RidingOnInsulin.org
Led by pro-snowboarder Sean Busby, who lives with Type 1 diabetes, Riding on Insulin camps teach snow skills and diabetes management to children and teens living with Type 1. The experience shows families that anything is possible—even with diabetes. The DHF Seeds grant will support conducting a Riding on Insulin camp at an indoor snow-site in London, expanding the reach of this successful camp program.
Rumor Mill
OurWisdomShared.org
Rumor Mill will be a graphic novel aimed at inspiring and informing teens living with Type 1 diabetes. The plot explores how a teen can respond constructively when the very action he must take to maintain his health (i.e., injecting insulin) is misunderstood, mislabeled, and become grist for the rumor mill. The DHF Seeds grant will support the writing, production, and distribution of this graphic novel.
Sweat-Betes
www.Living-In-Progress.com
Developed by Ginger Vieira, a Certified ISSA Personal Trainer, Certified Cognitive Coach, and diabetes blogger, Sweat-Betes will be a series of exercise videos aimed at people living with diabetes. These videos, developed for people with beginner-to-intermediate levels of fitness, will present sound, medically-based instruction and information on how a person with diabetes can exercise safely. The DHF Seeds grant will support the production of this specialized series of exercise videos.
You can view the submission videos for all of these funded projects at https://vimeo.com/channels/2012dhfseeds
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.
Until yesterday, I had never heard of the JDCA, the Juvenile Diabetes Cure Alliance, in my 14 years of living with Type 1D and volunteering in my local diabetes community.
Chris Schutt, his son, Ned, American Idol Singer Elliott Yamin and I advocate for sustained federal research funds with U.S. Rep. Eric Cantor, R-VA, in 2009.
Now I have. This month, the JDCA has introduced its latest report , “Is Type 1 Cure Research Funding Focused Enough?”
The report takes a look at a very important issue relating to cure research. Are the organizations being too broad when it comes to outlining plans for a type 1 diabetes cure and when funding projects? Based on JDCA’s research and the fact that there is no cure on the horizon, the non-profit’s analysis suggests that this is the case. The JDCA report says, “Without clearly defined goals, the non-profits are funding a wide array of research projects. As a result, a lot of money goes into efforts that are not working to deliver a Practical Cure for type 1 diabetes. This diverts resources from those projects that are working towards a specified cure goal that could help people now living with the disease.”
If you’re living with this chronic disease, you wanted a cure YESTERDAY. It’s been over 40 years since a group of parents founded the JDRF at their kitchen table and yet We R still seeking a Cure.
In order to improve the quality of life for Type 1Ds, it’s important to listen and gather as much relevant information as possible. We must keep asking the researchers, organizations and manufacturers “When?” When we will see real progress. We must push them to be smarter and more targeted with a limited amount of dollars because We R the Cure. We R doing this for ourselves and the generations to come.
The JDCA is a self-funded non-profit that aims to educate donors and prompt transparency in the charitable organizations that raise money to support research. JDCA says it is an independent analyst of the type 1 diabetes charitable universe and brings a business-like perspective to focus research toward a Practical Cure. Their mission is to direct donor contributions to the charitable organizations that are most effective at allocating funds to research opportunities that maximize chances of curing type 1 diabetes by 2025.
