My take on the Artificial Pancreas Project

The other night we sat in on a lecture about the Artificial Pancreas Project.  In all honesty, I have paid very little attention to this project. I heard the hub-bub when the JDRF announced that they were funding research that was not cure based.  I have seen the online petitions asking for the FDA to move the project along a lot faster. Other than that I have been fundamentally ignorant.

I have however slowly worked to educate myself whenever possible.  I had many concerns about the project and looked forward to learning and seeing if my fears were founded. Sadly I think that they are.

Dr's. Anhalt and Krishna (his first name but his last name is far too long and complex for me) explained that the project had many levels.  They were working on simply suspending insulin during a low and ultimately reaching the point where they could truly close the loop.  Their main focus at the moment was to see a viable product on the market sooner rather than later (within 4-7 years).  The bringing together of glucometers, CGM, insulin pump technology and human intelligence was a huge obstacle.  These things work fabulously apart but bringing them together brought many new issues. To make matters more complex, regulatory bodies have never before been asked to rule on the safety of medical devices that make decisions like this one will.

For me, one of the obstacles to an Artificial Pancreas as I envisioned it was the number of sites and devices that one had to carry and use.  I asked how this was to be handled.  They stated that it was a real challenge. You cannot get down to only one site (which my son would want) because you cannot deliver insulin and measure glucose levels in the same area. They would work towards one device but felt that the loop may never truly be closed.  It was also stated that artificial intelligence would not be put into the system in the foreseeable future. 

Another issue is in the fact that sensors lag behind in what they say the blood glucose level is.  Insulin lags behind in its action time.  There is no way, at the moment to get immediate results to immediate problems. We need more accurate and timely sensors as well as faster insulins. To date there is only predictions and educated guesses.  This is very concerning to me. 

Larry voiced his concerns as well. At the moment we are talking about devices "talking" to one another.  We have so many devices that we use on a regular basis, how could we be guarenteed that they would not interfere with one another? He wondered how my son could sit in his room with his cell phone, his laptop, his XBox head set, his pump, and his CGM and not have any of it interfere with each other.  We were told that this was a real concern.  At the moment they were working to secure specific radio frequencies to ensure that there would be no interference but we still had worries.

My final concern, and the concern of many others in the room was cost.  This is a huge project.  The actual dollar figures were not available but we all knew that it was way more than what we had in our pockets. Some of the cost of the project will most likely have to be recouped in sales at a later date. Would the Artificial Pancreas then be out of reach to those who need it most? 

We were assured that the JDRF in the US was working with insurance companies so that when the product did come to market, they would cover the device.  This does not help those of us in Canada.  Our system works differently and while it is important that private insurance companies are onside with this device, it is even more important that provinces recognize its value.  Who will be working on that angle? Currently we are asking our governments to cover the pieces--pumps, glucometers, CGMs and supplies.  Will they cover the Artificial Pancreas when it comes to market? We can hope.

While there are many issues to be overcome, the project does have some positive points as well.  Moving forward with sensor technology will hopefully provide us with more and better data on blood glucose trends. This data can be used to keep A1c's down and reduce the chance of complications.  These same sensors can ideally act as our watchdogs at night.  They can wake our children or ourselves when a blood glucose level is rising or dropping to a dangerous level. That is one thing that would help this mother sleep a lot easier at night. Now to just convince my son that this would be a far better system than him building me a room in his house!

Dear Government

Those of us in the Diabetes Community are quite well aware that November is Diabetes Awareness Month. For years, I have found something new and unique to do each year.  I have sent out general information letters to everyone I could think of, I created a book of the faces of diabetes with real people and their real stories, I have gotten a tattoo, and much more.  This year I decided that November was the perfect time to get back to a focus that is very dear to my heart--advocating for increased access to devices and supplies for people with diabetes.

November is a great time to do this because of course its Diabetes Awareness Month, but it is also the month after our new government formed and a time when they are beginning to plan for the spring budget.  I wanted politicians in my province to be thinking diabetes before they sat down to spend my money.  The following is the letter that I will be sending out to all Members of the House of Assembly.  If you live Newfoundland and Labrador, I would ask that you copy this letter and send it to the Minister of Health, the Finance Minister and your MHA (if you have a newly elected MHA, their contact can be found on their party websites).  I would then ask that you copy it and send it to your friends and have them do the same.  Public pressure works and we need to change this program. If you don't live in Newfoundland and Labrador, please feel free to copy this letter and tailor it to your own needs. While a cure is ideal, until it is found our loved ones deserve access to the best equipment out there to keep them alive!

November is Diabetes Awareness Month.  There are now almost 3 million Canadians living with diabetes.  Approximately 10% of those are living with Type 1 diabetes, an autoimmune disease that attacks the insulin producing cells of the body leaving the victim reliant on an external source of insulin to live.  A person without insulin is like a car without gas, their bodies cannot function and they will die.

In Newfoundland and Labrador, people living with Type 1 diabetes currently are able to receive their insulin through the best available delivery system—an insulin pump.  This small life sustaining unit allows the user to pre-program their insulin needs into a computer which will then delivers the insulin to its user at specific, minute amounts throughout the day and with meals or to combat high blood sugar levels.  When a person with Type 1 diabetes reaches 25 in this province, they must either have the financial resources to pay the extra $5500 per year for an insulin pump and supplies or go back to a less reliable method of insulin delivery through injections. We hope that soon the government of Newfoundland and Labrador will see fit to change this and join Ontario in extending its pump program coverage to all of their residents with Type 1 diabetes who do not have private health insurance regardless of age.

Despite the advances in technology and the availability of insulin pump therapy to manage Type 1 diabetes, on November 2, 2011 the American Juvenile Diabetes Research Foundation publicly noted that one in twenty people living with Type 1 diabetes will die because of a low blood glucose level (this occurs when there is too much insulin in their body and not enough sugar).  This number is unacceptable.  In a technologically advanced society such as ours it is also unnecessary.  Beyond the incredible emotional strain that this threat puts on families and people living with diabetes, such a high mortality rate also has a large financial impact in provinces such as Newfoundland and Labrador which have exceptionally high incidences of this disease. 

This number can be changed.  A cure is the most glaring way to “fix” this problem.  A cure would eliminate the need for government funding of insulin pumps and subsequent spending on diabetes related complications.  Many great organizations throughout the world, including the Diabetes Research Institute work solely on this mandate. 

Until a cure is found, another way to reduce the number of low blood glucose related deaths is to provide real access to the technology that is available which would protect all people living with diabetes.  Recent advances in pump technology offer suspended insulin delivery when a person is already low and non-responsive as well as Continuous Glucose Monitors (CGM) which “speak” to the insulin pump.  A CGM is a computerized device worn by a person with Type 1 diabetes that monitors the trends in blood glucose levels. It tells its user when they are in danger of having their blood glucose rise or fall.  These predictions help to maintain a stable blood glucose level which reduces long term complications. The alarms also help to ward off dangerous lows that will render the person with Type 1 Diabetes unresponsive or dead.

According to a 2009 Canadian Diabetes Association report on the economic costs of diabetes in Canada, the indirect cost of diabetes related illnesses and death was approximately $8 million in 2010 and another $3.1 million in direct cost. Those living with Type 1 diabetes are responsible for 40% of these costs. The funding of insulin pumps and continuous glucose monitoring can dramatically reduce this economic burden. Insulin pumps have been shown to significantly reduce hospital visits by people with diabetes. 

As November is Diabetes Awareness month, I would invite this government to learn the facts about Type 1 diabetes.   This is a silent killer that is claiming one in twenty people as its victims on a regular basis (after drafting this letter we learned of yet another young person who died because of hypoglycemia during the night of November 9^th). This number can be changed. It has to be changed.

With proper tools, education and awareness, people of all ages with Type 1 diabetes can live to be productive healthy members of our society. I would ask that you review the provincial insulin pump program and look to expand coverage to cover all people who live with Type 1 diabetes who do not have private insurance for both insulin pumps and continuous glucose monitors regardless of their age.

Sincerely;

Barb Wagstaff

(mother to a 14 year old with Type 1 diabetes, diagnosed March 2000 age 2)

Warm beds and Dead sites

Do you know those moments when you are half asleep and you cuddle right into your partner? All is right with the world. Its warm and safe.  Life is good...and then you realize that you have a child with diabetes who needs to be tested.  You fly out of your loved one's arms and hurry to get to your child's room. 

Yes, that has happened in our house...on a number of occasions. Last night I jumped away from Larry and raced out of the room. It was 4:30am and I had not woken at 3! I stumbled into my son's room and was out of sorts for a second. We had moved his furniture around the day before and he wasn't where he was supposed to be. Once I woke enough to remember the new layout of the room, I turned on his lamp, grabbed his meter and got ready to test him.

He mumbled something and I assumed he was talking in his sleep. He mumbled something again and then showed me a piece of white mush.  It was his site. He had rolled over when I came in and the site fell out.  Crap! I had to be a lot more awake for this.  I handed him the meter to test while I found the supplies for a site change.  I was pleased to see that he was only 9(160) when we tested but feared what the failed site would bring in a few hours.

Together we changed the site.  When all was said and done, my son rolled over to instantly fall back to sleep .  I stumbled back to my room in hopes of getting back to the spot where I should have been. As I crawled into bed, I felt bad for Larry and very grateful for his presence.  He had no idea what he was getting into when he became involved with a mother of a child with diabetes.  He didn't know about the crazy hours until he started living with it.  He didn't know that many times his snuggling into me would wake me at an opportune time to test my son when I would have otherwise continued to sleep. I am sure he grumbles as he goes to cuddle into me and my body slips away to another room leaving him with nothing but a warm pillow. 

On the other hand, I am very grateful for this.  This is yet another occasion when his cuddling has allowed me to catch a problem before it became dangerous.  My son seems to quickly elevate to ketones and vomiting lately with high blood glucose levels.  The 1 in 20 statistic has deepened my fear of nighttime lows.  With my second guardian angel around to help me wake at night we will beat this thing and keep my son healthy!

One in Twenty

Recently the JDRF in the US took out an ad in the New York Times and elsewhere that has generated a lot of talk amongst people living with type 1 diabetes.  It simply stated that 1 in 20 people with type 1 diabetes will die because of hypoglycemia. It was geared to speed up FDA approval on the Artificial Pancreas Project.  

The fact that people die because of hypoglycemia is not disputed.  Those who have diabetes living in their house are well aware of its dangers.  We remind our loved ones to test and be in range before driving anything from a bicycle to a motor vehicle.  We wake up multiple times throughout the night to test and make sure that our loved ones are safe. We know that diabetes is a deadly disease.

Many were shocked at the figure however--1 in 20.  Many of us have hundreds of friends with diabetes listed on Facebook.  A quick scan would mean that five of every one hundred people we know will die of hypoglycemia.  That is terrifying. It brings the worry and the desire for a cure and better treatments to a whole new level.

Is that a bad thing? Jessica Apple discussed this in her recent post.  She suggested that November not be a time of feeling good and turning things blue but asking for change to save lives.  Over the years I have taken this same approach--take no prisoners and show the down side.  Yes my son can do everything his brother can but.... and its the but that should not be there. Its the but that allows him to live. Its the "but" that we need to change.

Its a fine line however in giving your child hope and showing the world the darkness. I like the power of the JDRF ad but fear my son seeing it. While I present the dark to politician and the general public, we focus on the positives at home.  

As a parent though, when I stop, personalize the statistic and think of 20 children with Type1 diabetes including my son  and then realize that any one of them including my son will die of hypoglycemia? I just can't go there. I cannot spend more than a second on the thought. It makes me ill and shakes me to the core. My heart is crushed and I am terrified. Maybe that is not the worst thing either.

That fear motivates me to work harder.  It makes me want to spread information to a larger audience. It makes me want to focus more on ensuring access to things like pump therapy and a CGM for my son and the 19 other children (of all ages) whose lives could be saved by better technology.  It also makes me want to take a harder look at the work of the DRI and other groups who claim to be working for a cure. 

One in twenty people living with Type 1 diabetes will die because of hypoglycemia.  That stark number needs to change. We can work to prevent this. We can work to "fix it".  As a parent, I cannot fix my son's body and take diabetes away from him but I can work to fix a system that keeps lifesaving tools just out of reach.

This disease is serious.  We need to be equally serious about keeping out loved ones alive and providing everyone with access to the tools to do so. We would not deny someone who could not walk a wheelchair.  We cannot deny someone who cannot produce insulin the tools to deliver and monitor this lifesustaining liquid.

A Faulty Pancreas Lives Here

Last night I was sitting at the kitchen table with my youngest son. He was doing his math homework.  As we worked through the page, I began to get frustrated. He seemed to truly understand what he had to do but when pen went to paper the answers were just plain wrong. I had left him to do a few questions on his own.  When I came back, I saw that the answers were not correct and asked him how he came up with his responses.  He told me how he needed to figure things out.  The process was right but the results were a disaster.

We joked as we went along that he must be out of range. He was making foolish mistakes. I chalked it up to rushing through.  As we progressed 14-7 equalled 5 and I knew that there was something seriously wrong!  He looked a little pale and finally he took it upon himself to test.  He was 19(345).

"That explains it! I think its time to take a small break.  Show me some of the other homework that you have done while we wait for you to come down." I told him.

He got his other homework and a new infusion set. It turned out that his site change was due the day before. I had woke him up early that morning to change the site because he had gone up a bit overnight and I assumed the site was bad but being my son...well he didn't do it. 

Each year I talk to parents and educators about children with diabetes in schools. Each year I mention this very thing--children who are hyperglycemic are cognitively impaired.  I have seen it is effects in my son on occasions before. Each time it happens it both amazes and scares me. 

You cannot see diabetes. You cannot "see" a high--well if you know him he might look a little off but still for the most part it is invisible to the naked eye. The average person would just assume my son was not overly intelligent.  An uneducated teacher would assume he just was not getting the concept, had not paid attention or had not studied. 

Each time this happens, I see the reality.  My son cannot fix this. Yes he can change his site but highs will occur for other reasons that he cannot control. Diabetes does not play nice.  It does not show itself to the outside world.  There is no gaping hole in his stomach area to show that his pancreas has failed.  It just quietly impacts his life.  It silently attacks and as parents we must continue to work to train those around our loved ones what these attacks look like and how to handle them.  Until there is a cure, we can only educate and pray for the best.

Glucose in the bathroom

November is Diabetes Awareness month.  Many people are wearing blue on Fridays to raise awareness, Facebook pictures are appearing with blue circles posted around them, and others are gearing up for the Big Blue Test. 

Another awareness initiative that has been suggested was "30 days and 30 wishes".  The idea was to take the 30 days of November and each day publish a diabetes related wish.  The first day, I asked the question of what your wish was for day one on my Diabetes Advocacy Facebook page.  The overwhelming answer was "A Cure!" plain and simple.  That one is a given so my wish was posted in yesterday's post--that my son did not have to worry about his blood sugar before bed or know the danger of going low in his sleep.

Today's wish is that we did not have to have glucose stored all over the house and in our car.  As you can see by today's picture, my son believes in being prepared and recently has begun keeping a tube of glucose gel in the bathroom he uses to get ready for school and shower.  Now I just wish that I knew what in the world possessed him to put a tube there!

Another bump in the diabetes learning curve

My son came home from school yesterday and we talked about what he had done during the day.  He told me about having whipped cream thrown at him by little kids and showed me the treats that he had been given.  After our chat, I asked for his meter.  I looked through it and saw that once again he had not bothered to test after his breakfast.  His first test was at lunch time and he was 23 (414). I was not impressed.

"I am guessing that not only did you NOT remember to test, but you also forgot to bolus your breakfast didn't you?"

"Now Mom, would I do that?" He asked innocently as he began scrolling through his pump history.  "There is a bolus here at 7:30.  Oh wait, its just a correction. There doesn't seem to be a breakfast bolus.  Oops."

Once again I reminded him to test AND bolus.  He went off to do his thing and I was left to shake my head.  I felt a little guilty because I knew that I hadn't given him the carb count for his meal that morning but I also know that he is pretty good at knowing it on his own.  End of guilt. He messed up.

Before I went to bed that evening, I asked him what his bg level was.  I use that number as a gauge of when I should set my internal alarm clock to get up during the night. He said he was 4.1 (73).  I asked him what he was going to do about that. He said that he had had a glucose gel.  I thought that that might have been a bit much since he had eaten a snack not long ago and asked him why the gel?

He replied, "Never drive when you are under five and never sleep if you are under six!"

Well he could certainly regurgitate the information that I have given him over the years but when would he actually use a bit more of it? I responded, "Great, you can remember the rules but you can't remember to test and bolus in the morning?"

I rolled my eyes and left him to deal with his four (72) while I headed off to read.  The next morning he asked if he had been high the night before. I said that he was.  He said that it had taken him a lot of glucose to move past 4.1 so he was glad to see that at one point the sugar finally kicked in. Poor kid. What a thing to have to worry about before he could think about sleep.

The missed test and bolus in the morning didn't kill him. It could have been worse--he did correct the high before breakfast and did correct before his lunch. We still have a long ways to go but its also good to know that we are making some progress. I still wish however that my son and I did not have to have any of this knowledge--that it was not so important for him to have to learn.