Friday 20 May 2011

The Cure

How old were you the first time you found out that diabetes would be cured?

I have been diabetic for almost 25 years and having been diagnosed at the tiny age of just 4 years old, I don't fully remember when my family - who were shaken to the very core by the diagnosis - were first told about it. What I do remember is confidently telling people that diabetes was going to be cured in the next 5 years. I was 12 at the time. I am now 28. Many things have changed in my life since then and with both the benefit and burden of wisdom, there also came a point where I had to accept that ten years had passed since my cocky assertions as a 12 year old and diabetes still hadn't been cured. Maybe it never would. It was at the age of about 22 that it really began to sink in that this cure may be nothing more than a pipe dream and that the cure' that I had spouted about so self-assuredly at the age of 12, may not come in my life time. If ever.

Like many other people with the condition, I have always been aware that there is a great deal of research going on 'out there' all the time. We don't always know where, when and what about, but we know they exist. We hear talk about these projects in the newsletters we receive, the charity fundraising letters we open asking us for money and on the websites we scan. But it can feel as though we rarely see their outcomes - even if the evidence is right there in front of us, in the form of an insulin pump, slow acting insulin or blood glucose meters.

So when I recently signed up to a Diabetes Wellness Day and found out that one of the speakers was the recipient of a Pancreatic Islet Cell Transplant procedure and she was coming along to tell her story, the 12 year old inside of me started to surface, albeit cautiously and with a hint of scepticism. Last time I heard this research was going on but still not effective enough to warrant the cost, and that most people went back onto insulin with unstable sugars within months - if not weeks -of the procedure. This must mean there is good news on the horizon.

Pancreatic Islet Cell Transplantation is the process of removing healthy cells (known as the Islets of Langerhans believe it or not!) from a donor and implanting them into the liver of diabetic patients. These cells will then begin to produce insulin according to the needs of the donor. For many years this has been and still is, one of the most promising avenues being traversed in search of a cure. But this conference was the first time I had had the opportunity to meet anyone who had actually been through it and could talk about it.

I don't want to ramble on for too much longer, but to give you an idea of where Rae came from, I need to tell you a bit about her first. Rae was diagnosed with Type 1 diabetes at the age of 35, frustratingly close to the upper limit of when a person can be diagnosed with the disease. She was a healthy, fit woman with a high-powered job and fast-paced life. She had to adjust to the disease just as we have all had to, but being someone who already ate well and as a keen runner who exercised regulalry, she had a bit of a head start in incorporating some of the aspects which all diabetics need to be aware of, and the first 10 years after diagnosis passed without great incident.

But after around 10 years, Rae began to show signs of severe diabetic complications, including Retinopahty (death of the blood vessels in the eyes), Gastroparesis (spasming of the stomach causing extended periods of sickness) which in Rae's case led to numerous hospitalisations, a worryingly close call with a foot ulcer which narrowly avoided becoming an amputation and severe hypo unawareness leading to multiple and increasing episodes of hospitalisation. Rae eventually lost her driving license (which I am glad to say she got back!) and had to leave her job.

After the complications continued to worsen and the hospitalisations became more frequent, Rae was eventually told she would be a suitable candidate for a pancreatic islet transplant therapy trial taking place at Churchill Hospital in Oxford. Rae had to go through a rigorous selection procedure and had to wait a long time for the eventual donor to be found. Despite almost getting the procedure and missing out at last minute. Rae remained on the waiting list and eventually was called in for her first transplant. In total Rae had two transplant operations a few months apart.

I don't want to write too much more here because I think it is really important that you hear as much of the story from Rae as possible. But when I met Rae in March, she was insulin free and had been for several months. Her blood sugars were "better than her Doctors" in his own words, and she had suffered no hypos or hypers since the completion of her second transplant.

Rae's story has stayed with me in vivid detail since I met her and I can assure you by the end of the talk there was not a dry eye in the house, in part I believe down to the sheer appreciation and thanks you could see spilling out of Rae herself.

Here are the answers to the questions you put to Rae:

How old are you?
I am 60 years old but was 59 when I had both transplants. I was diagnosed at the age of 35 with Type 1 diabetes and have had it for 25 years.

What do they look for in a suitable candidate for Islet Cell Transplant Therapy?18-65

Had Type 1 diabetes for over 5 years

Weight within height Ratio

Not a smoker

Not a heavy drinker

Not pregnant or planning to become pregnant

Not to have been diagnosed with a serious illness such as cancer or heart disease

To be suffering from severe recurrent hypo's - requiring outside help - for at least 6 months

Development of diabetic complications e.g. retinopathy, neuropathy, gastroparesis etc

To be referred by the patient's own diabetic Consultant, who needs to complete an official referral to the Islet Cell Team at Oxford

These criteria however only form the start of the process. Following this the team decide if a potential patient is invited to Oxford to discuss the possibility of a transplant. This is only done following the receipt of extensive questionnaires and BG (blood glucose) readings and can take several months. Interviews and detailed investigations are then carried out before deciding if the potential patient is then to be placed on the waiting list.

Do you have any idea how many people are undergoing these kind of procedures?

It is quite difficult for me to answer this question with any degree of reliability. However I understand that the numbers are still quite low. I think Oxford had done approximately 20+ procedures however some recipients such as myself have undergone 2 transplants and some will need three. I am unsure if they go on number of patients or total procedures. Also Oxford through the isolation facility provide islet cells to other regional hospitals so nationwide the figure is likely to be higher. Also not all the cells are used for transplants. The website gives further information on how these cells are used.

Do you have to take any medication at all?

The answer to this is yes and is key to the maintenance of the transplant. Immediately after the transplant a dose of CAMPATH is injected into the vein. Following transplant, two main immune-suppression drugs are taken every day. In addition an anti-viral and antibiotics are prescribed for several months after the transplant. In addition any drugs taken prior to the transplant are resumed.

How do you cope with the immune-suppressants and did you have any side effects?

I did experience some side effects following the transplant, but am not sure if these were due to the procedure or the drugs. This was related to having Gastroparesis for 5 days following the transplant, and had a debilitating effect on my recovery. In addition five weeks after the first procedure I developed a chronic ear infection which required hospitalisation. However probably not related to the drugs. Additionally I did experience Diaorrhea for some time after this procedure also this was resolved.

The second side effect last several weeks following both procedures was a low white blood cell count and resulted in temporary suspension of one of my immune suppressant drugs. I am very organised in taking my medication as it is important that it is taken at strict times/doses.

Was the immune suppressants better than having diabetes?

From my perspective it seems a small price to pay for my current experience of being off insulin. However I do naturally have some concerns about the long term effects of taking these. I understand that current research has a focus on transplants in the future and could mean that these do not have to be taken and is the reason why this procedure is currently not available for children.

How did you find the donor?

This is something that as a recipient you have no control over. I understand that the current criteria takes cells from people 30 years old and under.The blood group/tissue type have to be complatible and time on the waiting list are also taken into account. However you must be available to travel to the Transplant Centre within a reasonable time. There have to be a minimum amount of harvested cells in order for the transplant to take place.

Following the transplant you are given the opportunity to write to the donor's family anonymously, and this is coordinated through the transplant coordinator. I found this very emotive but was pleased the opportunity existed to extend my appreciation.

Was it strange not taking injections? How did you feel about eating your first meal without having to inject?

I was on a Medtronic insulin pump for around 10 months prior to the transplant and did not come off it until Christmas 2010. However my doses after the second procedure was so small that I was advised to cease taking insulin. It took me ages to adjust to the habit of setting basal/bolus doses. Initially I felt not being wired to the pump really strange, especially the tasks associated with using a pump such as replacing catheters etc. The overwhelming feeling I got about not injecting before eating was really weird. Like I was forgetting to do something!!

Was it worth it?

A resounding 'Yes' to this question, however I feel appreciative of the opportunity to be a recipient. I can't help feeling emotional when I think of all the people who made this possible. All the fundraisers. The curiosity, commitment and passion of all those involved in the research, particularly the brilliant team at Churchill Hospital, Oxford led by Professor Paul Johnson. Locally my consultant Philip Coates. Of course my Donor and the generosity of their family for giving their permission for organ donation.

My own friends, family and colleagues all played major roles in supporting me through this process.

I understand however that guarantees do not, and cannot, exist regarding how long this will last and the implications for the future. It requires long term commitment to attend regular appointments and to protect and take responsibility for my own health.

However I clearly feel that most diabetics are already well-practised in being disciplined!

I hope you found this interesting and if you ever have the opportunity to hear a transplant recipient speak I would urge you to go. Rae's story truly inspired me and to be alive in the time when this is being done is truly humbling.

But it is also still important to remain realistic. These trials are still at the very early stages and remaining healthy and dedicated now will ensure that WHEN (not if) this procedure is ready for the masses, you will still have a healthy body with which to join in.

We also have to remember that the efficacy of the procedures is not yet known. We have all heard the stories about people being back on insulin after two years. It is too early to think that by next summer all of us post-diabetics will be cured for good if we get the opportunity to do this. There is still a lot to do and a lot to learn. Don't go bulk buying the maple syrup just yet!

But for people with diabetes, their parents and loved ones, this is a step forward which signals a brighter, better and healthier future for diabetics. While there is part of me that is sad that I am not someone who would be considered for a trial and while I am sure my friends and family would rejoice if I was ever put forward, I am confident in the knowledge that people like Rae are leading the way for the rest of us. It is only with the help of willing participants that these trials and the precious results they provide, that people like you and me, your child, your mother and your friend, have a twinkle of hope on the horizon.

Please share this post with your friends, family and especially with all those in 'Club D'.

People need to hear this

Monday 16 May 2011

Second time lucky - re-visiting CGM

It is no secret that I wasn't the biggest fan of CGM (Continuous Glucose Monitoring) when I first gave it a try. Don't get me wrong - the theory behind CGM is brilliant - pure genius in fact. And I hope that the person or team of people who came up with it are now being fed fresh fruit and fanned with a giant feather Cleopatra style on a beach somewhere, having retired at the age of 32. The idea, is great. But unfortunately when I tried one (the Medtronic Real-Time system) it left a fair deal to be desired. While the idea of information itself is invaluable if correct, there are several boxes CGM needs to tick in order for it to match up to the gold dust label it has acquired over the years.

For me, if I am to find a way to pay for CGM, there a 4 simple things it needs to be:

  • Reliable

  • Affordable

  • Comfortable

  • Easy

When I last tried CGM using Medtronic's Sofsensor, I found that the accuracy of the blood vs sensor readings were so wildly different that I reached new levels of blood testing madness, because I simply didn't know who or what to trust. I think on the first day I clocked up something ridiculous like 25 blood tests. If the sensor was to be believed, I was going from the brink of coma to surfing the teens several times a day. Even at best it was usually always 3mmol or so out. I also found that it got so 'confused' during periods of hypos, that I would end up turning the alarms off and letting it just get on with its melt down quietly. In fact CGM should always be used to look at trends instead of precise readings, but I experienced several episodes of moving in different directions entirely. Not particularly re-assuring for something desinged only to re-assure!

I also found that contrary to what people had claimed about wearing it for up to 21 days (!), after 6 days I would have paid Medtronic to take it back. I wanted to wear them longer because this would reduce the cost drastically. In fact I am fairly confident you could support a mild smack habit over affording CGM, if you only wear each sensor for 6 days. I wanted to wear it longer, but truth be told could have ripped it out sensor first given half the chance, because it caused so much irritation and discomfort. On top of all that the sensor left me with such sore, red and irritated blotches that it would have taken some serious work to convince people I wasn't harbouring some sort of infections disease - just what you want in bikini season!

So when Medtronic invited me to try out their new system after releasing the new 'Enlite' sensor and making some pretty big claims about the improvements, including a 69% smaller sensor, 98% of hypos detected (out-doing market leader Dexcom 7+) and being much more comfortable, I was rather excited at the prospect of giving it a go. So this weekend I was invited up to the Medtronic office in Watford (like going back to the Mother ship for some strange slightly star-struck reason) to get fitted with one of these 'magical' new sensors.

Well so far I have to say I am pretty impressed. Insertion (with the new automatic inserter) was easier and quicker than with the somewhat clumsy and fiddly predecessor. And to prove this we were encouraged to use the sensor in an area we hadn't used before. In my case, I used my 'luurrve' handles (sounds much less gross if said in an inappropriately sexual way, don't you think?!) and actually attached it without even seeing what I was doing (although with a little help from the Medtronic team).

Comfort wise, I have been wearing it over 2 days and honestly haven't really noticed it. Provided it is placed higher than your waistband (which common sense said it should be anyway) there is no rubbing to worry about. On top of this, Medtronic have added some extra adhesive material, meaning you don't need the sticky and extremely un-sexy medical Tegaderm that we were encouraged to use before (and left you looking like some sort of experiment). There is no 'flopping about' of the transmitter on the skin which bothered me so last time, and generally it feels very secure.

As for accuracy, although Medtronic only appear to have made claims about the accuracy of the hypo detection, it is actually the accuracy the rest of the time I have been impressed with. While I have still done several tests in the last two days, I have so far not proven the sensor wrong yet and there have been many times when the sensor and blood glucose have matched almost exactly (in fact 10 minutes ago my BG said 4.9 and then sensor now says 4.8.......). Bearing in mind there is a 15 minute difference between blood glucose and interstitial fluid glucose (which is what the sensor is reading), I call that pretty precise.

The biggest test for me knowing now how much the accuracy has improved, will be the longevity of wear. Unfortunately one thing Medtronic have not been able to achieve, is a lowering of the cost. In fact I believe the cost is marginally higher than in comparison to their old sensors. For the old Sofsensors with their sketchy accuracy and their trigger happy warning arrows, it just wasn't worth it. The new Enlite sensors however are vastly improved and if they can remain this comfortable even for 10 days rather than 6, this could just be something which can become manageable.

I will definitely keep you posted about amount of time I can wear it for and how reliable they remain and will let you know what my overall feeling is after the trial finishes. But for the time being at least, this previous sceptic is feeling positive.

Monday 2 May 2011

Medtronic 'Enlite' CGM sensor launch

The new 'Enlite' sensor launched in April 2011

Well, after having had a few weeks out of the 'blogosphere loop' thanks to barbecues and bank holidays requiring me to go outside and get re-acquainted with daylight, I thought it was time to clamber out of my holiday mode and tell you about the launch of Medtronic's newest product which if the marketing propaganda is correct, should see a real competitor emerge to rival the likes of Dexcom 7+.

Continuous Glucose Monitoring (CGM/CGMs) is something which many people in the Diabetic community are both excited and frustrated about. What is exciting is that CGM means diabetics could now have the tools to monitor blood sugar levels in real time, 24 hours a day without the need for constant finger pricking. It is linked to much better blood sugar control and may aid children and people needing to keep an enhanced level of control (don't we all?). The frustrating thing is the cost and lack of access on the NHS unless you fight a gruelling battle and have a super-supportive diabetes team (harder to come by than you would think).

But regardless of how difficult it can be to secure, CGM is the most promising tool we currently have on the horizon in order to keep diabetic complications and the endless grind at bay. It is also going to be utilised in the 'closed-loop' system which we so often now hear being discussed, which will incorporate an insulin pump and CGM in order to manage blood sugar levels 'automatically'. That is, CGM senses sugars are going up, pump releases more insulin. CGM senses sugars going down, pump is suspended until sugars rise. Simple. We hope.

Medtronic's sensor, which has been around since the dawn of CGM and was in fact (as I understand it) the first sensor produced fit for patient use, has been replaced with the new Medtronic Enlite sensor in Europe after gaining the required CE mark. It appears a very similar device to the previous version, but with some significant (claimed) improvements. Medtronic state the device now boasts a much smaller sensor (69% smaller no less), greatly improved accuracy (over 98% of hypos detected) and a much better system for securing the sensor to the skin. For anyone who has worn a Medtronic CGM sensor, you will know that it never felt particularly well affixed to the skin and required layers upon layers of cling-film style Tegaderm to keep it from 'flopping about' on the skin. As well as the smaller sensor offering hope that the site of insertion may now be less irritated after a few days (as I found during my trial), the improved fixing should offer a much more comfortable, reliable and precise system.

The system also now has a much improved insertion device similar to the way the Quick-sert system works, if you have ever used one. This means putting the thing in no longer means the navigation of oregami style tabs and flaps which the old system involved, which usually meant if you pulled the wrong tab, the whole thing was a sticky mess of flaps to un-flap!

On the 14th of May I will be trialling this CGM for a month and, seeing as I wasn't overwhelmed with the results of the two-week trial I underwent last year, it will be interesting to know whether the sensor is indeed more comfortable than it's predecessor. If it is, the long term goal would be to wear the sensor for longer stints in the hope that the cost of the system would be lowered. As with the previous systems, the CGM will speak to my pump meaning no need for extra hand held diabetic paraphernalia, which as any diabetic knows can grow at an alarming rate. Likewise this also means that I can view my blood sugars at the touch of a pump-button, and can set the pump to alarm when I am approaching the upper and lower limits of my acceptable range, meaning less nasty 4am surprises!

I will definitely keep you updated and will let you know if - as with last time - I am ready to rip the sensor out by the 7th day. Something I hope the improved, smaller and more streamlined design will solve.