INSULIN DEPENDENT
DIABETES TRUST
October 2006 NEWSLETTER
MORE ‘HUMAN’ INSULINS TO GO - BUT DOES MODERN MEAN
BEST?
In August, Novo Nordisk announced yet
further discontinuations of their ‘human’ insulin range, this time they
estimate that this will affect 16,000 people. In a letter to IDDT, Novo Nordisk
send their apologies for the inconvenience that it may cause people, so I pass
this on to you.
Inconvenience!
‘Inconvenience’ is used with every
discontinuation the company makes but what a word to use! It’s inconvenient if
I run out of milk, it’s inconvenient if the postman’s late delivering, it’s
inconvenient if my computer crashes. But 'inconvenience'
grossly underestimates what is involved for the people who are affected –
looking at that remaining choices; once chosen, more blood glucose testing
during the changeover period; learning about the peaks and duration of action
of new insulin and how it affects you as an individual; perhaps a change in
regime from two injections to four injections a day, especially with the
removal of pre-mixed insulins.
Only someone without diabetes could
describe changing insulin as an 'inconvenience' but as a marketing word to
health professionals for Novo Nordisk's policy, it’s a good word! Health
professionals will be inconvenienced by having to change the insulins of 16,000
people. For people who are happy and managing their diabetes satisfactorily,
any change of their insulin type is unnecessary
- a bad marketing word, not used in relation to insulin discontinuations! It
may be necessary for Novo Nordisk to maximise their profits by insulin
discontinuations but for people with diabetes, such changes are unnecessary and
an unwelcome disruption in their lives.
Change
for commercial reasons, not clinical reasons
Yet again we are witnessing a treatment
change that is being made for commercial reasons and not for clinical reasons.
Yet again 16000 people are having their insulin changed not because they and
their doctors have decided that it is best treatment for them but because a
pharmaceutical company has decided it is in the best interests for their
shareholders. It is a policy that further reduces patient, doctor and
prescribing nurse choice and from this perspective, it is a policy that is
indefensible. From a wider perspective and equally indefensible, it means that
the pharmaceutical industry is dictating treatments - not patient need, not
evidence of benefit and not doctors' experience and knowledge.
Belief
is not the evidence we need
But Novo Nordisk’s defence appears to be
that the ‘human’ insulins are being discontinued in favour of ‘modern’ insulin preparations that the
company 'believes' are best for
patients. Dear me – this really does insult our intelligence! Since when has
‘modern’ automatically meant better? The ‘modern’ drug for arthritis was Vioxx
and how many unnecessary heart attacks and deaths did that cause? Simply
calling a drug ‘modern’ does not mean it is the best treatment or even that it
is safe – evidence of superiority and both short and long-term safety is
what we need.
Novo
Nordisk says that it ‘believes’ that
insulin analogues are best for patients but belief
is not good enough – we need evidence
of what is best for patients! At one time it was believed that the world was
flat but the evidence proved otherwise and it is unacceptable in the 21st
century the word ‘belief’ is applied to medicines and treatment choices!
Treatment must be based on evidence of benefit, not beliefs or assumptions of
benefit. To health professionals Novo Nordisk's explanation for these latest
discontinuations on their website is that 'current treatment trends supported
by clinical evidence indicate that analogue insulin is now a preferred option
to human insulins'. But all this actually says is that analogues are prescribed
more frequently but not that the evidence is that they are better than the
alternatives. Indeed, even the reference the company quotes only concludes that
overall control was similar in people with Type 1 and Type 2 diabetes when
comparing pre-mixed analogue with premixed 'human' insulins. Note - not better,
just similar. [Diabetic Med, 2002, 19, 393-399]
Further
reduction of patient choice
While we cannot doubt Novo Nordisk’s belief
in their latest products, it is difficult to accept that they also truly
believe that reducing choice is best for patients! But it appears that they do
as it has been made clear to IDDT that they intend that their range of insulins
will be analogues only. This means eventually all 'human' insulins will be
discontinued. While this is their choice and their right, it is a policy that
ignores patient need, patient choice and even patient safety. What happens to
people who have adverse reactions to insulin analogues?
The easy and short-term answer for patients
is to use 'human' insulin made by other companies but in the longer term, it
really is not that simple. There are only 3 major suppliers of insulin in the
world and all three seem to function as if joined at the hip – all going in the
same direction, the analogue route. In the
Will
the marketing techniques work again?
Twenty years ago marketing techniques
managed to sell 'human' insulins to the medical profession without any evidence
of benefit, just assumptions, and 84% of the diabetic community were
transferred to it for no clinical reason. And here we go again, this time the
'human' insulins that we were told were so wonderful 20 years ago, are being
discontinued for 'modern' insulins, the analogues!
Have lessons been learnt? It appears not.
Will the marketing techniques work again? Will Novo Nordisk's belief that their modern insulins are best for patients, be sufficient to sell
analogues to the medical and nursing professionals who prescribe them? Being
realistic, the answer is, yes probably. This time will diabetes organisations
put people with diabetes first and fight for them to keep choices available, to
have insulins to suit all their differing needs and to have insulins which have
evidence of long-term safety? Will they
stand up to defend the health and wellbeing of people who require insulin both
now and in the future? IDDT will. IDDT has always believed that people should
have the insulin that suits them best and to achieve this, 'human', analogues
and animal insulins must remain available and we cannot allow the power and
influence of the pharmaceutical industry to dictate our treatment.
Doing nothing is not an option and IDDT
welcomes the support of anyone who wishes to add weight to our call for insulin
treatment to be prescribed by health professionals in conjunction with patients
and not dictated by industry.
SO
WHICH INSULINS ARE GOING THIS TIME AND WHEN?
Novo
Nordisk has stated that the following 'human' insulins are to be discontinued
and will not be available after December 2007 [and they could run out before]:
·
Mixtard 10 3ml
penfill cartridges
·
Mixtard 20 3ml
penfill cartridges
·
Mixtard 40 3ml
penfill cartridges
·
Mixtard 50 3ml
penfill cartridges
·
Velosulin 10ml vial
There
is no direct equivalent to these insulins and Novo Nordisk advise that the
following are the closest available insulin options:
Novo Nordisk
alternative products
·
MovoMix
30 Flexpen - analogue
·
NovoMix
30 Penfill - analogue
·
Mixtard
30 Penfill - 'human'
Non Novo Nordisk alternative products
·
Humulin
M3 [Lilly] - 'human'
·
Humalog
Mix 25 [Lilly] - analogue
·
Insuman
Comb 15, 25 or 50 [Sanofi-Aventis] - 'human'
·
Hypurin
Porcine 30/70 Mix [Wockhardt] - animal
But some are not
that close an alternative, so which one do you choose?
Your
health professional will have a support package from Novo Nordisk which
includes estimated numbers of people in each area affected by this
discontinuation, a standard letter to be sent to these patients and all the
above information. Health professionals should also have a copy of MIMs that
clearly shows the actions of all insulins - the peaks and duration of action
and these can be compared with the insulins that are being discontinued. It
shows the following:
·
Humalog
Mix 25 and NovoMix 30 both have a peak of action that starts much sooner and
lasts for a significantly shorter time.
·
The
peak of action of Humulin 3 starts much sooner and lasts longer.
·
The
peaks of action of all the Insuman Comb insulins are much shorter than the
Mixtard insulins being discontinued.
·
Mixtard
30 [human] and Hypurin Porcine 30/70 have the nearest and very similar action
profiles both in term of duration and peak of action.
So if the latest
discontinuations affect you, then your health professional should give you all
this information to provide you with an informed choice of insulins so discuss
your options with your health professional and decide on the best insulins for
you.
AVAILABILITY OF DIABETES PRODUCTS
Finding
products to help you manage your diabetes can seem like a search for a needle
in a haystack! Medical Shop is a Mail
Order service - you can buy products to help manage your diabetes as well as
travel products and other health products.
Products
include lancing devices, First Aid kits, small sharps bins, skin care products,
pill containers cases and cool wallets for carrying diabetes supplies and more…
A
Free copy of their catalogue is available or orders can be placed by telephone,
by mail order, or online:
Freephone 0800 731
6959, Medical Shop, Freepost OF1727,
"MY CLINIC
IS REFUSING TO ALLOW ME TO TRY ANIMAL INSULIN". What does NICE say?
This is something we hear all too often on
the IDDT phone line! Don't misunderstand, we want to hear from you but it is
the statement itself that we wish we didn't hear. As we know, there are no good
reasons for refusing animal insulin but there are wider implications. Firstly,
the clinic is not following the National Institute for Health and Clinical
Excellence [NICE] guidance on patient education [implementation Jan 2006] which
entitles you to an informed choice of insulin. Secondly and perhaps more
importantly, there are no NICE guidelines that recommend any particular type of
insulin for people with Type 1 or Type 2 diabetes which of course means that
there are no NICE guidelines that say animal insulin should not be used!
NICE
guidelines for Type 1 diabetes state:
Prescribe the type of insulin that allow
people optimum well-being.
·
Use
multiple insulin injection regimens in adults who prefer them in an integrated
package with education, food, skills training and appropriate self-monitoring.
·
Advise
twice daily insulin regimens [often bi-phasic pre-mixes: analogues in those
prone hypoglycaemia at night] for those who want them, who find adherence to
lunchtime insulin injections difficult, those with learning difficulties who
may require assistance.
NICE
guidelines for Type 2 diabetes state:
Insulin maybe used to help control your
blood glucose level if other medicines have not brought your HbA1c down to your
target. Your doctor will talk to you about the different types of insulin that
are available and when they should be taken so that you can agree on the one
that will suit you best.
Are
there guidelines that say that animal insulins should not be used? NO!
In
fact, NICE guidelines do not make any specific recommendations about the type
of insulin to be used. Indeed, NICE clearly emphasises that the needs and
wishes of the patient with the use of phrases such as 'in adults who prefer them', 'for
those who want them' and 'so that you
can agree on the one that will suit you best'.
Nowhere
does NICE state that animal insulin should not be used. The only insulins to
which that NICE says NO are long-acting insulin analogues in people with Type 2
diabetes, except under special circumstances.
What
can we conclude?
·
The
key recommendation is that the insulin used should be the ones that will allow
patients the optimum 'well-being'. The dictionary definition of well-being is
"a contented state". So for whatever reason, if you are more
'content' using animal insulin, then you will be using the insulin that
provides you with optimum well-being!
·
NICE
guidelines do not make any specific recommendations about the type of insulin
to be used.
·
NICE
emphasise the importance of the needs and wishes of patients.
So it
does seem that if your clinic is refusing to prescribe animal insulin, then the
clinic is NOT following NICE Guidelines and you can use this to argue your
case.
HAND LUGGAGE -
UPDATE AUGUST 2006
As a result of recent events hand luggage on aircraft is
restricted to a bag the size of a lap top and the rules for medications have
been tightened. At the time of writing the position is as follows.
The
advice for the
·
Carry a letter from your
GP explaining that insulin, syringes, pens and needles are essential for the
journey and must not be separated from you.
·
Speak to the supervisor
at the check-in desk and explain the situation and also explain to the cabin
crew that your diabetes supplies must stay with you on the journey.
·
All diabetes equipment should
be placed in a plastic bag.
·
Up to 50mls of insulin is
allowed on board a plane.
Warning!
The Dept of Transport is advising that if more insulin is
required, then it should be packed in the suitcase that goes in the hold.
However, as readers will know, we have always been told that insulin should NOT
go in the hold because of the risk of it freezing. Freezing insulin makes it
inactive and it would then have little or no effect on blood sugars. This issue
was highlighted by someone with diabetes in the Birmingham Mail [17.8.06] and
the Dept of Transport said that this matter had not been raised with them but
they would now be seeking advice. In the meantime, the airline gave special
dispensation for all her insulin to be onboard the aircraft.
Additional
advice from the American Transport Security Administration [TSA] and issued by
the American Diabetes Association is well worth following:
·
Insulin
and insulin loaded dispensing products should be clearly identified and
labelled. In other words keep your insulin in the packet with your name and
details on it, even if the vial/cartridge is in-use.
·
Glucagon
emergency kit should be clearly identified and labelled.
And for pump
wearers
Although
insulin pump manufacturers indicate that pumps can safely go through airport
security systems, pump wearers may request a visual inspection rather than
walking through the metal detector or being hand-wanded. Note that this may
subject you to closer scrutiny or a "pat-down."
·
Advise
the screener that the insulin pump cannot be removed because it is connected to
a catheter inserted under your skin.
·
Insulin
pumps and supplies must be accompanied by insulin with a label clearly
identifying the medication.
Note: Any medication
and/or associated supplies that cannot be cleared visually must be submitted
for x-ray screening. If you refuse, you will not be permitted to carry your
medications and related supplies into the sterile area.
IDDT
GOES TO
Thanks
to your help and that of your MPs, Parliamentary Questions were asked up to the
summer recess of Parliament all relating to the need for an insulin strategy
that ensures that choice of insulins remains available with special reference
to animal insulins. These have been answered by Minister of Health, Andy Burnham
MP.
Update:
Second supplier - following the
meeting at the Dept of Health in May, it is now in the public domain that
Wockhardt is looking to pass its technology for manufacturing animal insulins
to another company and they have expanded their production facilities. So it
seems that the contingency plans that we have been requesting are likely to be
put into place so in the event of production/supply problems at their
Patients having a
fully informed choice of all insulins – we know that this does not really happen
and so a Parliamentary Question asked what plans the Minister has to ensure
that diabetes patients receive a fully informed choice of all available
insulins and their risks and benefits, despite the absence of NICE guidelines.
The
Minister's answer is significant in particular: ‘from January 2006, NICE has required all primary care trusts to
implement NICE guidance on patient education by providing all people with
diabetes with high quality, structured education which should include
information on insulin use.’
Referring all
insulins to NICE
- IDDT believes that all insulins should be referred to the National Institute
for Clinical Excellence [NICE] for guidance on their clinical effectiveness and
their cost effectiveness with a view to developing standard guidance regarding
their comparative safety, efficacy and cost effectiveness. However, the
Minister has continually refused to do this and a further Question asked on
what grounds the Minister made this refusal. His answer is significant as it
once more publicly emphasises that synthetic human insulins have no advantages
over animal insulins and that patients have the right to be involved in
decisions about their insulin options.
‘NICE‘s
clinical guidance on the management of both type 1 and type 2 diabetes conclude
that the majority of studies indicate that both human and animal insulins are
equally effective and report no significant differences in hypoglycaemic
episodes and glycaemic control between insulin of human and animal structures.
I
understand that the choice of insulin is influenced by other factors such as
delivery systems and cultural preferences, and so the decision to use one or
other of the insulin types rests entirely with the physician in consultation
with the patient.’
All Party
Parliamentary Group for Diabetes [APPG] - while the above answer is significant,
without NICE involvement there is still no guidance or assessment of the
various insulins, so we have to pursue this. Thanks to the help and support of
Philip Dunne MP, IDDT was invited to make a presentation to the APPG to present
the case for NICE guidance on all insulins. Following the presentation and
various questions, the APPG agreed to support our request and follow this up
with the Minister. IDDT prepared a paper for NICE and we are waiting for news
on this.
Carcinogenic
potential of insulin analogues - a Parliamentary Question asked what
action the Dept of Health has taken following the European Agency for the Evaluation
of Medicinal Products [EMEA] recommendations regarding further investigation of
the carcinogenic potential of insulin analogues. The answer was unsatisfactory
- the Medicines and Healthcare products Regulatory Agency [MHRA] continually
monitor the safety of human analogue insulin and the MHRA have not requested
pre-clinical studies specifically on this issue. This answer fails to recognise
it is further pre-clinical research that is needed as recognised by the
European Agency [EMEA]. MHRA standard monitoring of adverse reactions will not
pick up possible tumours at this stage because they take years to develop.
So what's in the
pipeline?
During
the summer we have been assessing our strategy, especially in view of Novo
Nordisk's intention of reducing insulin choices even further with the eventual
aim of only analogue insulins being available. As this decision affects people
with diabetes globally, we are meeting with colleagues from other countries to
discuss a joint strategy to protect the health and interests of people with
insulin-requiring diabetes.
We
are still hoping for an Adjournment debate in the House of Commons and thank
David Amess MP for his support with this. Following the Earl Howe's meeting
with the Minister on our behalf, he received a written response and we shall be
discussing with him further steps that we can take.
We
are planning an Early Day Motion [EDM]. EDMs are a little strange because they
ask MPs to sign to show their support for a motion but there is no obligation
on the part of government to act on this. Nevertheless, EDMs with lots of MPs'
signatures are an indication of strength of feeling, so we will be asking for
your help with this in the coming months. No longer is this an issue that just
affects people who need animal insulin but all those who want choice of
insulins to remain available.
FOR READERS IN
On
August 25th Australian Health Minister, Tony Abbott announced that
following a recommendation by the Pharmaceutical Benefits Advisory Committee
[PBAC], long-acting insulins, Lantus and Levemir will be subsidised from
October 1st for treatment of Type 1 and Type 2 at a cost of
$145million [over £58million] during the next 3 years. Reports describe the
negotiations to achieve this as 'protracted and difficult'.
About
210,000 Australians will qualify for these insulins and the government expects
about 110,000 to use them in the first year with a rise to 160,000 by 2009. The
subsidised cost to patients is expected to be $9.40 for concession card holders
and $59 for non-concessional patients for a years supply.
WELL
WORTH A READ………….
TESTING TREATMENTS
Better Research for Better Healthcare
Imogen Evans, Hazel Thornton and
Iain Chalmers
In
out Newsletters we frequently talk about looking at evidence to support treatment
decisions, such as a change of insulin and how often have I said that GM
'human' insulin was introduced as first line treatment on assumptions of
benefit and not on evidence of benefit? 'Testing
Treatments' is a book well worth reading and makes what could be a
complicated subject easy to read and easy to understand for patients as well as
for doctors and health professionals. As Nick Ross says in the foreword, 'Once you have read this book you will never
feel quite the same about your doctor's advice again'.
The
book demonstrates the uncertainties about the effects of treatment - how two
doctors can give opposing advice for the same condition and highlights the need
for rigorous testing of treatments in order to ensure that we, the patients,
receive treatments and interventions based on available evidence.
While
the book points out that many medical practitioners are sincere and skilful,
they are not always aware of what makes good scientific evidence and their
treatment recommendations may be based on what they were taught at medical
school, what other doctors do or what has worked in their experience. The book
points out that this can be very misleading and ultimately harmful.
Nevertheless the book does not disparage doctors or modern medicine but aims to
encourage better research, more informed decision-making and therefore
healthcare.
It is well worth
obtaining a copy: Testing Treatments, Better Research for Better Healthcare is
published by the British Library, ISBN 0 712 3 4909
Very different books but useful to
dip into………….
Diabetes
for Dummies
Dr Sarah Jarvis and
Alan L Rubin, MD
Like
all the Dummie books, this is a book for beginners, those who are new to
diabetes who will come across many questions as they learn to live with their
condition. It is useful to have around to dip into when these questions arise.
Published
by Wiley, ISBN 0-7645-7036-6
The
GL Diet for Dummies
Nigel Denby and Sue
Baic
GL
stands for Glycaemic Load and again this book is one to dip into, it helps to
provide a better understanding of what many of us have come to know as the
glycaemic index of foods. It is not specifically for people with diabetes but
provides useful information and recipes.
Published
by Wiley, ISBN 0-470-02753-3
AND WELL WORTH A WATCH…………
Philip
Johnston of The Small Video Company has produced a range of DVDs about various
aspects of diabetes. The DVDs were produced with the help and advice of doctors
and so are reliable educational sources of information that can be watched and
re-watched as the need arises.
The DVDs are as
follows:
·
Childhood Diabetes
60mins
- for the family or carer of a child with Type 1 diabetes. Produced with Dr
Kenneth Robertson, Dr Louise Bath and Dr John Schulga.
·
Teenage Diabetes
60mins
- for teenagers with diabetes covering topics like blood glucose monitoring,
hypos, drinking, smoking, exercise. Produced with Dr Mike Small and Dr Kenneth
Robertson.
·
Pregnancy and
Diabetes 42mins -
a teaching aid for women with Type 1 diabetes who are planning to have a baby
or are in early pregnancy. Produced with Dr Donald Pearson , Dr Judith Steel
and Dr Mike Small.
·
From Pills to
insulin 42mins-
a positive outlook for people with Type 2 who have to go through the
progression from pills to insulin. Produced with Dr Chris Kelly and Dr Andrew
Gallagher.
·
Type 2 Diabetes -
The No Nonsense Guide 73mins - for people with Type 2 diabetes,
especially those who are newly diagnosed in primary care, their family and
carers. It also has a 43minute bonus feature containing 6 mini features ranging
from 'Foot care' to 'Holidays'. Produced
with Dr Ann Gold, Dr John Knight and Dr Andrew Collier.
The DVDs normally
cost £10.00 each including delivery for orders in the
[Further discounts are available to health
professionals for the use in diabetes clinics, if they mention that they heard
about the DVDs through IDDT's Newsletter]
RESEARCH
NEWS
'Human' insulin molecule produced in
safflower
A
Canadian company has achieved 1% insulin accumulation in safflower which is a
commercially viable level. It means that they can produce over one kilogram of
insulin per acre of safflower production - enough to supply 2,500 people for a
year. The company, SemBioSys Genetics, believe that they could supply the
world's total projected insulin demand in 2010 with less than 16,000 acres of
crop production. They plan to scale up production for sufficient insulin to
start clinical trials.
Marijuana Compound
May Help Stop Diabetic Retinopathy
Researchers
are studying a compound found in marijuana, cannabidiol, because there are
indications that it may protect the eye from growing new leaky blood vessels -
one of the main problems with diabetic retinopathy. They are looking at the
role of cannabinoid receptors in the body and trying to modulate them so they
can defend the eye against diabetic retinopathy by intervening early in the
process of the development of retinopathy. [American Journal of Pathology,
January 2006]
Insulin itself may be the trigger
for Type 1 diabetes –
research from two teams suggests that insulin itself may be the trigger that
actually causes Type 1 diabetes. One team cloned immune cells from people with
Type 1 diabetes and healthy people and discovered that the cells from the
people with diabetes reacted to insulin but those from the healthy people
didn’t. The second team genetically engineered mice so they lacked normal
insulin but still had a form of insulin hormone that is not recognised by
immune cells. None of the mice with the modified insulin developed diabetes.
The researchers say that if these results can be confirmed, it could be that
insulin is the driving force behind Type 1 diabetes and the next step would
then be to test the hormone to see if it can be manipulated to prevent the
condition.
We now have
diabetes Type 1.5!
This
is a new term used to describe a group of people who have diabetes but do not
seem to fit into either Type 1 or Type 2 diabetes. In this group of people
there does not seem to any evidence of autoimmunity as there is in Type 1
diabetes when the body’s own immune system kills off the insulin producing
cells. Equally, there does not seem to be any evidence of insulin resistance as
seen in Type 2 diabetes. Usually this group have good control by using
medications that increase insulin secretion but do not respond to those that
improve insulin resistance such as metformin or the glitazones [Actos and
Avandia]. After some years they may require insulin injections.
TIGHTER TARGETS - CAN WE DO
IT? YES WE CAN!
By Dr Katherine
Morrison
So
we are being set tighter targets for diabetes [IDDT Newsletter July 2006]. This
is not likely to be achievable by people with diabetes who stick to the advice
given to them in hospital clinics across the land. In a recent article in the
BMJ [ref1], only 37% of pregnant women had an HbA1c of less than 7% at 13 weeks
of pregnancy.
Pregnant
women run very high risks for themselves and their babies if they have high
blood sugars, Extensive pre-natal and peri-natal counselling and dietary advice
is given to this group, yet this most highly motivated group is not getting
anything like normal blood sugars.
Many
people who read this Newsletter know that they can achieve very good blood
sugar results and a major reason for this is that they never abandoned their
low or restricted carbohydrate diets in favour of the more popular high carbohydrate,
low fat diet.
If
50% of NHS dieticians are not happy about their own knowledge of carb-counting,
how do they expect patients to do it? Certainly in my own area carb-counting is
simply not on the agenda whatsoever, even for people who are insulin dependent.
In her article I was struck to see Jenny's simply suggestion that an egg-sized
portion of mashed potato amounted to 10g of carbohydrate. This is the sort of
eyeball technique tip which I suspect is almost second nature to more
experienced people who have had diabetes for many years. It concerns me that
this expertise could be lost if we do not record these sorts of tips for
posterity.
The
NHS is not going to educate the newly diagnosed on carb-counting for the
foreseeable future, but can you realistically match insulin to carbohydrate
intake when you haven't got a good idea how much carbohydrate is in the food
you intend to eat? I have struggled with various techniques to estimate carbs.
From
my previous article you may know that my son Steven is a teenager with Type 1
diabetes. I found that initially keeping 100g of carbohydrate or less a day
gave him excellent blood sugars with an HbA1c of around 5.0%. Now he has come
out of the honeymoon phase and is also undergoing a growth spurt he is needing
extra carbohydrate and insulin to keep up. We also cannot fully compensate for
the dawn phenomenon [highs in the morning]. Currently his HbA1c, some 3 months
after starting a 100-200g carb diet, is 6.0% but this has been at the expense
of blood sugar swings. We reach target blood sugars about 60% of the time but
he has hypos [below4] about 10% of the time and high blood sugars [over 8] 30%
of the time. These figures include post-prandial [after meal] peaks and delayed
sugar rises which can often be due to protein or higher fat content with higher
carb meals.
In
order to attempt to get some control over this I have come up with some tips of
my own which I am happy to share. I also hope there will be more contributions
from readers.
Insulin Tips
Tip 1: Steven takes
Levemir [long-acting analogue] as a basal insulin but during the summer we
found that he had to have less in the morning than at night because of
inexplicable afternoon hypos.
[Jenny's comment after 30 years: maybe the hypos aren't that inexplicable - hot
weather causes hypos and may be extra exercise.]
Tip 2: We found that
Tip 3: We find that
Actrapid is an excellent insulin to cover high-protein and high-fat meals. At
the current time the only availability in cartridge form is Wockhardt's pork or
bovine Neutral insulin but it is a pity that this is not available in half-unit
pens. [I have stockpiled a large supply of Actrapid and will simply have to
keep an eye on its potency]. Actrapid is also very helpful given in the
mornings not only to cover a high protein breakfast, but also to deal with the
dawn phenomenon and insulin resistance which is definitely more active in the
morning for most people with diabetes.
Tip 4: To cover meals
with high protein content, 2 units of Actrapid per deck of cards size of meat
works well to reduce delayed blood sugar rises.
Tip 5: NovoRapid
[analogue] works quickly and is good for correction doses if blood sugars are
high and also for higher carb meals, such as when at a restaurant.
Tip 6: After school we
have added exercise as an alternative to insulin injections for correction of
high sugars. We've got a rowing machine and it is very surprising how little
you have to do to bring sugars down abruptly with this, much more rapidly than
with insulin - a cycle ride is also effective.
Tip 7: Because Steven's
bedtime snack is at
Tip 8: In order to
prevent any spiking of blood sugars at all after meals, Dr Richard Bernstein
has worked out that 12g of slow-acting carbohydrate is the most that can be
consumed with each meal but this can be too restrictive for many people. From
experimentation I have found that carbohydrate:insulin ratios seem to work out
reasonably steadily up to 30g of carb but after 30g blood sugars after meals
tend to be much higher than expected and I found that we need to add an extra
0.5 units for every 10g of carbs up to 80g. After 60g results are getting a bit
unpredictable and really after 80g results become so increasingly unpredictable
that I don't recommend going over that
in one meal. This is of course, perfectly adequate for even the fussiest of
eaters. I call this tip "weighting" the insulin.
Tip 9: Steven has a
survival pack which he takes to school with him everyday containing: his
insulin pens, mobile phone, money, carb-count list, pastilles to cover
exercise, glucose for hypos, spare needles and his glucose monitor, Freestyle
to school because its smaller.
Tip 10: Because I am
worried about night-time hypos , which indeed he has never had, we go easy on
the insulin and give him only 2/3 of the estimated dose prior to bed time.
Because I am not adequately covering the insulin we stick to 35g or less at
bedtime, with most of the time any bedtime snacks being considerably less than
this. I try to get a good amount of fat and protein into him at this time too
as this slows down the absorption rate of the carbohydrate making it last
longer.
Tip 11: Whenever possible
we wait for the insulin to act before eating, 15minutes for NovoRapid and 45
minutes for Actrapid. These times can be extended to drop the blood sugars if
blood sugars are unusually high. The combination of "waiting" and
"weighting" seems to work well. Use the right insulin for the meal. Wait
for the insulin to work. Wait for the blood sugar to drop. Weight
the insulin according to the carb content of the meal.
If you have any
tips that you would like to share, especially those from the good old days, then
call Jenny at IDDT on 01604 622837 or write to her at IDDT, PO Box 294, Northampton NN1 4XS.
Ref 1 Peri-natal mortality and congenita;
anomalies in babies of women with Type 1 or Type 2 diabetes in
Test your knowledge and learn some carbohydrate values…
1. A normal blood sugar before meals is:
2. A normal blood sugar 2
hours after meals is:
(a) 20
(b) 10
(c) 8
(d) 6
3. Your blood sugar is
starting to be too low when it is:
(a) 1.9
(b) 2.9
(c) 3.9
(d) 4.9
4. The Dawn phenomenon
affects teenagers [and others] and:
(a) Makes their blood sugars
particularly high when they wake up
(b) Makes them sleepy and
unable to get up in the morning
(c) Makes their breakfast
digest more slowly than usual
(d) Makes the gut release
glucagon
5. If your blood sugar is
unexpectedly high:
(a) You could have an
infection brewing somewhere
(b) You have been drinking
too much diet fizzy drinks
(c) You could have given
yourself too much insulin at the last injection
(d) You may have eaten too
little carbohydrate with your last meal
6. 12g of carbohydrate is
present in all of these except:
(a) One thin slice of bread
(b) One cup of broccoli
(c) One cup of rice
(d) Half a grapefruit
7. 15g of carbohydrate is
present in all of these except:
(a) Half a cup of beans
(b) Half a cup of cereal
(c) Half a medium roll
(d) One hamburger bun
8. 15g of carbohydrate is
present in all of these except:
(a) One large banana
(b) One medium apple
(c) 3 pear halves in juice
(d) 3 medium satsumas
Answers
1 (c), 2 (d), 3 (c), 4 (c), 5 (a), 6 (a), 7 (c), 8 (d), 9 (a)
ANALOGUES - THE EVIDENCE
Recommendations
have been made to the Ministry of Health in Germany that health insurers [thus
the taxpayer] should only be obliged to pay for short-acting analogue insulins
for people with Type 2 diabetes in the event that they are no more expensive
than human insulin. And they are not! The decision was based on whether the use
of an analogue insulin would result in an additional benefit for the patient
that would justify its additional cost and to date the pharmaceutical industry
has been unable to demonstrate such a benefit. The majority of people with Type
2 diabetes can be treated perfectly adequately with the cheaper human insulins.
[There are some exceptions to this recommendation such as those who are
allergic to human insulins.]
Report from the
Institute for Quality and Efficiency in Health Care [IQWIG]
This
organisation is
"For
patient relevant outcomes, there is no convincing evidence of a superiority of
rapid-acting insulin analogues compared to regular human insulin [short-acting]
in diabetes mellitus type 2 therapy. Rapid acting insulin analogues have not
been sufficiently investigated with regard to their potential long-term
beneficial and harmful effects."
The key points in
the Report summary are:
·
No
relevant and fully published study was found on insulin aspart [NovoRapid] only
an abstract in 1999 and Novo Nordisk was not prepared to provide study data if
these data were to be published in this report. No relevant studies were found
on pre-mixed formulations of rapid-acting insulin analogues or short-acting
human insulin combined with longer-acting insulins. [Important lack of research
considering Novo Nordisk's removal of pre-mixed human insulins in the
·
None
of the studies were designed to investigate the effect of rapid-acting insulin
analogues on the reduction of diabetic complications or total mortality.
·
For
hypoglycaemia, no clear advantage was shown with analogues compared to human
insulin with regard to severe, symptomatic or nocturnal hypoglycaemia.
·
Quality
of life studies were limited but no clear advantage was shown with analogues
compared to human insulin and no definite conclusions could be drawn about
patient satisfaction as the studies were unsatisfactory.
·
There
was a tendency towards more people dropping out of the studies due to adverse
reactions in those treated with analogues compared with those on human insulin.
·
In
so far as reported, there were similar weight increases for both patients
receiving analogues and those receiving human insulin.
·
As
the maximum study period was 12months, no studies could show the safety of
long-term use of analogues in people with Type 2 diabetes. Unless proved
otherwise by adequately designed studies, the potential for mitogenic potency
of insulin analogues [cell mutiplication and formation of tumours] as described
in pre-clinical trials, is to be seen as a potential safety risk for long-term
treatment of people with Type 2 diabetes.
The full report is
available in English online at:
http://www.iqwig.de/index.media.538df941a1d274bea0b8b1f9ae06921b.pdf.
Note: Later this year
and early next year IQWIG is to produce Reports for [i] short-acting analogues
for Type 1 diabetes [ii] long-acting analogues for Type 1 and [iii] long-acting
analogues in Type 2 diabetes.
So where is the
As
readers know, IDDT has have requested that NICE assesses all insulins and
issues guidance on their use as part of our lobbying campaign to ensure that
animal insulins remain available and people with diabetes have an informed
choice of ALL insulins. However, the
IDDT
is mainly concerned about the unproven long-term safety of insulin analogues
but we are also concerned about the significant extra expense to the NHS [again
the taxpayer], especially as the evidence suggests little benefit for the
majority of people. The German Reports may well not affect UK Dept of Health
attitudes, but at least we, as patients and carers, can have the benefit of
their work to help inform our treatment decisions.
LATEST
RESEARCH ON ANALOGUES AND LONG-TERM SAFETY A Danish study [ref 1] involving
patients with type 1 diabetes acknowledges that diabetic patients are at higher
risk of cancer than the non-diabetic population. It also states that it is
still unknown whether lifelong treatment with the analogue, NovoRapid, will lead
to an elevated IGF-1-like bioactivity and subsequent mitogenic potency,
especially in a subgroup of patients who have high levels of insulin
antibodies.
·
The
question of carcinogenicity of insulin and insulin derivatives is of growing
relevance, because it is increasingly recognised that insulin is a growth
promoting hormone, and is associated with colorectal cancer [ref 2].
Furthermore, it is becoming increasingly clear that there exists a genetic
predisposition for carcinoma development, which is likely to be linked to the
insulin/insulin-like growth factor system. People with such a genetic
background may be particularly harmed by compounds like insulin analogues, the
carcinogenic properties of which are unknown.
·
Recent
research presented at the American Diabetes Association Conference [ref 13] has
shown that all insulin analogues tested were more mitogenic than insulin
[caused cell proliferation that can lead to benign or non-benign tumours]. It
also showed that this mitogenic effect was greater in cells from patients with
a high IGF-1 receptor system expression putting such patients at greater risk
than those with a low IGF-1 receptor system expression.
Ref 1. Chen J W, Frystyk J, Lauritzen,
Christiansen J S. Impact of insuin antibodies on insulin asoart pharmackinetics
and pharmacdynamics after 12-week treatment with multi daily injections of
biphasic insulin aspart 30 in patients with type 1 diabetes. European Journal
of Endocrinology [2005]; 153: 907-913
Ref 2. Yang
YX,Hennessy S, Lewis JD.Insulin therapy and colorectal cancer risk among type 2
diabetes mellitus patients. Gastroenterology 2004;127:1044-1050
Ref 3. Kristian Eckardt, Claudia May,
Marlis Koenen, Juergen Eckel
Enhanced
Mitogenic Potency of Insulin Analogs in Human Fibroplasts and Smooth Muscle
Cells is mediated by IGF-l Receptor Signaling Diabetes, June 2006 Vol 55 Suppl
1 463-P
HOW
CAN THE EXPERTS COME TO SUCH DIFFERENT CONCLUSIONS USING THE SAME EVIDENCE?
I
crave you indulgence here for a little musing but I can't help but wonder what
is going on. You see when high quality reviews or reports on the evidence of
benefit of drugs are carried out for organisations such as NICE in the
Bee
in my bonnet, yes but let's just take a look at the analogue insulins:
·
CEDAC
in Canada is not recommending funding for Lantus for either Type 1 or Type 2
diabetes for lack of evidence of benefit for high costs but NICE in the UK
does recommend it for Type 1 but not
Type 2 diabetes and neither Canada or the UK have reported on the use of
Levemir, so is it recommended or not?.
·
In
terms of short-acting analogues,
·
The
International Diabetes Federation Position statement, with the world's experts
involved, says that analogues offer potential advantages but they have not been
proven to deliver real long-term benefits safely and affordably.
The
only conclusions that are common to all are [i] that the long-term safety of
analogues is unknown and [ii] concerns about their potential for carcinogenic
effects.
I
don't claim to be brain of
How can experts in different countries look at what should be the same evidence
and come to different conclusions and recommendations? Do the experts assessing
the research and making recommendations to their governments have a range of
skills, some good and some not so good? If this is not the reason, then one has
to ask what the other reasons could be? Is there influence of some sort......?
My
final musing of the month is wondering just what would drug companies do if all
countries came to Germany's conclusions of not funding short-acting analogues
for people with Type 2 diabetes or indeed, Canada's conclusions of not funding
long-acting analogues in both Type 1 and Type 2 diabetes? Would the price come
down, would the companies' share prices fall or would they just remove all
other types of insulin to force the use of analogues????? But more worryingly,
what would happen if the necessary research was carried out and it confirmed
the fears of the carcinogenic potential of analogues?
EXERCISE
AND LANTUS - TO CHANGE DOSE OR NOT?
Some research really does make you
wonder!
Research
[Diabetes Care, March 2005] suggests that exercise does not appear to increase
the rate of absorption of Lantus [glargine], the long-acting insulin analogue.
So the authors suggest that Lantus can be safely and effectively administered
without a dose change during exercise but then they go on to note that the
study does not rule out the possibility of late exercise-induced hypoglycaemia
and "Lantus reduction may be
warranted depending on individual patient responses." They caution
against over interpreting these results saying that real-world exercise or
activity may have different effects on the absorption of Lantus.
So what
does this really tell us of value? Not very much but even less when you find
that the research was carried out in only 13 people. First the researchers
conclude that [i] exercise does not require a dose adjustment with Lantus, but
some people might and then [ii] we should be cautious over-interpreting these
findings! In other words perhaps we shouldn't take any notice at all! Why does
anyone even consider carrying out a study in only 13 people when the insulin
under investigation is used by thousands of different people of different ages
and health status and different insulin regimes? And why is it published?
LANTUS
- THE ONCE DAILY INSULIN, BUT IS IT REALLY?
It was someone in the
The results were interesting:
·
HBA1cs
and pre-breakfast blood glucose levels were no different between once and twice
daily Lantus.
·
Blood
glucose levels after breakfast, after lunch and before dinner were lower with
twice daily compared with once daily dinner time Lantus.
·
24hour
average blood glucose levels were lower with twice daily Lantus as was within
day variability of blood glucose levels.
The researchers concluded: that in some
people with Type 1 diabetes blood glucose levels rise in the late afternoon due
to falling insulin levels towards the end of the 24hour period after injecting
Lantus once a day at dinner time. This can be prevented by twice daily
injections of Lantus.
This gives rise to several questions:
Why
change to Lantus if it loses its main attraction of being a once daily
injection? Is the action of Lantus really flat and peakless? If so, why do
blood glucose levels rise towards the end of the 24hour period after injecting?
PREGNANCY AND DIABETES
·
'TOGETHER WE CARE' - IDDT partners the
The
Royal College of Midwives [RCM] has produced the second edition of 'Together We
Care' - a publication that offers reassurance and advice to pregnant women. It
also contains the latest information about current practices of early parenting
to help new parents make the best decisions for them and their baby.
IDDT
was invited to be a partner in this project as the RCM believe that it is
important that mums-to-be have someone they can talk to for support on specific
concerns such as diabetes. Pregnant women with diabetes need a lot of care as
do those with gestational diabetes, estimated to occur in between 3 and 5% of
all pregnant women.
The
book will be given free to every
expectant mum in the
·
IDDT Pregnancy
Information Pack
IDDT
has prepared a Pregnancy Pack which contains the following information specially
for pregnant women and their partners and we are also happy to supply it to
healthcare professionals. The Pack contains:
·
IDDT
leaflet 'Pregnancy and Diabetes'
which has recently been updated
·
A
new leaflet 'Gestational Diabetes'
·
An
Information Sheet on the 'The use of insulin during pregnancy'.
This is a gathering of information from the Specific Product Characteristic
[SPC] documents of insulins that provides details of which insulins can safely
be used during pregnancy. For example, trials of some insulins have not been
carried in pregnant women, or only limited trials have been carried out. This
is important so that women have an informed choice of insulin during this very
important time for them and their baby. [SPCs published when drugs are approved
by the MHRA.]
If you would like a
FREE IDDT Pregnancy Pack or leaflets, just call IDDT on 01604 622837, e-mail enquiries@iddtinternational.org
or write to IDDT,
WINTER COMING - FLU OR A COLD?
Colds
and flu are both caused by viruses and many of the symptoms are the same and so
it can be difficult to tell the difference between the two.
Colds - there are more
that 200 viruses that can cause colds and most of them cause mild infections.
You cannot get a cold from being out in cold weather or getting physically cold
but stress may make you more prone to getting a cold. Cold symptoms usually
start 2 to 3 days after being infected.
Flu - there are 3
families of flu viruses. The symptoms start 1 to 4 days after being infected
and it can be passed to others before you realise you have it.
Difference in
symptoms
- we are all aware of the symptoms of colds and while some of these are similar
to flu, there are symptoms which distinguish a cold from flu:
·
fever,
·
headaches,
·
aches
and pains
·
extreme
exhaustion
·
there
can be diarrhoea and vomiting, especially in children.
Flu
is more serious and can cause serious complications such as pneumonia and so
there may be problems with diabetes control. Flu jabs in the autumn can reduce
the risk of getting flu and people with diabetes are treated as a priority to
receive them. Injections to reduce the risk of pneumonia are also available
through the NHS.
Cochrane review on
flu vaccines
The
number of people having flu vaccines is increasing, so before winter it seems
sensible to look at the evidence relating to fu vaccines. The Cochrane Vaccines
Field based in
One
if the reasons that flu vaccinations are not very effective is that there are
many different viruses and it is unlikely that a single vaccine aimed at a tiny
proportion of these will be very effective. The two commonly used drugs to
prevent flu are Symmetrel and Flumadine and human flu bugs are very quickly
becoming resistant to these two drugs but they still have a place for
controlling flu epidemics and preventing elderly people from getting very sick.
MORE DRIVING WARNINGS!
Informing
the DVLA about health conditions
Researchers
from Auto Express say there is evidence suggesting that about a million drivers
with a notifiable medical condition have not informed the DVLA of their
condition. The police suggest that this figure could well be an
underestimation. Crashes involving drivers with a medical condition have risen
by 75% over the last 3 years and last year there was an increase in the police
notifications to the DVLA related to medical conditions. A motorist with one of
the notifiable medical conditions who does not report it to the DVLA faces a
fine of up to £1000.
Diabetes,
when treated with insulin and with tablets, is one of the conditions where the
DVLA have to be informed. People with diabetes are not being singled out or
discriminated against, there is a list of 22 conditions where it is necessary
to inform the DVLA.
DVLA updated guide
for people treated with insulin, May 2006
Revised
information on the DVLA website states: 'You
must inform the DVLA if your diabetes has become worse since your last licence
was issued'. Forgive the sarcasm but is what this meant by this??? They do
go on to mention changes in the following:
·
Eyes - vision, visual
fields or having retinopathy treatment in both eyes
·
Hypoglycaemia - impaired
awareness of hypos, a disabling hypo at the wheel or frequent hypos
·
Limb problems - such that these
problems are overcome by restricting driving to certain types of vehicle eg
automatics
·
Nerve problems or
circulation problems in your legs
If
you are completing application forms D1 or D2, you simply fill in details about
your condition in the health section. If you already hold a licence when the
condition is diagnosed, then you write to Drivers Medical Unit, DVLA,
LATEST ON INHALED INSULIN
In
August Pfizer launched the new inhaled insulin, Exubera in the
NICE's second draft
guidance for consultation, June 2006 - still does not recommend Exubera, for
people with Type 1 and Type 2 but has agreed to some exceptions:
1.
it
should an option for people who have HbA1c levels of 9% or higher, who are
unable to inject because of a proven injection phobia diagnosed by a
psychiatrist or psychologist,
2.
because
of severe persistent problems with injection sites, eg as a result of
lipohypertrophy.
It
also states that starting inhaled insulin and monitoring its effects should
only be done by a specialist centre which must collect the results as part of
an observational study.
Interesting
that one of the arguments used in favour of inhaled insulin in people with Type
2 diabetes is that many people delay going on to insulin to avoid injections,
increasing their risk of complications. Strange logic as long-acting insulin
would still have to be injected but it seems that more recently a real hole is
blown in this argument! A new drug for Type 2 diabetes, Byetta, has proved so
popular in the
And by the way…………
Novo
Nordisk is pursuing final studies on their version of inhaled insulin with
plans to launch in 2008 and Technosphere's inhaled insulin is entering the last
phase of clinical trials of a much smaller inhaler - it fits in the palm of your
hand which could be a big plus if it reaches the market.
FROM OUR OWN CORRESPONDENTS
Tightening Targets
Dear
Jenny,
I was interested in the article on Tighter Targets [July 2006
Newsletter] and agree that this does encroach a lot on lifestyle and day to day
living. As a child I was required to keep below 10 mmols/l and managed well
without the continual blood testing I need to do nowadays. I was a happy child, teenager and young
mother and do not remember ever being ill until the controls got tighter and
tighter. YES the stress of trying to be good does affect personal relationships
with friends and family as one is seen as being either nitpicking or autocratic
about mealtimes and food!!!!! One
appreciates that there are overall health effects of tighter control but the
mental strain and the high incidence of lows are not to my way of thinking a
progressive step towards a happy lifestyle.
Mrs M.B.
By e-mail
Thank
you for thinking about us
Dear Jenny,
Thank you so
much for the information that we in the
Miss L.E.
By e-mail from the
I feel much better back on beef and
pork insulin
Dear Jenny,
Thanks for
the information about obtaining pork insulin from the
I appreciate
all of the help that you have given to me.
I feel much better now that I am on the beef and pork insulin
combination and as such, I have much better blood sugar control and I am able
to do many more things and go many more places.
Mr L.D.
Don't forget the good work
Dear Jenny,
I know that
it is unfair and perhaps unjust that people are being denied the insulins that
suit them best and I understand the concerns about the power of industry. But I
think that sometimes you are in danger of forgetting the good work that our
researchers and our doctors do.
Ms D.L.
In a telephone conversation
Jenny's response: I hold my hands up and say, yes I
am and I'll try harder in future.
AND
HERE'S A WAY US MEMBERS CAN SUPPORT IDDT
My 15year old has diabetes - I want
to support IDDT
From Teresa Steadman
I live in
the
I have put
up ads on bulletin boards and in some local papers to try and help get the word
out about IDDT and I would also like to raise funds to help. I sell bath and
body products and I will donate a portion of all sales to IDDT - 10% of retail
sales and 5% of wholesale.
I have some
wonderful catalogs with bath & body products that I will send to anyone who
requests it. My company is Northwest Natural Soaps & Gifts, located at
So
if you live in the
IDDT
ANNUAL REPORT
Members
of IDDT are receiving a copy of the Annual Report with this Newsletter and will
see that we have had another year of hard work but a successful year which
leaves us in a financially stable position to carry on our activities. These
have not changed and the Report confirms that our aims are to help and support
people with diabetes and their families and to campaign for the continued
availability of animal insulins and to ensure that people receive an informed
choice of treatment. The Trustees are delighted that our membership is steadily
growing and that we are seeing a marked increase in the number of health
professionals who are requesting our Newsletters and leaflets. We would like to
thank everyone for their continued help and support and take this opportunity
to thank our two full time members of staff, Bev and Michael for all their hard
work.
Copies
of the Annual Accounts are available and we are happy to send them to anyone
who wants to see them. For copies contact IDDT,
TALKING METER PRICE REDUCED!
As
members will know, IDDT and other organisations have been lobbying government
and manufacturers to try to make sure that this very vulnerable group of people
are able to reliably measure their blood sugars to maintain good control and
just as importantly, their independence. In April 2005 a new talking meter, the
SensoCard Plus, was launched for visually impaired and blind people. The
original cost was £149.00 but new distributors, BBI Healthcare, have greatly
reduced the price to £49.99.
The
SensoCard Plus meter is the size of a credit card and the test strips are
available free on NHS prescription. The important details of the meter are:
·
Results
in less than 5 seconds
·
Memory
stores the last 150 results with built in
·
Only
small blood sample required
·
Easy
to operate - automatic operation on strip insertion.
IDDT
member, Alison Blackburn who is registered blind has tested the meter says:"The meter is fantastic. Without it, I
would have been really stuck on a solo trip to
To order or for
further information about the SensoCard Plus meter contact:
BBI Healthcare on
01792 229 333, or email info@bbihealthcare.com
UNITED
NATIONS RESOLUTION FOR DIABETES
The
International Diabetes Federation's Unite for Diabetes campaign aims to
highlight the alarming rise of diabetes worldwide and the
The
Resolution points out that:
·
new
data shows that more than 230 million people have been diagnosed with diabetes
and that the number of people living with diabetes is expected to grow to 350
million in less than 20 years if action is not taken
·
diabetes
is one of the major causes of premature death worldwide, as every 10 seconds a
person dies from diabetes-related causes and death rates are predicted to rise
by 25% over the next decade;
·
the
World Health Organisation research predicts that the condition could reduce
life expectancy globally for the first time in 200 years and that almost 6% of
the world's adult population now live with diabetes.
Naturally
the IDF campaign and the Resolution has IDDT's full support.
NOVO
NORDISK'S MISLEADING ADVERT IN THE LANCET
Jenny Hirst
In December
2005 The Lancet published an advert from Novo Nordisk for NovoMix 30 insulin
entitled 'Diabetes Insights'. The advert gave incorrect information by stating
that premix insulins came in only two types, human or analogue. But as we all
know, or should know, pork premix is available in the
Unbeknown to
me this was investigated by the MHRA as a complaint. The complaint was upheld
and 'Novo
Nordisk agreed to review their company procedures to ensure that materials
published in the
ARE THERE ERRORS JUST WAITING TO HAPPEN?
A
Parliamentary Question that arose several times in the last session was how
many people accidentally overdose with insulin. The answer from the Minister
was that records are not kept and while that maybe so, the question is an
important one because insulin is extremely powerful and can be dangerous. So we
thought that we should look at where some errors can occur.
Human error! There are a couple
of relatively common but understandable ones - not being able to remember
whether of not you did an injection and as soon as you start to think about it,
you can't remember whether you are thinking about today or yesterday! Giving
the morning dose instead of the evening dose or giving short-acting instead of
the long-acting insulin or vice versa is another error. These errors are just what they are called -
human errors, they shouldn't happen but occasionally they do because we are not
concentrating or something else is going on at the same time. But there are
other errors that can occur and we can be aware of these in advance.
Meter reading
errors
Meters
can go wrong and give the wrong results so if the results seem odd or
unexpected, consider the possibility that your meter may be giving false
results. A faulty meter reading can result in the wrong insulin dose being
given. In the
Insulin analogues
are clear
Both
short- and long-acting insulin analogues are clear and therefore there is a greater
chance of getting them mixed up. For 70 years long-acting insulins were cloudy
and short-acting insulins were clear so easily distinguishable and according to
Dr Irl B Hirsh [DOCNEWS May2006] errors were relatively uncommon. Even when the
first, clear short-acting analogues came on the market, the only long-acting
insulin was still cloudy, so there was less risk of mixing them up.
However,
the introduction of long-acting insulin analogue, Lantus added to the risks of
mix-ups. There are subtle differences in the vials of Lantus compared to other
insulins - they taller and skinnier and the vial top is a different colour but
do people notice this unless the two vials are standing together? But now the
short-acting analogue, Apidra, has come on the market and it is in the same
shape vial as Lantus so increasing the risk of errors. Yes, the colour of the
top is different, but this is not of help to people who are colour deficient or
have become colour deficient after laser treatment.
One
way to reduce the possibility of a mix-up is to use a pen for the meal time
injections of short-acting analogues and a syringe for the long-acting insulin.
But people using Novo Nordisk's
long-acting analogue, Levemir, cannot do this as Levemir is not being supplied
in vials in the
Pens
Although
very popular, pens have the potential for errors. Depending on the type of pen,
the insulin is not always visible so it is impossible to see if clear and
cloudy insulins are being used so this
has the potential for mix-ups.
The
imilarity of the pens also adds to the risks of mix-ups. Lantus and Apridra
cartridges are administered in the same pens and the pens for NovoRapid and
Levemir are very similar. For people using Hypurin animal insulins, there is
now only one Autopen so it is no longer possible to have different coloured
pens for short and long-acting insulins. Again, the way around this is as above
- pens for pre-meal injections and vial/syringe for the long-acting insulin,
except Levemir users can't so this.
Another
potential problem is that the markings on the pen can wear off so it is good
idea to replace your pen regularly.
The messages ………
·
Insulin
is powerful and dosing errors can have serious effects.
·
It
is likely that the risk of errors or mix-ups has increased with the latest
developments and these errors can be made by people themselves, by hospital
staff and by staff in residential homes.
·
We
all need to be aware that insulins, vials and pens in their present shapes,
sizes and colours can easily cause mix-ups and dosing errors.
·
Drug
companies need to ensure that pens are made in several colours so patients can
use one colour for their short-acting insulin and a different colour for their
long-acting insulin.
·
Drug
and device regulatory authorities need to look again at the standardisation of
insulin packaging - better and brighter colour coding, perhaps vial shapes
being according to the length of action of the various insulins and cartridges
for the pens not being interchangeable for long and short-acting insulins.
NEEDLES
Needle length for
pens
We
have learnt that some people using pens are unaware that there are various size
needles and with the exception of the OptiPen Pro 1, they can all be used with
any brand of pen. The available lengths are 5, 6, 8, 12, and 12.7mm and in four
gauges [widths] of 28G, 29G, 30G and 31G. Discuss with your nurse which length
of needle is most suitable for you - generally speaking people with more body
fat should use longer needles and thinner people need shorter needles to avoid
injecting into muscle and so running the risk of a hypo. Children and people
who are needle shy should use shorter needles.
By the way……….
MORE
ON NEUROPATHY
Charcot foot
Some
time ago, one of our members pointed out that the Newsletter has not provided
information about Charcot Foot, well here goes………..
It
is a non-ulerative foot condition that can occur in people with diabetes and is
associated with nerve damage [neuropathy]. It is a condition that affects
people who have lost their sense of pain in their feet. Pain protects the feet
as it warns people that they are doing too much walking, standing or
exercising. In Charcot foot the foot changes shape due to destruction of the
bones and joints and this is not caused by infection.
However,
it is difficult to detect and is often treated as an infection because areas of
the foot become red and swollen. It may also be mistaken for cellulitis.
Another problem with diagnosis is that the initial X-ray of the foot may appear
normal. Sometimes people are alerted to Charcot foot if they have a history of
injuries caused by tripping or falling. If the condition goes untreated or is badly
managed, then it can have very serious results. Despite difficulties with
diagnosis, immediate diagnosis and putting the foot out of action is
essential.
The
treatment of Charcot foot is continuous foot care education, protective
footwear and routine foot care to prevent the formation of ulcers.
Reducing pain -
thinking outside the box may be worth a try for those with painful neuropathy
Research
has confirmed that listening to music can have a significant positive impact on
perception of chronic pain. [Journal of Advanced Nursing May 2006] The effect
of music was tested on 60 patients who had endured chronic pain from
osteoarthritis, disc problems and rheumatoid arthritis for an average of
six-and-a-half years. Some listened to music for an hour everyday for a week
while others did not. Those who listened to music reported a cut in pain levels
of up to 21% and associated depression of up to 25%, compared to those who did
not listen. Music also helped people feel less disabled by their condition. Other
studies have also shown that music can have a beneficial effect on the
perception of pain. Previous research has also shown that listening to 45
minutes of soft music before going to bed can improve sleep by more than a
third.
LAUGHTER
IS GOOD FOR YOU
A
small study [ref1] showed that people with Type 2 diabetes may achieve better
control of their blood sugars after meals if they laugh. The researchers found
that people with diabetes who watched a comedy show had a smaller rise in their
blood sugar after meals than when they listened to a non-humorous lecture. The
same effect also happened in people without diabetes. Researchers are not sure
why laughter appears to reduce blood sugar, but suggested that it might
increase the consumption of energy by using the abdominal muscles, or it might
affect the neuroendocrine system, which controls glucose levels in the blood.
Previous
research has shown that laughter can be beneficial to the cardiovascular
system, respiratory system, muscular system, central nervous system and the
endocrine system. What we do know is that laughing
increases endorphins, decreases blood pressure, decreases pain, decreases
anxiety and it reduces stress.
Ref 1 Diabetes
Care May 2003;26:1651-1652
GETTING
YOUR WRISTS SLAPPED FOR PUTTING ON WEIGHT!
One
of the frequent cries from people with diabetes taking insulin is that they
cannot lose weight no matter how carefully they eat and do all the right
things. The clinic visit is the opportunity to seek help from the professionals
but all too often rather being given advice, people are made to feel as if it
is their fault for not obeying the rules or for not trying hard enough. When
you are really trying hard, this is very disheartening and not what you want or
need to hear. Is it yet another case of not believing patients or for some
reason, believing that they are not telling the truth?
Well,
there's a few reasons that can make losing weight difficult even when you try
hard and carefully you follow the rules and it's not always your fault!
·
The
Diabetes Control and Complications Trial (DCCT) showed that tight control with
multi- dose daily insulin treatment reduced levels of LDL cholesterol and
triglycerides but increased the risk of
major weight gain. [Circulation. 2005 May 2] So people on 3 or 4 injections
a day are at risk of weight gain - regime fault, not yours!
·
High
carbohydrate diets require larger doses of insulin, insulin itself increases
weight, so it is the fault of the recommended diet, not yours! [Less carb
requires less insulin and therefore less weight gain.]
·
Does
the term 'high carbohydrate diet' imply the wrong meaning so that people eat
more than is necessary? It is said that carbohydrates don't increase weight but
eating more food than you use up in energy, will put weight on.
·
Some
people have experienced large weight increases with GM insulins added to which
most GM insulins are of shorter duration than animal insulins and therefore
more daily injections are necessary and the DCCT showed that this increases the
risk of weight gain - a double whammy and not your fault.
GOOD NEWS FOR PEOPLE IN THE
For
Americans wishing to import pork or beef insulin from Wockhardt in the
USDA permit - the fee for the
USDA permit is currently not being charged. It is also now possible to obtain
this import permit online: http://www.aphis.usda.gov/NCIE/pdf/epermitslttr.pdf
Doctor's letter - Lilly's
discontinuation of pork insulin in the
If you need pork
insulins and want to order online here are the details:
http://www.getcanadiandrugs.com
Pharmawest Pharmacy
101 20560 56 Ave
Also
according to information from Nucro-Technics, the Canadian distributor, Hypurin
Regular Pork and NPH Pork are also available from eDrugs
SNIPPETS
Milk in schools -
tinkering at the edges
From
September 2006, state schools in
Choice of hospital is not the
public's top priority
A
British Medical Association survey asked 2000 people to rank 10 NHS spending
priorities. The findings showed that the government policy of having a choice
of hospital came 10th and having good service in a clean, local
hospital was top of the list, followed by improved A&E Departments and
shorter out-patient waits. These were followed by research into new treatments,
funds for prevention, better out of hours care, extended GP services, more time
with a doctor, better hospital food and then finally, choice of hospital!
NOP poll looks at
people with chronic conditions - the Centre for the New Europe published
a survey on the views of people with chronic illnesses towards their medicines.
The NOP poll found that more than a third of those quizzed would stop taking
their medication if side effects occurred and worryingly, without informing
their doctor.[Obviously this can't apply to insulin!]
Chili may help
reduce insulin spikes 
- research in
Obese people
unfairly treated at work - a survey of 2000 human resources professionals
carried out found that 93% of them would choose a job applicant of “normal
weight” over an obese applicant if they were of the same experience and
ability. 30% believe that they can refuse to employ someone on grounds of
obesity as a valid medical reason and 10% think that obesity is a fair reason
for dismissal [it's not]. Clearly this is discrimination and overweight people
are being given fewer opportunities than their slimmer counterparts.