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Insulin
Dependent
Diabetes
Trust
.
Insulin Pump Therapy
- Choosing your insulin type
- Insulin types
- One patients experience
- NICE guidelines
- Bits and pieces from research
Having an informed choice of treatment is the
right of patients and this applies to insulin treatment whether using an
insulin infusion pump or any other form of insulin delivery device. A
pump is really just a very sophisticated delivery device, and the
insulin being delivered is a very important part of the equation for
living healthily with diabetes along with diet, lifestyle, exercise and
much more. The decision about the type of insulin you wish to use should
be made in discussion with your doctor.
Many pumpers use an analogue of insulin, usually Humalog. It is easy to
believe that this is the only insulin that can be used with pumps as it
is increasingly being presented as such by the drug and pump companies,
as well as by diabetes teams.
Yet there are other types of insulin that are, and can be, used with
pumps. Both the pharmaceutical and medical professionals are aware that
about 10% of the population will not be able to tolerate any particular
drug and it is estimated that around 10% of people taking insulin are
unable to tolerate GM synthetic insulins. In addition, there are serious
concerns about the potential side effects of insulin analogues (Cochrane
Collaboration 2004) for which there is no long-term safety information.
So it is important to ensure that the type of insulin you use is the
right one for you, remembering that different insulins work better or
worse in different people; so one person's best insulin is not
necessarily your best insulin.
For more information on the adverse effects of GM insulins, so-called
'human' insulin and the analogue insulins.
Click on GM vs animal insulin
Insulin Types
Short-acting insulins are used in pumps and the
different types of short-acting insulins differ not only in their
origin, but also in their speed of onset and their duration of action.
Short-acting insulin analogues have the shortest onset of action,
followed by 'human' and then animal insulin.
Whatever insulin you use in your pump, it is important to remember that
the larger the dose of insulin, the longer it lasts so even analogues
last longer than stated in their leaflets.
Natural animal insulins
Until the early 1980s all insulins were derived from either pig or cow
pancreases. These natural animal insulins have a long safety record,
having been used since the 1920’s. Until the late 1970s these animal
insulins were impure and in the past there were problems with skin
rashes and hyperlipotrophy, the growth of fat tissue around injection
sites. However by the late 1970s and early 1980s purification systems
had been developed and all insulins became equally pure.
IDDT continues to receive quite a few queries about whether or not pork
insulin can be used in a pump and the answer is: yes it can and IDDT has
members who do!
Sadly people are often misinformed and told that they have to use GM
insulins if they want to use pump. Not so and it is worth remembering
that when pumps were developed, the only available insulins were animal
insulins!
In the UK, the available short-acting insulins are:
- Pork Actrapid made by Novo Nordisk Pharmaceuticals Ltd [vials only
- Hypurin Porcine Neutral made by CP Pharmaceuticals Ltd
- Hypurin Bovine Neutral made by CP Pharmaceuticals Ltd
GM 'Human' insulin
Human insulin was introduced in 1982 and is produced by recombinant DNA
technology from either e-coli or yeast. It is commonly known as GM or
synthetic insulin. Technically it is actually genetically engineered to
be identical molecularly to naturally produced human insulin.
In the UK the commonly used short-acting GM 'human' insulins are:
- 'Human' Actrapid made by Novo Nordisk.
- Humulin S made by Eli Lilly.
Insulin Analogues
Analogues were introduced in the late 1990s and the word analogue
actually means 'similar to something', so technically insulin analogues
are not insulin! They are produced by genetic engineering not to be
identical to 'human' insulin but to be similar with parts of the DNA
removed or altered so that they act differently yo GM 'human' insulin.
The short-acting analogue insulins available in the UK are:
- Humalog made by Eli Lilly.
- NovoRapid (called Novolog in the US) made by Novo Nordisk
Note: Apidra, a short-acting analogue insulin
made by Aventis is expected to reach the UK market in 2005.
One patient's experience
A letter from Mrs E.J. published the April 2004
edition of IDDT's Newsletter said that after many years of Type 1
diabetes, her blood sugars had huge swings and she had constant joint
pains. Basically she was fed up and applied to go on the pump.
In February 2003 the National Institute for Clinical Excellence [NICE]
issued guidelines for pump therapy recommending that "insulin pump
therapy is considered as a treatment option for people with Type 1
diabetes for whom multiple dose insulin therapy has failed and who have
the commitment and competence to use CSll therapy effectively."
They also state that injection regimes using 24hour-acting Lantus must
be tried before pump therapy can be funded by the NHS. This is perhaps a
surprising recommendation when Lantus had only been on the market a few
months and therefore the evidence of benefit or otherwise on the wider
population was unknown.
So Mrs E.J. tried Lantus [with Humalog] but this did not help and so
while she was waiting for her pump costs to be approved, she thought she
would try pork insulin. The results were that her blood sugars became
stable and predictable, her joint pains completely disappeared and she
lost a stone in weight. Mrs E.J. raised the question with IDDT about why
the NICE Guidelines do not recommend that people should also try animal
insulins as well as Lantus, as this would be an even cheaper option.
IDDT did put this forward in the public consultation for the NICE
Guidelines but not unsurprisingly, our views were not heard - yet again!
The use of pump therapy has increased in both adults and young children,
especially in the US and IDDT receives increasing numbers of enquiries
from people who are being advised to consider pump therapy because of
their erratic blood sugars. We have yet to hear from anyone being
advised to try animal insulin to see if this improves their control.
National Institute of Clinical Excellence [NICE]
Guidelines for pump therapy
Here is some of the evidence from the NICE guidelines to inform your decisions.
Objectives of pump therapy – better
control and improved flexibility of lifestyle
Research comparing pump therapy and multi-daily injections [MDI]
showed:
- On average only 0.6 percentage points lower HbA1cs were obtained with pumps compared to multi-daily injections, so the overall effect was to lower HbA1cs to below pre-pump levels but not greatly. Some studies showed an improvement in HbA1cs at 4 months but not at 6 months.
- Insulin usage went down at 4 months but not over a longer time.
- There was no difference in body weight.
- Patient preference slightly favoured pump therapy [many were using older pumps and so this may be biased] but only one study looked at quality of life.
- Only observational studies and not randomised controlled trials found a significant reduction in hypos. [Randomised controlled trials [RCTs] provide the best form of evidence]
- In pregnancy, there was no significant difference in HbA1cs or baby's birth weight between pump therapy and injections
- In adolescents there was generally no differences found, although in one study of 25 adolescents with poor control there was a reduction of 40% in the rates of hypoglycaemic episodes with pump therapy compared to injections
- In children, no randomised controlled trials have been carried out to compare pumps and injections, so there is no good evidence either way.
- In people with Type 2 diabetes – no research.
Costs
At the time of the guidelines, the additional costs of pump therapy over
‘normal’ insulin therapy was between £1100 to £1400 per year. Primary
Care Organisations and NHS Trusts were supposed to have funding
arrangements in place for implementation of these guidelines by February
2004 but many areas have still not done so. This has resulted in many
people still self-funding their pump therapy and others who qualify for
it being unable to get funding through the NHS.
Bits and pieces from research
Research shows that pump therapy in young
children is no better than injections and the number of hypos is greater
Research at Indiana University studied 42 pre-school children who were
treated in two groups one multi-daily injections and the other with an
insulin pump for 6 months. They found that blood glucose levels did not
differ between the two groups and the number of hypos, abnormally low
blood sugars, was higher in the children using pumps than those on
injections but both groups had one instance of seizure due to a severe
hypo. Parents were happy with pump therapy and 95% of the children
continued on pump therapy after the end of the study.
However, the authors commented that it remains to be seen whether the
benefits of pump therapy in terms of flexibility and convenience
justifies the extra cost. They also recommended that studies are
necessary to see the effects of long-term pump therapy in children of
very young ages.
Journal of Pediatrics, Sept 2004
Insulin analogues result in modest improvement in glycaemic control
compared with soluble insulin in pump therapy
A systematic review of trials of at least 10weeks which compared
rapid-acting insulin analogues with soluble insulin in pumps showed a
reduction in HbA1cs of only 0.26% with analogue insulin and some studies
reported fewer numbers of hypos, depending on the definition of
hypoglycaemia. There were no differences in weight or insulin dosage.
Only two studies reported on patient preference and in both cases
analogue insulin was preferred.
Diab Med 2003, 20:863-866