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com

Postgrad Med J (1994) 70, 675 -681 i) The Fellowship of Postgraduate Medicine, 1994

Leading Article

How to achieve optimal diabetic control in patients with

insulin-dependent diabetes
Simon R. Page and Robert B. Tattersall
Diabetes Unit, University Hospital NHS Trust, Queen's Medical Centre, Nottingham NG7 2UH, UK

Introduction
Whether good diabetic control prevents or delays major problem for the DCCT investigators was
the onset of diabetic complications has been how to recruit human diabetics who would be as
debated since the first clinical use of insulin in 1922. compliant as the dogs. It was solved by recruiting
The recently published Diabetes Control and Com- self-selected and highly motivated volunteers
plications Trial (DCCT)' shows that it does. through newspaper advertisements. The success of
Patients with insulin-dependent diabetes (IDDM) this approach can be judged from the fact that 99%
who had no complications (primary prevention of patients completed the study and more than
group, n = 726) or minor retinopathy (secondary 95% of all scheduled examinations were done.
prevention group, n = 715) were randomized to While the patients are to be applauded for their
receive 'intensified' or 'conventional' insulin adherence to the protocol, no one would suggest
therapy. The trial was halted after a mean of 6.5 that they are typical of 13-39 year old insulin-
years when it was clearly shown that intensive dependent diabetics.
therapy (resulting in a mean blood glucose of The goals of intensive therapy were preprandial
8.6 mmol/l versus 12.8 mmol/l in the conventional blood glucose concentrations between 3.9 and
group) reduced the risk of development and pro- 6.7 mmol/l, postprandial concentrations below
gression of diabetic retinopathy by 54-76%, 10 mmol/l, a weekly 3.00 a.m. blood glucose
microalbuminuria by 39-54% and neuropathy by greater than 3.6 mmol/l and a normal glycated
60%. The results are similar to those of smaller but haemoglobin (GHb) concentration. The tools were
equally persuasive studies such as the Stockholm four daily injections or continuous subcutaneous
Diabetes Intervention Study2 and provide con- insulin infusion (CSII) with at least four self-
clusive evidence of a link between high blood monitored blood glucose measurements every day
glucose concentrations and microvascular compli- and GHb measurement every month. Intensive
cations (retinopathy, nephropathy and therapy patients met a team of doctor, diabetes
neuropathy). specialist nurse, dietitian and psychologist monthly
As a result of the DCCT, the American and and were telephoned every week to discuss insulin
British Diabetic Associations recommend that a dose adjustment. In contrast, the conventionally
primary treatment objective in IDDM should be treated group took one or two injections of insulin
blood glucose control at least equal to that per day and were seen every 3 months. They were
achieved in the intensively treated group of the not given specific glycaemic targets and both they
DCCT.3'4 How this is to be achieved in ordinary and the team looking after them were masked to
practice is the question confronting diabetologists. GHb values unless these became excessively high
(over 13.1 1% where the upper limit of the normal
range was 6.05%).
How was near-normal blood glucose control These differences in management resulted in a
achieved in the DCCT? consistent difference in mean blood glucose con-
centrations of approximately 4.2 mmol/l and of
The DCCT was designed to answer the scientific GHb of about 2% for up to 1O years. It is important
question 'Does near-normoglycaemia prevent or to emphasize that glycaemic control was not nor-
delay diabetic complications?' Previous work with mal; nearly half the patients on intensive therapy
captive diabetic dogs5 had shown that it did and a had a normal GHb at least once during the study
but less than 5% had a normal value throughout.
Correspondence: S. Page, M.D., M.R.C.P. The 'down' side of intensive therapy was a three-
Received: 6 January 1994 fold increase in the frequency of severe hypo-
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676 S.R. PAGE & R.B. TATTERSALL

glycaemia and an average weight gain of 4.6 kg were the subject of the exam?'. The diabetes
compared to conventional therapy. knowledge of general practitioners and senior
How are these results to be translated into medical students leaves a lot to be desired9 and we
practice in the average diabetic clinic? The Belgian think that general practitioners do not see enough
diabetologist, Jean Pirart, suggested that in the best patients with IDDM to become expert and that
of all possible worlds the diabetic patient would be these patients should therefore be looked after by
'intelligent, educated, disciplined, persevering and specialists.
perfectly acquainted with all details of his treat- Whether the specialists need to be doctors is a
ment . . . he (would) lead a normal life without moot point. We do not have any evidence, but
sudden changes of routine . . . (and) . . . during believe that expert diabetes specialist nurses might
thirty or forty years, our model patient attended by optimize glycaemic control as well as, or better
model doctors will never have been hospitalised than, doctors, and certainly might be more alert to
because of diabetes'. This is, of course, pie in the and able to manage the psychological barriers
sky, as is the idea that every insulin-dependent which so often interfere.
diabetic will be (or needs to be) telephoned every
week and will (or needs to) attend the hospital
every month for separate consultations with a Education
physician, diabetes nurse specialist, dietitian and
psychologist. It is also self-evident that perfect Dr R.D. Lawrence, himself an insulin-dependent
diabetic control cannot be achieved by simply diabetic, claimed that the diabetic patient must be
switching all one's patients to four injections of his own 'doctor, biochemist and dietitian'. Educa-
insulin a day; good diabetic control depends on a tion is necessary because diabetes does not manage
complex and inter-dependent series of procedures itself between appointments, so that the patient
and supportive measures.6 What are these? must be in charge and make decisions on a
day-to-day basis. For education to be effective it
must take into account the patient's beliefs,
Organization of diabetes services knowledge, misconceptions and prejudices. Fac-
tual information and technical skills can be taught
Patients who took part in the DCCT were relatively easily, either individually or in group
volunteers, who, apart from wishing to do their bit sessions'0 but regular reassessment of knowledge"
for science, had an important financial incentive and technical skills'2 is vital to maintain motivation
in that they received all their diabetes supplies and adequate skill levels. We suggest that pur-
(syringes, blood glucose tests and insulin) free and chasers need to ask the following questions: (1) Is
also got free medical care - a saving of $2,000 or there a dedicated area for education? (2) Are the
more per year. For the ordinary patient with teachers competent, that is, have they been
IDDM in the UK, attendance at a diabetic clinic is educated about diabetes and teaching methods? (3)
voluntary and is not rewarded financially. If the Is there a syllabus with clearly defined aims? (4) Is
patient, to take the worse-case scenario, waits for there practical work or is it all theory? (5) Are
an hour in uncongenial surroundings for a 5- textbooks available? (6) Is there an exam? (7) Are
minute interview with an inexperienced doctor and there refresher courses?
then receives no feedback (for example, their GHb Most of us who passed 0-level physics would
value), one has to ask why they should bother to probably not be able to do so again 5 years later
come. Purpose-built, dedicated diabetes centres and, with time, diabetic patients also forget much
have been built in many towns and, although they of what they had originally learned and need
are not necessarily all they are cracked up to be, we regular refresher courses. The logistics ofdoing this
all agree that 'overcrowded and badly housed are daunting but regular re-education is essential
diabetic clinics are a nightmare to doctors and and not provided by most diabetes units.
useless to patients'.7 Patients in the DCCT were In addition to education (or re-education),
looked after by experts and we need to ask how patients with IDDM need motivation and
many such experts are available in our health care encouragement. The effect of motivation is most
system. As Dornan8 points out, most medical readily seen in women whose glycaemic control
schools do not give the holistic training which is almost invariably improved during pregnancy.
needed to look after a complex chronic disease such Another sure way of improving metabolic control
as diabetes. Examinations have a lot to answer for is to enrol patients in a clinical trial; what the
because, as Dornan says, 'You will fail if you intervention is matters little, because what is vir-
cannot distinguish mitral stenosis from aortic tually always found is that in these self-selected
incompetence, but would the examiner himself pass volunteers, control improved more in the run-in
if performance at telling a surrogate patient that period (typically, a fall in GHb of 1-2%) than
they were heading towards diabetic renal failure subsequently with whatever is being tested. For
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OPTIMAL DIABETIC CONTROL 677

example, Reeves et al. 13 set out to find ifCSII would provides a framework on which to base dietary
produce better control than multiple injections, as advice. These recommendations are broadly
many at the time believed to be the case. In the similar to the 'healthy eating' guidelines for the
event, they found the greatest improvement during population as a whole and go some way to
the run-in period, with little further gain whether removing the dietary stigma of diabetes. Few
twice, three times daily injections, or CSII were patients, however, achieve even these ideals.2' Why
used. What is being seen is the 'Hawthorne effect', a is this? Education once again plays a crucial role.
change in performance due to the attention being Dietary advice must be tailored to the individual
paid to the subjects who want to help and do the social and cultural needs of each patient. Dietary
right things, especially if they hold the investigator compliance is more likely if small modifications are
in high esteem. It is perhaps not surprising that the made than if an entirely new eating pattern is
benefits of entering a trial do not last once patients suggested. Many patients find diets based on
are no longer being studied. In a well-conducted carbohydrate exchanges or the 'glycaemic index' of
study of a diabetes education programme, Lennon different foods difficult to understand, and simple
et al.'4 found improved glycaemic control in 31 advice is often as effective.2223 An imaginative
'educated' patients compared with 25 receiving approach to teaching and evaluation may also help
routine clinic care, but 6 months after the education to improve compliance and glycaemic control in
programme glycaemic control had again drifted the short term24 but the example of the DCCT
back to baseline. emphasizes again the need for continued medical
It is self-evident that the patient who takes input to ensure long-term motivation. Most UK
IDDM seriously and manages it conscientiously diabetic clinics do not have the dietetic support to
must have some 'reward' for following the regimen. see patients even once a year to motivate, monitor
The Holy Grail of avoiding complications 30 years' and reinforce dietary advice.
hence may be one but, in the short term, the
greatest motivating factor is the attitude of the
family and diabetes team. Insulin regimens
Another aspect ofeducation is that patients must
be empowered to take control of their own treat- In health, insulin is secreted as prompt short-lived
ment. Most people are brought up to believe that peaks to dispose of meals with a constant basal
doctors are the people who treat you and to be told insulin delivery rate overnight. Modern insulin
that you, the patient, are in charge is a culture regimens (like those in use up to 1935, when the first
shock that must be conveyed gently but firmly. long-acting insulin was introduced) attempt, with
Muhlhauser and Berger'5 put it well when they said varying degrees of success, to imitate this physio-
'Many physicians still subject their patients to rigid logical profile. To the question 'Is there an ideal
dietary instructions and obedience training, an insulin regimen?', the answer is 'No'. Equivalent
approach which is mistaken for diabetes educa- control can be obtained in motivated compliant
tion.' It is also important that patients are given patients using either twice-daily, four-times daily
explicit goals with feedback about how well they injections, or CSII.25-27 Each of these has its
are doing. It is, unfortunately, too often the case advantages and disadvantages, and what is import-
that after a visit to the diabetic clinic, a letter is sent ant is that the patient is on a regimen which fits in
to the general practitioner saying what the GHb with their lifestyle and which they feel comfortable
result was but this information is never conveyed to with.
the patient. One of us has suggested that the answer
is to send copy letters to the patient, or even to write Twice-daily insulin
directly to the patient, sending a copy to the GP.'6
These usually consist of soluble with either
isophane (NPH) or lente insulins. There is little to
Diet choose between NPH or lente,28 although we think
that NPH is better because its absorption is less
Diet is always described as the cornerstone of erratic and it therefore produces more consistent
diabetic management and this may be true for the overnight control. Twice-daily regimens should not
patient with non-insulin-dependent diabetes. For necessarily be regarded as second class because
the patient with IDDM an excessively rigid or they were 'conventional' therapy in the DCCT. It is
peculiar diet (such as one containing 90 g of fibre quite possible (and needs testing) that DCCT
per day'7"18) is self-defeating. One of the advantages patients on twice-daily insulin would have done as
of intensified insulin therapy is that it enables the well as those in the intensive group had they been
diet to be simplified and liberalized.'9 telephoned every week, seen every month and given
Over the last decade a consensus has emerged feedback on GHb levels. Nevertheless, twice-daily
about what people with diabetes should eat20 which regimens have intrinsic drawbacks; first, and this is
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678 S.R. PAGE & R.B. TATTERSALL

true of multiple injections as well, the delay in What is the best insulin regimen?
absorption ofsoluble insulin results in a 'mismatch'
between the post-prandial increase of blood As pointed out earlier, virtually any regimen can
glucose and insulin levels. Post-prandial hyper- give adequate control if the patient is educated and
glycaemia is the inevitable consequence, with a motivated. We believe that insulin regimens must
greater risk of hypoglycaemia between meals. This be individualized to meet the lifestyle requirements
can be partly overcome by giving insulin 30-60 of the patient and reflect the stage of diabetes. For
minutes before a meal,29 but most patients find this example, newly diagnosed IDDM patients during
inconvenient. An alternative, untested, strategy is the 'honeymoon period' usually find control easy
to delay carbohydrate absorption with alpha- on twice-daily intermediate-acting insulin. Patients
glucosidase inhibitors.0 Second, no available long- who want flexibility with their meals usually prefer
acting insulin achieves the desired 'peaklessness', a multiple injection regimen. Poor control is not of
so that attempts to lower the morning blood itself a reason to alter an insulin regimen; it is more
glucose by increasing the dose of intermediate- important to make a diagnosis ofthe reason for the
acting insulin before the evening meal often pro- high blood sugars. A poorly controlled patient on
duces hypoglycaemia in the night.3' A popular twice-daily insulin who lives in psychosocial chaos
solution to this problem is to delay the injection of never improves on multiple injections or a change
intermediate-acting insulin until bedtime.32 33 A of insulin species. Glycaemic control may actually
final disadvantage of twice-daily insulin is deteriorate in some patients, especially young
inflexibility of lifestyle. Many patients would prefer women, who transfer from twice-daily to multiple
to have a flexible lunchtime or even no lunch at all injections.35
but, if they have injected themselves with
intermediate-acting insulin in the morning, they
cannot 'switch this off' and hence must eat, often Self-monitoring of blood glucose (SMBG)
more than they want.
Optimal glycaemic control relies heavily on the
Multiple injections accurate, reliable and regular use of SMBG. There
is a wide range of convenient meters which, if
The 'basal/bolus' regimen of soluble insulin before correctly used, enable patients to obtain accurate
each meal with intermediate-acting insulin last blood glucose measurements.36 Unfortunately,
thing at night should produce a more physiological diabetic control does not automatically improve
insulin profile. It is remarkably popular with when patients measure their blood sugars. The
patients who can be persuaded to try it, whether main reasons are a failure to act on the results and
they use a syringe or the more convenient pen not doing enough tests. Patients in the DCCT
injector. It does not necessarily result in better intensive therapy group measured their blood
glycaemic control but is liked because patients feel sugar at least four times a day every day for up to 10
more in control and can vary the times and size of years, a degree of compliance which is difficult to
meals.m obtain in the real world; indeed, one might argue
that it is pathological. The ideal frequency of
SMBG is unknown but to achieve near-
Continuous subcutaneous insulin infusion normoglycaemia it needs to be more than twice a
day.37
Insulin is delivered continuously through a sub-
cutaneous needle with pumps which have a (seem-
ingly) infinite variety of programmes. Improved Psychosocial factors
overnight insulin delivery may result in lower
fasting blood glucose,27 and the main advantage of The discrepancy between near-perfect control
CSII is improved glycaemic control at night. which can be obtained in a trial and poor control
However, it is expensive (none of the equipment is under ordinary conditions is most often due to
available on prescription) and many patients find what, for want of a better term, we will call
the pumps bulky and inconvenient. CSII has never intra-psychic factors in the patient himself.38 This
been popular in the United Kingdom, partly encompasses the whole field of compliance,
because of the expense but, more importantly, motivation, perseverance, health beliefs and reac-
because patients require considerable medical and tion to stress. In childhood diabetes, investigations
educational input together with a 24-hour of the family as a whole generally show a strong
telephone advice service. Again, one has to ask relationship between poor control in the child and
rhetorically if 'conventional' treatment would defective family functioning and integration39 and
work better if patients on it had the same support as the same is true of adolescents and probably most
those on pumps. adult diabetics.'" Those who are preoccupied with
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OPTIMAL DIABETIC CONTROL 679

financial, social and marital problems simply lack a three-fold increase in the frequency of severe
the time (and motivation) to manage diabetes. Any hypoglycaemia. Part of this increased risk may be
solution must take into account the whole family due to the reduced awareness of hypoglycaemia
and may require the skills of a psychiatrist, social which often accompanies a 'good' GHb.' This is
worker or family therapist. Personality is impor- reversible,47 especially in patients with a relatively
tant as well. A child's temperament (not surpris- short duration of diabetes but patients with fixed
ingly) seems to be one determinant of control. hypoglycaemic unawareness are unsuitable for
Children described by their parents as never fidget- intensive therapy. It should be noted that severe
ting, always sitting still and moving slowly, were in hypoglycaemia in the DCCT might well have been
the worst control; whereas children who were well more common but for two safeguards; first, after
organized (regular bedtimes and meals, and keep- the feasibility study, patients with a history of
ing their rooms tidy) had the best.4' In the real previous severe hypoglycaemia (and, by implica-
world, even the most motivated patients with tion, unawareness) were excluded. Second, patients
IDDM suffer eventually from tedium and 'burn measured their blood sugar four times or more each
out'42'43 and need to have their enthusiasm con- day, and had an unusual amount of medical input.
stantly rekindled. Who does this and how is less There was no fatality from hypoglycaemia among
important than that somebody does it. We have the study subjects, although a bystander was killed
emphasized that one of the aims of diabetes by a car driven by someone on intensive therapy in
education is to equip patients to manage circumstances leaving little doubt that the driver
themselves, but one must be careful not to carry was hypoglycaemic. We worry about the diabetic
this to such extremes that it is interpreted as salesman who drives 40,000 miles a year on Brit-
rejection. We agree with Ingelfinger" that a certain ain's congested roads who has been told to put his
amount of authoritarianism, paternalism and insulin dose up because his last GHb was 'too high'.
domination are the essence of the physicians Whose fault will the pile up on the MI be? There is
effectiveness. According to Ingelfinger, 'The also a worry that repeated severe hypoglycaemia
patient has to believe in the physician and have a will be bad for the brain. In the DCCT no adverse
conviction that not only can he be trusted but also effects on neuropsychological function were seen
has some special knowledge that the patient does but follow-up was relatively short and other studies
not possess ... A physician who merely spreads an suggest that repeated hypoglycaemia may be harm-
array of vendibles in front of the patient and says, ful.48
"Go ahead and choose, it's your life" is guilty of Like Santiago,49 we also see the lack of standard-
shirking his duty.... He should recommend a ization of GHb assays as a potentially serious risk.
specific course of action.' The normal range for serum calcium in every
Dealing with patients with a chronic disease such hospital in the country is 2.2-2.6 mmol/l but, even
as IDDM is part of the art of medicine which was within our own region (Trent), the upper limit of
brilliantly summarized by Peabody,45 who said: normal for GHb varies from 4.8% to 8.5%.
'Disease in man is never exactly the same as disease Supposing health care providers get the idea that
in an experimental animal, for in man the disease at GHb should be below 6.05%, the upper limit of
once affects and is affected by what we call the normal for the assay used in the DCCT, but do not
emotional life. Thus, the physician who attempts to realize that the assay in their local hospital has an
take care of the patient while he neglects this factor upper limit of 8.5%. One can imagine what would
is as unscientific as the investigator who neglects to happen. Is this a slur on the competence of the
control all the factors that may affect his experi- average doctor or practice nurse? No, because as
ment. The good physician knows his patients Santiago points out, 'Most diabetologists know
through and through and his knowledge is bought that differences exist, but most diabetic patients
dearly. Time, sympathy and understanding must and their physicians (in some ways the US equiva-
be lavishly dispensed. . One of the essential lent of the general practitioner) do not. Instead, the
qualities of the clinician is interest in humanity, for average patient and health care professional is
the secret of care of the patient is in caring for the posed with a dizzying array of HbAlc, total HbAl,
patient.' total glycated haemoglobin, fructosamine and
other measurements'.
What about the risks?
Conclusions
Apart from weight gain the major adverse effects of
attempting to achieve near-normoglycaemia are Long-term optimal glycaemic control requires a
likely to be hypoglycaemia and possibly psycho- heavy committment from medical, nursing, and
logical disturbance. dietetic staff and most of all from the patients
In the DCCT, patients on intensive therapy had themselves. The factors determining glucose cont-
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680 S.R. PAGE & R.B. TATTERSALL

rol are complex and interrelated, and the reasons DCCT, together with the recently published Con-
for poor control will vary between patients. A sensus Guidelines on managing IDDM5 provide a
'diagnosis' of the reasons for poor control must be framework around which to make such judgements
made before appropriate advice can be given. Not which, apart from scientific knowledge, depend
all patients will be suitable (or will want to) heavily on common sense, a quality with which
improve their glycaemic control, and individual diabetes nurses sometimes seem to be better
glycaemic targets need to be set for each patient endowed than doctors.
based on an assessment of benefit and risk. The

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Downloaded from http://pmj.bmj.com/ on March 9, 2015 - Published by group.bmj.com

How to achieve optimal

diabetic control in patients
with insulin-dependent
diabetes.
S. R. Page and R. B. Tattersall

Postgrad Med J 1994 70: 675-681

doi: 10.1136/pgmj.70.828.675

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