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Egger et al (1997) performed a meta-analysis of 14 trials, contributing 16 comparisons of 1028 patients
with Type 1 diabetes allocated to intensive insulin treatment and 1039 allocated to conventional
treatment. The authors found a substantial risk of adverse effects associated with intensive insulin
treatment, including an excess of severe hypoglycaemia, which confirmed that the findings of the DCCT
(1991) were not exceptional. Egger et al commented that multiple daily injection schemes may be safer
than treatment with insulin pumps.
Having accepted that there is evidence in the literature that intensive insulin regimens increase the rate of
hypoglycaemia, it is logical to postulate that one might predict the frequency of such hypoglycaemic
episodes and perhaps prevent them.
Cox et al (1994) studied 78 insulin dependent subjects with diabetes mellitus from two different sites
performing self-monitoring of blood glucose. Over the following six-month period these subjects
recorded their severe hypoglycaemic episodes (stupor or unconsciousness). There was no difference in the
number of severe hypoglycaemic episodes between the subjects in good versus poor metabolic control.
The higher frequency of severe hypoglycaemia during the subsequent six months of follow-up was
predicted by frequent and extremely low self-monitoring blood glucose readings and the variability in the
day-to-day readings of the blood glucose. Regression analysis indicated that 44 per cent of the variance in
severe hypoglycaemic episodes could be accounted for by initial measures of blood glucose variance and
the extent of low blood glucose readings. Individuals who had lower haemoglobin A1 levels were not at a
higher risk of severe hypoglycaemic episodes and thus blood glucose variability and low blood glucose
readings were good predictors of severe hypoglycaemia.
Casparie (1985) found that one of the causes of hypoglycaemia in a study of 32 severe hypoglycaemic
episodes in 26 patients (a patient per year incidence of 8 per cent) was often a lack of alertness or
carelessness in calculating the insulin dose. The author felt that by teaching patients to respond more
adequately to changing circumstances in daily life and to react to warning signs by appropriate action
would also reduce the incidence of hypoglycaemia. The difficulty in predicting hypoglycaemic episodes
in an individual patient was highlighted by Goldgewitch et al. (1983) when they found that emotional
factors were often given as a cause of hypoglycaemia, but in 11 per cent of cases there were no obvious
reasons for the hypoglycaemic attacks in spite of the appropriate management of their diabetic control.
ICAO Preliminary Unedited Version — March 2010 III-4A-3
ter Braak et al. (2000) carried out a retrospective study of 195 consecutive cases with Type 1 diabetes in
order to ascertain the frequency of severe hypoglycaemia and found this to be 150 episodes per 100
patient years, occurring in 40.5 per cent of the study population. The clinical characteristics which
predisposed to hypoglycaemic coma were the presence of neuropathy, coincident treatment with beta
blocking agents and the use of alcohol. These three observations were controlled to adjust for duration of
diabetes, which is also a significant predictor of hypoglycaemia.
The data on mild hypoglycaemia are more variable and it is difficult to obtain accurate estimates.
However, Pramming (1991) studied the frequency of the symptomatic hypoglycaemic episodes in 411
randomly selected Type 1 diabetic outpatients. From questionnaire analysis the retrospective frequencies
of mild and severe hypoglycaemia were 1.6 and 0.029 episodes per patient per week. From the patient
diaries prospective frequencies of mild and severe hypoglycaemic episodes were 1.8 and 0.027 episodes
per patient per week. Interestingly, symptomatic hypoglycaemia was more frequent on working days
than during weekends (1.8:1) and more frequent in the morning than during the afternoon, evening and
night (4.5: 2.2: 1.4:1). Importantly, the symptoms of hypoglycaemia were somewhat non-specific,
heterogeneous, and weakened with increasing duration of diabetes. These data are congruent with other
data in the literature suggesting that hypoglycaemic unawareness increases with duration of diabetes and,
of course, the duration of diabetes is also a predictor of hypoglycaemia.
The basic pathology in Type 1 diabetes is islet cell failure while that of Type 2 diabetes is abnormal
insulin resistance. It is, therefore, inappropriate to transpose hypoglycaemic frequency data from Type 1
to Type 2 individuals. The literature review above for Type 1 does not support the certification of Type 1
diabetic-treated applicants. The next paragraphs consider the risk of hypocyglycaemia in Type 2 insulintreated
　
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