INTENSIFIED INSULIN THERAPY AND THE RISK OF SEVERE HYPOGLYCEMIA

The objectives of the present analyses were to assess the association between HbA(1c) levels and severe hypoglycaemia (SH, treatment with gl ucose i.v. or glucagon injection) and to identify predictors of SH in a prospective multicentre trial. The study population consisted of 636 insulin-dependent diabetic patients who had participated in a structu red 5-day in-patient group treatment and teaching programme for intens ification of insulin therapy (ITTP) in one of 10 hospitals and who wer e re-examined after 1, 2, 3, and 6 years including assessment of demog raphic, disease and treatment related parameters, diabetes-related kno wledge, behaviour, and emotional coping. At baseline, age (mean +/- SD ) was 27 +/- 7 years, diabetes duration 9 +/- 7 years and HbA(1c) 8.3 +/- 1.9%. During the 6-year follow-up, the mean HbA(1c) value improved to 7.6%, and in patients with a diabetes duration of more than 1 year at entry into the study (n = 538) the incidence of SH decreased from 0.28 cases/patient/year during the year preceding the ITTP to 0.17 cas es/patient/year. The patient group was divided into decile groups acco rding to mean follow-up HbA(1c) values. In each group more than 230 pa tient years could be analysed. Groups with mean HbA(1c) values of 5.7, 7.0, 7.4, 7.7 and 8.9% had comparable risks of SH (0.15-0.19 cases/ p atient/year). In a logistic regression analysis, mean HbA(1c) during f ollow-up, a history of SH during the year preceding the ITTP, C-peptid e level, emotional coping, carrying emergency carbohydrates (as assess ed at the 1-year follow-up), and age at onset of diabetes were signifi cant independent predictors of SH. The incidence of SH between centres varied between 0.05 and 0.27 cases/patient/year. In conclusion, in th e present analyses no linear or exponential relationship between HbA(1 c) and severe hypoglycaemia could be identified by using simple group comparisons. Applying complex regression analyses, various patient-rel ated predictors of severe hypoglycaemia were identified.