MORTALITY AND TREATMENT SIDE-EFFECTS DURING LONG-TERM INTENSIFIED CONVENTIONAL INSULIN-TREATMENT IN THE STOCKHOLM DIABETES INTERVENTION STUDY

Altogether, 102 patients were randomized to intensified conventional t reatment (ICT) (n = 48) or standard treatment (ST) (n = 54). After 7.5 years, 89 patients remained, and it was shown that microangiopathy wa s retarded by the lower blood glucose concentrations seen in the patie nts in the ICT group. HbA(1c) was reduced from (means +/- SE) 9.5 +/- 0.2% to 7.1 +/- 0.1% in the ICT group and from 9.4 +/- 0.2% to 8.5 +/- 0.1% in the ST group (P < 0.001). Of the patients, 4 in the ICT group and 3 in the ST group died. Mortality was predicted by albuminuria, t he amplitude of the sural nerve action potential, and the test of arm blood flow during contraction of the contralateral hand (sympathetic n erve function) at baseline (P < 0.05). Weight increased by 4.4 +/- 1.1 kg in the ICT group and 1.8 +/- 0.7 kg in the ST group (P 0.05). Athe rosclerosis, measured with digital pulse plethysmography, was approxim ately the same in the groups at baseline and after five years. In each group, 3 patients had myocardial infarctions, and 2 from each group h ad ketoacidosis once. There was a mean of 1.1 episodes per patient and per year of serious hypoglycemia in the ICT group and 0.4 episodes pe r patient and per year in the ST group. No adverse incidents or accide nts were observed in either group, and there were no differences betwe en the groups with regard to cognitive function measured with a batter y of tests. In conclusion, intensified diabetes treatment, which retar ded the microvascular complications, caused some weight gain and an al most threefold increase of the frequency of serious hypoglycemia, but brain function did not deteriorate.