Intensive or conventional insulin therapy in type 2 diabetic patients? A population-based study on metabolic control and quality of life (The JEVIN-trial)

Long-term micro- and macrovascular complications cause major morbidity and mortality in patients with type 2 diabetes mellitus. Up to the present it i s not clear whether intensified or conventional insulin treatment is more e ffective to keep blood glucose concentrations close to the normal range. In the present trial 90% (n = 117) of all insulin-treated type 2 diabetic pat ients aged 16 to 60 years and living in the city of Jena (100,247 inhabitan ts), Thuringia, Germany were examined. Fourty patients (34%) were on intens ive insulin therapy (ICT, greater than or equal to 2 injections of normal- and greater than or equal to 1 injection of NPH-/mixed-insulin/day, greater than or equal to 1 insulin-dose adjustments/week, greater than or equal to 2 blood-glucose self-tests/day) and 77 patients (66%) were on conventional insulin therapy (CIT). Patients with ICT had more injections/d (4.3 +/- 0. 7 vs CIT 2.4 +/- 0.7, p < 0.001), more insulin-dose adjustments/week less t han or equal to 11.5 +/- 8.2 vs 2.2 +/- 5.2, p < 0.001) and more blood-gluc ose self-tests/week (25.2 +/- 5.7 vs 9.6 +/- 8.8, p < 0.001). Patients with IGT had higher insulin doses (0.71 +/- 0.32 vs 0.47 +/- 0.2 IU/kg body wt/ d, p < 0.001), were younger (50.5 +/- 6.7 vs 54.0 +/- 5.9 years, p = 0.004) and they had a non-significant tendency to a better HbA1c (8.7 +/- 2.2 vs 9.2 +/- 2.0%, p = 0.23, HPLC, Diamat(R), normal range 4.4-5,9%). There was a negative correlation between HbA1c and the frequency of blood-glucose sel f-tests/week (r = -0.23, p = 0.019) and the number of insulin-dose adjustme nts/week (r = -0.33, p < 0.001). There were no differences between the grou ps as regards body-mass index (29.7 +/- 4.9 vs 28.0 +/- 4.5 kg/m(2), p = 0. 06), diabetes duration (12.3 +/- 6.9 vs 12.2 +/- 7.5 years, p = 0.96), dura tion of insulin therapy (4.2 +/- 3.5 versus 4.5 +/- 4.8 years, p = 0.67), i ncidence of acute complications (severe hypoglycaemia, diabetic coma), prev alence of retino-, nephro- and neuropathy (assessed according to Young et a l.) and education or socio-economic factors. Also, in respect of quality of life and treatment satisfaction, assessed with standardized questionnaires according to Bradley et al. and Lewis et al., there were no differences be tween the two groups. In conclusion, in type 2 diabetic patients; ICT seems to be indicated in a second step in "problem-patients" with bad metabolic control under CIT and/ or individual's need for more flexibility. Perhaps, in these patients ICT l eads to an improvement in the quality of metabolic control.