Objective: To compare 2 modalities of bolus-basal insulin therapy with aspart-detemir, according to the moment of administration of detemir (DET), before the lunch or bed-time, in type 1 diabetic patients with poor metabolic control.
Methods: We conducted a prospective study of 40 type 1 diabetic patients, with poor metabolic control (HbAc 712%), randomized to receive treatment with 1 injection of DET before the lunch or bed-time and followed-up during 24 weeks. Physician decided the addition of one second dose, administering DET every 12 hours (DET-12 h) if the objectives in glycemic control were not obtained. Insulin analog aspart was used for the post-prandial control. Weight, insulin units/Kg/day, HbA1c, score in a test of quality of life (ITQ7) and hypoglycemias were determined.
Results: 19 patients in DET pre-lunch group and 16 in DET bed-time group completed the study. 10 patients of group DET pre-lunch and 12 of DET bed-time needed DET-12 h. After 24 weeks of bolus-basal insulin therapy, a reduction of HbA1c was demonstrated, and the group DET pre-lunch showed a major reduction of HbA1c. By groups of treatment: DET pre-lunch 8.5 vs 7.1% (P<0,05); DET bed-time 9.0 vs 7.6% (P<0.05.) and DET-12 h 8.8 vs 8.1% (P<0.05.). The ITQ7 demonstrated an improvement without differences between the groups (score baseline visit 74.5±17.3 versus 62.0±19.2; P<0.01). There were no differences in weight and number of non-serious hypoglycemia. Serious hypoglycemia was presented in one patient of DET bed-time group. An increase in the insulin requirements was demonstrated in the 3 groups of treatment (average: 0.78±0.2 u/kg/day in baseline visit versus 0.86±0.2; P<0.05).
Conclusion: after this study, we recommend to begin detemir insulin treatment with one injection administered before the lunch. However, a strict monitoring is necessary because some patients will require two injections of detemir.