Comparison of human insulin and insulin analogues on hypoglycaemia and metabolic variability in type 1 diabetes using standardized measurements (HYPO score and Lability Index).

To evaluate whether treatment with insulin analogues is associated with a lower risk of hypoglycaemia (HYPO score) and less glycaemic variability (Lability Index) than treatment with human insulin in patients with type 1 diabetes. In a 6-month prospective, open-labelled trial, we randomized 47 patients treated with human insulin to receive treatment with human insulin (n = 21) or insulin analogues (n = 26). HYPO score, Lability Index (LI), and hypoglycaemic episode characteristics were assessed at baseline and at the end of follow-up. A 72-h, continuous glucose monitoring was performed at the end in a subgroup of patients. Groups were compared with nonparametric tests. Significance was defined as P < 0.05. HYPO score (71.5 [36.0-162] vs. 260 [52.0-676], P < 0.05), nocturnal hypoglycaemia (0.4 vs. 1.4 events/patient/4-week, P < 0.05), and <2.5 mmol/l hypoglycaemic events were lower in insulin analogue group after 6 months. There was a trend towards a lower LI in insulin analogue group (74.3 [51.3-133] vs. 123 [76.4-171] mmol/l(2)/h week(-1), P = 0.064). HbA1c and insulin dose were comparable between groups. In type 1 diabetes, insulin analogues were associated with a lower hypoglycaemic risk and a trend towards reduced glycaemic variability compared with human insulin. These effects occurred despite comparable metabolic control.

RCT Entities:   Population Interventions Outcomes