title: Comparison of human insulin and insulin analogues on hypoglycaemia and metabolic variability in type 1 diabetes using standardized measurements (HYPO score and Lability Index).
abstract: 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.
authors.affiliation: Endocrine Unit (13-2), Hospital Universitari Bellvitge, Feixa Llarga, s/n, 08907, L'Hospitalet de Llobregat, Barcelona, Spain, mmperez@bellvitgehospital.cat.
authors.forename: M
authors.initials: M
authors.lastname: Pérez-Maraver
authors.forename: J
authors.initials: J
authors.lastname: Caballero-Corchuelo
authors.forename: A
authors.initials: A
authors.lastname: Boltana
authors.forename: R
authors.initials: R
authors.lastname: Insa
authors.forename: J
authors.initials: J
authors.lastname: Soler
authors.forename: E
authors.initials: E
authors.lastname: Montanya
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000378:metabolism; D003922:Diabetes Mellitus, Type 1 / Q000150:complications* / Q000188:drug therapy* / Q000378:metabolism; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000453:epidemiology / Q000209:etiology* / Q000378:metabolism; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D007328:Insulin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods / Q000592:standards*; D011446:Prospective Studies; D013030:Spain / Q000453:epidemiology; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin