title: Insulin lispro therapy in pregnancies complicated by type 1 diabetes mellitus.
abstract: OBJECTIVE
  To compare the efficacy and safety of preprandial administration of rapid-acting lispro analogue with regular short-acting insulin to pregnant women with type 1 diabetes.
  
  
  METHODS
  Open randomised multicentre study. Women were treated with multiple insulin injections aiming at normoglycaemia. Blood glucose was determined six times daily, HbA(1c) every 4 weeks. Diurnal profiles of blood glucose were analysed at gestational week 14 and during the study period at weeks 21, 28 and 34.
  
  
  METHODS
  33 pregnant women with type 1 DM were randomised to treatment with lispro insulin (n=16) or regular insulin (n=17).
  
  
  RESULTS
  Blood glucose was significantly lower (P<0.01) after breakfast in the lispro group, while there were no significant group differences in glycemic control during the rest of the day. Severe hypoglycaemia occurred in two patients in the regular group but biochemical hypoglycaemia (blood glucose <3.0 mmol/l) was more frequent in the lispro than in the regular group (5.5 vs. 3.9%, respectively). HbA(1c) values at inclusion were 6.5 and 6.6% in the lispro and regular group respectively. HbA(1c) values declined during the study period and were similar in both groups. There was no perinatal mortality. Complications during pregnancy, route of delivery and foetal outcome did not differ between the groups. Retinopathy progressed in both groups, one patient in the regular group developed proliferative retinopathy.
  
  
  CONCLUSIONS
  The results suggest that it is possible to achieve at least as adequate glycemic control with lispro as with regular insulin therapy in type 1 diabetic pregnancies.
authors.affiliation: Department of Pediatrics, Karolinska Hospital, 171 76 Stockholm, Sweden. bengt.persson@swipnet.se
authors.forename: B
authors.initials: B
authors.lastname: Persson
authors.forename: M-L
authors.initials: ML
authors.lastname: Swahn
authors.forename: R
authors.initials: R
authors.lastname: Hjertberg
authors.forename: U
authors.initials: U
authors.lastname: Hanson
authors.forename: E
authors.initials: E
authors.lastname: Nord
authors.forename: E
authors.initials: E
authors.lastname: Nordlander
authors.forename: L-O
authors.initials: LO
authors.lastname: Hansson
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D003925:Diabetic Angiopathies / Q000453:epidemiology; D003930:Diabetic Retinopathy / Q000453:epidemiology; D004334:Drug Administration Schedule; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D007231:Infant, Newborn; D007328:Insulin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D061268:Insulin Lispro; D061389:Insulin, Regular, Pork; D010298:Parity; D011247:Pregnancy; D011256:Pregnancy Outcome; D011254:Pregnancy in Diabetics / Q000188:drug therapy*
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D061268:Insulin Lispro; D061389:Insulin, Regular, Pork; C000006:insulin, neutral