title: Comparison of a multiple daily insulin injection regimen (basal once-daily glargine plus mealtime lispro) and continuous subcutaneous insulin infusion (lispro) in type 1 diabetes: a randomized open parallel multicenter study.
abstract: OBJECTIVE
  Insulin pump therapy (continuous subcutaneous insulin infusion [CSII]) and multiple daily injections (MDIs) with insulin glargine as basal insulin and mealtime insulin lispro have not been prospectively compared in people naïve to either regimen in a multicenter study. We aimed to help close that deficiency.
  
  
  METHODS
  People with type 1 diabetes on NPH-based insulin therapy were randomized to CSII or glargine-based MDI (both otherwise using lispro) and followed for 24 weeks in an equivalence design. Fifty people were correctly randomized, and 43 completed the study.
  
  
  RESULTS
  Total insulin requirement (mean +/- SD) at end point was 36.2 +/- 11.5 units/day on CSII and 42.6 +/- 15.5 units/day on MDI. Mean A1C fell similarly in the two groups (CSII -0.7 +/- 0.7%; MDI -0.6 +/- 0.8%) with a baseline-adjusted difference of -0.1% (95% CI -0.5 to 0.3). Similarly, fasting blood glucose and other preprandial, postprandial, and nighttime self-monitored plasma glucose levels did not differ between the regimens, nor did measures of plasma glucose variability. On CSII, 1,152 hypoglycemia events were recorded by 23 of 28 participants (82%) and 1,022 in the MDI group by 27 of 29 patients (93%) (all hypoglycemia differences were nonsignificant). Treatment satisfaction score increased more with CSII; however, the change in score was similar for the groups. Costs were approximately 3.9 times higher for CSII.
  
  
  CONCLUSIONS
  In unselected people with type 1 diabetes naïve to CSII or insulin glargine, glycemic control is no better with the more expensive CSII therapy compared with glargine-based MDI therapy.
authors.affiliation: Department of Internal Medicine, University of Perugia, Perugia, Italy. gbolli@unipg.it
authors.forename: Geremia B
authors.initials: GB
authors.lastname: Bolli
authors.forename: David
authors.initials: D
authors.lastname: Kerr
authors.forename: Reena
authors.initials: R
authors.lastname: Thomas
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Torlone
authors.forename: Agnès
authors.initials: A
authors.lastname: Sola-Gazagnes
authors.forename: Ester
authors.initials: E
authors.lastname: Vitacolonna
authors.forename: Jean Louis
authors.initials: JL
authors.lastname: Selam
authors.forename: Philip D
authors.initials: PD
authors.lastname: Home
mesh_terms: D000328:Adult; D017668:Age of Onset; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000453:epidemiology; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D007279:Injections, Subcutaneous; D007328:Insulin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000069036:Insulin Glargine; D007332:Insulin Infusion Systems; D061268:Insulin Lispro; D049528:Insulin, Long-Acting; D007700:Kinetics; D008297:Male; D008875:Middle Aged
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D000069036:Insulin Glargine; D061268:Insulin Lispro; D049528:Insulin, Long-Acting