title: Intuitiveness, instruction time, and patient acceptance of a prefilled insulin delivery device and a reusable insulin delivery device in a randomized, open-label, crossover handling study in patients with type 2 diabetes.
abstract: BACKGROUND
  Because the use of insulin therapy can place a substantial burden on patients with diabetes, insulin administration should be as simple as possible.
  
  
  OBJECTIVE
  The primary aim of this trial was to compare the use of 2 insulin delivery devices-one prefilled (NovoMix 30 FlexPen [FP]; Novo Nordisk, Copenhagen, Denmark) and the other reusable (HumaPen Luxura [HL]; Eli Lilly and Company, Indianapolis, Indiana)-in patients with type 2 diabetes in terms of intuitiveness and training time. A secondary aim was to evaluate the ease of use and overall acceptance of the 2 devices.
  
  
  METHODS
  This was a randomized, open-label, comparative, crossover handling study in adult patients with type 2 diabetes who had been treated with oral antidiabetic drugs for >or=2 years and had no previous experience with insulin injection devices. Patients were randomly allocated to the intuitiveness group (no instruction in the use of the devices provided) or the instruction group (instruction provided). The time taken to deliver an injection into a cushion was measured for each device in both groups. Patients answered questionnaires concerning the intuitiveness and ease of use of the 2 devices, their trust and confidence in the devices to deliver the insulin dose, and their overall pen preference.
  
  
  RESULTS
  Sixty-one patients were enrolled in the study (70.5% male; mean [SD] age, 61.80 [7.60] years), 30 in the intuitiveness group and 31 in the instruction group. When all handling steps for the HL device were included, the mean (SD) injection time was significantly shorter for the FP device compared with the HL device in the intuitiveness group (1.21 [1.04] vs 1.74 [0.79] minutes, respectively; P = 0.035). The outcome was similar in the instruction group (0.71 [0.29] vs 1.09 [0.49] minutes; P < 0.001). When the time for cartridge insertion in the HL device was excluded, there was no significant difference in injection time for the respective devices in either group (intuitiveness group: 1.21 [1.04] and 1.07 [0.91] minutes; instruction group: 0.63 [0.35] and 0.71 [0.29] minutes). Twenty-two patients preferred the FP device in terms of ease of learning, compared with 8 patients preferring the HL device (P = 0.007).
  
  
  CONCLUSIONS
  In this study, when all handling steps were included, the FP device was associated with significantly greater intuitiveness and a shorter injection time compared with the HL device. Further research is needed to determine whether these differences between devices are clinically meaningful.
authors.affiliation: Institute for Clinical Research and Development GmbH, Mainz, Germany.
authors.forename: Tanja
authors.initials: T
authors.lastname: Reimer
authors.forename: Cloth
authors.initials: C
authors.lastname: Hohberg
authors.forename: Anke H
authors.initials: AH
authors.lastname: Pfützner
authors.forename: Christina
authors.initials: C
authors.lastname: Jørgensen
authors.forename: Klaus H
authors.initials: KH
authors.lastname: Jensen
authors.forename: Andreas
authors.initials: A
authors.lastname: Pfützner
mesh_terms: D000368:Aged; D018592:Cross-Over Studies; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004209:Disposable Equipment; D016503:Drug Delivery Systems / Q000295:instrumentation / Q000379:methods*; D004349:Drug Packaging; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D007328:Insulin / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care / Q000523:psychology / Q000706:statistics & numerical data; D010349:Patient Compliance / Q000523:psychology; D010353:Patient Education as Topic; D011795:Surveys and Questionnaires; D013997:Time Factors
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin