A randomized, open-label, comparative crossover handling trial between two durable pens in patients with type 1 or 2 diabetes mellitus

J Diabetes Sci Technol. 2011 Sep 1;5(5):1212-21. doi: 10.1177/193229681100500529.

Abstract

Background: This open-label, randomized, comparative crossover usability study investigated preference between durable insulin pens, NovoPen® 4 and NovoPen 3, among patients with types 1 and 2 diabetes.

Methods: In a timed test, 82 current NovoPen 3 users (mean age, 48.5 years) assessed intuitiveness of NovoPen 4. After timed training, this group and 34 insulin-naïve patients (mean age, 61.8 years) were randomized to a handling evaluation of NovoPen 4 followed by NovoPen 3, or vice versa, in which participants made three injections into a foam cushion. A device-specific questionnaire was filled out for each pen. A third questionnaire asked participants to compare pens.

Results: Current NovoPen 3 users completed the intuitive assessment of NovoPen 4 in an average time of 1.94 min (range, 0.57-4.98 min). The training of insulin-naïve patients occurred in slightly less time with NovoPen 4 than with NovoPen 3 but did not reach significance (9.9 versus 11.5 min; p = .32). Survey responses showed that both groups had less difficulty and were more confident in handling NovoPen 4 than NovoPen 3; 96.3% of the NovoPen 3 users and 100% of the insulin-naïve group preferred to use NovoPen 4 (p < .0001).

Conclusion: Patients currently using NovoPen 3 or who were insulin naïve expressed a preference for NovoPen 4 in this study, reporting it to be simpler to learn and easier to use than NovoPen 3. NovoPen 4 may help facilitate insulin therapy among newly diagnosed patients and potentially improve adherence and treatment satisfaction among current NovoPen 3 users.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Cross-Over Studies
  • Diabetes Mellitus, Type 1 / drug therapy*
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Disposable Equipment
  • Drug Delivery Systems / instrumentation*
  • Female
  • Humans
  • Hypoglycemic Agents / administration & dosage*
  • Hypoglycemic Agents / therapeutic use
  • Injections, Subcutaneous / instrumentation
  • Insulin / administration & dosage*
  • Insulin / therapeutic use
  • Male
  • Middle Aged
  • Patient Preference*
  • Patient Satisfaction
  • Surveys and Questionnaires

Substances

  • Hypoglycemic Agents
  • Insulin