PDS290 Focused Usability Test of colour-blind individuals’ ability to differentiate between Tresiba® 100 units/mL FlexTouch®, Tresiba® 200 units/mL FlexTouch®, and NovoRapid® FlexPen® pen-injectors and cartons

Study type

• Study topic:
  Medical device
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Device usability study
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Device usability study

Population studied

• Short description of the study population:
  People with diabetes who were red-green colour blind.; Individuals with Type 1 or Type 2 diabetes who currently self-administer insulin daily using a prefilled pen-injector, vial and syringe, or insulin pump, or who have self-administered insulin in the past were included. Participants with other mild and moderate visual impairments (e.g., near-sightedness, glaucoma) were included to the extent that they were identified during participant recruitment. All participants who were able to read the numerals displayed in the prefilled pen-injector’s dose window (e.g., 16). Participants with various levels of education were included.
• Age groups:
  • Paediatric Population (< 18 years)

    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  15

Study design details

• Main study objective:
  The test objective is to investigate whether people suffering from red-green colour-blindness can differentiate between different pen-injectors and their respective packages (i.e. cartons).
• Data analysis plan:
  After completing the test, test data will be analysed and consolidated as follows:- Review test data and apply professional judgment to describe and determine the root cause(s) for use errors, close calls, and operational difficulties- Count the total number of each type of use error, close call, and operational difficulty- Calculate the means and ranges of the ratings and visualize the data as a bar graph- Summarize participant demographic / background information