Healthcare Professional Survey to Assess the Effectiveness of Additional Risk Minimization Measures for Prescribing and Administration of Concentrated Insulin Human (Humulin R U-500 KwikPen) (B5K-MC-B012)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Survey Design

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  INSULIN HUMAN

Population studied

• Age groups:
  • 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:
  200

Study design details

• Main study objective:
  The primary study objective is to evaluate the impact of the Dear Healthcare Professional letter on prescriber understanding about the risk of hypoglycemia associated with Humulin R U-500 KwikPen and educational points to be emphasized in discussion with patients.
• Outcomes:
  The risk minimization tools will be considered effective if the majority of respondents demonstrate they are aware of the key risks communicated.
• Data analysis plan:
  Data collected from the survey will be reported as descriptive statistics. Frequency distributions with 95% CIs will be calculated for respondent responses to all questions that address the survey objectives. In addition to the overall analysis, survey data will be analyzed to determine if there are any differences for HCPs and medical specialty.