Healthcare Professional and Patient Surveys to Assess the Effectiveness of Risk Minimization Measures for Concentrated Insulin Lispro (Humalog 200 units/mL KwikPen) (F3Z-MC-B020)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Evaluation of the Effectiveness of a Risk Minimization Plan

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 LISPRO

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  560

Study design details

• Main study objective:
  This primary study objective is to evaluate the impact of the risk minimization measures on HCP and patient understanding regarding the risk of hypoglycemia and/or hyperglycemia due to medication errors associated with administration of Humalog KwikPen 200 units/ml as communicated through the risk minimization measures.
• 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.