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.