An Observational Study Evaluating Patient Satisfaction and Quality of Life Associated With Switching Insulin

Study Overview
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Brief Summary
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The purpose of this study is to estimate the direct costs associated with switching, in either direction, between a rapid-acting analog therapy and short-acting human insulin therapy within the first year following the switch. The additional goals are: 1)to assess the impact of a switch from or to a rapid-acting analog insulin therapy on patient treatment satisfaction, 2) to assess the impact of a switch from or to a rapid-acting analog insulin therapy on patient quality of life, 3) to assess the impact of switch from or to the rapid-acting analog insulin therapy on the quality of metabolic control and, 4) to estimate the total costs (direct and indirect) associated with switching, in either direction between rapid-acting analog and short-acting human insulin within the first year following the switch.

Official Title
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Resource Utilisation and Patient Satisfaction With SWitching INsulin (SWING)

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Analog or Human Insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: are at least 18 years of age according to the clinical judgement of the investigator have been diagnosed with type II diabetes have presented within the normal course of care at the baseline visit are being treated with any therapy including a rapid-acting analog insulin component or any therapy including a short-acting human insulin component and are switching from one form of therapy to the other are not simultaneously participating in a study that includes an investigational drug or procedure at entry into the study have been fully informed and have given their written consent for the use of their data have a sufficient understanding of the primary language of the country such that they will be able to complete the questionnaires Exclusion Criteria: no specific exclusion criteria exist for this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rapid acting to short acting<br>Patients on rapid-acting analog insulins who switch to short-acting human insulin | Drug: Analog or Human Insulin<br>* prescribed in accordance with usual clinical practice<br>|
| Short acting to rapid acting<br>Patients on short-acting human insulins who switch to rapid-acting analog insulin | Drug: Analog or Human Insulin<br>* prescribed in accordance with usual clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The estimation of the direct costs associated with switching, in either direction, between a rapid-acting analog therapy and a short-acting human insulin therapy within the first year following the switch. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Euro Quality of Life (EQ-5D) |  | 1 year | 
| Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) |  | 1 year | 
| Change in Diabetes Health Profile (DHP-18) |  | 1 year | 
| The estimation of the total costs (direct and indirect) associated with switching, in either direction, between rapid-acting analog and short-acting human insulin within the first year following the switch |  | 1 year |