Skip to main content
Clinical Trials/NCT00916513
NCT00916513
Completed
Not Applicable

Quality of Life and Treatment Satisfaction of People With Type 2 Diabetes: A European Survey

AstraZeneca1 site in 1 country5,926 target enrollmentMay 2009
ConditionsDiabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes
Sponsor
AstraZeneca
Enrollment
5926
Locations
1
Primary Endpoint
Diabetes-related QoL and treatment satisfaction questionnaires: DTSQ, ADDQoL, HFSws and EQ5D
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

The present European survey seeks to assess quality of life and satisfaction with treatment in people with T2DM and to appreciate disease and treatment variables including hypoglycaemia and level of glycaemic control. It will also provide relevant information on other important aspects such as the level of correlation of objective measures such as HbA1c with health status, QoL and satisfaction with current treatment. Overall 5000 randomly selected patients will be invited to participate from a representative sample of clinical practices during a pre-specified period. The study will entail a single patient visit. Patients who agree to the study and give their informed consent will complete questionnaires which, combined with retrospective notes review & an HbA1c test, will allow patient, disease and treatment variables to be collected. An HbA1c test is a finger prick test to measure glycosylated haemoglobin in the blood indicating the level of blood glucose over the last 8-12 weeks.

Registry
clinicaltrials.gov
Start Date
May 2009
End Date
March 2010
Last Updated
16 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • With T2DM, diagnosed at least 1 year prior to entry in the study
  • Currently treated with diet, OAD(s) and/or insulin with no change in the type of OAD(s) or insulin in the previous three months

Exclusion Criteria

  • Type 1 diabetes and/or history of diabetic ketoacidosis
  • Secondary diabetes (including disease of the exocrine pancreas, endocrinopathies or drug-induced)
  • Treatment with systemic glucocorticoids other than replacement therapy. Inhaled, local injected and topical use of glucocorticoids is allowed

Outcomes

Primary Outcomes

Diabetes-related QoL and treatment satisfaction questionnaires: DTSQ, ADDQoL, HFSws and EQ5D

Time Frame: Cross-sectional and retrospective

Secondary Outcomes

  • Disease-related variables: Years with diabetes, use of SMBG and frequency of monitoring, Hypoglycaemic episodes, Past Medical History, Macro and micro-vascular complications(Retrospective (previous 24 months))
  • Health-economic variables: Use of healthcare resources Days off work (for either hypoglycaemias, acute or chronic complications)(Retrospective (previous 24 months))

Study Sites (1)

Loading locations...

Similar Trials