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

Completed

• Conditions: Diabetes

• Registration Number: NCT00916513
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-05
• Study First Submitted QC: 2009-06-08
• Study First Posted: 2009-06-09
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-26
• Last Update Posted: 2010-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5926

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diabetes-related QoL and treatment satisfaction questionnaires: DTSQ, ADDQoL, HFSws and EQ5D	Cross-sectional and retrospective

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Research Site; 🇬🇧 St Albans, United Kingdom