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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00916513
First received: June 5, 2009
Last updated: April 26, 2010
Last verified: April 2010
  Purpose

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.


Condition
Diabetes

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Quality of Life and Treatment Satisfaction of People With Type 2 Diabetes: A European Survey

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Diabetes-related QoL and treatment satisfaction questionnaires: DTSQ, ADDQoL, HFSws and EQ5D [ Time Frame: Cross-sectional and retrospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-related variables: Years with diabetes, use of SMBG and frequency of monitoring, Hypoglycaemic episodes, Past Medical History, Macro and micro-vascular complications [ Time Frame: Retrospective (previous 24 months) ] [ Designated as safety issue: No ]
  • Health-economic variables: Use of healthcare resources Days off work (for either hypoglycaemias, acute or chronic complications) [ Time Frame: Retrospective (previous 24 months) ] [ Designated as safety issue: No ]

Enrollment: 5926
Study Start Date: May 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients ³ 40 years old, with T2DM diagnosed and followed up in the participating site at least 1 year prior to entry in the study, treated with diet, OADs and/or insulin for at least the past three months

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

To be recruited in Primary Care Centres mainly, but hospitals will be allowed in some countries

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916513

  Show 302 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Angeles Porta Medical Department.AstraZeneca Spain
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00916513     History of Changes
Other Study ID Numbers: NIS-CEU-DUM-2008/2
Study First Received: June 5, 2009
Last Updated: April 26, 2010
Health Authority: Belgium: Institutional Review Board
Germany: Ethics Commission
Greece: Ethics Committee
Greece: Ministry of Health and Welfare
Italy: Ethics Committee
Spain: Ethics Committee
Turkey: Ethics Committee
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by AstraZeneca:
Diabetes
Treatment Satisfaction
Quality of Life
HbA1c levels and goals
Healthcare resources consumption

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014