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OpenTrials
Completed

NCT Number: NCT00916513

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Antibes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Cross-sectional and retrospective

Secondary outcomes

  1. 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)

  2. Health-economic variables: Use of healthcare resources Days off work (for either hypoglycaemias, acute or chronic complications)

    Time frame: Retrospective (previous 24 months)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: PANORAMA

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 9, 2009
Registry last updated
Apr 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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