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OPtimal Type 2 dIabetes Management Including Benchmarking and Standard trEatment. (Optimise)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00681850
First received: May 19, 2008
Last updated: June 1, 2010
Last verified: June 2010
History of Changes
  Purpose

Demonstrate that the use of benchmarking improves quality of patient care, in particular the control of diabetes, lipids and blood pressure, by determining the percentage of patients in the benchmarking group achieving pre-set targets for HbA1c 14,18, LDL-cholesterol16,18 and Systolic Blood Pressure17,18 versus control group (non-benchmarking group) after 12 months of follow-up.


Condition
Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: OPtimal Type 2 dIabetes Management Including Benchmarking and Standard trEatment.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • HbA1c, LDL-cholesterol, Systolic Blood Pressure [ Time Frame: Visit 1; Visit 2 (after approximately 4 months after visit 1); Visit 3 (after approximately 8 months after visit 1); Visit 4 (after approximately 12 months after visit 1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glycaemia, Triglycerides, Total and HDL-Cholesterol, Diastolic Blood Pressure, Waist circumference, Smoking habits, Microalbuminuria, Body Mass Index, Physical activity (Rating scale and step counter), Degree of ophthalmic control and dietary advice [ Time Frame: Visit 1Visit 2 (after approximately 4 months after visit 1)Visit 3 (after approximately 8 months after visit 1)Visit 4 (after approximately 12 months after visit 1) ] [ Designated as safety issue: No ]

Enrollment: 4027
Study Start Date: March 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Control group
2
Benchmarking group

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

General Practioners

Criteria

Inclusion Criteria:

  • Provision of informed Consent
  • Patients suffering from diabetes type II, insulin dependent or not insulin dependent.

Exclusion Criteria:

  • Type I diabetes
  • Pregnancy diabetes
  • Hospitalisation, as this is a primary care study
  • Patients who are member of the Belgian Diabetes Convention
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681850

  Show 252 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Hermans, M. Prof. UCL
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eugène Vissers, MD, Therapeutic Area Leader Cardivascular and Diabetes., AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00681850     History of Changes
Other Study ID Numbers: D3560L00071
Study First Received: May 19, 2008
Last Updated: June 1, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by AstraZeneca:
Diabetes
Benchmarking
quality of patient care
Diabetic Population

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

ClinicalTrials.gov processed this record on May 22, 2013