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

January 21, 2020 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

Diabetes

Study Type

Observational

Enrollment (Actual)

4027

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - ATH, Belgium
    - Research Site
  - Aalst, Belgium
    - Research Site
  - Aarschot, Belgium
    - Research Site
  - Alsemberg, Belgium
    - Research Site
  - Amay, Belgium
    - Research Site
  - Antoing, Belgium
    - Research Site
  - Antwerpen, Belgium
    - Research Site
  - Anzegem, Belgium
    - Research Site
  - Baisy-thy, Belgium
    - Research Site
  - Balleul, Belgium
    - Research Site
  - Bastogne, Belgium
    - Research Site
  - Battice, Belgium
    - Research Site
  - Beerse, Belgium
    - Research Site
  - Bellaire, Belgium
    - Research Site
  - Bertogne, Belgium
    - Research Site
  - Betekom, Belgium
    - Research Site
  - Beveren, Belgium
    - Research Site
  - Bilzen, Belgium
    - Research Site
  - Binche, Belgium
    - Research Site
  - Boezinge, Belgium
    - Research Site
  - Boirs, Belgium
    - Research Site
  - Borgerhout, Belgium
    - Research Site
  - Bouillon, Belgium
    - Research Site
  - Brain-l'alleud, Belgium
    - Research Site
  - Brugge, Belgium
    - Research Site
  - Bruxelles, Belgium
    - Research Site
  - Cercxhe-heuseux, Belgium
    - Research Site
  - Champion, Belgium
    - Research Site
  - Clabeoq, Belgium
    - Research Site
  - Corbion, Belgium
    - Research Site
  - De Pinte, Belgium
    - Research Site
  - Diest, Belgium
    - Research Site
  - Dottignies, Belgium
    - Research Site
  - Dworp, Belgium
    - Research Site
  - Ekeren, Belgium
    - Research Site
  - Enghien, Belgium
    - Research Site
  - Erembodegem, Belgium
    - Research Site
  - Essen, Belgium
    - Research Site
  - Eupen, Belgium
    - Research Site
  - Geel, Belgium
    - Research Site
  - Genk, Belgium
    - Research Site
  - Genly, Belgium
    - Research Site
  - Gent, Belgium
    - Research Site
  - Geraardsbergen, Belgium
    - Research Site
  - Ghlin, Belgium
    - Research Site
  - Gilly, Belgium
    - Research Site
  - Gozée, Belgium
    - Research Site
  - Gribomont, Belgium
    - Research Site
  - HAM, Belgium
    - Research Site
  - Haaltert, Belgium
    - Research Site
  - Halen, Belgium
    - Research Site
  - Halle, Belgium
    - Research Site
  - Hannut, Belgium
    - Research Site
  - Hasselt, Belgium
    - Research Site
  - Havinnes, Belgium
    - Research Site
  - Havre, Belgium
    - Research Site
  - Herent, Belgium
    - Research Site
  - Herstal, Belgium
    - Research Site
  - Herzele, Belgium
    - Research Site
  - Hoboken, Belgium
    - Research Site
  - Hooglede, Belgium
    - Research Site
  - Houthalen-helchteren, Belgium
    - Research Site
  - Incourt, Belgium
    - Research Site
  - Jemappes, Belgium
    - Research Site
  - Kapellen, Belgium
    - Research Site
  - Knokke, Belgium
    - Research Site
  - Kuringen, Belgium
    - Research Site
  - La Hulpe, Belgium
    - Research Site
  - La Louvière, Belgium
    - Research Site
  - La Roche, Belgium
    - Research Site
  - Laakdal, Belgium
    - Research Site
  - Lanaken, Belgium
    - Research Site
  - Lauwe, Belgium
    - Research Site
  - Lessines, Belgium
    - Research Site
  - Libramont, Belgium
    - Research Site
  - Liege, Belgium
    - Research Site
  - Lier, Belgium
    - Research Site
  - Ligne, Belgium
    - Research Site
  - Ligney, Belgium
    - Research Site
  - Linkebeek, Belgium
    - Research Site
  - Lo-reninge, Belgium
    - Research Site
  - Louveigne, Belgium
    - Research Site
  - MOL, Belgium
    - Research Site
  - Manage, Belgium
    - Research Site
  - Marche, Belgium
    - Research Site
  - Marchin, Belgium
    - Research Site
  - Marchovelette, Belgium
    - Research Site
  - Marloie, Belgium
    - Research Site
  - Mechelen, Belgium
    - Research Site
  - Merksem, Belgium
    - Research Site
  - Merksplas, Belgium
    - Research Site
  - Mettet, Belgium
    - Research Site
  - Moerkerke, Belgium
    - Research Site
  - Moorlede, Belgium
    - Research Site
  - Moorsel, Belgium
    - Research Site
  - Mouscron, Belgium
    - Research Site
  - Noorderwijk, Belgium
    - Research Site
  - Olen, Belgium
    - Research Site
  - Ooigem, Belgium
    - Research Site
  - Oostende, Belgium
    - Research Site
  - Oostrozebeke, Belgium
    - Research Site
  - Oppuurs, Belgium
    - Research Site
  - Outer, Belgium
    - Research Site
  - Perk, Belgium
    - Research Site
  - Pittem, Belgium
    - Research Site
  - Poederlee, Belgium
    - Research Site
  - Poelkapelle, Belgium
    - Research Site
  - Quaregnon, Belgium
    - Research Site
  - Rance, Belgium
    - Research Site
  - Ransart, Belgium
    - Research Site
  - Retie, Belgium
    - Research Site
  - Retinne, Belgium
    - Research Site
  - Roeselare, Belgium
    - Research Site
  - Ronse, Belgium
    - Research Site
  - Rotheux-rimiere, Belgium
    - Research Site
  - Ruiselede, Belgium
    - Research Site
  - Saint Vaast, Belgium
    - Research Site
  - Saintes, Belgium
    - Research Site
  - Saive, Belgium
    - Research Site
  - Schilde, Belgium
    - Research Site
  - Selayn, Belgium
    - Research Site
  - Sint-lambrechts-herk, Belgium
    - Research Site
  - Sint-niklaas, Belgium
    - Research Site
  - Staden, Belgium
    - Research Site
  - Steenokkerzeel, Belgium
    - Research Site
  - Templeuve, Belgium
    - Research Site
  - Tessenderlo, Belgium
    - Research Site
  - Thuin, Belgium
    - Research Site
  - Tielt, Belgium
    - Research Site
  - Tubize, Belgium
    - Research Site
  - Veurne, Belgium
    - Research Site
  - Vosselaar, Belgium
    - Research Site
  - Waasmunster, Belgium
    - Research Site
  - Wanze, Belgium
    - Research Site
  - Waremme, Belgium
    - Research Site
  - Wasseiges, Belgium
    - Research Site
  - Watervliet, Belgium
    - Research Site
  - Wellin, Belgium
    - Research Site
  - Wenduine, Belgium
    - Research Site
  - Wervik, Belgium
    - Research Site
  - Westrozebeke, Belgium
    - Research Site
  - Wetteren, Belgium
    - Research Site
  - Willebroek, Belgium
    - Research Site
  - Wingene, Belgium
    - Research Site
  - Zedelgem, Belgium
    - Research Site
  - Zemst, Belgium
    - Research Site
  - Zoersel, Belgium
    - Research Site
  - Zonnebeke, Belgium
    - Research Site
  - Zottegem, Belgium
    - Research Site
  - Zwevegem, Belgium
    - Research Site
Greece
- - Agrinio, Greece
    - Research Site
  - Alexandroupolis, Greece
    - Research Site
  - Amaliada, Greece
    - Research Site
  - Arta, Greece
    - Research Site
  - Athens, Greece
    - Research Site
  - Chalkida, Greece
    - Research Site
  - Crete, Greece
    - Research Site
  - Drama, Greece
    - Research Site
  - Edessa, Greece
    - Research Site
  - Giannitsa, Greece
    - Research Site
  - Grevena, Greece
    - Research Site
  - Ioannina, Greece
    - Research Site
  - Kastoria, Greece
    - Research Site
  - Kavala, Greece
    - Research Site
  - Kerkyra, Greece
    - Research Site
  - Komotini, Greece
    - Research Site
  - Kos, Greece
    - Research Site
  - Kozani, Greece
    - Research Site
  - Lakonia, Greece
    - Research Site
  - Lamia, Greece
    - Research Site
  - Larissa, Greece
    - Research Site
  - Naousa, Greece
    - Research Site
  - Patra, Greece
    - Research Site
  - Peiraias, Greece
    - Research Site
  - Rodos, Greece
    - Research Site
  - Serres, Greece
    - Research Site
  - Thermo, Greece
    - Research Site
  - Thessaloniki, Greece
    - Research Site
  - Volos, Greece
    - Research Site
Luxembourg
- - Bertrange, Luxembourg
    - Research Site
  - Bissen, Luxembourg
    - Research Site
  - Bridel, Luxembourg
    - Research Site
  - Diekierch, Luxembourg
    - Research Site
  - Differdange, Luxembourg
    - Research Site
  - Dudelange, Luxembourg
    - Research Site
  - Esch-sur-alzette, Luxembourg
    - Research Site
  - Ettelbruck, Luxembourg
    - Research Site
  - Hollenfels, Luxembourg
    - Research Site
  - Hosingen, Luxembourg
    - Research Site
  - Kehlen, Luxembourg
    - Research Site
  - Larochette, Luxembourg
    - Research Site
  - Luxembourg, Luxembourg
    - Research Site
  - Obercorn, Luxembourg
    - Research Site
  - Redange/attert, Luxembourg
    - Research Site
  - Rodange, Luxembourg
    - Research Site
  - Rumelange, Luxembourg
    - Research Site
  - Sanem, Luxembourg
    - Research Site
  - Strassen, Luxembourg
    - Research Site
Portugal
- - Beja, Portugal
    - Research Site
  - Elvas, Portugal
    - Research Site
  - Faro, Portugal
    - Research Site
  - Gaia, Portugal
    - Research Site
  - Lisboa, Portugal
    - Research Site
  - Penafiel, Portugal
    - Research Site
  - Porto, Portugal
    - Research Site
  - Santarém, Portugal
    - Research Site
  - Torres Novas, Portugal
    - Research Site
  - Torres Vedras, Portugal
    - Research Site
  - Viana do Castelo, Portugal
    - Research Site
Spain
- - La Coruna, Spain
    - Research Site
  - Lugo, Spain
    - Research Site
  - Madrid, Spain
    - Research Site
  - Valencia, Spain
    - Research Site
  - Zaragoza, Spain
    - Research Site
- Asturias
  - Ribadesella, Asturias, Spain
    - Research Site
- Barceloan
  - Barcelona, Barceloan, Spain
    - Research Site
  - Sant Fruitos de Bages, Barceloan, Spain
    - Research Site
- Barcelona
  - Badalona, Barcelona, Spain
    - Research Site
  - Manresa, Barcelona, Spain
    - Research Site
  - Monistrol de Montserrat, Barcelona, Spain
    - Research Site
- Lugo
  - Begonte, Lugo, Spain
    - Research Site
  - Guitiriz, Lugo, Spain
    - Research Site
  - Viveiro, Lugo, Spain
    - Research Site
- Madrid
  - San Fernando de Henares, Madrid, Spain
    - Research Site
- Valencia
  - Villar del Arzobispo, Valencia, Spain
    - Research Site
- Zamora
  - Mombuey, Zamora, Spain
    - Research Site
  - Tabara, Zamora, Spain
    - Research Site
- Zaragoza
  - Letux, Zaragoza, Spain
    - Research Site
United Kingdom
- - Aldershot, United Kingdom
    - Research Site
  - Atherstone, United Kingdom
    - Research Site
  - Belfast, United Kingdom
    - Research Site
  - Blackburn, United Kingdom
    - Research Site
  - Bolton, United Kingdom
    - Research Site
  - Bradford, United Kingdom
    - Research Site
  - Cardiff, United Kingdom
    - Research Site
  - Coventry, United Kingdom
    - Research Site
  - Crawley, United Kingdom
    - Research Site
  - Crowthorne, United Kingdom
    - Research Site
  - Doncaster, United Kingdom
    - Research Site
  - Glasgow, United Kingdom
    - Research Site
  - Great Sutton, United Kingdom
    - Research Site
  - Harrow, United Kingdom
    - Research Site
  - High Valleyfield, United Kingdom
    - Research Site
  - Leamington Spa, United Kingdom
    - Research Site
  - Peterborough, United Kingdom
    - Research Site
  - Slough, United Kingdom
    - Research Site
  - Sneinton, United Kingdom
    - Research Site
  - Stevenage, United Kingdom
    - Research Site
  - Sunbury on Thames, United Kingdom
    - Research Site
  - Watford, United Kingdom
    - Research Site
  - Wellingborough, United Kingdom
    - Research Site
  - Westbury, United Kingdom
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

General Practioners

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1 Control group
2 Benchmarking group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	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)

Secondary Outcome Measures

Outcome Measure	Time Frame
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)	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)

Outcome Measure

Time Frame

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)

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Principal Investigator: Hermans, M. Prof., UCL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

May 19, 2008

First Submitted That Met QC Criteria

May 20, 2008

First Posted (Estimate)

May 21, 2008

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

D3560L00071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Study Type

Enrollment (Actual)

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Diabetes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations