NCT00681850

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,027

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2008

Geographic Reach
6 countries

252 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

January 22, 2020

Status Verified

June 1, 2010

Enrollment Period

1.8 years

First QC Date

May 19, 2008

Last Update Submit

January 21, 2020

Conditions

Keywords

DiabetesBenchmarkingquality of patient careDiabetic Population

Outcome Measures

Primary Outcomes (1)

  • HbA1c, LDL-cholesterol, Systolic Blood Pressure

    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 Outcomes (1)

  • 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

    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)

Study Arms (2)

1

Control group

2

Benchmarking group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

General Practioners

You may qualify if:

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

You may not qualify if:

  • Type I diabetes
  • Pregnancy diabetes
  • Hospitalisation, as this is a primary care study
  • Patients who are member of the Belgian Diabetes Convention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (252)

Research Site

Aalst, Belgium

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Aarschot, Belgium

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Alsemberg, Belgium

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Amay, Belgium

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Antoing, Belgium

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Antwerp, Belgium

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Anzegem, Belgium

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Ath, Belgium

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Baisy-Thy, Belgium

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Balleul, Belgium

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Bastogne, Belgium

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Battice, Belgium

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Beerse, Belgium

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Bellaire, Belgium

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Bertogne, Belgium

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Betekom, Belgium

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Beveren, Belgium

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Bilzen, Belgium

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Binche, Belgium

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Boezinge, Belgium

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Boirs, Belgium

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Borgerhout, Belgium

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Bouillon, Belgium

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Brain-l'alleud, Belgium

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Bruges, Belgium

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Brussels, Belgium

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Cercxhe-heuseux, Belgium

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Champion, Belgium

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Clabeoq, Belgium

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Corbion, Belgium

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De Pinte, Belgium

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Diest, Belgium

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Dottignies, Belgium

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Dworp, Belgium

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Ekeren, Belgium

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Enghien, Belgium

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Erembodegem, Belgium

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Essen, Belgium

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Eupen, Belgium

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Geel, Belgium

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Genk, Belgium

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Genly, Belgium

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Geraardsbergen, Belgium

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Ghent, Belgium

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Ghlin, Belgium

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Gilly, Belgium

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Gozée, Belgium

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Gribomont, Belgium

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Haaltert, Belgium

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Halen, Belgium

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Halle, Belgium

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Ham, Belgium

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Hannut, Belgium

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Hasselt, Belgium

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Havinnes, Belgium

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Havré, Belgium

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Herent, Belgium

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Herstal, Belgium

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Herzele, Belgium

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Hoboken, Belgium

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Hooglede, Belgium

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Houthalen-Helchteren, Belgium

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Incourt, Belgium

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Jemappes, Belgium

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Kapellen, Belgium

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Knokke, Belgium

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Kuringen, Belgium

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La Hulpe, Belgium

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La Louvière, Belgium

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La Roche, Belgium

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Laakdal, Belgium

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Lanaken, Belgium

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Lauwe, Belgium

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Lessines, Belgium

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Libramont, Belgium

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Lier, Belgium

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Liège, Belgium

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Ligne, Belgium

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Ligney, Belgium

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Linkebeek, Belgium

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Lo-reninge, Belgium

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Louveigné, Belgium

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Manage, Belgium

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Marche, Belgium

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Marchin, Belgium

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Marchovelette, Belgium

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Marloie, Belgium

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Mechelen, Belgium

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Merksem, Belgium

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Merksplas, Belgium

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Mettet, Belgium

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Moerkerke, Belgium

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Mol, Belgium

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Moorlede, Belgium

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Moorsel, Belgium

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Mouscron, Belgium

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Noorderwijk, Belgium

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Olen, Belgium

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Ooigem, Belgium

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Oostrozebeke, Belgium

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Oppuurs, Belgium

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Ostend, Belgium

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Outer, Belgium

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Perk, Belgium

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Pittem, Belgium

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Poederlee, Belgium

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Poelkapelle, Belgium

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Quaregnon, Belgium

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Rance, Belgium

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Ransart, Belgium

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Retie, Belgium

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Retinne, Belgium

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Roeselare, Belgium

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Ronse, Belgium

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Rotheux-Rimière, Belgium

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Ruiselede, Belgium

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Saint-Vaast, Belgium

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Saintes, Belgium

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Saive, Belgium

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Schilde, Belgium

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Selayn, Belgium

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Sint-Lambrechts-Herk, Belgium

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Sint-Niklaas, Belgium

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Staden, Belgium

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Steenokkerzeel, Belgium

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Templeuve, Belgium

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Tessenderlo, Belgium

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Thuin, Belgium

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Tielt, Belgium

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Tubize, Belgium

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Veurne, Belgium

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Vosselaar, Belgium

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Waasmunster, Belgium

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Wanze, Belgium

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Waremme, Belgium

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Wasseiges, Belgium

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Watervliet, Belgium

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Wellin, Belgium

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Wenduine, Belgium

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Wervik, Belgium

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Westrozebeke, Belgium

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Wetteren, Belgium

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Willebroek, Belgium

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Wingene, Belgium

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Zedelgem, Belgium

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Zemst, Belgium

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Zoersel, Belgium

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Zonnebeke, Belgium

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Zottegem, Belgium

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Zwevegem, Belgium

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Crete, Crete, Greece

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Corfu, Kerkyra, Greece

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Lakonia, Lakonia, Greece

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Piraeus, Peiraias, Greece

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Agrinio, Greece

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Alexandroupoli, Greece

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Amaliáda, Greece

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Arta, Greece

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Athens, Greece

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Chalcis, Greece

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Drama, Greece

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Edessa, Greece

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Giannitsá, Greece

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Grevená, Greece

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Ioannina, Greece

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Kastoria, Greece

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Kavala, Greece

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Komotini, Greece

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Kos, Greece

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Kozani, Greece

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Lamia, Greece

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Larissa, Greece

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Náousa, Greece

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Pátrai, Greece

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Rhodes, Greece

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Serres, Greece

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Thessaloniki, Greece

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Thérmo, Greece

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Volos, Greece

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Bertrange, Luxembourg

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Bissen, Luxembourg

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Bridel, Luxembourg

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Diekierch, Luxembourg

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Differdange, Luxembourg

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Dudelange, Luxembourg

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Esch-sur-Alzette, Luxembourg

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Ettelbruck, Luxembourg

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Hollenfels, Luxembourg

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Hosingen, Luxembourg

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Kehlen, Luxembourg

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Larochette, Luxembourg

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Luxembourg, Luxembourg

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Obercorn, Luxembourg

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Redange, Luxembourg

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Rodange, Luxembourg

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Rumelange, Luxembourg

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Sanem, Luxembourg

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Strassen, Luxembourg

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Beja, Portugal

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Elvas, Portugal

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Faro, Portugal

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Gaia, Portugal

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Lisbon, Portugal

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Penafiel, Portugal

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Porto, Portugal

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Santarém, Portugal

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Torres Novas, Portugal

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Torres Vedras, Portugal

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Viana do Castelo, Portugal

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Barcelona, Barceloan, Spain

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Sant Fruitós de Bages, Barceloan, Spain

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Badalona, Barcelona, Spain

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Manresa, Barcelona, Spain

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Monistrol de Montserrat, Barcelona, Spain

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Begonte, Lugo, Spain

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Guitiriz, Lugo, Spain

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Viveiro, Lugo, Spain

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San Fernando de Henares, Madrid, Spain

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Ribadesella, Principality of Asturias, Spain

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Villar del Arzobispo, Valencia, Spain

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Mombuey, Zamora, Spain

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Tábara, Zamora, Spain

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Letux, Zaragoza, Spain

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A Coruña, Spain

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Lugo, Spain

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Madrid, Spain

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Valencia, Spain

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Zaragoza, Spain

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Aldershot, United Kingdom

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Atherstone, United Kingdom

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Belfast, United Kingdom

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Blackburn, United Kingdom

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Bolton, United Kingdom

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Bradford, United Kingdom

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Cardiff, United Kingdom

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Coventry, United Kingdom

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Crawley, United Kingdom

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Crowthorne, United Kingdom

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Doncaster, United Kingdom

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Glasgow, United Kingdom

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Harrow, United Kingdom

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High Valleyfield, United Kingdom

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Peterborough, United Kingdom

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Royal Leamington Spa, United Kingdom

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Slough, United Kingdom

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Sneinton, United Kingdom

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Stevenage, United Kingdom

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Sunbury-on-Thames, United Kingdom

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Sutton, United Kingdom

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Watford, United Kingdom

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Wellingborough, United Kingdom

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Westbury, United Kingdom

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Related Publications (5)

  • Tsimihodimos V, Kostapanos MS, Moulis A, Nikas N, Elisaf MS. Effects of benchmarking on the quality of type 2 diabetes care: results of the OPTIMISE (Optimal Type 2 Diabetes Management Including Benchmarking and Standard Treatment) study in Greece. Ther Adv Endocrinol Metab. 2015 Oct;6(5):199-209. doi: 10.1177/2042018815592803.

  • Hermans MP, Elisaf M, Michel G, Muls E, Nobels F, Vandenberghe H, Brotons C; OPTIMISE International Steering Committee. Benchmarking is associated with improved quality of care in type 2 diabetes: the OPTIMISE randomized, controlled trial. Diabetes Care. 2013 Nov;36(11):3388-95. doi: 10.2337/dc12-1853. Epub 2013 Jul 11.

  • Michel G; OPTIMISE. [The OPTIMISE study (Optimal Type 2 Diabetes Management Including Benchmarking and Standard Treatment]. Results for Luxembourg]. Bull Soc Sci Med Grand Duche Luxemb. 2012;(1):43-9. French.

  • Hermans MP, Brotons C, Elisaf M, Michel G, Muls E, Nobels F; (for the OPTIMISE (OPtimal Type 2 dIabetes Management Including benchmarking and Standard trEatment) International Steering Committee). Optimal type 2 diabetes mellitus management: the randomised controlled OPTIMISE benchmarking study: baseline results from six European countries. Eur J Prev Cardiol. 2013 Dec;20(6):1095-105. doi: 10.1177/2047487312449414. Epub 2012 May 17.

  • Nobels F, Debacker N, Brotons C, Elisaf M, Hermans MP, Michel G, Muls E; OPTIMISE (OPtimal Type 2 dIabetes Management Including benchmarking and Standard trEatment) International Steering Committee. Study rationale and design of OPTIMISE, a randomised controlled trial on the effect of benchmarking on quality of care in type 2 diabetes mellitus. Cardiovasc Diabetol. 2011 Sep 22;10:82. doi: 10.1186/1475-2840-10-82.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Hermans, M. Prof.

    UCL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 19, 2008

First Posted

May 21, 2008

Study Start

March 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

January 22, 2020

Record last verified: 2010-06

Locations