Clinical trial NCT00681850: OPtimal Type 2 dIabetes Management Including Benchmarking and Standard trEatment.
Official title: OPtimal Type 2 dIabetes Management Including Benchmarking and Standard trEatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: Diabetes
Benchmarking
quality of patient care
Diabetic Population
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-21
Enrollment: 4027
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: General Practioners

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.


Eligibility 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

Primary outcomes:
measure: HbA1c, LDL-cholesterol, Systolic Blood Pressure
timeFrame: 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:
measure: 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
timeFrame: 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)
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Research Site
city: Aarschot
country: Belgium
facility: Research Site
city: Alsemberg
country: Belgium
facility: Research Site
city: Amay
country: Belgium
facility: Research Site
city: Antoing
country: Belgium
facility: Research Site
city: Antwerpen
country: Belgium
facility: Research Site
city: Anzegem
country: Belgium
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city: ATH
country: Belgium
facility: Research Site
city: Baisy-thy
country: Belgium
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city: Balleul
country: Belgium
facility: Research Site
city: Bastogne
country: Belgium
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city: Battice
country: Belgium
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city: Beerse
country: Belgium
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city: Bellaire
country: Belgium
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city: Bertogne
country: Belgium
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city: Betekom
country: Belgium
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city: Beveren
country: Belgium
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city: Bilzen
country: Belgium
facility: Research Site
city: Binche
country: Belgium
facility: Research Site
city: Boezinge
country: Belgium
facility: Research Site
city: Boirs
country: Belgium
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city: Borgerhout
country: Belgium
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city: Bouillon
country: Belgium
facility: Research Site
city: Brain-l'alleud
country: Belgium
facility: Research Site
city: Brugge
country: Belgium
facility: Research Site
city: Bruxelles
country: Belgium
facility: Research Site
city: Cercxhe-heuseux
country: Belgium
facility: Research Site
city: Champion
country: Belgium
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city: Clabeoq
country: Belgium
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city: Corbion
country: Belgium
facility: Research Site
city: De Pinte
country: Belgium
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city: Diest
country: Belgium
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city: Dottignies
country: Belgium
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city: Dworp
country: Belgium
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city: Ekeren
country: Belgium
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city: Enghien
country: Belgium
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city: Erembodegem
country: Belgium
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city: Essen
country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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city: Gent
country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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city: Hooglede
country: Belgium
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city: Houthalen-helchteren
country: Belgium
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city: Incourt
country: Belgium
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country: Belgium
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city: Kapellen
country: Belgium
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country: Belgium
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city: Kuringen
country: Belgium
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country: Belgium
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country: Belgium
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city: La Roche
country: Belgium
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city: Laakdal
country: Belgium
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country: Belgium
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country: Belgium
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city: Lessines
country: Belgium
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country: Belgium
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city: Liege
country: Belgium
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country: Belgium
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city: Ligney
country: Belgium
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city: Ligne
country: Belgium
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city: Linkebeek
country: Belgium
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city: Lo-reninge
country: Belgium
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city: Louveigne
country: Belgium
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city: Manage
country: Belgium
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city: Marche
country: Belgium
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city: Marchin
country: Belgium
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city: Marchovelette
country: Belgium
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city: Marloie
country: Belgium
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city: Mechelen
country: Belgium
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city: Merksem
country: Belgium
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city: Merksplas
country: Belgium
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city: Mettet
country: Belgium
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city: Moerkerke
country: Belgium
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city: MOL
country: Belgium
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city: Moorlede
country: Belgium
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city: Moorsel
country: Belgium
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city: Mouscron
country: Belgium
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city: Noorderwijk
country: Belgium
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city: Olen
country: Belgium
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city: Ooigem
country: Belgium
facility: Research Site
city: Oostende
country: Belgium
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city: Oostrozebeke
country: Belgium
facility: Research Site
city: Oppuurs
country: Belgium
facility: Research Site
city: Outer
country: Belgium
facility: Research Site
city: Perk
country: Belgium
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city: Pittem
country: Belgium
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city: Poederlee
country: Belgium
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city: Poelkapelle
country: Belgium
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city: Quaregnon
country: Belgium
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city: Rance
country: Belgium
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city: Ransart
country: Belgium
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city: Retie
country: Belgium
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city: Retinne
country: Belgium
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city: Roeselare
country: Belgium
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city: Ronse
country: Belgium
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city: Rotheux-rimiere
country: Belgium
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city: Ruiselede
country: Belgium
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city: Saint Vaast
country: Belgium
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country: Belgium
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city: Saive
country: Belgium
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country: Belgium
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city: Selayn
country: Belgium
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city: Sint-lambrechts-herk
country: Belgium
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city: Sint-niklaas
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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city: Tielt
country: Belgium
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city: Tubize
country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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city: Westrozebeke
country: Belgium
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city: Wetteren
country: Belgium
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country: Belgium
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city: Wingene
country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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city: Zonnebeke
country: Belgium
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city: Zottegem
country: Belgium
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city: Zwevegem
country: Belgium
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city: Agrinio
country: Greece
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city: Alexandroupolis
country: Greece
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city: Amaliada
country: Greece
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city: Arta
country: Greece
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city: Athens
country: Greece
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city: Chalkida
country: Greece
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city: Crete
country: Greece
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city: Drama
country: Greece
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city: Edessa
country: Greece
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city: Giannitsa
country: Greece
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city: Grevena
country: Greece
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city: Ioannina
country: Greece
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country: Greece
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country: Greece
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country: Greece
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city: Komotini
country: Greece
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city: Kos
country: Greece
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city: Kozani
country: Greece
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city: Lakonia
country: Greece
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city: Lamia
country: Greece
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city: Larissa
country: Greece
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city: Naousa
country: Greece
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city: Patra
country: Greece
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city: Peiraias
country: Greece
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city: Rodos
country: Greece
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city: Serres
country: Greece
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city: Thermo
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
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city: Volos
country: Greece
facility: Research Site
city: Bertrange
country: Luxembourg
facility: Research Site
city: Bissen
country: Luxembourg
facility: Research Site
city: Bridel
country: Luxembourg
facility: Research Site
city: Diekierch
country: Luxembourg
facility: Research Site
city: Differdange
country: Luxembourg
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city: Dudelange
country: Luxembourg
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city: Esch-sur-alzette
country: Luxembourg
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city: Ettelbruck
country: Luxembourg
facility: Research Site
city: Hollenfels
country: Luxembourg
facility: Research Site
city: Hosingen
country: Luxembourg
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city: Kehlen
country: Luxembourg
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city: Larochette
country: Luxembourg
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city: Luxembourg
country: Luxembourg
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city: Obercorn
country: Luxembourg
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city: Redange/attert
country: Luxembourg
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city: Rodange
country: Luxembourg
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city: Rumelange
country: Luxembourg
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city: Sanem
country: Luxembourg
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city: Strassen
country: Luxembourg
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city: Beja
country: Portugal
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city: Elvas
country: Portugal
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city: Faro
country: Portugal
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city: Gaia
country: Portugal
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city: Lisboa
country: Portugal
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city: Penafiel
country: Portugal
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city: Porto
country: Portugal
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city: Santarém
country: Portugal
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city: Torres Novas
country: Portugal
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city: Torres Vedras
country: Portugal
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city: Viana do Castelo
country: Portugal
facility: Research Site
city: Ribadesella
country: Spain
facility: Research Site
state: Asturias
city: Barcelona
country: Spain
facility: Research Site
state: Barceloan
city: Sant Fruitos de Bages
country: Spain
facility: Research Site
state: Barceloan
city: Badalona
country: Spain
facility: Research Site
state: Barcelona
city: Manresa
country: Spain
facility: Research Site
state: Barcelona
city: Monistrol de Montserrat
country: Spain
facility: Research Site
state: Barcelona
city: Begonte
country: Spain
facility: Research Site
state: Lugo
city: Guitiriz
country: Spain
facility: Research Site
state: Lugo
city: Viveiro
country: Spain
facility: Research Site
state: Lugo
city: San Fernando de Henares
country: Spain
facility: Research Site
state: Madrid
city: Villar del Arzobispo
country: Spain
facility: Research Site
state: Valencia
city: Mombuey
country: Spain
facility: Research Site
state: Zamora
city: Tabara
country: Spain
facility: Research Site
state: Zamora
city: Letux
country: Spain
facility: Research Site
state: Zaragoza
city: La Coruna
country: Spain
facility: Research Site
city: Lugo
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Aldershot
country: United Kingdom
facility: Research Site
city: Atherstone
country: United Kingdom
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Blackburn
country: United Kingdom
facility: Research Site
city: Bolton
country: United Kingdom
facility: Research Site
city: Bradford
country: United Kingdom
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Crawley
country: United Kingdom
facility: Research Site
city: Crowthorne
country: United Kingdom
facility: Research Site
city: Doncaster
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Great Sutton
country: United Kingdom
facility: Research Site
city: Harrow
country: United Kingdom
facility: Research Site
city: High Valleyfield
country: United Kingdom
facility: Research Site
city: Leamington Spa
country: United Kingdom
facility: Research Site
city: Peterborough
country: United Kingdom
facility: Research Site
city: Slough
country: United Kingdom
facility: Research Site
city: Sneinton
country: United Kingdom
facility: Research Site
city: Stevenage
country: United Kingdom
facility: Research Site
city: Sunbury on Thames
country: United Kingdom
facility: Research Site
city: Watford
country: United Kingdom
facility: Research Site
city: Wellingborough
country: United Kingdom
facility: Research Site
city: Westbury
country: United Kingdom
facility: Research Site
Study officials:
affiliation: UCL
name: Hermans, M. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.