DiabetesOptimiseNCT00681850

OPtimal Type 2 dIabetes Management Including Benchmarking and Standard trEatment.

An observational study of Diabetes, run by AstraZeneca at 252 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes
How many people: 4,027 participants
Where: 252 sitesin 6 countries
Study dates: Mar 2008to Jan 2010
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: General Practioners

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

252 sites in 6 countries.

Country

City, postcode or hospital

252 sites in 6 countries

Belgium150 sites

Research Site
Aalst
Research Site
Aarschot
Research Site
Alsemberg
Research Site
Amay
Research Site
Antoing
Research Site
Antwerp
Research Site
Anzegem
Research Site
Ath
Research Site
Baisy-Thy
Research Site
Balleul
Research Site
Bastogne
Research Site
Battice
Research Site
Beerse
Research Site
Bellaire
Research Site
Bertogne
Research Site
Betekom
Research Site
Beveren
Research Site
Bilzen
Research Site
Binche
Research Site
Boezinge
Research Site
Boirs
Research Site
Borgerhout
Research Site
Bouillon
Research Site
Brain-l'alleud
Research Site
Bruges
Research Site
Brussels
Research Site
Cercxhe-heuseux
Research Site
Champion
Research Site
Clabeoq
Research Site
Corbion
Research Site
De Pinte
Research Site
Diest
Research Site
Dottignies
Research Site
Dworp
Research Site
Ekeren
Research Site
Enghien
Research Site
Erembodegem
Research Site
Essen
Research Site
Eupen
Research Site
Geel
Research Site
Genk
Research Site
Genly
Research Site
Geraardsbergen
Research Site
Ghent
Research Site
Ghlin
Research Site
Gilly
Research Site
Gozée
Research Site
Gribomont
Research Site
Haaltert
Research Site
Halen
Research Site
Halle
Research Site
Ham
Research Site
Hannut
Research Site
Hasselt
Research Site
Havinnes
Research Site
Havré
Research Site
Herent
Research Site
Herstal
Research Site
Herzele
Research Site
Hoboken
Research Site
Hooglede
Research Site
Houthalen-Helchteren
Research Site
Incourt
Research Site
Jemappes
Research Site
Kapellen
Research Site
Knokke
Research Site
Kuringen
Research Site
La Hulpe
Research Site
La Louvière
Research Site
La Roche
Research Site
Laakdal
Research Site
Lanaken
Research Site
Lauwe
Research Site
Lessines
Research Site
Libramont
Research Site
Liège
Research Site
Lier
Research Site
Ligne
Research Site
Ligney
Research Site
Linkebeek
Research Site
Lo-reninge
Research Site
Louveigné
Research Site
Manage
Research Site
Marche
Research Site
Marchin
Research Site
Marchovelette
Research Site
Marloie
Research Site
Mechelen
Research Site
Merksem
Research Site
Merksplas
Research Site
Mettet
Research Site
Moerkerke
Research Site
Mol
Research Site
Moorlede
Research Site
Moorsel
Research Site
Mouscron
Research Site
Noorderwijk
Research Site
Olen
Research Site
Ooigem
Research Site
Oostrozebeke
Research Site
Oppuurs
Research Site
Ostend
Research Site
Outer
Research Site
Perk
Research Site
Pittem
Research Site
Poederlee
Research Site
Poelkapelle
Research Site
Quaregnon
Research Site
Rance
Research Site
Ransart
Research Site
Retie
Research Site
Retinne
Research Site
Roeselare
Research Site
Ronse
Research Site
Rotheux-Rimière
Research Site
Ruiselede
Research Site
Saint-Vaast
Research Site
Saintes
Research Site
Saive
Research Site
Schilde
Research Site
Selayn
Research Site
Sint-Lambrechts-Herk
Research Site
Sint-Niklaas
Research Site
Staden
Research Site
Steenokkerzeel
Research Site
Templeuve
Research Site
Tessenderlo
Research Site
Thuin
Research Site
Tielt
Research Site
Tubize
Research Site
Veurne
Research Site
Vosselaar
Research Site
Waasmunster
Research Site
Wanze
Research Site
Waremme
Research Site
Wasseiges
Research Site
Watervliet
Research Site
Wellin
Research Site
Wenduine
Research Site
Wervik
Research Site
Westrozebeke
Research Site
Wetteren
Research Site
Willebroek
Research Site
Wingene
Research Site
Zedelgem
Research Site
Zemst
Research Site
Zoersel
Research Site
Zonnebeke
Research Site
Zottegem
Research Site
Zwevegem

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Greece29 sites

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United Kingdom24 sites

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Belfast
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Bolton
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Bradford
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Cardiff
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Coventry
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Crawley
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Crowthorne
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Doncaster
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Glasgow
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Harrow
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High Valleyfield
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Peterborough
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Royal Leamington Spa
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Slough
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Sneinton
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Stevenage
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Sunbury-on-Thames
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Sutton
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Watford
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Luxembourg19 sites

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Bissen
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Bridel
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Esch-sur-Alzette
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Ettelbruck
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Spain19 sites

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Letux, Zaragoza
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Lugo
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Madrid
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Manresa, Barcelona
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Mombuey, Zamora
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Monistrol de Montserrat, Barcelona
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Ribadesella, Principality of Asturias
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Santarém
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About this study

Conditions: Diabetes
Keywords: Diabetes, Benchmarking, quality of patient care, Diabetic Population
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00681850
Study group	Role	What they receive
1		Control group
2		Benchmarking group

What is being measured

The primary outcome is the main question the study is designed to answer.

HbA1c, LDL-cholesterol, Systolic Blood Pressure
Measured: 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
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Jan 2010

First posted21 May 2008 (estimated)
Study startMar 2008
Primary completionJan 2010
Study completionJan 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 4,027 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00681850
Sponsor's protocol ID: D3560L00071
Acronym: Optimise
Status last verified: Jun 2010
First submitted: 19 May 2008
Last updated: 22 Jan 2020
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 26445642
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.
PubMed 23846810
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.
PubMed 22822562
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.
PubMed 22605788
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.
PubMed 21939502

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: OPtimal Type 2 dIabetes Management Including Benchmarking and Standard trEatment.
ClinicalTrials.gov ID: NCT00681850
Acronym / sponsor ID: Optimise / D3560L00071
Conditions: Diabetes
Keywords: Diabetes, Benchmarking, quality of patient care, Diabetic Population
Study type: Observational
Recruitment status: Completed
Enrolment: 4,027 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 21 May 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
1	–	–Control group
2	–	–Benchmarking group

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: General Practioners

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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)

1 secondary outcome

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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
Derived from this study: PubMed 26445642Tsimihodimos 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.
Derived from this study: PubMed 23846810Hermans 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.
Derived from this study: PubMed 22822562Michel 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.
Derived from this study: PubMed 22605788Hermans 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.
Derived from this study: PubMed 21939502Nobels 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.

Related trials for Diabetes

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Type 2 Diabetes
Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hermans, M. Prof. principal investigator

UCL

252 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes, run by AstraZeneca at 252 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 252 sites in Belgium, Greece, United Kingdom, Luxembourg, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00681850, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.