OPtimal Type 2 dIabetes Management Including Benchmarking and Standard Treatment in CEEMEA
OPTIMISE
1 other identifier
observational
733
2 countries
20
Brief Summary
OPTIMISE-CEEMEA is a multinational, multi-centre, observational, prospective study which will include patients suffering from diabetes type 2, treated or untreated, insulin dependent or not insulin dependent. In this study we aim to explore at a primary care level whether the use of benchmarking against a set of guideline-based reference values on a patient basis, may improve quality of patient care, in particular control of diabetes, lipids and blood pressure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2012
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2012
CompletedFirst Posted
Study publicly available on registry
September 27, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedAugust 15, 2014
August 1, 2014
1.3 years
September 25, 2012
August 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients in the benchmarking group achieving pre-set targets for HbA1c1
To investigate whether the use of benchmarking could improve quality of patient care, in particular the control of diabetes, lipids and blood pressure, expressed as the percentage of patients in the benchmarking group achieving pre-set targets for HbA1c1
after 12 months of follow-up
Secondary Outcomes (3)
Quality of patient care improvement, in particular the control of diabetes, lipids and blood pressure
after 12 months of follow-up versus baseline
Markers of preventive screening
after 12 months of follow-up versus baseline
The LDL cholesterol parameter of the primary and secondary objectives according to ATP III guidelines
after 12 months of follow-up versus baseline
Study Arms (1)
Patients with diabetes type 2
Eligibility Criteria
Patients with diabetes type 2
You may qualify if:
- Subjects suffering from diabetes type 2,
- treated or untreated,
- insulin dependent or not insulin dependent Able to read and send SMS (if SMS applicable)
You may not qualify if:
- Type 1 diabetes Pregnancy diabetes
- Hospitalization at the moment of enrollment in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (20)
Research Site
Blagoevgrad, Bulgaria
Research Site
Pleven, Bulgaria
Research Site
Plovdiv, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Alexandria, Romania
Research Site
Brasov, Romania
Research Site
Bucharest, Romania
Research Site
Cluj-Napoca, Romania
Research Site
Constanța, Romania
Research Site
Craiova, Romania
Research Site
Galati, Romania
Research Site
Giurgiu, Romania
Research Site
Iași, Romania
Research Site
Oradea, Romania
Research Site
Piteşti, Romania
Research Site
Ploieşti, Romania
Research Site
Satu Mare, Romania
Research Site
Tg Jiu, Romania
Research Site
Tg Mures, Romania
Research Site
Timișoara, Romania
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dan Isacoff, ASSOC. PROF.
University of Medicine and Pharmacy Carol Davila, Bucharest, Romania
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2012
First Posted
September 27, 2012
Study Start
November 1, 2012
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
August 15, 2014
Record last verified: 2014-08