Clinical trial NCT01694758: OPtimal Type 2 dIabetes Management Including Benchmarking and Standard Treatment in CEEMEA
Official title: OPtimal Type 2 dIabetes Management Including Benchmarking and Standard Treatment in CEEMEA (OPTIMISE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Keywords: Benchmarking could improve quality of patient care
ESC and ATP III Guidelines
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-09-27
Enrollment: 733
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diabetes type 2

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.


Eligibility criteria: Inclusion Criteria:

* Subjects suffering from diabetes type 2,
* treated or untreated,
* insulin dependent or not insulin dependent Able to read and send SMS (if SMS applicable)

Exclusion Criteria:

* Type 1 diabetes Pregnancy diabetes
* Hospitalization at the moment of enrollment in the study

Primary outcomes:
measure: Percentage of patients in the benchmarking group achieving pre-set targets for HbA1c1
timeFrame: after 12 months of follow-up
Secondary outcomes:
measure: Quality of patient care improvement, in particular the control of diabetes, lipids and blood pressure
timeFrame: after 12 months of follow-up versus baseline
measure: Markers of preventive screening
timeFrame: after 12 months of follow-up versus baseline
measure: The LDL cholesterol parameter of the primary and secondary objectives according to ATP III guidelines
timeFrame: after 12 months of follow-up versus baseline
Other outcomes:
Locations:
city: Blagoevgrad
country: Bulgaria
facility: Research Site
city: Pleven
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Alexandria
country: Romania
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Cluj
country: Romania
facility: Research Site
city: Constanta
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Galati
country: Romania
facility: Research Site
city: Giurgiu
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
city: Pitesti
country: Romania
facility: Research Site
city: Ploiesti
country: Romania
facility: Research Site
city: Satu Mare
country: Romania
facility: Research Site
city: Tg Jiu
country: Romania
facility: Research Site
city: Tg Mures
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
Study officials:
affiliation: University of Medicine and Pharmacy Carol Davila, Bucharest, Romania
name: Dan Isacoff, ASSOC. PROF.
role: PRINCIPAL_INVESTIGATOR
References: