OPtimal Type 2 dIabetes Management Including Benchmarking and Standard Treatment in CEEMEA

Diabetes Mellitus, Non-Insulin-Dependent Clinical Trial

— OPTIMISE  

Official title:

OPtimal Type 2 dIabetes Management Including Benchmarking and Standard Treatment in CEEMEA (OPTIMISE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01694758
• Other study ID #: NIS-CME-XXX-2012/1
• Status: Completed
• Phase: N/A
• First received: September 25, 2012
• Last updated: August 13, 2014
• Start date: November 2012
• Est. completion date: March 2014

Study information

• Verified date: August 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Medicine and Medical Devices AgencyBulgaria: Bulgarian Drug Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 733
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Non-Insulin-Dependent
• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
Bulgaria	Research Site	Blagoevgrad
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Sofia
Romania	Research Site	Alexandria
Romania	Research Site	Brasov
Romania	Research Site	Bucuresti
Romania	Research Site	Cluj
Romania	Research Site	Constanta
Romania	Research Site	Craiova
Romania	Research Site	Galati
Romania	Research Site	Giurgiu
Romania	Research Site	Iasi
Romania	Research Site	Oradea
Romania	Research Site	Pitesti
Romania	Research Site	Ploiesti
Romania	Research Site	Satu Mare
Romania	Research Site	Tg Jiu
Romania	Research Site	Tg Mures
Romania	Research Site	Timisoara

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Bulgaria,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Quality of patient care improvement, in particular the control of diabetes, lipids and blood pressure	To investigate whether the use of benchmarking could improve quality of patient care, in particular the control of diabetes, lipids and blood pressure	after 12 months of follow-up versus baseline	No
Secondary	Markers of preventive screening	To follow up evolution markers of preventive screening; retinopathy, neuropathy, dietary counseling, smoking habits, BMI, waist circumference, physical activity	after 12 months of follow-up versus baseline	No
Secondary	The LDL cholesterol parameter of the primary and secondary objectives according to ATP III guidelines	To investigate the LDL cholesterol parameter of the primary and secondary objectives according to ATP III guidelines	after 12 months of follow-up versus baseline	No