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

Completed

• Conditions: Diabetes Mellitus, Non-Insulin-Dependent

• Registration Number: NCT01694758
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-25
• Study First Submitted QC: 2012-09-26
• Study First Posted: 2012-09-27
• Study Start: 2012-11
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-13
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 733

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients in the benchmarking group achieving pre-set targets for HbA1c1	after 12 months of follow-up	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

Secondary Outcome Measures

Name	Time	Method
The LDL cholesterol parameter of the primary and secondary objectives according to ATP III guidelines	after 12 months of follow-up versus baseline	To investigate the LDL cholesterol parameter of the primary and secondary objectives according to ATP III guidelines
Quality of patient care improvement, in particular the control of diabetes, lipids and blood pressure	after 12 months of follow-up versus baseline	To investigate whether the use of benchmarking could improve quality of patient care, in particular the control of diabetes, lipids and blood pressure
Markers of preventive screening	after 12 months of follow-up versus baseline	To follow up evolution markers of preventive screening; retinopathy, neuropathy, dietary counseling, smoking habits, BMI, waist circumference, physical activity

Trial Locations

Locations (1)

Research Site; 🇷🇴 Timisoara, Romania