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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01694758

Acronym

OPTIMISE

Enrollment

733

Registered

2012-09-27

Start date

2012-11-30

Completion date

2014-03-31

Last updated

2014-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Keywords

Benchmarking could improve quality of patient care, ESC and ATP III Guidelines

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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

Countries

Bulgaria, Romania

Outcome results