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Completed

NCT Number: NCT01694758

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

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.

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Key information

Conditions

Diabetes Mellitus, Non-Insulin-Dependent Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Blagoevgrad, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of patients in the benchmarking group achieving pre-set targets for HbA1c1

    Time frame: 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 outcomes

  1. Quality of patient care improvement, in particular the control of diabetes, lipids and blood pressure

    Time frame: 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

  2. Markers of preventive screening

    Time frame: 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

  3. The LDL cholesterol parameter of the primary and secondary objectives according to ATP III guidelines

    Time frame: 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: OPTIMISE

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 27, 2012
Registry last updated
Aug 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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