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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01694758
First received: September 25, 2012
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

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.


Condition
Diabetes Mellitus, Non-Insulin-Dependent

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: OPtimal Type 2 dIabetes Management Including Benchmarking and Standard Treatment in CEEMEA (OPTIMISE)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percentage of patients in the benchmarking group achieving pre-set targets for HbA1c1 [ Time Frame: after 12 months of follow-up ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: after 12 months of follow-up versus baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: after 12 months of follow-up versus baseline ] [ Designated as safety issue: No ]
    To investigate the LDL cholesterol parameter of the primary and secondary objectives according to ATP III guidelines


Enrollment: 733
Study Start Date: November 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with diabetes type 2

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with diabetes type 2

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694758

Locations
Bulgaria
Research Site
Blagoevgrad, Bulgaria
Research Site
Pleven, Bulgaria
Research Site
Plovdiv, Bulgaria
Research Site
Sofia, Bulgaria
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, Romania
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Dan Isacoff, ASSOC. PROF. University of Medicine and Pharmacy Carol Davila, Bucharest, Romania
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01694758     History of Changes
Other Study ID Numbers: NIS-CME-XXX-2012/1
Study First Received: September 25, 2012
Last Updated: August 13, 2014
Health Authority: Romania: National Medicine and Medical Devices Agency
Bulgaria: Bulgarian Drug Agency

Keywords provided by AstraZeneca:
Benchmarking could improve quality of patient care
ESC and ATP III Guidelines

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 19, 2014