OPtimal Type 2 dIabetes Management Including Benchmarking and Standard Treatment in CEEMEA (OPTIMISE)
This study is currently recruiting participants.
Verified April 2013 by AstraZeneca
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01694758
First received: September 25, 2012
Last updated: April 19, 2013
Last verified: April 2013
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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
| Estimated Enrollment: | 500 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | January 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01694758
Contacts
| Contact: AstraZeneca Clinical Study Information | informatie.medicala@astrazeneca.com |
Locations
| Romania | |
| Research Site | Recruiting |
| Alexandria, Romania | |
| Research Site | Recruiting |
| Brasov, Romania | |
| Research Site | Recruiting |
| Bucuresti, Romania | |
| Research Site | Recruiting |
| Cluj, Romania | |
| Research Site | Recruiting |
| Constanta, Romania | |
| Research Site | Not yet recruiting |
| Craiova, Romania | |
| Research Site | Recruiting |
| Galati, Romania | |
| Research Site | Recruiting |
| Giurgiu, Romania | |
| Research Site | Recruiting |
| Iasi, Romania | |
| Research Site | Recruiting |
| Oradea, Romania | |
| Research Site | Recruiting |
| Pitesti, Romania | |
| Research Site | Not yet recruiting |
| Ploiesti, Romania | |
| Research Site | Recruiting |
| Satu Mare, Romania | |
| Research Site | Recruiting |
| Tg Jiu, Romania | |
| Research Site | Recruiting |
| Tg Mures, Romania | |
| Research Site | Recruiting |
| 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: | April 19, 2013 |
| Health Authority: | Romania: National Medicine and Medical Devices 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 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013