Epidemiologic Survey to Describe the Current Medical Practice of General Practitioners Treating Subjects With Type 2 Diabetes Mellitus in Latina (DEAL)
|Study Design:||Observational Model: Other
Time Perspective: Cross-Sectional
|Official Title:||A Multi-center, Epidemiologic Survey to Describe the Current Medical Practice of General Practitioners Treating Subjects With Type 2 Diabetes Mellitus in Latin America|
- The achievement of the planned completed number of questionnaires. [ Time Frame: up to 1 year ]
- Changes in glycemic parameters in accordance with the historical information provided by the GPs and her/his judgement of control based on that information. [ Time Frame: up to 1 year ]
- Proportion of subjects who respond to any given treatment applied through the level of HbA1c responders (defined as subjects who have achieved HbA1c <7%) [ Time Frame: up to 1 year ]
- Assessment of total cholesterol [ Time Frame: up to 1 year ]
- Assessment of free fatty acids [ Time Frame: up to 1 year ]
- Assessment of high-density lipoprotein [ Time Frame: up to 1 year ]
- Assessment low-density lipoprotein [ Time Frame: up to 1 year ]
- Assessment of triglycerides [ Time Frame: up to 1 year ]
- Assessment of LDL relative flotation [ Time Frame: up to 1 year ]
- Assessment of total cholesterol/HDL ratio [ Time Frame: up to 1 year ]
- Assessment of LDL/HDL ratio [ Time Frame: up to 1 year ]
- Assessment of fasting blood glucose [ Time Frame: up to 1 year ]
|Study Start Date:||October 2004|
|Study Completion Date:||October 2005|
|Primary Completion Date:||October 2005 (Final data collection date for primary outcome measure)|
males and females between 18 and 75 years of age who been diagnosed with T2DM as defined by the American Diabetes Association
were receiving an oral hypoglycemic agent (OHA) or insulin
The DEAL (Diabetes En America Latina) study was a multicenter, cross-sectional, epidemiological, questionnaire based study carried out between October 2004 and October 2005 in 9 Latin American countries. General practitioners (GP) from private settings were selected for participation in the study if they were in full time active clinical practice (three or more days per week and treating at least 100 patients per week), had been practicing for at least two years and were seeing at least five type 2 diabetes mellitus (T2DM) patients per week. Over a period of two weeks after receipt of study questionnaires, GPs were required to review the charts of the first 10 (+/- 2) consecutive diabetic patients to visit the clinic and to provide information about their treatment in accordance with the supplied questionnaire.
Patients were eligible for inclusion in the study if they were males or females aged 18-75 with Type II Diabetes Mellitus - T2DM - (defined by the criteria of the American Diabetes Association (12)), were receiving an oral hypoglycemic agent (OHA) or insulin and had given written informed consent, where required. Measurement of glycosylated hemoglobin (HbA1c) performed at the diagnosis and within the previous three months was collected; if the measure was not available for the period, the sponsor supported the laboratory test when necessary, according to the physician's judgment of the patient's need.
Demographic data were collected including information regarding the patient's lifestyle. The most recent fasting blood glucose, lipid level and blood pressure measurements were recorded along with the existence of diabetes related complications such as dyslipidemia, hypertension, macrovascular diseases, eye disorders, kidney disorders, erectile dysfunction and diabetic neuropathy. Antidiabetic medication and/or insulin therapy and therapy for prevention of macrovascular events were also recorded. Information was collected on visits to specialists, challenges to managing the patient's T2DM and on future plans for management. No explanations or clarifications related to the questions were provided and the physicians answered them based on their own understanding. Instructions on how to answer the questionnaire were provided to maximize the validation of the questionnaires.
Descriptive statistical analysis was performed on all variables. Multivariate logistic regression analyses were performed to test the possibility of association between the outcome measures and duration of disease. The independent variables were age, gender, BMI (body-mass index) category, current prescription, drug insurance coverage, glycemic management, lifestyle, number of co-morbidities and compliance to recommendations/therapy. All statistical analyses were conducted using SAS software. A p value <0.05 was considered statistically significant.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01387165
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|