Epidemiologic Survey to Describe the Current Medical Practice of General Practitioners Treating Subjects With Type 2 Diabetes Mellitus in Latina
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Treatment
Intervention type(s): Drug
Intervention description(s): were receiving an oral hypoglycemic agent (OHA) or insulin
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Males and females 18-75 years of age, inclusive, with T2DM, as defined by the criteria of
        the American Diabetes Association (2003), under oral anti-diabetics (OAD) or insulin
        treatment for diabetes and that have given written informed consent.

        The total number of patients planned for this study was up to 6,000 patients: Mexico -
        1,500, Argentina - 1,000, Brazil - 1,500, CariCam - 1,100 (Colombia, Costa Rica, Ecuador,
        Guatemala, Honduras, Peru, Dominican Republic and Venezuela) and Chile - 500.
      
Keywords: Latin America; diabetes complications; patient compliance; Diabetes mellitus, type 2; health services accessibility