Intensive Self-care on Glycemic Control in Outpatients With Type 2 Diabetes Mellitus: The Diabetes Care (D-CARE) Study

Educação em saúde Intensiva na atenção primária à saúde em Pacientes Com Diabetes Mellitus Tipo 2: um Ensaio clínico Randomizado - The Diabetes Care (D-CARE) Study

Type 2 diabetes mellitus (T2DM) leads to a high burden of morbidity and mortality, usually attributable to cardiovascular (CVD) causes. A major concern about the disease is that the success of the treatment is highly dependent on self-management, which very often incurs the necessity of behavior change. However, modifying such behaviors, usually linked to daily-life activities, is challenging. Then, the investigators aimed to test the optimal self-management that could be achieved in a reasonable manner carried forward through the Prochaska and DiClemente behavior-changing strategy in a follow-up of 18 months, compared to usual care. Our primary outcome is the between-group difference in HbA1c (%) levels.

Inclusion Criteria:

• Outpatients diagnosed with type 2 diabetes mellitus - T2DM (HbA1c % - ≥ 6.5%, or taking at least one oral hypoglycaemic agent, or medical diagnosis);
• To be regularly assisted by the Sistema Único de Saúde and to have been saw at least one year before randomization;
• Readiness for behavior-changing within the pre-action stages: pre-contemplation, contemplation and preparation;
• T2DM patient of challenging handling (e.g., frequent hypoglycaemic seizures, cardiovascular disease (CVD), etc.);

Exclusion Criteria:

• Pregnant women;
• People living with HIV/AIDS;
• T2DM patients taking erythropoietin, recent blood loss, recent blood transfusion and severe anaemia;
• T2DM patients with CVD under non-optimized treatment; or those that made any CVD procedure; or CVD event (e.g., myocardial infarction) within three months before randomization;
• T2DM patients with severe eye and retine disease;
• Patients participating in another study simultaneously;
• Patients living with others in the same place.