Objective: To evaluate the effect of system interventions (data recording procedures and
complete coverage of medications and supplies) with or without physician and/or patient
education, upon the psychological, clinical, metabolic and therapeutic indicators and the
costs of care of people with type 2 diabetes.
Design: Randomized 2x2 design; sample size was determined considering the change in
haemoglobin A1c (primary outcome variable) using a two-sided test at the 5% level of
significance, and 80% power using a paired t-test. Sample size was increased by 25% to
account for non-independence and patient drop-out.
Setting: Primary care level in the city of Corrientes, Argentina with involvement of all
three Argentinean health subsectors (public health, social security and the private, prepaid
Participants: 36 general practitioners and 468 adults (62-71% women, mean age 62 years) with
type 2 diabetes. Patients of the participating physicians (nine in each group), were randomly
selected and assigned to one of four groups (117 patients each): control, provider education,
patient education, and provider/patient education.
Intervention: Structured group education programmes were delivered to provider and/or people
with type 2 diabetes by trained professionals; identical system interventions were applied to
all four groups.
Main outcome measures: Body mass index, blood pressure, fasting glucose, haemoglobin A1c
levels, lipid profile, drug consumption, resource use, and patient well being (WHO-5
questionnaire and Lowe score), at baseline and up to 42 months at every 6 months intervals.