Summary of Study Procedures
POTENTIALLY ELIGIBLE
- Diabetes Mellitus (type 1 or 2)
- Male or Female
- No diagnosed occlusive arterial disease
- Aged >= 40 years
IDENTIFICATION AND INVITATION
- Potentially eligible patients identified from existing diabetes registers and databases
- Permission sought from GP to approach suitable individuals
- Invitation letter sent (by GP or Diabetologist) with Information Leaflet, Consent Form and brief Screening Questionnaire (& central Freefone number for any questions)
SCREENING PROCESS (-2 MONTHS)
- Screening Questionnaire [PDF] returned, which identifies eligible and consenting patients
- Run-in pack with 2-month supply of treatment mailed to patient
- GP informed of patient's possible participation, and asked to return form if patient not to be randomised
- Blood and urine samples (optional) collected locally and mailed to central laboratory
- Freefone number for medical advice and any questions
RANDOMISATION (0 MONTHS)
- Randomisation Questionnaire [PDF] sent to re-confirm eligibility, and to characterize the patient more fully
- Randomisation Questionnaire returned, and eligible patient randomised by central computer
- Allocated treatment pack mailed to patient: 100 mg aspirin daily or matching placebo tablet, and 1g omega-3 FA daily or matching placebo capsule
- GP informed of patient's randomisation
FOLLOW-UP QUESTIONNAIRES (6-monthly)
- Follow-up Questionnaires [PDF] and treatment packs sent 6-monthly
- Freefone number for medical advice and any questions
- Further details sought from responsible clinicians about any relevant events reported on Follow-up questionnaires
- Flagging for mortality and cancer at central registries