INS and diabetes mellitus: As shown in Table 3, the following were associated with greater frequency of hypoglycaemia overall (level 1 or worse) and with at least a consistent direction of effect for the more severe levels; female sex; longer diabetes duration; lower HbA1c; greater self-monitored glucose and glucose variability; higher score for hypoglycaemia across the 6 week baseline period; using human rather than analogue only insulin; lower BMI; lower diastolic BP; lower total cholesterol; lower triglycerides; and use of anti-inflammatory and psychoactive drugs.