Glycaemic control and severe hypoglycaemia following training in flexible, intensive insulin therapy to enable dietary freedom in people with type 1 diabetes:: a prospective implementation study

Aims/hypothesis: The aim of this study was to evaluate the implementation of a course teaching flexible, intensive insulin therapy on glycaemic control and severe hypoglycaemia in routine care. Methods: This is a continuous quality-assurance project involving hospital diabetes centres. Every third year each centre re-examines 50 consecutive patients (evaluation sample) 1 year after participation in the course. Ninety-six diabetes centres in Germany participated and 9,583 patients with type 1 diabetes (190 evaluation samples) were re-examined between 1992 and 2004. The intervention was a 5-day inpatient course for groups of up to ten patients with a fixed curriculum of education and training for dietary flexibility and insulin adjustment. The main outcome measures were HbA(1)c and severe hypoglycaemia. Results: Mean baseline HbA(1)c was 8.1%, and had decreased to 7.3% at follow-up; incidence of severe hypoglycaemia was 0.37 events per patient per year prior to intervention and 0.14 after intervention. In mixed-effects models adjusted for effects of centres, age and diabetes duration, the mean difference was -0.7% (95% CI -0.9 to -0.6%, p < 0.0001) for HbA(1)c and -0.21 events per patient per year (95% CI -0.32 to -0.11, p=0.0001) for severe hypoglycaemia, with similar results for evaluation samples, with a maximum of 10% of patients lost to follow-up. Before intervention, the incidence of severe hypoglycaemia was three-fold higher in the lowest quartile than in the highest quartile of HbA(1)c, whereas the risk was comparable across the range of HbA(1)c values after intervention. Conclusions/interpretation: Implemented as part of a continuous quality-assurance programme the self-management programme is effective and safe in routine care. Improvement of glycaemic control can be achieved without increasing the risk of severe hypoglycaemia.