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QUESTION: Does training in flexible intensive insulin management (combining dietary freedom and insulin adjustment) improve glycaemic control and quality of life in patients with type 1 diabetes?
Randomised (allocation concealed*), unblinded,* wait list controlled trial with follow up at 6 months (Dose Adjustment for Normal Eating [DAFNE]).
3 hospital diabetes clinics in Sheffield, Northumbria, and London, UK.
169 patients >18 years of age with clinical features of type 1 diabetes, moderate or poor glycaemic control (glycated haemoglobin [HbA1c] 7.5–12%), and duration of diabetes >2 years without advanced complications. Exclusion criteria were inability to understand English, severe psychiatric illness, pregnancy, and unawareness of hypoglycaemia. 136 patients (80%) completed baseline and 6 month assessments (mean age 40 y, 56% women).
84 patients were allocated to the intervention, which comprised a 5 day skills course delivered by 2–3 educators (diabetes specialist nurses or dieticians) to groups of 6–8 participants in each …