Trial design
T1D
HYPOGLYCAEMIA
In this 16-week single arm within-participant controlled intervention study, adults with T1D completed a 4-week control period followed by a 12-week intervention period consisting of a dietitian-delivered LC diet (25–75 g/day digestible carbohydrates). Since multiple lifestyle factors influence T1D management, and with consideration of individual personal needs and preferences, a single arm within-patient intervention study where participants act as their own controls was deemed to be the most appropriate design. The primary outcome was HbA1c. Secondary outcomes were glycaemic variability (GV), frequency of hypoglycaemia, total daily insulin use, and quality of life. The study protocol containing full details of this clinical trial has been published elsewhere [