Flash glucose monitoring for the safe use of a 2-day intermittent energy restriction in patients with type 2 diabetes at risk of hypoglycaemia: an exploratory study

AIMS:Two medication change protocols were tested, both based on haemoglobin A1c (HbA1c), with one protocol also accounting for hypoglycaemic events. The aim was to compare the two protocols during intermittent energy restriction (5:2 diet). METHODS:Forty-two adults with type 2 diabetes (HbA1c ≥ 7% [53 mmol/mol], BMI of ≥27 kg/m2) treated with sulphonylureas and/or insulin were recruited and randomised 1:1 to fixed or adjusted medication protocols. Participants experiencing hypoglycaemia during a 2-week usual diet period then followed the 5:2 diet for 2 weeks (2 non-consecutive very-low-calorie days [500-600 kcal] and 5 habitual eating days/week), following the allocated medication protocol. The primary outcome was to determine if the adjusted protocol was superior to the fixed protocol at reducing hypoglycaemic events during the 5:2 diet. Flash glucose monitoring was used throughout to detect hypoglycaemia. RESULTS:There was a significant difference in change in the number of hypoglycaemic events between fixed and adjusted protocols (-1.0 vs. -3.5; P = 0.04). Over 60% of participants on the adjusted protocol had no hypoglycaemic events. CONCLUSIONS:This pilot study demonstrates the importance of assessing the risk of hypoglycaemia before starting a 5:2 diet and that the adjusted medication protocol is likely the best option for patients at risk. CLINICAL TRIAL REGISTRY:This study has been registered with the Australia New Zealand Clinical Trial Registry (ANZCTR) www.anzctr.org.au and given the registration number ACTRN12617000512325.S. Carter, P. M. Clifton, J. P. Keog