Weight-based hypoglycaemia treatment protocol for adults with Type 1 diabetes: a randomized crossover clinical trial

To determine whether a weight-based hypoglycaemia treatment using 0.3 g/kg (or 0.2 g/kg) glucose effectively treats adults with Type 1 diabetes mellitus compared with an internationally recommended 15-g treatment.

Patients with frequent hypoglycaemia were recruited from hospital-based diabetes clinics. The treatment for each hypoglycaemic episode, defined as capillary glucose <4.0 mmol/l, was randomly assigned to one of three protocols: 0.2 g/kg, 0.3 g/kg, or 15 g, using Dextro(TM) glucose tablets (Dextro Energy, Krefeld, Germany). Each participant received each treatment in random order for up to 15 hypoglycaemic episodes. Capillary glucose was re-tested 10 min after treatment, with a repeat dose if still < 4 mmol/l.

The study recruited 34 participants aged 22-71 years, whose mean (sd) BMI was 25.2 (3.1) kg/m(2) and HbA1c 63 (10.4) mmol/mol [7.9 (0.9)%]. Two people withdrew because they did not like the taste of the Dextro tablets and one was excluded because they used their own glucose preparation. Unadjusted for clustering within participants, the mean (sd) capillary glucose after 10 min was 4.67 (1.25) mmol/l for 0.3 g/kg (141 episodes), 4.29 (0.94) mmol/l for 0.2 g/kg (132 episodes), and 4.37(0.99) mmol/l for 15 g (136 episodes). Capillary glucose, adjusted for clusters and baseline, was higher after 10 min for 0.3 g/kg glucose compared with 15 g glucose; a difference of 0.26 (95% CI 0.04-0.48) mmol/l (P = 0.02), but not for 0.2 g/kg; -0.07 (95% CI -0.29-0.16) mmol/l (P = 0.56). Capillary glucose for only three hypoglycaemic episodes rose above 8 mmol/l.

A weight-based protocol of 0.3 g/kg glucose appears more effective for treating symptomatic hypoglycaemia in adults with Type 1 diabetes than either the most common current recommendation of 15 g glucose or a 0.2 g/kg glucose dose.