Efficacy of single hormone and dual hormone artificial pancreas during continuous and interval exercise in adult patients with type 1 diabetes: randomised controlled crossover trial
Aims/hypothesisThe aim of this study was to assess whether the dual hormone (insulin and glucagon) artificial pancreas reduces hypoglycaemia compared with the single hormone (insulin alone) artificial pancreas during two types of exercise.MethodsAn open label randomised crossover study comparing both systems in 17 adults with type 1 diabetes (age, 37.2 13.6 years; HbA1c, 8.0 1.0% [63.9 10.2 mmol/mol] during two exercise types on an ergocycle and matched for energy expenditure: continuous (60% V.O2peak$ \overset{{V}\mathrm{O}}_{2\mathrm{peak} for 60 min) and interval (2 min alternating periods at 85% and 50% V.O2peak$ \overset{{V}\mathrm{O}}_{2\mathrm{peak} for 40 min, with two 10 min periods at 45% V.O2peak$ \overset{{V}\mathrm{O}}_{2\mathrm{peak} at the start and end of the session) Blocked randomisation (size of four) with a 1:1:1:1 allocation ratio was computer generated. The artificial pancreas was applied from 15:30 hours until 19:30 hours; exercise was started at 18:00 hours and announced 20 min earlier to the systems. The study was conducted at the Institut de recherches cliniques de Montreal.ResultsDuring single hormone control compared with dual hormone control, exercise induced hypoglycaemia (plasma glucose <3.3 mmol/l with symptoms or <3.0 mmol/l regardless of symptoms) was observed in four (23.5% vs two (11.8% interventions (p 0.5) for continuous exercise and in six (40% vs one (6.25% intervention (p 0.07) for interval exercise. For the pooled analysis (single vs dual hormone) the median (interquartile range) percentage time spent at glucose levels below 4.0 mmol/l was 11% (0.0 46.7% vs 0% (0 0% p 0.0001) and at glucose levels between 4.0 and 10.0 mmol/l was 71.4% (53.2 100% vs 100% (100 100% p 0.003) Higher doses of glucagon were needed during continuous (0.126 0.057 mg) than during interval exercise (0.093 0.068 mg) (p 0.03) with no reported side effects in all interventions.Conclusions/interpretationThe dual hormone artificial pancreas outperformed the single hormone artificial pancreas in regulating glucose levels during announced exercise in adults with type 1 diabetes.Trial registration:ClinicalTrials.gov NCT01930110Funding:Societe Francophone du Diabete and Diabete Quebec
Diabetologia