Sample size
This was an exploratory study with an aim for at least 24 participants to complete both closed-loop and control therapy periods, with a minimum of 48 h of sensor glucose data for each of these participants. As previous studies using closed-loop systems in an inpatient setting and in outpatients requiring dialysis may not provide reliable information about the s.d. of the primary endpoint in this particular population, no formal power calculation was applied. The sample size corresponds to the sample size of previous feasibility closed-loop randomized trials