Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation - Part 2
Status:
Completed
Trial end date:
2017-03-01
Target enrollment:
Participant gender:
Summary
In previous studies, investigators have studied if a pre-meal insulin bolus based on
estimated carbohydrate meal size would alleviate the burden of carbohydrate counting without
a significant degradation in postprandial glucose control. With this strategy, the patient
would only have to evaluate the size of the meal in terms of carbohydrate (snack, regular,
large or very large). It is however important to establish the safety of this simplified meal
bolus approach. The safety of overestimating a meal insulin bolus in the context of
closed-loop strategy needs to be assessed. For ethical reasons, only dual-hormone closed-loop
will be tested.
Investigators hypothesize that dual-hormone closed-loop with overestimated meal size bolus
will not increase time below 4.0 mmol/L compared to dual-hormone closed-loop with an
adequately estimated meal size bolus.