Abstract
Single- and dual-hormone closed-loop systems (CLS) have the potential to reduce carbohydrate-counting burden for patients with type 1 diabetes; however, simplification of meal insulin calculation should not compromise glycemic control. We compared in a randomized outpatient pilot trial: 1) single-hormone CLS accompanied with carbohydrate-content matched boluses vs. accompanied with a simplified meal bolus strategy, and 2) dual-hormone CLS accompanied with carbohydrate-content matched boluses vs. accompanied with a simplified meal bolus strategy. Carbohydrate-matched boluses were based on participant's carbohydrate meal content estimation while the simplified strategy involved the selection, by participants, of a semi-quantitative meal carbohydrate-content size; snack, regular, large or very large meal. Participants also underwent sensor-augmented pump therapy. Basal insulin delivery was more aggressive with the simplified bolus. Twelve participants were recruited (48.2±16.0 years old; HbA1c 7.4±0.9%) to compare the 2 bolus strategies during single- and dual-hormone closed-loop delivery. Similar mean sensor glucose level (15-hour period; primary outcome) was achieved with the carbohydrate-matched boluses and simplified strategy using single-hormone (median [IQR]: 7.6 [7.2 to 8.1] vs. 8.0 [7.0 to 8.6] mmol/L; p=0.90) and dual-hormone CLS (7.6 [7.2 to 8.1] vs. 7.0 [6.4 to 8.2] mmol/L; p=0.08). Exploratory analyses showed that, as compared to sensor-augmented pump therapy, there was an increased time spent in hypoglycemia with the simplified strategy but not with the carbohydrate-matched boluses. Though the algorithm employed in this pilot study may lead to an increased risk for hypoglycemia, this strategy has the potential to reduce the carbohydrate counting burden in patients with type 1 diabetes while generally maintaining adequate glucose control.
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