Closed-loop Control of Postprandial Glucose Levels in Children and Adults With Type 1 Diabetes
Status:
Withdrawn
Trial end date:
2018-07-01
Target enrollment:
Participant gender:
Summary
Current intensive insulin therapy in T1D involves prandial insulin boluses depending on the
carbohydrate content of each ingested meal. Carbohydrate content of ingested meals is the
main determinant of post-meal glucose excursion. Therefore, accurate carbohydrate counting is
a critical aspect of managing postprandial blood glucose levels in type 1 diabetes in order
to avoid too much or too little insulin resulting in hypoglycemia and hyperglycemia,
respectively. Precision of carbohydrate counting is associated with better glycemic control.
However, accurate carbohydrate counting is a challenging task for many patients with type 1
diabetes. Recent developments of continuous glucose sensors and insulin infusion pumps have
motivated the research toward "closed-loop'' strategies to regulate glucose levels in
patients with type 1 diabetes. In a closed-loop strategy, the pump insulin infusion rate is
altered based on a computer generated recommendation that rely on continuous glucose sensor
readings. A dual-hormone closed-loop strategy has also been recently proposed to regulate
glucose levels. In a dual-hormone strategy, subcutaneous insulin delivery is accompanied by
subcutaneous glucagon infusion. Postprandial meal glucose control with closed-loop strategy
still needs some improvements. The objective of this study is to test in outpatient
unrestricted settings whether, in the context of closed-loop strategy, conventional meal
carbohydrate counting could be reduced to a simplified qualitative meal size estimation
without a significant degradation in overall glycemic control in children and adult patients
with type 1 diabetes. The investigators hypothesize that 1) dual-hormone closed-loop strategy
with qualitative meal size estimation is equivalent to dual-hormone closed-loop strategy with
CHO counting in terms of mean glucose; 2) single-hormone closed-loop strategy with
qualitative meal size estimation is equivalent to single-hormone closed-loop strategy with
CHO counting in terms of mean glucose;