Closed-loop Control of Postprandial Glucose Levels in Adults With Type 1 Diabetes
Status:
Completed
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
Postprandial meal glucose control with closed-loop systems (CLS) still needs some
improvements. In the postprandial period, sensor delay in detecting blood glucose rise after
a meal together with delays in insulin absorption expose patients to early risk of
hyperglycemia and then to late-postprandial hypoglycemia. Glucagon infusion in dual-hormone
CLS has the potential to improve post-meal control as compared to single-hormone CLS allowing
a better glucose excursion related to a more aggressive insulin infusion while minimizing
hypoglycemic risk. Several approaches have been tested for the determination of prandial
boluses during closed-loop operation.
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 adult patients with type 1 diabetes.
The investigators hypothesize that in outpatient free-living conditions: 1) Dual-hormone CLS
with partial boluses is equivalent to dual-hormone CLS with full boluses in terms of mean
glucose; 2) Single-hormone CLS with partial boluses is equivalent to single-hormone CLS with
full boluses in terms of mean glucose. Secondary hypothesis are: 3) Dual-hormone CLS with
partial boluses will decrease time in hypoglycemia compared to single-hormone CLS with
partial boluses; 4) Dual-hormone CLS with partial boluses is better than sensor-augmented
pump therapy in terms of mean glucose; 5) Single-hormone CLS with partial boluses is better
than sensor-augmented pump therapy in terms of mean glucose.