Closed-loop Control of Glucose Levels (Artificial Pancreas) for 15 Weeks in Adolescents and Adults With Type 1 Diabetes
Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,
insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required
insulin dosages based on the sensor's readings. A dual-hormone closed loop strategy regulates
glucose levels through the infusion of two hormones: insulin and glucagon.
The objective of this study is to compare, in a randomized multicenter trial, the
effectiveness of single-hormone closed-loop, dual-hormone closed-loop, and sensor-augmented
pump therapy with low-glucose suspend in regulating day-and-night glucose levels in
outpatient settings for 15 weeks in adolescents and adults.
The investigators hypothesize that dual-hormone closed-loop will reduce time spent in
hypoglycemia compared to single-hormone closed-loop, which in turn will be more effective
than sensor-augmented pump therapy with low-glucose suspend.