drugset / Trial / NCT02846857

Closed-loop Control of Glucose Levels (Artificial Pancreas) for 15 Weeks in Adolescents and Adults With Type 1 Diabetes

NCT02846857

RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
Primary completion
2019-07-22
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Glucagon Peptide Subcutaneous
Comparator Insulin Lispro Protein / enzyme biologic Subcutaneous
Comparator Insulin glulisine Protein / enzyme biologic Subcutaneous
Comparator insulin aspart Protein / enzyme biologic Subcutaneous