drugset / Trial / NCT02846831

Closed-loop Control of Glucose Levels (Artificial Pancreas) for 12 Days in Adults With Type 1 Diabetes

NCT02846831

Phase 2 Completed 36 enrolled Montreal Clinical Research Institute
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. The objective of this study is to compare the effectiveness of single-hormone closed-loop and sensor-augmented pump therapy in regulating day-and-night glucose levels in adults with T1D for 12 days in outpatient settings. The investigators hypothesize that dual-hormone closed-loop will increase the percentage of time of glucose levels spent in the target range in adults compared to single-hormone closed-loop, which in turn will be more effective than sensor-augmented pump therapy.

Timeline

Start
2019-01-24
Primary completion
2020-01-27
Completion
2020-01-27

Drugs

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