drugset / Trial / NCT02488616

Closed-loop Control of Glucose Levels (Artificial Pancreas) for 5 Days in Adults With Type 1 Diabetes

NCT02488616

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 main objective of this project is to compare the efficacy of single-hormone closed-loop strategy and sensor-augmented pump therapy to regulate glucose levels in outpatient settings for 5 consecutive days in adults with type 1 diabetes. The investigators hypothesized that single-hormone closed-loop strategy will increase the time spent in the target range compared to sensor-augmented pump therapy.

Timeline

Start
2018-03
Primary completion
2018-11
Completion
2018-11

Drugs

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