Recent developments of continuous glucose sensors and insulin infusion pumps have motivated the research toward closed-loop strategies to regulate glucose levels in patients with type 1 diabetes. In a closed-loop strategy, the pump(s) infusion rate is altered based on a computer-generated recommendation that relies on continuous glucose sensor readings. In this study, we aim to compare the effectiveness of dual-hormone (insulin+glucagon) closed-loop strategy to open-loop conventional continuous subcutaneous insulin infusion pump (CSII) therapy in regulating glucose levels during an evening exercise and on a night following an exercise in adults with type 1 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Institut de Recherches Cliniques de Montréal (IRCM)
Montreal, Quebec, Canada
Percentage of time of plasma glucose concentrations spent in target range (4.0-10.0 mmol/l from 4:00p.m.-11:00p.m. and 4.0-8.0 mmol/l from 11:00p.m.-7:00a.m.)
Time frame: 4 p.m. - 7 a.m.
Percentage of time of plasma glucose concentrations spent in the low range (< 4.0 mmol/l).
Time frame: 4 p.m. - 7 a.m.
Percentage of time of plasma glucose concentrations spent in the high range (>10.0 mmol/l from 4:00p.m.-11:00 p.m. and >8.0 mmol/l from 11:00 p.m.-7:00 a.m.).
Time frame: 4 p.m. - 7 a.m
Percentage of overnight time of plasma glucose concentrations spent in target range (4.0 - 8.0 mmol/l).
Time frame: 11 p.m. - 7 a.m.
Percentage of overnight time of plasma glucose concentrations spent in the low range ( < 4.0 mmol/l).
Time frame: 11 p.m. - 7 a.m.
Percentage of overnight time of plasma glucose concentrations spent in the high range (above 8 mmol/l).
Time frame: 11 p.m. - 7 a.m.
Total insulin delivery.
Time frame: 4 p.m. - 7 a.m.
Total overnight insulin delivery (11 p.m. - 7 a.m.).
Time frame: 11 p.m. - 7 a.m.
Standard deviation and/or MAGE (Mean Amplitude of Glycemic Excursions) index of plasma glucose concentrations as measures of glucose variability.
Time frame: 4 p.m. - 7 a.m.
Number of subjects with at least one plasma glucose measurement less than 3.9 mmol/l.
Time frame: 4 p.m. - 7 a.m.
Number of subjects with at least one overnight plasma glucose measurement less than 3.9 mmol/l.
Time frame: 11 p.m. - 7 a.m
Number of subjects with at least one exercise-induced plasma glucose measurement less than 3.9 mmol/l.
Time frame: 5:50 p.m. - 7:20 p.m
Number of subjects with as at least one plasma glucose measurement below 3.3 mmol/l.
Time frame: 4 p.m. - 7 a.m.
Number of subjects with at least one overnight plasma glucose measurement below 3.3 mmol/l.
Time frame: 11 p.m. - 7 a.m
Number of subjects with at least one exercise-induced plasma glucose measurement below 3.3 mmol/l.
Time frame: 5:50 p.m. - 7:20 p.m
Number of subjects with as at least one plasma glucose measurement below 3.0 mmol/l.
Time frame: 4 p.m. - 7 a.m.
Number of subjects with at least one overnight plasma glucose measurement below 3.0 mmol/l.
Time frame: 11 p.m. - 7 a.m
Number of subjects with at least one exercise-induced plasma glucose measurement below 3.0 mmol/l.
Time frame: 5:50 p.m. - 7:20 p.m
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