This is a cross-over study to evaluate if insulin infusion sets can be used up to 7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Insulin infusion sets will be used for up to 7 days or until failure
Insulin infusion sets will be used for up to 7 days or until failure
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, Germany
Time to infusion set failure due to an occlusion
an occlusion is defined by blood ketone concentration is \> or = 0.6 mmol/l with blood glucose (BG) concentration \>250 mg/dl, or BG concentration is \>250 mg/dl for more than 2 h and a subsequent correction bolus failed, or pump occlusion alarm that cannot be fixed.
Time frame: up to 7 days
Frequency of early infusion set changes
Time frame: up to 7 days
Time to early infusion set changes
Time frame: up to 7 days
Frequency of early infusion set changes due to infusion site infection
Time frame: up to 7 days
Median infusion set wearing time
Time frame: up to 7 days
Daily mean glucose
Based on Continuous Glucose Monitoring
Time frame: day 1, 2, 3, 4, 5, 6, 7
Daily mean glucose
Based on self measured blood glucose
Time frame: day 1, 2, 3, 4, 5, 6, 7
Total daily insulin dose
Time frame: day 1, 2, 3, 4, 5, 6, 7
Glucose variability
Coefficient of variation
Time frame: day 1, 2, 3, 4, 5, 6, 7
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