German Multi-centered, randomized, crossover study in diabetic patients evaluating two infusion sets under real life conditions at home. Subjects will be randomized to use one of the infusion set devices during the first period of 4 weeks, and be switched to the other infusion set for the second period of 4 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
80
Insulin pump device used for 4-weeks under real life conditions
Insulin pump device used for 4-weeks under real life conditions
Unnamed facility
Aschaffenburg, Germany
Unnamed facility
Berlin, Germany
Unnamed facility
Berlin, Germany
Unnamed facility
Rostock, Germany
Unnamed facility
Ulm, Germany
Perception of pain during infusion set insertion assessed by means of a visual analogue scale (VAS)
Time frame: 8 weeks
Incidence of kinked cannulas
Time frame: 8 weeks
Pump settings, including insulin dosage
Time frame: 8 weeks
Device satisfaction/preference as assessed by patient surveys
Time frame: 8 weeks
Investigator assessment of patient device use
Time frame: At Baseline and Week 4
Incidence of adverse events
Time frame: 8 weeks
Insulin set replacement pattern
Time frame: 8 weeks
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