This is a multi-center, non-randomized, and interventional study in which subjects will use the Integrated sensor and infusion set with MiniLink Transmitter and the Medtronic Paradigm® VEO™ insulin pump (Sensor augmented pump) for 15 days. The purpose of this study is to collect performance data on the Integrated sensor and infusion set for approximately 15 days, with the intention for each subject to wear 5 sets for 3 days each.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Fredericia Hospital
Fredericia, Denmark
Hilleroed Hospital
Hilleroed, Denmark
Hvidovre Hospital
Hvidovre, Denmark
Accuracy endpoint
Agreement Rate (% within 20%) using VEO Pump
Time frame: 5 months
Safety endpoint
Descriptive summary of SAE, Adverse events and Device complaints
Time frame: 5 months
Accuracy endpoint
Agreement Rate (% within 20%) using re-analyzed Guardian® REAL-Time and Paradigm® REAL-Time algorithm data
Time frame: 5 months
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