Collection of Performance Data From the Integrated Sensor and Infusion Set. TRIAL 4
Recruitment status was: Not yet recruiting
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.
Diabetes Mellitus Type I
Diabetes Mellitus Type II
Device: Integrated sensor and infusion set.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- Accuracy endpoint [ Time Frame: 5 months ] [ Designated as safety issue: No ]Agreement Rate (% within 20%) using VEO Pump
- Safety endpoint [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]Descriptive summary of SAE, Adverse events and Device complaints
- Accuracy endpoint [ Time Frame: 5 months ] [ Designated as safety issue: No ]Agreement Rate (% within 20%) using re-analyzed Guardian® REAL-Time and Paradigm® REAL-Time algorithm data
- Accuracy endpoint [ Time Frame: 5 months ] [ Designated as safety issue: No ]MARD(%), BIAS(mg/dl), MAD(mg/dl) during study
|Study Start Date:||March 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
|Experimental: Integrated sensor and infusion set.||Device: Integrated sensor and infusion set.|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775059
|Fredericia, Denmark, 7000|
|Hilleroed, Denmark, 3400|
|Hvidovre, Denmark, 2650|
|Principal Investigator:||Ulrik Pedersen-Bjergaard, MD||Hilleroed Hospital|