The purpose of this study is to collect performance data on the Integrated sensor and infusion set during 3 days of use and demonstrate performance adequacy of the integrated sensor and infusion set with glucose sensing and insulin delivery functionalities. The hypothesis of this study is that having the infusion of insulin in close proximity to the sensor does not interfere with the sensor accuracy. This study focuses on high bolus patients. A high bolus is defined as 12 units or more.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Skåne University Hospital, Department of Endokrinology
Malmö, Sweden
Performance data
The purpose of this study is to collect performance data on the integrated sensor and infusion set during 3 days of use and demonstrate performance adequacy of the integrated sensor and infusion set with glucose sensing and insulin delivery functionalities.
Time frame: 4 months
Performance characteristics
Comparative analysis of performance characteristics of the sensors of the Integrated sensor and infusion set with the Enlite sensors will be performed. SMBG data will be used as reference.
Time frame: 4 months
Functionality
Gluco-dynamic effect of insulin delivered via the integrated sensor and infusion set demonstrating that insulin was successfully delivered.
Time frame: 4 months
Longevity
The longevity of the insulin delivery and glucose sensing functionalities will be assessed by comparing day 1 and day 3 of device wear
Time frame: 4 months
skin impact
Skin condition after removal of the integrated sensor and infusion set will be evaluated and assessed by the clinical staff in the study survey (CRF)
Time frame: 4 months
Physical duration
Investigational Center and subject's report on physical duration of the Integrated sensor and infusion set assessed in study survey (CFR)
Time frame: 4 months
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