This is an open label, interventional, monocentric, prospective early feasibility study, designed to evaluate the safety of implant and short-term integration into the tissue of the YANG sensor. In addition, the set up will enable data collection which will be used to develop the software algorithm to allow real-time, continuous measurement of glucose, ketone and lactate levels in the interstitial fluid in adults with diabetes mellitus, in a future version of the device.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
7
The YANG SENSOR is an active implantable device, that is intended to be implanted in the subcutaneous abdominal tissue, approximately 10mm below the skin. The SENSOR is battery powered. The battery is wirelessly recharged through the skin by the YANGEXD, using a charging coil ('Donut') applied to the skin with an adhesive patch at the level of the SENSOR. The 'Donut' also receives data from the sensor.
University Hospital Antwerp
Edegem, Antwerp, Belgium
Incidence of device-related or sensor insertion/removal procedure-related adverse events
Time frame: 57 days
Assessment of foreign body reaction due subcutaneous implantation with biopsy
Assessment of i.e. inflammation, infection, tissue vascularization, formation of fibrotic scar tissue
Time frame: 27 days
Incidence of sensor failure
Time frame: 27 days
Collection of users feedback in the form of clinical questionnaire to assess the 'easiness' of surgical procedure with questionnaire
Time frame: 1 day
Requirements of duration of implantation and explantation procedure
Time frame: 27 days
Post explantation follow-up
Removal of sutures and wound healing after 10 days post explantation of the sensor. Follow-up via phone call after 30 days
Time frame: 30 days
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