An interventional study of The YANG SENSOR is an active implantable device, for Real Time Continuous Glucose, Lactate and Ketone Measurement in Diabetes Mellitus and Glucose, sponsored by Indigo Diabetes NV. Completed at 1 site in Belgium. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-21.
Sponsored by Indigo Diabetes NV · Not applicable, Interventional, and Device feasibility
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.
10,926 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 7 is below the median of 80 across 8,368 interventional studies indexed under Diabetes Mellitus.
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T1DM patients
Healthy Volunteers
Exclusion Criteria:
Device: The YANG SENSOR is an active implantable device, for Real Time Continuous Glucose, Lactate and Ketone Measurement
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.
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
Assessment of sensor ability to measure glucose and β-hydroxybutyrate and lactate levels to allow the development of the algorithm
Exploratory endpoint
Time frame: 27 days
Assessment of influence of interference substances (i.e. ethanol, lactate, ketones, paracetamol, acetylsalicylic acid, sorbitol, fructose, aspartame, ibuprofen, caffeine and ascorbic acid [Vitamin C])
Exploratory endpoint: blood samples will be taken each 2.5 or 5 min to measure glucose, lactate and ketones. Glucose will also be measured with a CGM. The influence of the confounders on the glucose measurement by the sensor in the interstitial fluid will be investigated.
Time frame: 27 days
Plan to share: No
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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