NCT04782934

The GLOW Study - The YANG System

Early Feasibility and First in Human Study of the YANG System for Continuous Monitoring of Glucose, Ketones and Lactate - The GLOW Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Indigo Diabetes NV · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Diabetes Mellitus
• Glucose

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-02-25
• Primary completion: 2021-06-19
• Completion: 2021-06-19
• First posted: 2021-03-04
• Last updated: 2021-09-21

Locations

1 site across 1 country: Belgium