Condition: Diabetes Mellitus · Sponsor: Glucotrack
The goal of this early first in man clinical trial is to evaluate the safety of an implantable continuous blood glucose monitoring system in participants with Diabetes Mellitus. Safety will be assessed by looking at the absence of procedure or device related adverse events. Additionally, the surgical procedure and device performance will be evaluated. Key Research Questions: 1. Were there any adverse events associated with the insertion of the Sensor Lead? 2. Did Participants experience any device-related adverse events from the Sensor Lead insertion through the 96-hour observation period and subsequent removal of the Sensor Lead? 3. How effectively did the device capture data during the 96-hour wear period?
This description comes directly from the study's public registry record.
Sandra L Martha · 6198892412 · smartha@glucotrack.com
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| Instituto do Coração (InCor) | | São Paulo, Brazil, Brazil | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06764069