NCT06560177

Biolinq External Interferent Protocol

Acetaminophen Interferent Evaluation of the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Biolinq Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate the interference effect of acetaminophen (APAP) on the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System during a single in-clinic day on Day 3 of the sensor wear period. All participants will be asked to wear the Biolinq System and a commercial CGM comparator for three days while taking fingersticks on a commercial Self-Monitoring Blood Glucose Meter. All participants will come back to the clinic on the third day of sensor wear for an in-clinic day which will include blood draws and fingersticks to compare glucose measurements to a Lab Analyzer. At the end of the in clinic day the subjects will have the sensors removed and then exit the study.

Conditions

• Diabetes
• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	The Biolinq MicroArray Intradermal Continuous Glucose Biowearable System	All participants will wear 1 Biolinq System on volar forearm.

Timeline

• Start date: 2024-09-10
• Primary completion: 2024-09-27
• Completion: 2024-09-27
• First posted: 2024-08-19
• Last updated: 2026-02-13
• Results posted: 2026-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study