NCT06229743

Biolinq Safety and Effectiveness Trial

Safety and Effectiveness Study of the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: Biolinq Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate the safety and effectiveness of the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System, which is intended to be worn for up to five (5) days (up to 120 hours) in adults with diabetes mellitus (DM). Data collected from this study is intended to be used to support commercial marketing application(s) for the intended commercial patient population of non-insulin-users. All participants will be asked to wear the Biolinq System and a commercial CGM comparator for five to seven days while taking fingersticks on a commercial Self-Monitoring Blood Glucose Meter. Throughout the sensor wear all participants will come back to the clinic twice for in-clinic days where venous blood draws and fingersticks will be used to compare glucose measurements to a Lab Analyzer (YSI). At the end of sensor wear subjects will return to the clinic to have the sensors removed and then exit the study.

Conditions

• Diabetes
• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Biolinq System	Participants will wear at least one Biolinq Sensor. The estimated glucose value from the Biolinq Sensor will be compared to a YSI 2300 glucose value from venous blood within a 5 minute window (paired samples).

Timeline

• Start date: 2024-02-29
• Primary completion: 2024-06-10
• Completion: 2024-06-10
• First posted: 2024-01-29
• Last updated: 2026-01-30
• Results posted: 2026-01-30

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study