Biolinq Safety and Effectiveness Trial
Public ClinicalTrials.gov record NCT06229743. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety and Effectiveness Study of the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06229743
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 247 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 22 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2024
- Primary completion
- Jun 9, 2024
- Completion
- Jun 9, 2024
- Last update posted
- Jan 29, 2026
2024
United States locations
- U.S. sites
- 6
- U.S. states
- 5
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced Metabolic Care + Research Institute | Escondido | California | 92025 | — |
| Diablo Clinical Research | Walnut Creek | California | 94598 | — |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | — |
| Rocky Mountain Clinical Research | Idaho Falls | Idaho | 83404 | — |
| Diabetes and Glandular Disease Clinic | San Antonio | Texas | 78229 | — |
| Rainier Clinical Research | Renton | Washington | 90857 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06229743, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 29, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06229743 live on ClinicalTrials.gov.