NCT06229743

Biolinq Safety and Effectiveness Trial

Completed NA Results posted Last updated 30 January 2026

What this trial tests

NA trial testing Biolinq System in Diabetes in 247 participants. Completed in 10 June 2024.

Timeline

29 February 2024

Primary endpoint
10 June 2024

10 June 2024

Quick facts

Lead sponsor	Biolinq Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	247
Start date	29 February 2024
Primary completion	10 June 2024
Estimated completion	10 June 2024
Sites	6 locations across United States

Drugs / interventions tested

• Biolinq System

Conditions studied

• Diabetes — all drugs for Diabetes →
• Diabetes Mellitus — all drugs for Diabetes Mellitus →

Sponsor

Biolinq Inc.

Who can join

22 and older, any sex, with Diabetes or Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

In Target Color Indicator - Blue Primary · 5 days

Number of paired samples of YSI Glucose Readings between 55-207 mg/dL when an unblinded Biolinq sensor would have displayed a blue color indicator (70-180 mg/dL).

Group	Value	95% CI
Performance Cohort	7494	93.3 – 96.0

In Target Color Indicator - Yellow Primary · 5 days

Number of paired samples of YSI Glucose Readings between 154-460 mg/dL when an unblinded Biolinq sensor would have displayed a yellow color indicator (181-400 mg/dL).

Group	Value	95% CI
Performance Cohort	5776	95.5 – 97.8

Overall Adverse Device Effect Rate Secondary · 5 days

Overall adverse device effect rate

Group	Value	95% CI
Treated Cohort	3.5

Individual Adverse Device Effect Rate Secondary · 5 Days

Adverse events related to the Biolinq System.

Pruritus/Itchiness

Group	Value	95% CI
Treated Cohort	2

Erythema

Group	Value	95% CI
Treated Cohort	2

Edema

Group	Value	95% CI
Treated Cohort	2

Ecchymosis/Bruising

Group	Value	95% CI
Treated Cohort	2

Scabbed Wound

Group	Value	95% CI
Treated Cohort	1

Mean Bias (mg/dL) Secondary · 5 days

Bias is defined by the paired Biolinq Glucose Sensor value minus venous blood sample (YSI) value.

Group	Value	95% CI
Performance Cohort	-7.6	± 33.8

Mean Relative Difference Secondary · 5 days

Relative Difference is defined by the paired Biolinq Glucose Sensor value minus venous blood sample (YSI) value divided by the venous blood sample (YSI) value.

Group	Value	95% CI
Performance Cohort	-0.7	± 19.0

Type 2 DM Parkes Consensus Error Grid Percentages Secondary · 5 days

The Parkes Error Grid was used to assess the clinical signifiance of blood glucose measurement errors of the Biolinq Glucose Sensor compared to reference values (YSI 2300) by categorizing the errors into risk zones from A-E. The error zone bands were defined in 1994 ADA meeting by a 100 physican survey to assign risk to errors in defined blood glucose ranges then mathmatically calculated to form Zone A-E as described in Parkes et al. Diabetes Care 23:1143-1148, 2000. The outcome measure is the count and percentage of paired samples of Biolinq Glucose Sensor and the YSI 2300 falling into each z

Zone A- Clinically accurate measurements, no effect on clinical action

Group	Value	95% CI
Performance Cohort	12508

Zone B - Altered clinical action, little or no effect on clinical outcome

Group	Value	95% CI
Performance Cohort	1339

C - Altered clinical action, likely to affect clinical outcome

Group	Value	95% CI
Performance Cohort	21

Zone D - Altered clinical action, could have significant clinical risk

Group	Value	95% CI
Performance Cohort	0

Zone E - Altered clinical action, could have dangerous consequences

Group	Value	95% CI
Performance Cohort	0

Mean Display Rate Secondary · 5 days

The display rate of the Biolinq Glucose Sensor, which occurs every 5 minutes, is the number of displayable glucose readings (red, blue, and yellow displays) provided divided by the number of expected glucose readings for the given sensor lifetime.

Group	Value	95% CI
Performance Cohort	93.9	± 13.7

Median Display Rate Secondary · 5 days

The display rate of the Biolinq Glucose Sensor, which occurs every 5 minutes, is the number of displayable glucose readings (red, blue, and yellow displays) provided divided by the number of expected glucose readings for the given sensor lifetime.

Group	Value	95% CI
Performance Cohort	98.4	± 13.7

Number of Paired Samples With an Absolute Relative Difference (Between 70-400 mg/dL) Within 20%. Secondary · 5 days

Absolute Relative Difference is defined by the absolute value of Biolinq Glucose Sensor minus venous blood sample (YSI) divided by venous blood sample.

Group	Value	95% CI
Performance Cohort	10459

Number of Paired Samples With Biolinq < 70 mg/dL to YSI Agreement <70 mg/dL, <80 mg/dL, <90 mg/dL, or <100 mg/dL Secondary · 5 days

Number of paired samples of YSI Glucose Readings \<70 mg/dL, \<80 mg/dL, \<90 mg/dL, or \<100 mg/dL when an unblinded Biolinq sensor would have displayed a red color indicator (\< 70 mg/dL).

YSI < 70 mg/dL

Group	Value	95% CI
Performance Cohort	498

YSI < 80 mg/dL

Group	Value	95% CI
Performance Cohort	609

YSI < 90 mg/dL

Group	Value	95% CI
Performance Cohort	632

YSI < 100 mg/dL

Group	Value	95% CI
Performance Cohort	649

Number of Paired Samples With an Absolute Relative Difference (Between 70-400 mg/dL) Within 40% Secondary · 5 days

Absolute Relative Difference is defined by the absolute value of Biolinq Glucose Sensor minus venous blood sample (YSI) divided by venous blood sample.

Group	Value	95% CI
Performance Cohort	13402

Adverse events — posted to ClinicalTrials.gov

Time frame: From enrollment to end of follow up, up to 7 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Enrollment Cohort

Serious: 0/247 (0%)

Deaths: 0/247

Other adverse events (16 terms — click to expand)

Reaction	System	Enrollment Cohort
Ecchymosis/bruising	Vascular disorders	—
Headache	Nervous system disorders	—
Pain, IV site	Skin and subcutaneous tissue disorders	—
Vasovagal reaction	Nervous system disorders	—
Vomiting	Gastrointestinal disorders	—
Pruritus/Itchiness	Skin and subcutaneous tissue disorders	—
Erythema	Skin and subcutaneous tissue disorders	—
Edema	Skin and subcutaneous tissue disorders	—
Allergic Reaction	Immune system disorders	—
Hypoglycemia level 2	Endocrine disorders	—
Nausea	Gastrointestinal disorders	—
Pain	Musculoskeletal and connective tissue disorders	—
Irritation/Redness	Skin and subcutaneous tissue disorders	—
Acute sinusitis	Infections and infestations	—
Viral infection	Infections and infestations	—
Scabbed Wound	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT06229743 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.