Trial Outcomes & Findings for Biolinq Safety and Effectiveness Trial (NCT NCT06229743)
NCT ID: NCT06229743
Last Updated: 2026-01-30
Results Overview
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).
COMPLETED
NA
247 participants
5 days
2026-01-30
Participant Flow
Enrollment was defined as completing the Informed consent process.
Participant milestones
| Measure |
Treated Arm
All participants who wore at least 1 Biolinq System.
|
|---|---|
|
Overall Study
STARTED
|
247
|
|
Overall Study
Treated (Primary Sensor)
|
202
|
|
Overall Study
Left Forearm (Primary Sensor)
|
60
|
|
Overall Study
Right Forearm (Primary Sensor)
|
65
|
|
Overall Study
Left Proximal Forearm (Primary Sensor)
|
21
|
|
Overall Study
Left Distal Forearm (Primary Sensor)
|
20
|
|
Overall Study
Right Proximal Forearm (Primary Sensor)
|
19
|
|
Overall Study
Right Distal Forearm (Primary Sensor)
|
17
|
|
Overall Study
COMPLETED
|
190
|
|
Overall Study
NOT COMPLETED
|
57
|
Reasons for withdrawal
| Measure |
Treated Arm
All participants who wore at least 1 Biolinq System.
|
|---|---|
|
Overall Study
Screen Failure
|
45
|
|
Overall Study
Sensors worn did not meet the revised device specifications
|
12
|
Baseline Characteristics
Biolinq Safety and Effectiveness Trial
Baseline characteristics by cohort
| Measure |
Treated Cohort
n=202 Participants
All Participants who wore a Biolinq sensor (sensors were blinded and displayed no glucose information to all participants and study personnel).
|
|---|---|
|
Age, Customized
Age
|
49.4 years
STANDARD_DEVIATION 15.6 • n=41 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
161 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
49 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
153 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: 5 daysPopulation: Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and the data reported in the Outcome Measures are limited to the primary sensor.
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).
Outcome measures
| Measure |
Performance Cohort
n=7904 Paired Samples - YSI to Biolinq
190 participants/sensors that met the final device specifications.
|
|---|---|
|
In Target Color Indicator - Blue
|
7494 Paired Samples - YSI to Biolinq
Interval 93.3 to 96.0
|
PRIMARY outcome
Timeframe: 5 daysPopulation: Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and the data reported in the Outcome Measures are limited to the primary sensor.
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).
Outcome measures
| Measure |
Performance Cohort
n=5964 Paired Samples- YSI to Biolinq
190 participants/sensors that met the final device specifications.
|
|---|---|
|
In Target Color Indicator - Yellow
|
5776 Paired Samples- YSI to Biolinq
Interval 95.5 to 97.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysPopulation: It was pre-specified in the study protocol to report adverse events for participants irrespective of the number and placement of sensors.
Overall adverse device effect rate
Outcome measures
| Measure |
Performance Cohort
n=202 Participants
190 participants/sensors that met the final device specifications.
|
|---|---|
|
Overall Adverse Device Effect Rate
|
3.5 Percentage of Subjects with ADE
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 DaysPopulation: It was pre-specified in the study protocol to report adverse events for participants irrespective of the number and placement of sensors.
Adverse events related to the Biolinq System.
Outcome measures
| Measure |
Performance Cohort
n=202 Participants
190 participants/sensors that met the final device specifications.
|
|---|---|
|
Individual Adverse Device Effect Rate
Pruritus/Itchiness
|
2 Number of Subjects with ADE
|
|
Individual Adverse Device Effect Rate
Erythema
|
2 Number of Subjects with ADE
|
|
Individual Adverse Device Effect Rate
Scabbed Wound
|
1 Number of Subjects with ADE
|
|
Individual Adverse Device Effect Rate
Edema
|
2 Number of Subjects with ADE
|
|
Individual Adverse Device Effect Rate
Ecchymosis/Bruising
|
2 Number of Subjects with ADE
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysPopulation: Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and the data reported in the Outcome Measures are limited to the primary sensor.
Bias is defined by the paired Biolinq Glucose Sensor value minus venous blood sample (YSI) value.
Outcome measures
| Measure |
Performance Cohort
n=190 Participants
190 participants/sensors that met the final device specifications.
|
|---|---|
|
Mean Bias (mg/dL)
|
-7.6 mg/dL
Standard Deviation 33.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysPopulation: Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and the data reported in the Outcome Measures are limited to the primary sensor.
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.
Outcome measures
| Measure |
Performance Cohort
n=190 Participants
190 participants/sensors that met the final device specifications.
|
|---|---|
|
Mean Relative Difference
|
-0.7 percentage
Standard Deviation 19.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysPopulation: Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and per protocol the data reported in the Outcome Measures are limited to the primary sensor.
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 zone of the pre-defined grid.
Outcome measures
| Measure |
Performance Cohort
n=13868 Errors
190 participants/sensors that met the final device specifications.
|
|---|---|
|
Type 2 DM Parkes Consensus Error Grid Percentages
Zone A- Clinically accurate measurements, no effect on clinical action
|
12508 Errors
|
|
Type 2 DM Parkes Consensus Error Grid Percentages
Zone B - Altered clinical action, little or no effect on clinical outcome
|
1339 Errors
|
|
Type 2 DM Parkes Consensus Error Grid Percentages
C - Altered clinical action, likely to affect clinical outcome
|
21 Errors
|
|
Type 2 DM Parkes Consensus Error Grid Percentages
Zone D - Altered clinical action, could have significant clinical risk
|
0 Errors
|
|
Type 2 DM Parkes Consensus Error Grid Percentages
Zone E - Altered clinical action, could have dangerous consequences
|
0 Errors
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysPopulation: Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and per protocol the data reported in the Outcome Measures are limited to the primary sensor.
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.
Outcome measures
| Measure |
Performance Cohort
n=190 Participants
190 participants/sensors that met the final device specifications.
|
|---|---|
|
Mean Display Rate
|
93.9 percentage of displayable readings
Standard Deviation 13.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysPopulation: Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and per protocol the data reported in the Outcome Measures are limited to the primary sensor.
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.
Outcome measures
| Measure |
Performance Cohort
n=190 Participants
190 participants/sensors that met the final device specifications.
|
|---|---|
|
Median Display Rate
|
98.4 percentage of displayable readings
Standard Deviation 13.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysPopulation: Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and per protocol the data reported in the Outcome Measures are limited to the primary sensor.
Absolute Relative Difference is defined by the absolute value of Biolinq Glucose Sensor minus venous blood sample (YSI) divided by venous blood sample.
Outcome measures
| Measure |
Performance Cohort
n=13868 Paired Samples - YSI to Biolinq
190 participants/sensors that met the final device specifications.
|
|---|---|
|
Number of Paired Samples With an Absolute Relative Difference (Between 70-400 mg/dL) Within 20%.
|
10459 Paired Samples - YSI to Biolinq
|
POST_HOC outcome
Timeframe: 5 daysPopulation: Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and per protocol the data reported in the Outcome Measures are limited to the primary sensor.
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).
Outcome measures
| Measure |
Performance Cohort
n=674 Paired Samples - YSI to Biolinq
190 participants/sensors that met the final device specifications.
|
|---|---|
|
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
YSI < 70 mg/dL
|
498 paired samples - ysi to biolinq
|
|
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
YSI < 80 mg/dL
|
609 paired samples - ysi to biolinq
|
|
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
YSI < 90 mg/dL
|
632 paired samples - ysi to biolinq
|
|
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
YSI < 100 mg/dL
|
649 paired samples - ysi to biolinq
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysPopulation: Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and per protocol the data reported in the Outcome Measures are limited to the primary sensor.
Absolute Relative Difference is defined by the absolute value of Biolinq Glucose Sensor minus venous blood sample (YSI) divided by venous blood sample.
Outcome measures
| Measure |
Performance Cohort
n=13868 Paired Samples - YSI to Biolinq
190 participants/sensors that met the final device specifications.
|
|---|---|
|
Number of Paired Samples With an Absolute Relative Difference (Between 70-400 mg/dL) Within 40%
|
13402 Paired Samples - YSI to Biolinq
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1Population: Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and per protocol the data reported in the Outcome Measures are limited to the primary sensor.
Agreement is defined by the Biolinq Glucose Sensor minus venous blood sample (YSI) divided by venous blood sample.
Outcome measures
| Measure |
Performance Cohort
n=4718 Paired Samples - YSI to Biolinq
190 participants/sensors that met the final device specifications.
|
|---|---|
|
Number of Paired Samples With a Day 1 Agreement ± 20%
|
3540 Paired Samples - YSI to Biolinq
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 3Population: Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and per protocol the data reported in the Outcome Measures are limited to the primary sensor.
Agreement is defined by the Biolinq Glucose Sensor minus venous blood sample (YSI) divided by venous blood sample.
Outcome measures
| Measure |
Performance Cohort
n=4730 Paired Samples - YSI to Biolinq
190 participants/sensors that met the final device specifications.
|
|---|---|
|
Number of Paired Samples With a Day 3 Agreement Within ± 20%
|
3521 Paired Samples - YSI to Biolinq
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 5Population: Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and per protocol the data reported in the Outcome Measures are limited to the primary sensor.
Agreement is defined by the Biolinq Glucose Sensor minus venous blood sample (YSI) divided by venous blood sample.
Outcome measures
| Measure |
Performance Cohort
n=4420 Paired Samples - YSI to Biolinq
190 participants/sensors that met the final device specifications.
|
|---|---|
|
Number of Paired Samples With a Day 5 Agreement ± 20%
|
3398 Paired Samples - YSI to Biolinq
|
Adverse Events
Enrollment Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Enrollment Cohort
n=247 participants at risk
Participants who signed the Informed Consent.
|
|---|---|
|
Infections and infestations
Viral infection
|
0.40%
1/247 • Number of events 1 • From enrollment to end of follow up, up to 7 days.
It was pre-specified in the study protocol to report adverse events for participants irrespective of the number and placement of sensors.
|
|
Skin and subcutaneous tissue disorders
Pruritus/Itchiness
|
0.81%
2/247 • Number of events 3 • From enrollment to end of follow up, up to 7 days.
It was pre-specified in the study protocol to report adverse events for participants irrespective of the number and placement of sensors.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.81%
2/247 • Number of events 3 • From enrollment to end of follow up, up to 7 days.
It was pre-specified in the study protocol to report adverse events for participants irrespective of the number and placement of sensors.
|
|
Skin and subcutaneous tissue disorders
Edema
|
0.81%
2/247 • Number of events 2 • From enrollment to end of follow up, up to 7 days.
It was pre-specified in the study protocol to report adverse events for participants irrespective of the number and placement of sensors.
|
|
Immune system disorders
Allergic Reaction
|
0.40%
1/247 • Number of events 1 • From enrollment to end of follow up, up to 7 days.
It was pre-specified in the study protocol to report adverse events for participants irrespective of the number and placement of sensors.
|
|
Vascular disorders
Ecchymosis/bruising
|
1.6%
4/247 • Number of events 4 • From enrollment to end of follow up, up to 7 days.
It was pre-specified in the study protocol to report adverse events for participants irrespective of the number and placement of sensors.
|
|
Endocrine disorders
Hypoglycemia level 2
|
0.40%
1/247 • Number of events 1 • From enrollment to end of follow up, up to 7 days.
It was pre-specified in the study protocol to report adverse events for participants irrespective of the number and placement of sensors.
|
|
Gastrointestinal disorders
Nausea
|
0.40%
1/247 • Number of events 1 • From enrollment to end of follow up, up to 7 days.
It was pre-specified in the study protocol to report adverse events for participants irrespective of the number and placement of sensors.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.40%
1/247 • Number of events 1 • From enrollment to end of follow up, up to 7 days.
It was pre-specified in the study protocol to report adverse events for participants irrespective of the number and placement of sensors.
|
|
Skin and subcutaneous tissue disorders
Irritation/Redness
|
0.40%
1/247 • Number of events 1 • From enrollment to end of follow up, up to 7 days.
It was pre-specified in the study protocol to report adverse events for participants irrespective of the number and placement of sensors.
|
|
Infections and infestations
Acute sinusitis
|
0.40%
1/247 • Number of events 1 • From enrollment to end of follow up, up to 7 days.
It was pre-specified in the study protocol to report adverse events for participants irrespective of the number and placement of sensors.
|
|
Nervous system disorders
Headache
|
1.2%
3/247 • Number of events 3 • From enrollment to end of follow up, up to 7 days.
It was pre-specified in the study protocol to report adverse events for participants irrespective of the number and placement of sensors.
|
|
Skin and subcutaneous tissue disorders
Pain, IV site
|
0.81%
2/247 • Number of events 2 • From enrollment to end of follow up, up to 7 days.
It was pre-specified in the study protocol to report adverse events for participants irrespective of the number and placement of sensors.
|
|
Nervous system disorders
Vasovagal reaction
|
0.81%
2/247 • Number of events 2 • From enrollment to end of follow up, up to 7 days.
It was pre-specified in the study protocol to report adverse events for participants irrespective of the number and placement of sensors.
|
|
Gastrointestinal disorders
Vomiting
|
0.81%
2/247 • Number of events 2 • From enrollment to end of follow up, up to 7 days.
It was pre-specified in the study protocol to report adverse events for participants irrespective of the number and placement of sensors.
|
|
Skin and subcutaneous tissue disorders
Scabbed Wound
|
0.40%
1/247 • Number of events 1 • From enrollment to end of follow up, up to 7 days.
It was pre-specified in the study protocol to report adverse events for participants irrespective of the number and placement of sensors.
|
Additional Information
SVP of Regulatory and Clinical Affairs
Biolinq Incorporated
Results disclosure agreements
- Principal investigator is a sponsor employee No publication before publication of the results from all of the study centers in a peer-reviewed scientific journal or if no article within 12 months after completion of the finalization of the multi-center database. Institution may publish in a peer-reviewed scientific journal. Investigators must provide sponsor with a copy of manuscript 45 days prior to submission for publication.
- Publication restrictions are in place
Restriction type: OTHER