Trial Outcomes & Findings for Biolinq External Interferent Protocol (NCT NCT06560177)
NCT ID: NCT06560177
Last Updated: 2026-02-13
Results Overview
This measures how often (percentage), within the first hour after taking APAP, the Biolinq sensor's color matches the YSI blood sugar readings. BLUE on the sensor means a glucose level between 70 and 180 mg/dL, which matches YSI values from 55 to 207 mg/dL. YELLOW means a sensor reading between 181 and 400 mg/dL, matching YSI values from 154 to 460 mg/dL.
COMPLETED
NA
31 participants
First hour post Acetaminophen (APAP) intake
2026-02-13
Participant Flow
Randomization allocation was 1:1 between left and right volar forearm in order to negate possible performance bias between locations. It was pre-specified in the study protocol to report the baseline and outcome measure data for participants irrespective of placement of sensors.
Participant milestones
| Measure |
Biolinq MicroArray Intradermal Continuous Glucose Biowearable System
Single-arm study where all participants were assigned to receive the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System.
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
Treated
|
30
|
|
Overall Study
Paired Data for Analysis
|
28
|
|
Overall Study
Left Forearm
|
14
|
|
Overall Study
Right Forearm
|
16
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Biolinq MicroArray Intradermal Continuous Glucose Biowearable System
Single-arm study where all participants were assigned to receive the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System.
|
|---|---|
|
Overall Study
One (1) eligible subject did not complete device application due to an unanticipated scheduling conf
|
1
|
Baseline Characteristics
Biolinq External Interferent Protocol
Baseline characteristics by cohort
| Measure |
Biolinq MicroArray Intradermal Continuous Glucose Biowearable System
n=30 Participants
Single-arm study where all participants were assigned to received the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System.
|
|---|---|
|
Age, Customized
Age
|
43.6 years
STANDARD_DEVIATION 19.3 • n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
2 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: First hour post Acetaminophen (APAP) intakePopulation: Performance analysis was limited to 28 sensors with matching YSI values. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of arm randomized for placement of sensor.
This measures how often (percentage), within the first hour after taking APAP, the Biolinq sensor's color matches the YSI blood sugar readings. BLUE on the sensor means a glucose level between 70 and 180 mg/dL, which matches YSI values from 55 to 207 mg/dL. YELLOW means a sensor reading between 181 and 400 mg/dL, matching YSI values from 154 to 460 mg/dL.
Outcome measures
| Measure |
Biolinq MicroArray Intradermal Continuous Glucose Biowearable System
n=115 Paired Samples - YSI to Biolinq
Single-arm study where all participants were assigned to received the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System.
|
|---|---|
|
Number of Samples Where YSI Values Matched the Biolinq Sensor's Color During the First Hour Post Acetaminophen (APAP) Intake.
|
112 Paired Samples - YSI to Biolinq
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 daysOverall adverse device effect rate. It was pre-specified in the protocol to report adverse event data irrespective of arm randomized for placement of sensor.
Outcome measures
| Measure |
Biolinq MicroArray Intradermal Continuous Glucose Biowearable System
n=30 Participants
Single-arm study where all participants were assigned to received the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System.
|
|---|---|
|
Number of Participants With Adverse Device Effects
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Second hour post Acetaminophen (APAP) intakePopulation: Performance analysis was limited to 28 sensors with matching YSI values. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of arm randomized for placement of sensor.
Percentage of correctly displayed color in the second hour post APAP intake; BLUE on the sensor means a glucose level between 70 and 180 mg/dL, which matches YSI values from 55 to 207 mg/dL. YELLOW means a sensor reading between 181 and 400 mg/dL, matching YSI values from 154 to 460 mg/dL.
Outcome measures
| Measure |
Biolinq MicroArray Intradermal Continuous Glucose Biowearable System
n=106 Paired Samples - YSI to Biolinq
Single-arm study where all participants were assigned to received the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System.
|
|---|---|
|
Number of Samples Where YSI Values Matched the Biolinq Sensor's Color During the Second Hour Post Acetaminophen (APAP) Intake.
|
101 Paired Samples - YSI to Biolinq
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Third hour post Acetaminophen (APAP) intakePopulation: Performance analysis was limited to 28 sensors with matching YSI values. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of arm randomized for placement of sensor.
Percentage of correctly displayed color in the third hour post APAP intake; BLUE on the sensor means a glucose level between 70 and 180 mg/dL, which matches YSI values from 55 to 207 mg/dL. YELLOW means a sensor reading between 181 and 400 mg/dL, matching YSI values from 154 to 460 mg/dL
Outcome measures
| Measure |
Biolinq MicroArray Intradermal Continuous Glucose Biowearable System
n=109 Paired Samples - YSI to Biolinq
Single-arm study where all participants were assigned to received the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System.
|
|---|---|
|
Number of Samples Where YSI Values Matched the Biolinq Sensor's Color During the Third Hour Post Acetaminophen (APAP) Intake.
|
106 Paired Samples - YSI to Biolinq
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Fourth hour post Acetaminophen (APAP) intakePopulation: Performance analysis was limited to 28 sensors with matching YSI values. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of arm randomized for placement of sensor.
Percentage of correctly displayed color in the fourth hour post APAP intake; BLUE on the sensor means a glucose level between 70 and 180 mg/dL, which matches YSI values from 55 to 207 mg/dL. YELLOW means a sensor reading between 181 and 400 mg/dL, matching YSI values from 154 to 460 mg/dL
Outcome measures
| Measure |
Biolinq MicroArray Intradermal Continuous Glucose Biowearable System
n=111 Paired Samples - YSI to Biolinq
Single-arm study where all participants were assigned to received the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System.
|
|---|---|
|
Number of Samples Where YSI Values Matched the Biolinq Sensor's Color During the Fourth Hour Post Acetaminophen (APAP) Intake.
|
107 Paired Samples - YSI to Biolinq
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Fifth hour post Acetaminophen (APAP) intakePopulation: Performance analysis was limited to 28 sensors with matching YSI values. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of arm randomized for placement of sensor.
Percentage of correctly displayed color in the fifth hour post APAP intake; BLUE on the sensor means a glucose level between 70 and 180 mg/dL, which matches YSI values from 55 to 207 mg/dL. YELLOW means a sensor reading between 181 and 400 mg/dL, matching YSI values from 154 to 460 mg/dL
Outcome measures
| Measure |
Biolinq MicroArray Intradermal Continuous Glucose Biowearable System
n=112 Paired Samples - YSI to Biolinq
Single-arm study where all participants were assigned to received the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System.
|
|---|---|
|
Number of Samples Where YSI Values Matched the Biolinq Sensor's Color During the Fifth Hour Post Acetaminophen (APAP) Intake.
|
101 Paired Samples - YSI to Biolinq
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Sixth hour post Acetaminophen (APAP) intakePopulation: Performance analysis was limited to 28 sensors with matching YSI values. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of arm randomized for placement of sensor.
Percentage of correctly displayed color in the sixth hour post APAP intake; BLUE on the sensor means a glucose level between 70 and 180 mg/dL, which matches YSI values from 55 to 207 mg/dL. YELLOW means a sensor reading between 181 and 400 mg/dL, matching YSI values from 154 to 460 mg/dL
Outcome measures
| Measure |
Biolinq MicroArray Intradermal Continuous Glucose Biowearable System
n=106 Paired Samples - YSI to Biolinq
Single-arm study where all participants were assigned to received the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System.
|
|---|---|
|
Number of Samples Where YSI Values Matched the Biolinq Sensor's Color During the Sixth Hour Post Acetaminophen (APAP) Intake.
|
98 Paired Samples - YSI to Biolinq
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Six hours post Acetaminophen (APAP) intakePopulation: Performance analysis was limited to 28 sensors with matching YSI values. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of arm randomized for placement of sensor.
The mean of maximum bias (Biolinq minus YSI glucose values) of less than 10 mg/dL computed from maximum biases between the difference in the maximum bias one-hour pre-intake and maximum bias at every hour up to 6 hours post-intake.
Outcome measures
| Measure |
Biolinq MicroArray Intradermal Continuous Glucose Biowearable System
n=28 Participants
Single-arm study where all participants were assigned to received the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System.
|
|---|---|
|
Mean of Maximum Bias
First Hour Post APAP intake
|
2.0 mg/dL
Standard Deviation 11.1
|
|
Mean of Maximum Bias
Second hour post APAP intake
|
3.4 mg/dL
Standard Deviation 9.6
|
|
Mean of Maximum Bias
Third hour post APAP intake
|
0.8 mg/dL
Standard Deviation 8.5
|
|
Mean of Maximum Bias
Fourth hour post APAP intake
|
0.5 mg/dL
Standard Deviation 9.4
|
|
Mean of Maximum Bias
Fifth hour post APAP intake
|
3.2 mg/dL
Standard Deviation 13.4
|
|
Mean of Maximum Bias
Sixth Hour post APAP intake
|
1.4 mg/dL
Standard Deviation 10.5
|
Adverse Events
Biolinq MicroArray Intradermal Continuous Glucose Biowearable System
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Biolinq MicroArray Intradermal Continuous Glucose Biowearable System
n=31 participants at risk
Single-arm study where all participants were assigned to received the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System.
|
|---|---|
|
Infections and infestations
Upper Respiratory Illness
|
3.2%
1/31 • Adverse Events were monitored from enrollment (signing the consent form, up to 30 days prior to device application) though active study device wear to study completion (between a minimum of 55 total hours and up to 73 hours (Day 3)).
It was pre-specified in the study protocol to report adverse events for participants irrespective of arm randomized for placement of sensor.
|
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