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The primary objective of the study is to evaluate the interference effect of acetaminophen (APAP) on the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System during a single in-clinic day on Day 3 of the sensor wear period.
All participants will be asked to wear the Biolinq System and a commercial CGM comparator for three days while taking fingersticks on a commercial Self-Monitoring Blood Glucose Meter. All participants will come back to the clinic on the third day of sensor wear for an in-clinic day which will include blood draws and fingersticks to compare glucose measurements to a Lab Analyzer. At the end of the in clinic day the subjects will have the sensors removed and then exit the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Biolinq MicroArray Intradermal Continuous Glucose Biowearable System | Device | All participants will wear 1 Biolinq System on volar forearm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Samples Where YSI Values Matched the Biolinq Sensor's Color During the First Hour Post Acetaminophen (APAP) Intake. | 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. | First hour post Acetaminophen (APAP) intake |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Device Effects | Overall adverse device effect rate. It was pre-specified in the protocol to report adverse event data irrespective of arm randomized for placement of sensor. | 3 days |
| Number of Samples Where YSI Values Matched the Biolinq Sensor's Color During the Second Hour Post Acetaminophen (APAP) Intake. |
Inclusion Criteria:
General
≥ 18 years old.
Willing and able to provide written signed and dated informed consent.
Diabetes History and Health
Diagnosis of diabetes (Type 1, 2 or LADA)
Weigh at least 110 lbs (50 kilograms).
Be otherwise in good health, as determined by a medical care professional.
Willing to refrain from Acetaminophen (APAP) use for 72 hours prior to Biolinq application and for the duration of the study the duration of study enrollment (except for as administered In-Clinic).
Device and Glucose Assessments - Willing to:
Wear one (1) Biolinq sensor following the application procedure on the volar forearm for up to 3 days.
Wear one (1) commercial CGM on the abdomen for up to 3 days per approved labeling.
Participate in one (1) In-Clinic session lasting up to 8 hours of blood draws (anticipated up to 10 hours on site).
Perform up to five (5) fingersticks a day with the SMBG device provided during non-in-clinic days.
Avoid immersing study devices into water (e.g., no hot tub, SCUBA diving).
Exclusion Criteria:
General
Current participation in another investigational study protocol. (If a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study.) Note: Subjects will not be excluded if enrolled in another observational trial, wherein the subject is in the follow-up phase and no tests/procedures impacting the subject's health are required. Subjects will be excluded if they have been previously enrolled in this study.
Work for, are family members with, or live with someone that works for the sponsor or competitor diabetes-related company (includes social media influencers or bloggers).
In the investigator's opinion, any reason that may lead to subject non-compliance with study requirements or confound study data.
Health
Currently taking Hydroxyurea or chronic use of a medication containing acetaminophen in the last 30 days.
Known allergy to medical grade adhesives, acrylic, latex, or isopropyl alcohol.
Known contraindication to taking the In-Clinic recommended oral dose of APAP (e.g., cirrhosis, chronic heavy ethanol use, breast feeding).
Have dermatological conditions that preclude wearing Biolinq Biowearables (e.g., extensive psoriasis, recent burns, severe sunburn, extensive eczema, extensive scarring, dermatitis herpetiformis, skin lesions, erythema, infection, or other conditions at the discretion of the investigator).
For subjects of child-bearing potential, pregnant or not practicing an acceptable form of birth control during the study.
Hematocrit measurement via point-of-care (POC) or laboratory testing that is less than the applicable below-mentioned value:
a. Male: 36.0% b. Female: 33.0% 10. Have donated blood, had significant blood loss, or participated in a study with significant blood sampling (420 cc or more) within 56 days prior to study enrollment or plan to participate in such activities during study wear.
11. Required or scheduled to have diathermy, X-ray, MRI, or CT during study wear.
12. In the investigator's opinion, the subject has a history of concomitant medical condition that could interfere with the study participation or present a risk to the safety and welfare of the subject or study staff. Such historical conditions include but are not limited to:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Clinical Research | Idaho Falls | Idaho | 83404 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All Participants who wore a Biolinq sensor. It was pre-specified in the study protocol to report the baseline data for participants irrespective of arm randomized for placement of sensor.
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| ID | Title | Description |
|---|---|---|
| BG000 | Biolinq MicroArray Intradermal Continuous Glucose Biowearable System | Single-arm study where all participants were assigned to received the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Samples Where YSI Values Matched the Biolinq Sensor's Color During the First Hour Post Acetaminophen (APAP) Intake. | 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. | 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. | Posted | Count of Units | Paired Samples - YSI to Biolinq | First hour post Acetaminophen (APAP) intake | Paired Samples - YSI to Biolinq | Paired Samples - YSI to Biolinq |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Biolinq MicroArray Intradermal Continuous Glucose Biowearable System | Single-arm study where all participants were assigned to received the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Illness | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SVP of Regulatory and Clinical Affairs | Biolinq Incorporated | (833)317-5518 | support@biolinq.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 6, 2024 | Dec 4, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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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. |
| Second hour post Acetaminophen (APAP) intake |
| Number of Samples Where YSI Values Matched the Biolinq Sensor's Color During the Third Hour Post Acetaminophen (APAP) Intake. | 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 | Third hour post Acetaminophen (APAP) intake |
| Number of Samples Where YSI Values Matched the Biolinq Sensor's Color During the Fourth Hour Post Acetaminophen (APAP) Intake. | 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 | Fourth hour post Acetaminophen (APAP) intake |
| Number of Samples Where YSI Values Matched the Biolinq Sensor's Color During the Fifth Hour Post Acetaminophen (APAP) Intake. | 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 | Fifth hour post Acetaminophen (APAP) intake |
| Number of Samples Where YSI Values Matched the Biolinq Sensor's Color During the Sixth Hour Post Acetaminophen (APAP) Intake. | 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 | Sixth hour post Acetaminophen (APAP) intake |
| Mean of Maximum Bias | 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. | Six hours post Acetaminophen (APAP) intake |
| years |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Single-arm study where all participants were assigned to received the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System. |
|
|
| Other Pre-specified | Number of Participants With Adverse Device Effects | Overall adverse device effect rate. It was pre-specified in the protocol to report adverse event data irrespective of arm randomized for placement of sensor. | Posted | Count of Participants | Participants | 3 days |
|
|
|
| Other Pre-specified | Number of Samples Where YSI Values Matched the Biolinq Sensor's Color During the Second Hour Post Acetaminophen (APAP) Intake. | 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. | 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. | Posted | Count of Units | Paired Samples - YSI to Biolinq | Second hour post Acetaminophen (APAP) intake | Paired Samples - YSI to Biolinq | Paired Samples - YSI to Biolinq |
|
|
|
| Other Pre-specified | Number of Samples Where YSI Values Matched the Biolinq Sensor's Color During the Third Hour Post Acetaminophen (APAP) Intake. | 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 | 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. | Posted | Count of Units | Paired Samples - YSI to Biolinq | Third hour post Acetaminophen (APAP) intake | Paired Samples - YSI to Biolinq | Paired Samples - YSI to Biolinq |
|
|
|
| Other Pre-specified | Number of Samples Where YSI Values Matched the Biolinq Sensor's Color During the Fourth Hour Post Acetaminophen (APAP) Intake. | 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 | 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. | Posted | Count of Units | Paired Samples - YSI to Biolinq | Fourth hour post Acetaminophen (APAP) intake | Paired Samples - YSI to Biolinq | Paired Samples - YSI to Biolinq |
|
|
|
| Other Pre-specified | Number of Samples Where YSI Values Matched the Biolinq Sensor's Color During the Fifth Hour Post Acetaminophen (APAP) Intake. | 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 | 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. | Posted | Count of Units | Paired Samples - YSI to Biolinq | Fifth hour post Acetaminophen (APAP) intake | Paired Samples - YSI to Biolinq | Paired Samples - YSI to Biolinq |
|
|
|
| Other Pre-specified | Number of Samples Where YSI Values Matched the Biolinq Sensor's Color During the Sixth Hour Post Acetaminophen (APAP) Intake. | 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 | 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. | Posted | Count of Units | Paired Samples - YSI to Biolinq | Sixth hour post Acetaminophen (APAP) intake | Paired Samples - YSI to Biolinq | Paired Samples - YSI to Biolinq |
|
|
|
| Other Pre-specified | Mean of Maximum Bias | 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. | 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. | Posted | Mean | Standard Deviation | mg/dL | Six hours post Acetaminophen (APAP) intake |
|
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| 0 |
| 31 |
| 0 |
| 31 |
| 1 |
| 31 |
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.
| Title | Measurements |
|---|---|
|
| Fourth hour post APAP intake |
|
| Fifth hour post APAP intake |
|
| Sixth Hour post APAP intake |
|