Biolinq External Interferent Protocol

Acetaminophen Interferent Evaluation of the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Diabetes
• Intervention / Treatment: Device: The Biolinq MicroArray Intradermal Continuous Glucose Biowearable System

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rocky Mountain Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

General

1. ≥ 18 years old.

2. Willing and able to provide written signed and dated informed consent.

   Diabetes History and Health

3. Diagnosis of diabetes (Type 1, 2 or LADA)
4. Weigh at least 110 lbs (50 kilograms).
5. Be otherwise in good health, as determined by a medical care professional.

6. 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:

7. Wear one (1) Biolinq sensor following the application procedure on the volar forearm for up to 3 days.
8. Wear one (1) commercial CGM on the abdomen for up to 3 days per approved labeling.
9. Participate in one (1) In-Clinic session lasting up to 8 hours of blood draws (anticipated up to 10 hours on site).
10. Perform up to five (5) fingersticks a day with the SMBG device provided during non-in-clinic days.
11. Avoid immersing study devices into water (e.g., no hot tub, SCUBA diving).

Exclusion Criteria:

General

1. 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.
2. 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).

3. In the investigator's opinion, any reason that may lead to subject non-compliance with study requirements or confound study data.

   Health

4. Currently taking Hydroxyurea or chronic use of a medication containing acetaminophen in the last 30 days.
5. Known allergy to medical grade adhesives, acrylic, latex, or isopropyl alcohol.
6. Known contraindication to taking the In-Clinic recommended oral dose of APAP (e.g., cirrhosis, chronic heavy ethanol use, breast feeding).
7. 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).
8. 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:

1. Syncope in past 6 months
2. Severe hypoglycemia (loss of consciousness, seizure, or emergency medical technician assistance within the past 6 months)
3. Diabetic ketoacidosis (DKA) requiring hospital admission in the past 6 months
4. Coagulopathy
5. Chronic infectious disease (e.g., HIV/AIDS, Hepatitis B or C)
6. End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period
7. History of congestive heart failure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm	Device: The Biolinq MicroArray Intradermal Continuous Glucose Biowearable System; All participants will wear 1 Biolinq System on volar forearm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Biolinq Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2024
• Primary Completion (Actual): September 27, 2024
• Study Completion (Actual): September 27, 2024

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus
• Other Study ID Numbers: CP013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No