Biolinq External Interferent Protocol

NCT06560177 | Completed Results FDA Device

• 1 other identifier: CP013
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of Participants With Adverse Device Effects

  3 days

• Number of Samples Where YSI Values Matched the Biolinq Sensor's Color During the Second Hour Post Acetaminophen (APAP) Intake.

  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.

  Third hour post Acetaminophen (APAP) intake

Study Arms (1)

Single arm

EXPERIMENTAL

Device: The Biolinq MicroArray Intradermal Continuous Glucose Biowearable System

Interventions

The Biolinq MicroArray Intradermal Continuous Glucose Biowearable System DEVICE

All participants will wear 1 Biolinq System on volar forearm.

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• \. Required or scheduled to have diathermy, X-ray, MRI, or CT during study wear.
• \. 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:
• Syncope in past 6 months

Sponsors & Collaborators

• Biolinq Inc.: lead

Study Sites (1)

Rocky Mountain Clinical Research

Idaho Falls, Idaho, 83404, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: SVP of Regulatory and Clinical Affairs
• Organization: Biolinq Incorporated

support@biolinq.com

(833)317-5518

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: September 10, 2024
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: February 13, 2026
• Results First Posted: February 13, 2026

Record last verified: 2026-01

Locations

US (1)