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Biolinq External Interferent Protocol | Clinical Trials | Clareo Health

COMPLETEDNA

Biolinq External Interferent Protocol

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

NCT06560177•Biolinq Inc.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

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.
+11 more criteria

Locations (1)

Rocky Mountain Clinical Research

Idaho Falls, Idaho, United States

Key Dates

Start Date

September 10, 2024

Primary Completion Date

September 27, 2024

Completion Date

September 27, 2024

Last Updated

February 13, 2026

Enrollment

ACTUAL participants

Conditions

DiabetesDiabetes Mellitus

Interventions

The Biolinq MicroArray Intradermal Continuous Glucose Biowearable System

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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