DiabetesNCT06560177
Biolinq External Interferent Protocol
A study testing The Biolinq MicroArray Intradermal Continuous Glucose Biowearable System in people with Diabetes and Diabetes Mellitus, run by Biolinq Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus
- What is being tested?
- The Biolinq MicroArray Intradermal Continuous Glucose Biowearable System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2024to 27 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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).
Who cannot join
- 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.
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- 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:
- 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:
- Syncope in past 6 months
- Severe hypoglycemia (loss of consciousness, seizure, or emergency medical technician assistance within the past 6 months)
- Diabetic ketoacidosis (DKA) requiring hospital admission in the past 6 months
- Coagulopathy
- Chronic infectious disease (e.g., HIV/AIDS, Hepatitis B or C)
- End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period
- History of congestive heart failure
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404
About this study
Official title: 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.
- Conditions
- Diabetes, Diabetes Mellitus
- Being tested
- The Biolinq MicroArray Intradermal Continuous Glucose Biowearable System
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Biolinq MicroArray Intradermal Continuous Glucose Biowearable SystemDevice
All participants will wear 1 Biolinq System on volar forearm.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Not described Receives: Device: The Biolinq MicroArray Intradermal Continuous Glucose Biowearable System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First hour post Acetaminophen (APAP) intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start10 Sep 2024
- Primary completion27 Sep 2024
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biolinq Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560177
- Sponsor's protocol ID
- CP013
- Status last verified
- Jan 2026
- First submitted
- 15 Aug 2024
- Last updated
- 13 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetaminophen Interferent Evaluation of the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System
- ClinicalTrials.gov ID
- NCT06560177
- Acronym / sponsor ID
- CP013
- Conditions
- Diabetes, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Biolinq Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Posted 13 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: The Biolinq MicroArray Intradermal Continuous Glucose Biowearable System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Biolinq MicroArray Intradermal Continuous Glucose Biowearable SystemAll participants will wear 1 Biolinq System on volar forearm. | Device | Single arm |
Primary outcome
Number of Samples Where YSI Values Matched the Biolinq Sensor's Color During the First Hour Post Acetaminophen (APAP) Intake.
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Biolinq MicroArray Intradermal Continuous Glucose Biowearable System in people with Diabetes and Diabetes Mellitus, run by Biolinq Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Samples Where YSI Values Matched the Biolinq Sensor's Color During the First Hour Post Acetaminophen (APAP) Intake. (time frame: First hour post Acetaminophen (APAP) intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.