DiabetesNCT06229743
Biolinq Safety and Effectiveness Trial
A study testing Biolinq System in people with Diabetes and Diabetes Mellitus, run by Biolinq Inc. at 6 sites in United States.
Trial summary
The primary objective of the study is to evaluate the safety and effectiveness of the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System, which is intended to be worn for up to five (5) days (up to 120 hours) in adults with diabetes mellitus (DM). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus
- What is being tested?
- Biolinq System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 6 sitesUnited States
- Study dates
- 29 Feb 2024to 10 Jun 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 22 years old.
- Willing and able to provide written signed and dated informed consent.
- Access to phone or computer with internet to complete subject log.
- Diagnosis of type 1 diabetes (T1D)/ LADA or type 2 diabetes (T2D) and on intensive insulin therapy (IIT) with known dosing parameters for at least three (3) months prior to the Screening Visit with an A1c of 5.5%-10% or diagnosis of type 2 diabetes (T2D) and on non-intensive insulin therapy (NIIT) or T2D not using insulin with an A1c of 7.5% to 11%.
- Weigh at least 110 lbs (50 kilograms).
- Be otherwise in good health, as determined by a medical care professional.
Show all 15Show fewer
- Willing to refrain from Acetaminophen use for the duration of study enrollment.
- If using an automated insulin delivery (AID) system, willing to disable automated features and go into open loop mode during the duration of in-clinic days.
- Device and Glucose Assessments - Willing to:
- Wear one (1) commercial CGM system on the abdomen per approved labeling and have up to 1 replacement.
- Wear up to two (2) Biolinq Biowearables simultaneously following the application procedures on the volar forearm for up to 7 days.
- Participate in two (2) In-Clinic sessions lasting up to 11.5 hours of blood draws (anticipated up to 13 hours on site per visit) each.
- 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).
- Wear an activity tracker or record activity levels on a daily log.
Who cannot join
- 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.
- Currently taking Hydroxyurea.
- Known allergy to medical grade adhesives, acrylic, latex, or isopropyl alcohol.
- 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).
Show all 20Show fewer
- 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%
- Female: 33.0%
- Have donated blood, had significant blood loss, or participated in a study with significant blood sampling (340 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
- 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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Advanced Metabolic Care + Research Institute
Escondido, California, 92025
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404
Rainier Clinical Research
Renton, Washington, 90857
Diabetes and Glandular Disease Clinic
San Antonio, Texas, 78229
Diablo Clinical Research
Walnut Creek, California, 94598
About this study
Official title: Safety and Effectiveness Study of the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System
The primary objective of the study is to evaluate the safety and effectiveness of the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System, which is intended to be worn for up to five (5) days (up to 120 hours) in adults with diabetes mellitus (DM). Data collected from this study is intended to be used to support commercial marketing application(s) for the intended commercial patient population of non-insulin-users.
All participants will be asked to wear the Biolinq System and a commercial CGM comparator for five to seven days while taking fingersticks on a commercial Self-Monitoring Blood Glucose Meter. Throughout the sensor wear all participants will come back to the clinic twice for in-clinic days where venous blood draws and fingersticks will be used to compare glucose measurements to a Lab Analyzer (YSI). At the end of sensor wear subjects will return to the clinic to have the sensors removed and then exit the study.
- Conditions
- Diabetes, Diabetes Mellitus
- Being tested
- Biolinq System
- Keywords
- Continuous Glucose Monitoring, Glucose Range Monitoring 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.
Biolinq SystemDevice
Participants will wear at least one Biolinq Sensor. The estimated glucose value from the Biolinq Sensor will be compared to a YSI 2300 glucose value from venous blood within a 5 minute window (paired samples).
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | All participants will wear at least 1 Biolinq System. Receives: Device: Biolinq System |
What is being measured
The primary outcome is the main question the study is designed to answer.
In Target Color Indicator - Blue
Number of paired samples of YSI Glucose Readings between 55-207 mg/dL when an unblinded Biolinq sensor would have displayed a blue color indicator (70-180 mg/dL).
Measured: 5 days
In Target Color Indicator - Yellow
Number of paired samples of YSI Glucose Readings between 154-460 mg/dL when an unblinded Biolinq sensor would have displayed a yellow color indicator (181-400 mg/dL).
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start29 Feb 2024
- Primary completion10 Jun 2024
- Study completion10 Jun 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
- 247 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
- NCT06229743
- Sponsor's protocol ID
- CP-011
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2024
- Last updated
- 30 Jan 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 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Study of the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System
- ClinicalTrials.gov ID
- NCT06229743
- Acronym / sponsor ID
- CP-011
- Conditions
- Diabetes, Diabetes Mellitus
- Keywords
- Continuous Glucose Monitoring, Glucose Range Monitoring System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Biolinq Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 29 Jan 2024 (actual)
- Results
- Posted 30 Jan 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 safety and effectiveness of the Biolinq MicroArray Intradermal Continuous Glucose Biowearable System, which is intended to be worn for up to five (5) days (up to 120 hours) in adults with diabetes mellitus (DM). Data collected from this study is intended to be used to support commercial marketing application(s) for the intended commercial patient population of non-insulin-users.
All participants will be asked to wear the Biolinq System and a commercial CGM comparator for five to seven days while taking fingersticks on a commercial Self-Monitoring Blood Glucose Meter. Throughout the sensor wear all participants will come back to the clinic twice for in-clinic days where venous blood draws and fingersticks will be used to compare glucose measurements to a Lab Analyzer (YSI). At the end of sensor wear subjects will return to the clinic to 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: Biolinq SystemAll participants will wear at least 1 Biolinq System. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- ≥ 22 years old.
- Willing and able to provide written signed and dated informed consent.
- Access to phone or computer with internet to complete subject log.
- Diagnosis of type 1 diabetes (T1D)/ LADA or type 2 diabetes (T2D) and on intensive insulin therapy (IIT) with known dosing parameters for at least three (3) months prior to the Screening Visit with an A1c of 5.5%-10% or diagnosis of type 2 diabetes (T2D) and on non-intensive insulin therapy (NIIT) or T2D not using insulin with an A1c of 7.5% to 11%.
- Weigh at least 110 lbs (50 kilograms).
Key exclusion criteria (20 listed)
- 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.
- Currently taking Hydroxyurea.
- Known allergy to medical grade adhesives, acrylic, latex, or isopropyl alcohol.
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 |
|---|---|---|
| Biolinq SystemParticipants will wear at least one Biolinq Sensor. The estimated glucose value from the Biolinq Sensor will be compared to a YSI 2300 glucose value from venous blood within a 5 minute window (paired samples). | Device | Single arm |
Primary outcome
In Target Color Indicator - Blue
Time frame: 5 days
Number of paired samples of YSI Glucose Readings between 55-207 mg/dL when an unblinded Biolinq sensor would have displayed a blue color indicator (70-180 mg/dL).
In Target Color Indicator - Yellow
Time frame: 5 days
Number of paired samples of YSI Glucose Readings between 154-460 mg/dL when an unblinded Biolinq sensor would have displayed a yellow color indicator (181-400 mg/dL).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Diabetes
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes
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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biolinq System in people with Diabetes and Diabetes Mellitus, run by Biolinq Inc. at 6 sites 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 15 inclusion and 20 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 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 30 Jan 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?
In Target Color Indicator - Blue (time frame: 5 days). The study lists 2 primary outcomes in all. 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 30 Jan 2026.