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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | All participants will wear at least 1 Biolinq System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biolinq System | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 5 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Adverse Device Effect Rate | Overall adverse device effect rate | 5 days |
| Individual Adverse Device Effect Rate | Adverse events related to the Biolinq System. |
Inclusion Criteria:
≥ 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.
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.
Exclusion Criteria:
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).
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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Metabolic Care + Research Institute | Escondido | California | 92025 | United States | ||
| Diablo Clinical Research |
Enrollment was defined as completing the Informed consent process.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treated Arm | All participants who wore at least 1 Biolinq System. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
202 participants received at least 1 Biolinq Glucose Sensor. It was pre-specified in the study protocol to report the baseline data for participants irrespective of the number and placement of sensors.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treated Cohort | All Participants who wore a Biolinq sensor (sensors were blinded and displayed no glucose information to all participants and study personnel). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and the data reported in the Outcome Measures are limited to the primary sensor. | Posted | Count of Units | Paired Samples - YSI to Biolinq | 5 days | Paired Samples - YSI to Biolinq | Paired Samples - YSI to Biolinq |
|
From enrollment to end of follow up, up to 7 days.
It was pre-specified in the study protocol to report adverse events for participants irrespective of the number and placement of sensors.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enrollment Cohort | Participants who signed the Informed Consent. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SVP of Regulatory and Clinical Affairs | Biolinq Incorporated | +1 (833)317-5518 | support@biolinq.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 3, 2025 | Nov 7, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 5 Days |
| Mean Bias (mg/dL) | Bias is defined by the paired Biolinq Glucose Sensor value minus venous blood sample (YSI) value. | 5 days |
| Mean Relative Difference | Relative Difference is defined by the paired Biolinq Glucose Sensor value minus venous blood sample (YSI) value divided by the venous blood sample (YSI) value. | 5 days |
| Type 2 DM Parkes Consensus Error Grid Percentages | The Parkes Error Grid was used to assess the clinical signifiance of blood glucose measurement errors of the Biolinq Glucose Sensor compared to reference values (YSI 2300) by categorizing the errors into risk zones from A-E. The error zone bands were defined in 1994 ADA meeting by a 100 physican survey to assign risk to errors in defined blood glucose ranges then mathmatically calculated to form Zone A-E as described in Parkes et al. Diabetes Care 23:1143-1148, 2000. The outcome measure is the count and percentage of paired samples of Biolinq Glucose Sensor and the YSI 2300 falling into each zone of the pre-defined grid. | 5 days |
| Mean Display Rate | The display rate of the Biolinq Glucose Sensor, which occurs every 5 minutes, is the number of displayable glucose readings (red, blue, and yellow displays) provided divided by the number of expected glucose readings for the given sensor lifetime. | 5 days |
| Median Display Rate | The display rate of the Biolinq Glucose Sensor, which occurs every 5 minutes, is the number of displayable glucose readings (red, blue, and yellow displays) provided divided by the number of expected glucose readings for the given sensor lifetime. | 5 days |
| Number of Paired Samples With an Absolute Relative Difference (Between 70-400 mg/dL) Within 20%. | Absolute Relative Difference is defined by the absolute value of Biolinq Glucose Sensor minus venous blood sample (YSI) divided by venous blood sample. | 5 days |
| Number of Paired Samples With an Absolute Relative Difference (Between 70-400 mg/dL) Within 40% | Absolute Relative Difference is defined by the absolute value of Biolinq Glucose Sensor minus venous blood sample (YSI) divided by venous blood sample. | 5 days |
| Number of Paired Samples With a Day 1 Agreement ± 20% | Agreement is defined by the Biolinq Glucose Sensor minus venous blood sample (YSI) divided by venous blood sample. | Day 1 |
| Number of Paired Samples With a Day 3 Agreement Within ± 20% | Agreement is defined by the Biolinq Glucose Sensor minus venous blood sample (YSI) divided by venous blood sample. | Day 3 |
| Number of Paired Samples With a Day 5 Agreement ± 20% | Agreement is defined by the Biolinq Glucose Sensor minus venous blood sample (YSI) divided by venous blood sample. | Day 5 |
| Walnut Creek |
| California |
| 94598 |
| United States |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | United States |
| Rocky Mountain Clinical Research | Idaho Falls | Idaho | 83404 | United States |
| Diabetes and Glandular Disease Clinic | San Antonio | Texas | 78229 | United States |
| Rainier Clinical Research | Renton | Washington | 90857 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Paired Samples - YSI to Biolinq |
|
|
| Primary | 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). | Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and the data reported in the Outcome Measures are limited to the primary sensor. | Posted | Count of Units | Paired Samples- YSI to Biolinq | 5 days | Paired Samples- YSI to Biolinq | Paired Samples- YSI to Biolinq |
|
|
|
| Other Pre-specified | Overall Adverse Device Effect Rate | Overall adverse device effect rate | It was pre-specified in the study protocol to report adverse events for participants irrespective of the number and placement of sensors. | Posted | Number | Percentage of Subjects with ADE | 5 days |
|
|
|
| Other Pre-specified | Individual Adverse Device Effect Rate | Adverse events related to the Biolinq System. | It was pre-specified in the study protocol to report adverse events for participants irrespective of the number and placement of sensors. | Posted | Number | Number of Subjects with ADE | 5 Days |
|
|
|
| Other Pre-specified | Mean Bias (mg/dL) | Bias is defined by the paired Biolinq Glucose Sensor value minus venous blood sample (YSI) value. | Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and the data reported in the Outcome Measures are limited to the primary sensor. | Posted | Mean | Standard Deviation | mg/dL | 5 days |
|
|
|
| Other Pre-specified | Mean Relative Difference | Relative Difference is defined by the paired Biolinq Glucose Sensor value minus venous blood sample (YSI) value divided by the venous blood sample (YSI) value. | Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and the data reported in the Outcome Measures are limited to the primary sensor. | Posted | Mean | Standard Deviation | percentage | 5 days |
|
|
|
| Other Pre-specified | Type 2 DM Parkes Consensus Error Grid Percentages | The Parkes Error Grid was used to assess the clinical signifiance of blood glucose measurement errors of the Biolinq Glucose Sensor compared to reference values (YSI 2300) by categorizing the errors into risk zones from A-E. The error zone bands were defined in 1994 ADA meeting by a 100 physican survey to assign risk to errors in defined blood glucose ranges then mathmatically calculated to form Zone A-E as described in Parkes et al. Diabetes Care 23:1143-1148, 2000. The outcome measure is the count and percentage of paired samples of Biolinq Glucose Sensor and the YSI 2300 falling into each zone of the pre-defined grid. | Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and per protocol the data reported in the Outcome Measures are limited to the primary sensor. | Posted | Count of Units | Errors | 5 days | Errors | Errors |
|
|
|
| Other Pre-specified | Mean Display Rate | The display rate of the Biolinq Glucose Sensor, which occurs every 5 minutes, is the number of displayable glucose readings (red, blue, and yellow displays) provided divided by the number of expected glucose readings for the given sensor lifetime. | Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and per protocol the data reported in the Outcome Measures are limited to the primary sensor. | Posted | Mean | Standard Deviation | percentage of displayable readings | 5 days |
|
|
|
| Other Pre-specified | Median Display Rate | The display rate of the Biolinq Glucose Sensor, which occurs every 5 minutes, is the number of displayable glucose readings (red, blue, and yellow displays) provided divided by the number of expected glucose readings for the given sensor lifetime. | Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and per protocol the data reported in the Outcome Measures are limited to the primary sensor. | Posted | Median | Standard Deviation | percentage of displayable readings | 5 days |
|
|
|
| Other Pre-specified | Number of Paired Samples With an Absolute Relative Difference (Between 70-400 mg/dL) Within 20%. | Absolute Relative Difference is defined by the absolute value of Biolinq Glucose Sensor minus venous blood sample (YSI) divided by venous blood sample. | Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and per protocol the data reported in the Outcome Measures are limited to the primary sensor. | Posted | Count of Units | Paired Samples - YSI to Biolinq | 5 days | Paired Samples - YSI to Biolinq | Paired Samples - YSI to Biolinq |
|
|
|
| Post-Hoc | Number of Paired Samples With Biolinq < 70 mg/dL to YSI Agreement <70 mg/dL, <80 mg/dL, <90 mg/dL, or <100 mg/dL | Number of paired samples of YSI Glucose Readings <70 mg/dL, <80 mg/dL, <90 mg/dL, or <100 mg/dL when an unblinded Biolinq sensor would have displayed a red color indicator (< 70 mg/dL). | Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and per protocol the data reported in the Outcome Measures are limited to the primary sensor. | Posted | Number | paired samples - ysi to biolinq | 5 days | Paired Samples - YSI to Biolinq | Paired Samples - YSI to Biolinq |
|
|
|
| Other Pre-specified | Number of Paired Samples With an Absolute Relative Difference (Between 70-400 mg/dL) Within 40% | Absolute Relative Difference is defined by the absolute value of Biolinq Glucose Sensor minus venous blood sample (YSI) divided by venous blood sample. | Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and per protocol the data reported in the Outcome Measures are limited to the primary sensor. | Posted | Count of Units | Paired Samples - YSI to Biolinq | 5 days | Paired Samples - YSI to Biolinq | Paired Samples - YSI to Biolinq |
|
|
|
| Other Pre-specified | Number of Paired Samples With a Day 1 Agreement ± 20% | Agreement is defined by the Biolinq Glucose Sensor minus venous blood sample (YSI) divided by venous blood sample. | Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and per protocol the data reported in the Outcome Measures are limited to the primary sensor. | Posted | Count of Units | Paired Samples - YSI to Biolinq | Day 1 | Paired Samples - YSI to Biolinq | Paired Samples - YSI to Biolinq |
|
|
|
| Other Pre-specified | Number of Paired Samples With a Day 3 Agreement Within ± 20% | Agreement is defined by the Biolinq Glucose Sensor minus venous blood sample (YSI) divided by venous blood sample. | Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and per protocol the data reported in the Outcome Measures are limited to the primary sensor. | Posted | Count of Units | Paired Samples - YSI to Biolinq | Day 3 | Paired Samples - YSI to Biolinq | Paired Samples - YSI to Biolinq |
|
|
|
| Other Pre-specified | Number of Paired Samples With a Day 5 Agreement ± 20% | Agreement is defined by the Biolinq Glucose Sensor minus venous blood sample (YSI) divided by venous blood sample. | Performance analysis was limited to the 190 primary sensors to reflect final device specifications. It was pre-specified in the study protocol to report the outcome measures for participants irrespective of the number and placement of sensors, and per protocol the data reported in the Outcome Measures are limited to the primary sensor. | Posted | Count of Units | Paired Samples - YSI to Biolinq | Day 5 | Paired Samples - YSI to Biolinq | Paired Samples - YSI to Biolinq |
|
|
|
| 247 |
| 0 |
| 247 |
| 23 |
| 247 |
| Pain, IV site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Vasovagal reaction | Nervous system disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Allergic Reaction | Immune system disorders | Systematic Assessment |
|
| Ecchymosis/bruising | Vascular disorders | Systematic Assessment |
|
| Hypoglycemia level 2 | Endocrine disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Irritation/Redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | Systematic Assessment |
|
| Viral infection | Infections and infestations | Systematic Assessment |
|
| Pruritus/Itchiness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Scabbed Wound | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
No publication before publication of the results from all of the study centers in a peer-reviewed scientific journal or if no article within 12 months after completion of the finalization of the multi-center database. Institution may publish in a peer-reviewed scientific journal. Investigators must provide sponsor with a copy of manuscript 45 days prior to submission for publication.
|
| Ecchymosis/Bruising |
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| Scabbed Wound |
|
|
| Zone D - Altered clinical action, could have significant clinical risk |
|
| Zone E - Altered clinical action, could have dangerous consequences |
|
| Title | Measurements |
|---|---|
|
| YSI < 100 mg/dL |
|