Biolinq Safety and Effectiveness Trial

Biolinq Inc.

Status: Completed

Conditions: Diabetes; Diabetes Mellitus

Treatments: Device: Biolinq System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06229743

CP-011

Details and patient eligibility

About

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.

Enrollment: 247 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥ 22 years old.

2. Willing and able to provide written signed and dated informed consent.

3. Access to phone or computer with internet to complete subject log.

4. 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%.

5. Weigh at least 110 lbs (50 kilograms).

6. Be otherwise in good health, as determined by a medical care professional.

7. Willing to refrain from Acetaminophen use for the duration of study enrollment.

8. 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:

9. Wear one (1) commercial CGM system on the abdomen per approved labeling and have up to 1 replacement.

10. Wear up to two (2) Biolinq Biowearables simultaneously following the application procedures on the volar forearm for up to 7 days.

11. 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.

12. Perform up to five (5) fingersticks a day with the SMBG device provided during non-in-clinic days.

13. Avoid immersing study devices into water (e.g., no hot tub, SCUBA diving).

14. Wear an activity tracker or record activity levels on a daily log.

Exclusion criteria

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.

4. Currently taking Hydroxyurea.

5. Known allergy to medical grade adhesives, acrylic, latex, or isopropyl alcohol.

6. 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).

7. For subjects of child-bearing potential, pregnant or not practicing an acceptable form of birth control during the study.

8. Hematocrit measurement via point-of-care (POC) or laboratory testing that is less than the applicable below-mentioned value:

   1. Male: 36.0%
   2. Female: 33.0%

9. 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.

10. Required or scheduled to have diathermy, X-ray, MRI, or CT during study wear.

11. 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:

    1. Syncope in past 6 months
    2. Severe hypoglycemia (loss of consciousness, seizure, or emergency medical technician assistance within the past 6 months)
    3. Diabetic ketoacidosis (DKA) requiring hospital admission in the past 6 months
    4. Coagulopathy
    5. Chronic infectious disease (e.g., HIV/AIDS, Hepatitis B or C)
    6. End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period
    7. History of congestive heart failure

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

247 participants in 1 patient group

Single arm

Experimental group

Description:

All participants will wear at least 1 Biolinq System.

Treatment:

Device: Biolinq System