Biolinq Safety and Effectiveness Trial (NCT06229743) | Clinical Trial Compass
CompletedNot Applicable
Biolinq Safety and Effectiveness Trial
United States247 participantsStarted 2024-02-29
Plain-language 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). 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.
Who can participate
Age range22 Years
SexALL
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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.
. 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: