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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ≥ 18 years old.
✓. Willing and able to provide written signed and dated informed consent.
✓. Diagnosis of diabetes (Type 1, 2 or LADA)
✓. Weigh at least 110 lbs (50 kilograms).
✓. 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).
✓. 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.
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.
What they're measuring
1
Number of Samples Where YSI Values Matched the Biolinq Sensor's Color During the First Hour Post Acetaminophen (APAP) Intake.
Timeframe: First hour post Acetaminophen (APAP) intake
✕. 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 or chronic use of a medication containing acetaminophen in the last 30 days.
✕. 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.