Diabetes, Diabetes Mellitus
Conditions
Brief summary
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.
Interventions
DEVICEThe Biolinq MicroArray Intradermal Continuous Glucose Biowearable System
All participants will wear 1 Biolinq System on volar forearm.
Sponsors
Biolinq Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General 1. ≥ 18 years old. 2. Willing and able to provide written signed and dated informed consent. Diabetes History and Health 3. Diagnosis of diabetes (Type 1, 2 or LADA) 4. Weigh at least 110 lbs (50 kilograms). 5. Be otherwise in good health, as determined by a medical care professional. 6. 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). Device and Glucose Assessments - Willing to: 7. Wear one (1) Biolinq sensor following the application procedure on the volar forearm for up to 3 days. 8. Wear one (1) commercial CGM on the abdomen for up to 3 days per approved labeling. 9. Participate in one (1) In-Clinic session lasting up to 8 hours of blood draws (anticipated up to 10 hours on site). 10. Perform up to five (5) fingersticks a day with the SMBG device provided during non-in-clinic days. 11. Avoid immersing study devices into water (e.g., no hot tub, SCUBA diving).
Exclusion criteria
General 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. Health 4. Currently taking Hydroxyurea or chronic use of a medication containing acetaminophen in the last 30 days. 5. Known allergy to medical grade adhesives, acrylic, latex, or isopropyl alcohol. 6. Known contraindication to taking the In-Clinic recommended oral dose of APAP (e.g., cirrhosis, chronic heavy ethanol use, breast feeding). 7. 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). 8. 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: a. Male: 36.0% b. Female: 33.0% 10. Have donated blood, had significant blood loss, or participated in a study with significant blood sampling (420 cc or more) within 56 days prior to study enrollment or plan to participate in such activities during study wear. 11\. Required or scheduled to have diathermy, X-ray, MRI, or CT during study wear. 12\. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Samples Where YSI Values Matched the Biolinq Sensor's Color During the First Hour Post Acetaminophen (APAP) Intake. | First hour post Acetaminophen (APAP) intake | This measures how often (percentage), within the first hour after taking APAP, the Biolinq sensor's color matches the YSI blood sugar readings. BLUE on the sensor means a glucose level between 70 and 180 mg/dL, which matches YSI values from 55 to 207 mg/dL. YELLOW means a sensor reading between 181 and 400 mg/dL, matching YSI values from 154 to 460 mg/dL. |
Countries
United States
Participant flow
Pre-assignment details
Randomization allocation was 1:1 between left and right volar forearm in order to negate possible performance bias between locations. It was pre-specified in the study protocol to report the baseline and outcome measure data for participants irrespective of placement of sensors.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age | 43.6 years STANDARD_DEVIATION 19.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 1 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
None listed