Status:
COMPLETED
Type 2 Diabetes Glucose Biomarker Study With a Continuous Glucose Monitoring System
Lead Sponsor:
Klick Inc.
Collaborating Sponsors:
Mittal Global Clinical Trial Services
Conditions:
Healthy
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-60 years
Brief Summary
Current gold standard methodologies for diagnosing type 2 diabetes (T2D) or prediabetes can be unreliable and inaccurate, and require the need for multiple different tests for comparison. It is possib...
Eligibility Criteria
Inclusion
- Either male or non-pregnant, non-lactating female aged \> 18-60 \<years (both inclusive)
- Subjects willing to give written informed consent
- Healthy Volunteers
- Subjects able to comply with the study protocol
- Women of child bearing potential must have a negative urine pregnancy test prior to study entry
- Minimum 4 subjects in each interval of approx 7 years (18-25/26-32/32-38/39-45/46-52/53-59)
- Minimum 40% subjects of one gender to mark relative distribution
Exclusion
- Any person below the age of 18 years
- Suspected or confirmed pregnancy
- Currently breastfeeding
- Diagnosis of any known chronic or acute medical disease of any kind (e.g., cardiovascular disease, respiratory disease, influenza, pneumonia, etc.)
- Diagnosis of any known neurological disease or psychological disorder of any kind (e.g., brain lesion, epilepsy, anxiety, eating disorder, mood disorder, sleep disorder, etc.)
- Any implanted electrical medical device (e.g., pacemaker, insulin pump, deep brain stimulator, etc.)
- Any form of prescription medication
- Use of antibiotics in the three months prior to enrollment
- Any person planning to undergo a Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment during the duration of the study (as per restrictions of the FreeStyle Libre pro device)
Key Trial Info
Start Date :
August 31 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04529239
Start Date
August 31 2020
End Date
March 1 2022
Last Update
March 29 2022
Active Locations (1)
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1
Klick Inc.
Toronto, Ontario, Canada, M4W 3R8