Status:
UNKNOWN
BGM and HbA1c POC Device Evaluation
Lead Sponsor:
Foundation for Innovative New Diagnostics, Switzerland
Conditions:
Diabetes
Eligibility:
All Genders
13+ years
Phase:
NA
Brief Summary
This study aims to assess analytical performance of four BGMs and four HbA1c POC devices in comparison to suitable comparator or reference methods, with the view to evaluate performance in the hands o...
Eligibility Criteria
Inclusion
- Arm 1:
- 13-17 years, diagnosed with diabetes and able to manage condition independently (ideally at least 10% of total Arm 1 population)
- •≥18 years, diagnosed with diabetes
- Able and willing to provide informed consent/assent
- Naïve to the SMBG use of the investigational devices
- 10% naïve to any SMBG (defined as not having performed any SMBG in the last 24 months)
- Haematocrit within 20-60%
- Pre-screen BGM result qualifies for inclusion in any of the five glucose concentration ranges based on % of subjects required to meet the target number per concentration range
- Arm 2:
- •≥18 years
- Able and willing to provide informed consent
- Diagnosed or not diagnosed with diabetes
- Haemoglobin values ≥ 8g/dL
- Pre-screen HbA1c result qualifies for inclusion in the target HbA1c range and % of subjects required for the mid-range values
Exclusion
- Arm 1:
- \<13 years
- 13-17 years and not diagnosed with diabetes or unable to manage condition independently
- Previous use of investigational BGM for SMBG
- Haematocrit outside normal range
- Pre-screen BGM result falling in a glucose concentration range that already has sufficient participants.
- Arm 2:
- \<18 years
- Haemoglobin value \< 8g/dL
- Pre-screen HbA1c result falling in a concentration range that already has sufficient participants.
Key Trial Info
Start Date :
April 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2024
Estimated Enrollment :
910 Patients enrolled
Trial Details
Trial ID
NCT06170515
Start Date
April 3 2023
End Date
March 31 2024
Last Update
December 14 2023
Active Locations (3)
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1
Sihanouk Hospital Centre of Hope
Phnom Penh, Cambodia, 12253
2
Asociación Colombiana de Diabetes
Bogotá, Bogota D.C., Colombia, 111311
3
Lagos University Teaching Hospital
Lagos, Nigeria