BGM and HbA1c POC Device Evaluation

Inclusion Criteria

• •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