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

Exclusion criteria

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.