Clinical Research Directory

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.