BGM and HbA1c POC Device Evaluation

Foundation for Innovative New Diagnostics (FIND)

Status: Enrolling

Conditions: Diabetes

Treatments: Diagnostic Test: Affinion (Abbott), HbA1c 501 (HemoCue), A1Care (iSens), DCA Vantage (Siemens); Diagnostic Test: CareSens N-Eco (i-Sens), • CareSens N-Premier (i-Sens), CodeFree (SD Biosensor), GlucoNavii GDH (SD Biosensor)

Study type: Interventional

Funder types: Other

Identifiers

NCT06170515

NC002

Details and patient eligibility

About

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 of trained users, as well as intended users who are unfamiliar with the system (lay users, for BGMs only). System usability will also be assessed for all BGMs (including lancing devices) and HbA1c devices.

Enrollment: 910 estimated patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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910 participants in 2 patient groups

BGM Evaluation

Other group

Treatment:

Diagnostic Test: CareSens N-Eco (i-Sens), • CareSens N-Premier (i-Sens), CodeFree (SD Biosensor), GlucoNavii GDH (SD Biosensor)

HbA1c evaluation

Other group

Treatment:

Diagnostic Test: Affinion (Abbott), HbA1c 501 (HemoCue), A1Care (iSens), DCA Vantage (Siemens)