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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
910
BGM Test
HbA1c Test
Sihanouk Hospital Centre of Hope
Phnom Penh, Phnom Penh, Cambodia
Asociación Colombiana de Diabetes
Bogotá, Bogota D.C., Colombia
Lagos University Teaching Hospital
Lagos, Lagos, Nigeria
BGM Performace
For BGMs: Performance accuracy is based on ISO 15197 criteria, mean relative bias, 95% limits of agreement, and regression slopes of each BGM with respect to two independently validated comparator BGMs (each investigational BGM will be compared to each comparator BGMs independently).
Time frame: 1 year
HbA1c Performance
For HbA1c: Performance accuracy is based on regression slopes, mean relative bias, 95% limits of agreement, and of each HbA1c device versus the reference method and the concordance between capillary and venous blood results.
Time frame: 1 year
Comprehension
Proportion of label comprehension, system usability and result/symbol interpretation scale rating per question across all lay users stratified by BGM and lancing device; Total system usability score scale per BGM and lancing device.
Time frame: 1 year
Usability
Proportion of system usability and result/symbol interpretation scale rating per question across all lay users stratified by BGM and lancing device; Total system usability score scale per BGM and lancing device.
Time frame: 1 year
Interpretation
Proportion of result/symbol interpretation scale rating per question across all lay users stratified by BGM and lancing device; Total system usability score scale per BGM and lancing device
Time frame: 1 year
Number of errors as observed
Number and type of errors observed; proportion of error type observed per BGM and lancing device .
Time frame: 1 year
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Type of errors as observed
Number and type of errors observed; proportion of error type observed per BGM and lancing device .
Time frame: 1 year
Proportion of label comprehension
Proportion of system usability scale rating per question across all healthcare professionals, stratified by HbA1c POC device; Total system usability score scale per HbA1c POC device
Time frame: 1 year
Number of errors as displayed.
Number and type of errors as displayed on the BGM or HbA1c POC devices, stratified by type of user (BGMs only) and device
Time frame: 1 year
Type of errors as displayed
Number and type of errors as displayed on the BGM or HbA1c POC devices, stratified by type of user (BGMs only) and device
Time frame: 1 year