BGM and HbA1c POC Device Evaluation

Study Overview
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Brief Summary
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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.

Official Title
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Performance Evaluation of Blood Glucose Meters and HbA1c Point-of-care Devices

Conditions
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Diabetes

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Arm 1: Evaluation of BGM's (listed below) CareSens N-Eco (i-Sens) CareSens N-Premier (i-Sens) CodeFree (SD Biosensor) GlucoNavii GDH (SD Biosensor) Comparator BGMs: Ascensia Contour Next One and Nova Statstrip Xpress (BG); using strip lots meeting CLSI POCT12 acceptance criteria as validated at an experienced laboratory using traceable analysers Arm 2: HbA1c evaluation (listed below) Affinion (Abbott) HbA1c 501 (HemoCue) A1Care (iSens) DCA Vantage (Siemens) Reference: NGSP-certified HbA1c laboratory method, validated with ERL reference samples
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: BGM Evaluation<br> | Diagnostic Test: CareSens N-Eco (i-Sens), • CareSens N-Premier (i-Sens), CodeFree (SD Biosensor), GlucoNavii GDH (SD Biosensor)<br>* BGM Test<br>|
| Other: HbA1c evaluation<br> | Diagnostic Test: Affinion (Abbott), HbA1c 501 (HemoCue), A1Care (iSens), DCA Vantage (Siemens)<br>* HbA1c Test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 1 year | 
| Number of errors as observed | Number and type of errors observed; proportion of error type observed per BGM and lancing device . | 1 year | 
| Type of errors as observed | Number and type of errors observed; proportion of error type observed per BGM and lancing device . | 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 | 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 | 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 | 1 year |