BGM and HbA1c POC Device Evaluation

Not Applicable

Recruiting

• Conditions: Diabetes
• Interventions: 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)

• Registration Number: NCT06170515
• Lead Sponsor: Foundation for Innovative New Diagnostics, Switzerland

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-03
• Study First Submitted: 2023-10-27
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-05
• Last Update Submitted: 2023-12-05
• Study First Posted: 2023-12-14
• Last Update Posted: 2023-12-14
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 910

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HbA1c evaluation	Affinion (Abbott), HbA1c 501 (HemoCue), A1Care (iSens), DCA Vantage (Siemens)	-
BGM Evaluation	CareSens N-Eco (i-Sens), • CareSens N-Premier (i-Sens), CodeFree (SD Biosensor), GlucoNavii GDH (SD Biosensor)	-

Primary Outcome Measures

Name	Time	Method
BGM Performace	1 year	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).
HbA1c Performance	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Interpretation	1 year	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
Type of errors as observed	1 year	Number and type of errors observed; proportion of error type observed per BGM and lancing device .
Number of errors as observed	1 year	Number and type of errors observed; proportion of error type observed per BGM and lancing device .
Comprehension	1 year	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.
Usability	1 year	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.
Proportion of label comprehension	1 year	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
Number of errors as displayed.	1 year	Number and type of errors as displayed on the BGM or HbA1c POC devices, stratified by type of user (BGMs only) and device
Type of errors as displayed	1 year	Number and type of errors as displayed on the BGM or HbA1c POC devices, stratified by type of user (BGMs only) and device

Trial Locations

Locations (3)

Asociación Colombiana de Diabetes; 🇨🇴 Bogotá, Bogota, Colombia

Sihanouk Hospital Centre of Hope; 🇰🇭 Phnom Penh, Cambodia

Lagos University Teaching Hospital; 🇳🇬 Lagos, Nigeria