BGM and HbA1c POC Device Evaluation

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06170515
• Other study ID #: NC002
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: December 2023
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: Priyanka Singh
• Phone: +41786271626
• Email: priyanka.singh[@]finddx.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 910
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes

Intervention

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

Locations

Country	Name	City	State
Cambodia	Sihanouk Hospital Centre of Hope	Phnom Penh
Colombia	Asociación Colombiana de Diabetes	Bogotá	Bogota
Nigeria	Lagos University Teaching Hospital	Lagos

Sponsors (1)

Lead Sponsor	Collaborator
Foundation for Innovative New Diagnostics, Switzerland

Countries where clinical trial is conducted

Cambodia,  Colombia,  Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of errors as observed	Number and type of errors observed; proportion of error type observed per BGM and lancing device .	1 year
Secondary	Type of errors as observed	Number and type of errors observed; proportion of error type observed per BGM and lancing device .	1 year
Secondary	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
Secondary	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
Secondary	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