BGM and HbA1c POC Device Evaluation

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

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 Overview

• Status: Recruiting
• Conditions: Diabetes
• Intervention / Treatment: 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)

• Study Type: Interventional
• Enrollment (Estimated): 910
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Priyanka Singh; Phone Number: +41786271626; Email: priyanka.singh@finddx.org
• Study Contact Backup: Name: Mugil Murya; Phone Number: +917032802286; Email: mugil.murya@finddx.org

Study Locations

• Cambodia
  • Phnom Penh, Cambodia, 12253
    • Recruiting
    • Sihanouk Hospital Centre of Hope
    • Contact: Kimcheng Choun; Phone Number: +85512896405; Email: kimchengchoun@sihosp.org
• Colombia
  • Bogota
    • Bogotá, Bogota, Colombia, 111311
      • Not yet recruiting
      • Asociación Colombiana de Diabetes
      • Contact: Pablo Aschner
• Nigeria
  • Lagos, Nigeria
    • Recruiting
    • Lagos University Teaching Hospital
    • Contact: Olufemi Fasanmade; Phone Number: +2348033008127; Email: ofasanmade@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Foundation for Innovative New Diagnostics, Switzerland
• Investigators: Study Director: Priyanka Singh, Foundation for Innovative New Diagnostics (FIND)

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Estimated): December 14, 2023

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NC002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No