BGM and HbA1c POC Device Evaluation

NCT06170515 | Unknown

• 1 other identifier: NC002
• Study Type: interventional
• Target: 910
• Locations: 3 countries
• Sites: 3

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Comprehension

  1 year

• Usability

  1 year

• Interpretation

  1 year

• Number of errors as observed

  1 year

• Type of errors as observed

  1 year

Study Arms (2)

BGM Evaluation

OTHER

Diagnostic Test: CareSens N-Eco (i-Sens), • CareSens N-Premier (i-Sens), CodeFree (SD Biosensor), GlucoNavii GDH (SD Biosensor)

HbA1c evaluation

OTHER

Diagnostic Test: Affinion (Abbott), HbA1c 501 (HemoCue), A1Care (iSens), DCA Vantage (Siemens)

Interventions

CareSens N-Eco (i-Sens), • CareSens N-Premier (i-Sens), CodeFree (SD Biosensor), GlucoNavii GDH (SD Biosensor) DIAGNOSTIC_TEST

BGM Test

BGM Evaluation

Affinion (Abbott), HbA1c 501 (HemoCue), A1Care (iSens), DCA Vantage (Siemens) DIAGNOSTIC_TEST

HbA1c Test

HbA1c evaluation

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Arm 1:
• 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
• % naïve to any SMBG (defined as not having performed any SMBG in the last 24 months)
• Haematocrit within 20-60%
• Arm 2:
• ≥18 years
• Able and willing to provide informed consent
• Diagnosed or not diagnosed with diabetes
• Haemoglobin values ≥ 8g/dL

You may not qualify if:

• Arm 1:
• \<13 years
• 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.

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead

Study Sites (3)

Sihanouk Hospital Centre of Hope

Phnom Penh, 12253, Cambodia

RECRUITING

Asociación Colombiana de Diabetes

Bogotá, Bogota D.C., 111311, Colombia

NOT YET RECRUITING

Lagos University Teaching Hospital

Lagos, Nigeria

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Priyanka Singh

  Foundation for Innovative New Diagnostics (FIND)

  STUDY DIRECTOR

Central Study Contacts

Priyanka Singh

CONTACT

+41786271626; priyanka.singh@finddx.org

Mugil Murya

CONTACT

+917032802286; mugil.murya@finddx.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: December 14, 2023
• Study Start: April 3, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1); NG (1); CA (1)