BGM and HbA1c POC Device Evaluation

Last updated: December 5, 2023
Sponsor: Foundation for Innovative New Diagnostics, Switzerland
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetic Macular Edema

Diabetic Kidney Disease

Diabetic Foot Ulcers

Treatment

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

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

Clinical Study ID

NCT06170515
NC002
  • Ages > 13
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 concentrationranges based on % of subjects required to meet the target number per concentrationrange 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 % ofsubjects required for the mid-range values

Exclusion

Exclusion Criteria: Arm 1:

  • <13 years
  • 13-17 years and not diagnosed with diabetes or unable to manage conditionindependently
  • Previous use of investigational BGM for SMBG
  • Haematocrit outside normal range
  • Pre-screen BGM result falling in a glucose concentration range that already hassufficient participants. Arm 2:
  • <18 years
  • Haemoglobin value < 8g/dL
  • Pre-screen HbA1c result falling in a concentration range that already has sufficientparticipants.

Study Design

Total Participants: 910
Treatment Group(s): 2
Primary Treatment: Affinion (Abbott), HbA1c 501 (HemoCue), A1Care (iSens), DCA Vantage (Siemens)
Phase:
Study Start date:
April 03, 2023
Estimated Completion Date:
March 31, 2024

Connect with a study center

  • Sihanouk Hospital Centre of Hope

    Phnom Penh, 12253
    Cambodia

    Active - Recruiting

  • Asociación Colombiana de Diabetes

    Bogotá, Bogota 111311
    Colombia

    Site Not Available

  • Lagos University Teaching Hospital

    Lagos,
    Nigeria

    Active - Recruiting

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