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BGM and HbA1c POC Device Evaluation

NCT ID: NCT06170515

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

910 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-03

Study Completion Date

2024-03-31

Brief Summary

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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

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Conditions

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Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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BGM Evaluation

Group Type OTHER

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

Intervention Type DIAGNOSTIC_TEST

BGM Test

HbA1c evaluation

Group Type OTHER

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

Intervention Type DIAGNOSTIC_TEST

HbA1c Test

Interventions

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

BGM Test

Intervention Type DIAGNOSTIC_TEST

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

HbA1c Test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Foundation for Innovative New Diagnostics, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Priyanka Singh

Role: STUDY_DIRECTOR

Foundation for Innovative New Diagnostics (FIND)

Locations

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Sihanouk Hospital Centre of Hope

Phnom Penh, , Cambodia

Site Status RECRUITING

Asociación Colombiana de Diabetes

Bogotá, Bogota D.C., Colombia

Site Status NOT_YET_RECRUITING

Lagos University Teaching Hospital

Lagos, , Nigeria

Site Status RECRUITING

Countries

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Cambodia Colombia Nigeria

Central Contacts

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Priyanka Singh

Role: CONTACT

Phone: +41786271626

Email: [email protected]

Mugil Murya

Role: CONTACT

Phone: +917032802286

Email: [email protected]

Facility Contacts

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Kimcheng Choun

Role: primary

Pablo Aschner

Role: primary

Olufemi Fasanmade

Role: primary

Other Identifiers

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NC002

Identifier Type: -

Identifier Source: org_study_id