Clinical trial NCT06170515: BGM and HbA1c POC Device Evaluation
Official title: Performance Evaluation of Blood Glucose Meters and HbA1c Point-of-care Devices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 910
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: BGM Performace
timeFrame: 1 year
measure: HbA1c Performance
timeFrame: 1 year
Secondary outcomes:
measure: Comprehension
timeFrame: 1 year
measure: Usability
timeFrame: 1 year
measure: Interpretation
timeFrame: 1 year
measure: Number of errors as observed
timeFrame: 1 year
measure: Type of errors as observed
timeFrame: 1 year
measure: Proportion of label comprehension
timeFrame: 1 year
measure: Number of errors as displayed.
timeFrame: 1 year
measure: Type of errors as displayed
timeFrame: 1 year
Other outcomes:
Locations:
city: Phnom Penh
country: Cambodia
facility: Sihanouk Hospital Centre of Hope
city: Bogotá
country: Colombia
facility: Asociación Colombiana de Diabetes
state: Bogota
city: Lagos
country: Nigeria
facility: Lagos University Teaching Hospital
Study officials:
affiliation: Foundation for Innovative New Diagnostics (FIND)
name: Priyanka Singh
role: STUDY_DIRECTOR
References: