DiabetesNCT06170515
BGM and HbA1c POC Device Evaluation
A study testing CareSens N-Eco (i-Sens), • CareSens N-Premier (i-Sens), CodeFree (SD Biosensor), GlucoNavii GDH (SD Biosensor) and Affinion (Abbott), HbA1c 501 (HemoCue), A1Care (iSens), DCA Vantage (Siemens) in people with Diabetes, run by Foundation for Innovative New Diagnostics, Switzerland at 3 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- CareSens N-Eco (i-Sens), • CareSens N-Premier (i-Sens), CodeFree (SD Biosensor), GlucoNavii GDH (SD Biosensor) and Affinion (Abbott), HbA1c 501 (HemoCue), A1Care (iSens), DCA Vantage (Siemens)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 910 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 9 Jun 2023to 24 Jul 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 14Show fewer
- 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
Who cannot join
- 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.
Show all 10Show fewer
- Arm 2:
- <18 years
- Haemoglobin value < 8g/dL
- Pre-screen HbA1c result falling in a concentration range that already has sufficient participants.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Cambodia1 site
Sihanouk Hospital Centre of Hope
Phnom Penh, Phnom Penh, 12253
About this study
Official title: 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.
- Conditions
- Diabetes
- Being tested
- CareSens N-Eco (i-Sens), • CareSens N-Premier (i-Sens), CodeFree (SD Biosensor), GlucoNavii GDH (SD Biosensor), Affinion (Abbott), HbA1c 501 (HemoCue), A1Care (iSens), DCA Vantage (Siemens)
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CareSens N-Eco (i-Sens), • CareSens N-Premier (i-Sens), CodeFree (SD Biosensor), GlucoNavii GDH (SD Biosensor)Diagnostic test
BGM Test
Affinion (Abbott), HbA1c 501 (HemoCue), A1Care (iSens), DCA Vantage (Siemens)Diagnostic test
HbA1c Test
| Study group | Role | What they receive |
|---|---|---|
| BGM Evaluation | Other | Not described Receives: Diagnostic Test: CareSens N-Eco (i-Sens), • CareSens N-Premier (i-Sens), CodeFree (SD Biosensor), GlucoNavii GDH (SD Biosensor) |
| HbA1c evaluation | Other | Not described Receives: Diagnostic Test: Affinion (Abbott), HbA1c 501 (HemoCue), A1Care (iSens), DCA Vantage (Siemens) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 1 year
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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
Measured: 1 year
Number of errors as observed
Number and type of errors observed; proportion of error type observed per BGM and lancing device .
Measured: 1 year
Type of errors as observed
Number and type of errors observed; proportion of error type observed per BGM and lancing device .
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start9 Jun 2023
- Primary completion24 Oct 2023
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 910 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Priyanka Singh, Study director, Foundation for Innovative New Diagnostics (FIND)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170515
- Sponsor's protocol ID
- NC002
- Status last verified
- Sep 2026
- First submitted
- 27 Oct 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singh P, Lenters-Westra E, Choun K, Fasanmade O, Erkosar B, Watson M, Haldane C, Vetter B. Analytical performance of four HbA1c point-of-care devices: a cross-sectional evaluation in low- and middle-income countries. BMJ Open. 2026 May 12;16(5):e113491. doi: 10.1136/bmjopen-2025-113491.
PubMed 42129995