Evaluation of blood glucose and HbA1c point-of-care devices

Performance Evaluation of Blood Glucose Meters and HbA1c Point-of-care Devices

This study tests how well different blood glucose and HbA1c devices work for people with diabetes, whether they are trained users or just regular folks, to see if they can get accurate readings.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 910 (estimated)
• Ages: 13 Years and up
• Sex: All
• Sponsor: Foundation for Innovative New Diagnostics, Switzerland (Academic / other)
• Locations: 3 sites (Phnom Penh and 2 other locations)
• Trial ID: NCT06170515 on ClinicalTrials.gov

What this trial studies

This study evaluates the analytical performance of four blood glucose meters (BGMs) and four HbA1c point-of-care (POC) devices against established reference methods. It aims to assess how well these devices perform when used by trained users and by lay users who are unfamiliar with the systems. Additionally, the usability of all devices, including lancing devices, will be evaluated. The study includes participants aged 13 and older diagnosed with diabetes or those who are not diagnosed but meet specific criteria.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 13 years and older diagnosed with diabetes who can manage their condition independently, as well as adults who may or may not have diabetes but meet specific health criteria.

Not a fit: Patients under 13 years old or those who are unable to manage their diabetes independently will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diabetes management through more effective and user-friendly monitoring devices.

How similar studies have performed: Other studies have shown success in evaluating point-of-care devices, indicating that this approach is supported by prior research.

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.

Where this trial is running

Phnom Penh and 2 other locations

• Sihanouk Hospital Centre of Hope — Phnom Penh, Cambodia (Recruiting)
• Asociación Colombiana de Diabetes — Bogotá, Bogota, Colombia (Not_yet_recruiting)
• Lagos University Teaching Hospital — Lagos, Nigeria (Recruiting)

Study contacts

• Study coordinator: Priyanka Singh

Conditions Diabetes