Glycated haemoglobin A1c (HbA1c) measurement is essential for managing diabetes, yet limited data exist on the performance of point-of-care (POC) HbA1c devices in low- and middle-income countries (LMICs). This study evaluated the analytical performance and usability of HbA1c devices in different LMIC settings.

This prospective, cross-sectional multicentre study evaluated the accuracy and usability of four POC devices (i-SENS A1Care, HemoCue HbA1c 501 System, Abbott Afinion 2 and Siemens DCA Vantage) against a laboratory-based HbA1c method at two hospitals in Nigeria and Cambodia.

Adults with or without diabetes and haemoglobin ≥8 g/dL were enrolled.

The primary objective was to evaluate HbA1c POC device accuracy versus laboratory reference testing; secondary objectives evaluated device usability and technical characteristics when used by trained professionals.

Capillary and venous blood samples were tested on all devices using two cartridge lots followed by reference testing. Usability was assessed via operator questionnaires. Accuracy was evaluated using regression slopes, intercept, absolute bias at 30, 48 and 75 mmol/mol, and Bland-Altman analysis, including capillary-venous concordance.

A total of 248 participants completed all study procedures (n=125 in Cambodia, n=123 in Nigeria). Siemens DCA Vantage and Abbott Afinion 2 showed strong agreement with the reference method, with no clinically significant differences and narrow limits of agreement. In contrast, i-SENS A1Care and HemoCue HbA1c 501 System displayed greater bias, especially at elevated HbA1c levels. Most results fell within limits of agreement, though high-HbA1c outliers were more common with the A1Care and HbA1c 501 System devices. Usability feedback was positive overall, when devices were rated across various dimensions, such as clarity of instructions, safety and labelling, although limited user sample size constrains the generalisability of these findings.

Siemens DCA Vantage and Abbott Afinion 2 demonstrated reliable accuracy and usability. In contrast, i-SENS A1Care and HemoCue HbA1c 501 System require cautious interpretation at high HbA1c levels. Ongoing evaluation is critical to ensure the appropriate use of POC devices in diverse clinical settings.

NCT06170515.

To assess the acceptability and adoption of multiparameter point-of-care testing (POCT) devices for the diagnosis and management of non-communicable diseases (NCDs) at the primary healthcare level in a resource-limited region of Peru.

Qualitative case-control process evaluation.

Eight primary healthcare facilities in northern Peru, including both urban and rural centres, where routine chronic care and laboratory services are provided.

Sixty-three participants: 36 patients, 12 laboratory technicians, 10 healthcare professionals and five facility heads. Eligible patients were ≥18 years, residing in the catchment area, with or without prior NCD diagnoses. Healthcare workers, including physicians, nurses, laboratory staff and facility managers.

Multiparameter POCT devices were installed in four intervention facilities, accompanied by staff training and community awareness activities, while four control facilities continued with conventional laboratory diagnostics.

Primary outcome: perceptions of patients and healthcare workers regarding the acceptability and adoption of POCT devices. Secondary outcomes: identification of facilitators and barriers to implementation, including infrastructure, supply chains and training gaps.

(1) Individuals: POCT was valued for speed and comfort, but concerns over accuracy were mentioned. (2) Intervention characteristics: laboratory staff valued POCT’s practicality in emergencies, but noted limitations in handling multiple samples. (3) Outer setting: urban centres outperformed rural facilities, with more staff and longer operating hours. (4) Inner setting: calibration gaps impacted POCT and conventional test reliability, requiring quality control and training. (5) Process: clear staff communication boosted patient confidence in POCT, but inconsistent training could lead to reliability doubts.

Multiparameter POCT devices show promise for enhancing NCD care in resource-limited primary healthcare settings, particularly in rural areas. However, their sustainability depends on broader health system reforms, including reliable supply chains, expanded training and stronger quality assurance mechanisms. Further research should examine strategies for embedding POCT within national regulatory and policy frameworks.

Alcohol dependence (AD) is highly prevalent and has severe consequences on health and quality of life. However, the efficacy of approved pharmacotherapies such as naltrexone (NTX) remains limited, highlighting the need for novel pharmacotherapeutic approaches. Cannabidiol (CBD) is a promising candidate, which has shown potential to reduce craving and alcohol use by modulating brain circuits involved in craving and addiction. Preclinical studies suggest that CBD may enhance NTX’s therapeutic effects.

This is a three-armed, randomised, double-blind, placebo-controlled parallel group, multicentre phase II clinical trial. A total of 150 patients with AD will be randomised (1:1:1) to receive either 800 mg or 1200 mg CBD plus 50 mg oral NTX or placebo plus 50 mg oral NTX for 14 days. Alcohol craving will be assessed using the Obsessive Compulsive Drinking Scale (OCDS-G) where the primary endpoint is the change from baseline to the end of treatment. Secondary outcomes include craving during the entire study, quality of life, depressive symptoms, anxiety, patient-reported outcomes, neural brain activation, CBD plasma levels, time to relapse, alcohol use and treatment safety. For the comparison of each experimental group to the control group, a strata-adjusted (centre and baseline OCDS-G) van Elteren test is applied with adjustment for multiple testing by Bonferroni-Holm.

The trial has been approved by the Ethics Committee and the competent authority (ID: B_03510). All participants will provide written informed consent. An independent Data and Safety Monitoring Board will monitor safety. This trial complies with national and international regulations.

NCT06845124; EU Trial Number: 2024-518164-12-00.