Performance and usability of cardiometabolic point of care devices in Nepal: A prospective, quantitative, accuracy study.

Non-communicable diseases (NCDs), such as cardiovascular disease and diabetes, represent a serious global health concern. There is an urgent need for prompt diagnosis and effective monitoring at point of care, especially in low- and middle-income countries. Here we present the results of a study assessing the quantitative accuracy of two devices that may fit the target product profile for a cardiometabolic point-of-care device.

Development of a target product profile for new glucose self-monitoring technologies for use in low- and middle-income countries.

Aims: Most glucose self-monitoring devices have been developed with high-income countries in mind. We developed a target product profile (TPP) for new glucose self-monitoring technologies for users in low- and middle-income countries (LMICs).

Methods: A draft TPP including 39 characteristics was developed by an expert group including diabetes specialists, device specialists, and people with diabetes, incorporating findings from qualitative research in LMICs.

The cost of adding rapid screening for diabetes, hypertension, and COVID-19 to COVID-19 vaccination queues in Johannesburg, South Africa.

Background: Non-communicable diseases (NCDs) are responsible for 51% of total mortality in South Africa, with a rising burden of hypertension (HTN) and diabetes mellitus (DM). Incorporating NCDs and COVID-19 screening into mass activities such as COVID-19 vaccination programs could offer significant long-term benefits for early detection interventions. However, there is limited knowledge of the associated costs and resources required.

Implementation research: a protocol for two three-arm pragmatic randomised controlled trials on continuous glucose monitoring devices in people with type 1 diabetes in South Africa and Kenya.

Background: Self-monitoring of glucose is an essential component of type 1 diabetes (T1D) management. In recent years, continuous glucose monitoring (CGM) has provided an alternative to daily fingerstick testing for the optimisation of insulin dosing and general glucose management in people with T1D. While studies have been conducted to evaluate the impact of CGM on clinical outcomes in the US, Europe and Australia, there are limited data available for low- and middle-income countries (LMICs) and further empirical evidence is needed to inform policy decision around their use in these countries.

Co-creation process of an intervention to implement a multiparameter point-of-care testing device in a primary healthcare setting for non-communicable diseases in Peru.

Background: Point-of-care testing (POCT) devices are diagnostic tools that can provide quick and accurate results within minutes, making them suitable for diagnosing non-communicable diseases (NCDs). However, these devices are not widely implemented in healthcare systems and for this reason is relevant to understand the implementation process.

Aim: To describe the process and define a strategy to implement a multiparameter POCT device for diagnosing and managing NCDs in one region of Peru.

Estimates of hospitalisations and deaths in patients with COVID-19 associated with undiagnosed diabetes during the first phase of the pandemic in eight low-income and middle-income countries: a modelling study.

Background: Patients with COVID-19 that had diagnosed chronic diseases - including diabetes - may experience higher rates of hospitalisation and mortality relative to the general population. However, the burden of undiagnosed co-morbidities during the pandemic has not been adequately studied.

Methods: We developed a model to estimate the hospitalisation and mortality burden of patients with COVID-19 that had undiagnosed type 1 and type 2 diabetes (UD).

Benefits of Usability Evaluation in the Development Process of Diabetes Technologies Using the Example of a Continuous Glucose Monitoring System Prototype.

Background: Usability engineering analyzes the interaction between the intended users and a device. Its implementation is mandatory for manufacturers to obtain regulatory approval for the European market. The aim of this evaluation was assessing the role of usability testing in the development process.

User requirements for non-invasive and minimally invasive glucose self-monitoring devices in low-income and middle-income countries: a qualitative study in Kyrgyzstan, Mali, Peru and Tanzania.

Aims: Development of non-invasive and minimally invasive glucose monitoring devices (NI-MI-GMDs) generally takes place in high-income countries (HICs), with HIC's attributes guiding product characteristics. However, people living with diabetes (PLWD) in low-income and middle-income countries (LMICs) encounter different challenges to those in HICs. This study aimed to define requirements for NI-MI-GMDs in LMICs to inform a target product profile to guide development and selection of suitable devices.

Integration of point-of-care screening for type 2 diabetes mellitus and hypertension into the COVID-19 vaccine programme in Johannesburg, South Africa.

Background: South Africa grapples with a substantial burden of non-communicable diseases (NCDs), particularly type 2 diabetes (diabetes) and hypertension. However, these conditions are often underdiagnosed and poorly managed, further exacerbated by the strained primary healthcare (PHC) system and the disruptive impact of the COVID-19 pandemic. Integrating NCD screening with large-scale healthcare initiatives, such as COVID-19 vaccination campaigns, offers a potential solution, especially in low- and middle-income countries (LMICs).

The cost of adding rapid screening for diabetes, hypertension, and COVID-19 to COVID-19 vaccination queues in Johannesburg, South Africa.

Background: Non-communicable diseases (NCDs) are responsible for 51% of total mortality in South Africa, with a rising burden of hypertension (HTN) and diabetes mellitus (DM). Incorporating NCD and COVID-19 screening into mass activities such as COVID-19 vaccination programs could offer significant long-term benefits for early detection interventions. However, there is limited knowledge of the associated costs and resources required.

Performance Assessment of Three Continuous Glucose Monitoring Systems in Adults With Type 1 Diabetes.

Background: FIND, the global alliance for diagnostics, identified the nonmarket-approved continuous glucose monitoring (CGM) system, FiberSense system (FBS), as a potential device for use in low- and middle-income countries. Together with two market-approved, factory-calibrated CGM systems, namely, the FreeStyle Libre 2 (FL2) and the GlucoRx AiDEX (ADX), the FBS was subjected to a clinical performance evaluation.

Methods: Thirty adult participants with type 1 diabetes were enrolled.

Toward 70% cervical cancer screening coverage: Technical challenges and opportunities to increase access to human papillomavirus (HPV) testing.

The World Health Organization (WHO) has called for the elimination of cervical cancer as a public health problem. Cervical cancer screening through human papillomavirus (HPV) testing is a core component of the strategy for elimination, with a set target of screening 70% of women twice in their lifetimes. In this review, we discuss technical barriers and opportunities to increase HPV screening globally.

Integration of point-of-care screening for type 2 diabetes mellitus and hypertension with COVID-19 rapid antigen screening in Johannesburg, South Africa.

Aims: We sought to evaluate the yield and linkage-to-care for diabetes and hypertension screening alongside a study assessing the use of rapid antigen tests for COVID-19 in taxi ranks in Johannesburg, South Africa.

Methods: Participants were recruited from Germiston taxi rank. We recorded results of blood glucose (BG), blood pressure (BP), waist circumference, smoking status, height, and weight.

Diabetes and blood glucose monitoring knowledge and practices among pharmacy professionals in Cambodia and Viet Nam: digital survey and education.

Background: In Southeast Asia, pharmacies are critical sources of healthcare advice for under-served communities, including those with/at risk of diabetes.

Aim: Explore knowledge/practices relating to diabetes and blood glucose monitoring (BGM) among pharmacy professionals in Cambodia and Viet Nam, using digital professional education to address gaps.

Methods: An online survey was distributed to pharmacy professionals in Cambodia and Viet Nam registered on SwipeRx mobile application.

Facilitators and barriers of the implementation of point-of-care devices for cardiometabolic diseases: a scoping review.

Background: Point-of-care testing (POCT) devices may facilitate the delivery of rapid and timely results, providing a clinically important advantage in patient management. The challenges and constraints in the implementation process, considering different levels of actors have not been much explored. This scoping review aimed to assess literature pertaining to implementation facilitators and barriers of POCT devices for the diagnosis or monitoring of cardiometabolic diseases.

Use of continuous glucose monitors in low- and middle-income countries: A scoping review.

Aims: The use of continuous glucose monitors (CGMs) has been shown to have positive impact on diabetes management for people with type 1 diabetes (T1DM), type 2 diabetes (T2DM) and gestational diabetes (GDM) in high-income countries. However, as useful as CGMs are, the experience in low- and middle-income countries (LMICs) is limited and has not been summarized.

Methods: A scoping review of the scientific literature was conducted.

Validation of Blood Pressure Devices as per 2020 World Health Organization Technical Specifications: A Scoping Review of Global Literature.

Background: To identify and summarize the global research literature on validation of automated noninvasive blood pressure measurement devices (BPMDs) with upper arm cuff, develop a repository of validated BPMDs in compliance with the 2020 World Health Organization technical specifications, and identify challenges and gaps in evidence base on validated BPMDs.

Methods: A scoping review was conducted. Primary research validating BPMDs complying with the 2020 World Health Organization technical specifications (ie, semiautomated/automated noninvasive devices with upper arm cuff), published in English between January 2000 and December 2021, was included.

Assessment of laboratory capacity in conflict-affected low-resource settings using two World Health Organization laboratory assessment tools.

Objectives: Laboratory diagnostic services are essential to drive evidence-based treatment decisions, manage outbreaks, and provide population-level data. Many low- and middle-income countries (LMICs) lack sufficient diagnostic capacity, often further exacerbated in conflict-affected areas. This project assessed laboratory services in conflict-affected LMICs to understand gaps and opportunities for improving laboratory capacity.

Addressing the diagnostic gap in hypertension through possible interventions and scale-up: A microsimulation study.

Background: Cardiovascular diseases (CVDs) are the leading cause of mortality globally with almost a third of all annual deaths worldwide. Low- and middle-income countries (LMICs) are disproportionately highly affected covering 80% of these deaths. For CVD, hypertension (HTN) is the leading modifiable risk factor.

International perspectives on the development, application, and evaluation of a multicancer early detection strategy.

The development and implementation of a multicancer early detection (MCED) test that is effective and affordable has the potential to change cancer care systems around the world. However, careful consideration is needed within the context of different health care settings (both low- and middle-income countries and high-income countries) to roll out an MCED test and promote equity in access.

Development of a target product profile for a point-of-care cardiometabolic device.

Introduction: Multi-parameter diagnostic devices can simplify cardiometabolic disease diagnosis. However, existing devices may not be suitable for use in low-resource settings, where the burden of non-communicable diseases is high. Here we describe the development of a target product profile (TPP) for a point-of-care multi-parameter device for detection of biomarkers for cardiovascular disease and metabolic disorders, including diabetes, in primary care settings in low- and middle-income countries (LMICs).

Products for Monitoring Glucose Levels in the Human Body With Noninvasive Optical, Noninvasive Fluid Sampling, or Minimally Invasive Technologies.

Background: Conventional home blood glucose measurements require a sample of blood that is obtained by puncturing the skin at the fingertip. To avoid the pain associated with this procedure, there is high demand for medical products that allow glucose monitoring without blood sampling. In this review article, all such products are presented.