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Optimising insulin use in people living with type 2 diabetes at primary healthcare facilities : the Tshwane insulin project
Rheeder, Paul; Botha, G.; Mohlala, Maryangela G.; Eales, Owen; Van Zyl, Danie G.; Ngassa Piotie, Patrick (South african Medical Association, 2025-07)
BACKGROUND : In South Africa (SA), glucose control for individuals with type 2 diabetes follows a stepwise approach. According to the guidelines, insulin therapy is started after using two oral agents. However, various challenges may delay the initiation of insulin. OBJECTIVES : To implement a nurse-led, telehealth-assisted programme to address these challenges, aiming to transition patients to insulin safely to achieve better glycaemic control. METHODS : From 2021 to 2023, we conducted a single-arm, unblinded before-and-after study in primary care facilities in Tshwane District, Gauteng Province, SA. Participants were on insulin or two oral agents at maximum doses. Study nurses monitored glycated haemoglobin (HbA1c) results, and participants with HbA1c levels of ≥8% (≥10% during the COVID‑19 pandemic) were counselled about insulin use. During an initiation visit, participants received demonstrations and education on using insulin and glucose meters. The participants then tested their glucose levels at home according to a fixed schedule. Over 14 weeks, we implemented monthly clinic visits supplemented by home visits facilitated by community healthcare worker teams. During these visits, glucose results were communicated to the clinic physician via the Vula mobile app, allowing timely adjustments to insulin therapy. RESULTS : Of the 293 participants, 65% (n=192) were women and 35% (n=101) were men. The mean (standard deviation (SD)) age was 53 (10) years, with a baseline mean (SD) HbA1c level of 12.1% (1.7%). Of those initiated, 169 (58%) were on oral agents and 124 (42%) were on insulin. Biphasic mixed human insulin was prescribed to 185 participants (63%) and intermediate human neutral protamine Hagedorn (NPH) insulin to 108 (37%). Immediately after baseline assessment and during the 14-week study period, 72 participants (23%) were lost to follow-up, and seven were hospitalised during the study period. Glucose values decreased over 14 weeks, with approximately one-third of participants having no insulin adjustments, one-third having one adjustment, and one-third having more than one adjustment. The mean (SD) HbA1c level decreased from 12.1% (1.6%) to 8.8% (1.6%) over the 14 weeks in 240 paired samples (p<0.001). Ten percent of these participants achieved HbA1c levels <7%, and 34% had levels <8%. CONCLUSION : The nurse-led, telehealth-supported intervention successfully transitioned participants onto twice-daily mixed insulin or night-time intermediate NPH insulin, resulting in a significant decrease in HbA1c from 12.1% to 8.8%. However, clinics will require additional resources to initiate or intensify insulin therapy in primary care settings.
Nocardia species epidemiology and susceptibility profiles from 2019 to 2022 in South Africa
Thomas, T.; Lowe, M.; Le Roux, K.; Strydom, Kathy-Anne (South african Medical Association, 2025-08)
BACKGROUND : Nocardia species cause infections in humans, from localised to disseminated disease. They constitute a public health threat owing to the lack of sufficient information about them. In South Africa (SA), the last publication on this organism was in 2010. Predominant species types and antibiotic susceptibilities may have changed over this period. OBJECTIVE : To address the knowledge gap surrounding Nocardia species and their antibiotic susceptibilities in SA. METHODS : This was a retrospective and cross-sectional study. Data were collected from the Central Data Warehouse (CDW) of the National Health Laboratory Service (NHLS) on suspected Nocardia species from 1 January 2019 to 31 December 2022. Organism speciation was performed using 16S rRNA sequencing and antibiotic susceptibility testing (AST) by the broth microdilution (BMD) method. Data analysis included patient age, sample types from which the organism was cultured, distribution in the various SA provinces, species types and species AST profiles, including a record of trimethoprim-sulfamethoxazole (TMP/SMX) non-susceptibility. RESULTS : One hundred and sixty-five positive culture results were analysed. The majority of positive cultures (28%, n=46) were from the 30 - 39-year age group. The organism was predominantly cultured from pus samples (31%, n=51). The top two provinces from which the largest numbers of isolates were submitted were Gauteng (69%, n=114) and Western Cape (18%, n=30) provinces. Two percent (n=4) of isolates were not sequenced, and 18% (n=30) of isolates lacked AST results. Twenty-nine percent (n=47) of the Nocardia species that were sequenced could not be speciated using 16S rRNA sequencing. The top two species country-wide were N. abscessus complex (25%, n=42) and N. cyriacigeorgica (18%, n=29). Approximately 90% (n=121) of all isolates tested were TMP/SMX susceptible. CONCLUSION : The predominant isolation of Nocardia species from pus samples suggests that the majority were deep-seated infections. The most common Nocardia species types and the AST profiles have changed over time. The study highlights the need for alternative methods for the speciation of this organism.
Heritable human genome editing in South Africa - time for a reality check
Ramsay, Michele; Pepper, Michael Sean; De Vries, Jantina; Mahomed, Safia; Flack-Davison, Eleni (South african Medical Association, 2025-02)
Referring to the third edition of the South African Ethics in Health Research Guidelines: Principles, Processes and Structures (the guidelines) dated May 2024, Baylis and Hasson assert that the guidelines support heritable human genome editing (HHGE), which allows for children conceived from ‘gene-edited’ cells to be born. On 7 November 2024, a news item appeared in Nature titled ‘Will South Africa become first country to accept controversial form of human genome editing?’ As South African (SA) scholars in the fields of genetics, biology, law and ethics, we wish to express our dismay that national and international audiences should be misled to believe that SA law accommodates or should be changed to allow for the clinical application of HHGE. What is at stake is not whether HHGE is permissible for research purposes in SA, but whether it is permissible to create live births.
Progress in advanced cellular and gene therapies in South Africa and barriers to patient access : a National Consortium paper on behalf of the BloodSA Cell and Gene Therapy working party
Hendricks, Candice Laverne; Viljoen, I.; Botes, M.; Brittain, D.; Mahlangu, J.; Verburgh, E.; Gerdener, T.; Herd, C.; Logan, M.G.; Marais, A.L.; Glatt, T.N.; Cockeran, R.; Poole, C.; Du Toit, J.; Pepper, Michael Sean (South african Medical Association, 2025-06)
The fields of molecular and cellular medicine have, in recent years, witnessed a great deal of progress globally, particularly in understanding disease pathogenesis and through the development of advanced cellular therapy products and gene therapies. Despite the transformative potential of these new therapies, low- and middle-income countries face significant barriers to their access. Advanced cellular therapy legislation in South Africa (SA) has not kept up with this fast-advancing field, and requires a fast-tracked renewal. Furthermore, the prohibitive cost of commercial therapies, including chimeric antigen receptor (CAR) T-cell products, and the lack of infrastructure, manufacturing and research capacity, must be addressed to make equitable patient access an achievable goal in our setting. To this end, a national cell and gene therapy consortium, comprising clinicians, clinician-scientists, scientists, legal experts, postgraduate students and representatives from industry, the national blood service and the pharmaceutical industry, was initiated. The mandate of this group is to aid the progression of advanced cellular therapies in SA, and the purpose of this article is to outline the progress that has been made. We will highlight the gaps in each core field of practice within this space, and provide a proposal for making these therapies more accessible in SA.
Addressing the limitations of the regulatory landscape in South Africa regarding advanced cell and gene therapies and related sectors involving human cells, tissues and organs
Viljoen, Ignatius M.; Pepper, Michael Sean (South african Medical Association, 2025-02)
Advanced cell-based and gene therapy products emerged during the 1990s as new health product categories for treating and curing previously untreatable or incurable conditions. These products are complex, diverse and therapeutically specific, requiring specialised regulatory frameworks. During the last three decades, several jurisdictions have constructed specific regulatory frameworks to ensure these products’ safety, clinical efficacy and quality. As these are new and disruptive products, these frameworks are continuously evolving. However, South Africa (SA)’s regulatory frameworks for medicines, human biological materials and genetically modified organisms have not kept pace with scientific and technological developments, leaving regulatory gaps. We briefly describe these novel products and their regulatory frameworks, and propose a way forward in SA.