RESUMEN
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. METHODS: This trial was designed as a pragmatic, parallel-group, open-label, multicentre, three-arm, randomised (1:1:1) controlled trial of continuous or periodic CGM device use versus standard of care in people with T1D in South Africa and Kenya. The primary objective of this trial will be to assess the impact of continuous or periodic CGM device use on glycaemic control as measured by change from baseline glycosylated haemoglobin (HbA1c). Additional assessments will include clinical outcomes (glucose variation, time in/below/above range), safety (adverse events, hospitalisations), quality of life (EQ-5D, T1D distress score, Glucose Monitoring Satisfaction Survey for T1D), and health economic measures (incremental cost-effectiveness ratios, quality adjusted life years). DISCUSSION: This trial aims to address the substantial evidence gap on the impact of CGM device use on clinical outcomes in LMICs, specifically South Africa and Kenya. The trial results will provide evidence to inform policy and treatment decisions in these countries. TRIAL REGISTRATION: NCT05944731 (Kenya), July 6, 2023; NCT05944718 (South Africa), July 13, 2023.
Asunto(s)
Diabetes Mellitus Tipo 1 , Hemoglobina Glucada , Humanos , Glucemia/análisis , Monitoreo Continuo de Glucosa/instrumentación , Análisis Costo-Beneficio , Diabetes Mellitus Tipo 1/diagnóstico , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Hemoglobina Glucada/análisis , Control Glucémico/instrumentación , Hipoglucemiantes/uso terapéutico , Ciencia de la Implementación , Insulina/uso terapéutico , Kenia , Estudios Multicéntricos como Asunto , Ensayos Clínicos Pragmáticos como Asunto , Calidad de Vida , Sudáfrica , Resultado del TratamientoRESUMEN
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. Eligible participants dispensed medicines and/or were involved in purchasing products, and worked at retail pharmacies stocking ≥ 1 BGM product. An accredited continuing professional development module was then made available to pharmacy professionals and students on SwipeRx in both countries. After completing the 1-2 h module, users were required to correctly answer ≥ 60% (Cambodia) or ≥ 70% (Viet Nam) of knowledge assessment questions to achieve accreditation units from local partners. RESULTS: Whereas 33% of survey respondents in Cambodia (N = 386) and 63% in Viet Nam (N = 375) reported performing blood glucose testing at the pharmacy, only 19% and 14% were aware that clients taking multiple daily doses of insulin should check blood glucose levels several times a day. Of 1,137 and 399 pharmacy professionals/students who completed the module and passed the assessment in Cambodia and Viet Nam, 1,124 (99%) and 376 (94%) received accreditation. Knowledge levels improved substantially in 10 of 14 learning areas in Cambodia and 6 of 10 in Viet Nam. CONCLUSIONS: Digital education can strengthen pharmacy professional capacity to provide comprehensive and accurate information on diabetes management and the awareness of quality BGM products in Southeast Asia.