ABSTRACT
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.
Subject(s)
Blood Glucose Self-Monitoring , Blood Glucose , Diabetes Mellitus, Type 1 , Glycated Hemoglobin , Multicenter Studies as Topic , Pragmatic Clinical Trials as Topic , Humans , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 1/diagnosis , Blood Glucose Self-Monitoring/instrumentation , Kenya , Blood Glucose/metabolism , Blood Glucose/analysis , Blood Glucose/drug effects , Glycated Hemoglobin/metabolism , Glycated Hemoglobin/analysis , South Africa , Quality of Life , Glycemic Control/instrumentation , Hypoglycemic Agents/therapeutic use , Hypoglycemic Agents/administration & dosage , Hypoglycemic Agents/adverse effects , Implementation Science , Insulin/administration & dosage , Insulin/therapeutic use , Treatment Outcome , Cost-Benefit Analysis , Continuous Glucose MonitoringABSTRACT
Diabetes is the world's fastest growing chronic disease and affects people of all ages. Reliable statistics are not readily available for South Africa; but data held by companies that supply insulin suggest that approximately 200 000 people in South Africa use injectable therapies to treat their diabetes. Health outcomes are affected if the incorrect injection technique is used; and this is a frequent occurrence which can be remedie
