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. 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.

Healthcare Resource Utilization in Controlled Versus Uncontrolled Adults Living With Type 1 Diabetes in the South African Public Healthcare Sector.

OBJECTIVES: This study aimed to understand the cost implications of managing people living with type 1 diabetes mellitus in the South African public healthcare system. METHODS: A multicenter, noninterventional retrospective chart review study was performed. Data on healthcare resource consumption, demographics, risk factors, clinical history, and acute events were collected. Direct medical costs were collected over a 1-year period, stratified by controlled versus uncontrolled patients. In addition, the costs in people with controlled (glycated hemoglobin < 7%) versus uncontrolled glycated hemoglobin (≥ 7%) at time horizons of 1, 5, 10, and 25 years were modeled using the IQVIA Core Diabetes Model. RESULTS: The costs based on the retrospective chart review were $630 versus $1012 (controlled versus uncontrolled population). The modeled costs at various time horizons were as follows: at 1 year, $900 versus $1331; at 5 years, $4163 versus $6423; at 10 years, $7759 versus $16 481; and at 25 years, $16 969 versus $66 268. The largest cost in the controlled population was severe hypoglycemia requiring nonmedical assistance, severe hypoglycemia requiring medical assistance, and treatment costs. In the uncontrolled population, the largest cost was the cost of diabetic ketoacidosis, severe hypoglycemia requiring nonmedical assistance, severe hypoglycemia requiring medical assistance, and foot complications. CONCLUSIONS: Strict glycemic control reduces healthcare resource use overall. Patients in the controlled group still experienced high resource use related to hypoglycemic events. The introduction of a structured patient education program and analog insulins may result in less episodes of hypoglycemia and potential cost savings.

"Those People Motivate and Inspire Me to Take My Treatment." Peer Support for Adolescents Living With HIV in Cape Town, South Africa.

Adherence to antiretroviral therapy (ART) and psychosocial support to manage stigma and disclosure is essential for adolescents living with HIV (ALHIV). Peer support groups can help ALHIV and their families live successfully with HIV. This qualitative study aimed to examine adolescent and caregiver perspectives on peer support groups. Three themes emerged: (1) peer support encouraged adherence to ART, (2) serostatus disclosure outside the family was perceived as difficult, and (3) the peer support group fostered fundamental and meaningful peer relationships for ALHIV. Caregivers felt peer support groups increased self-acceptance and adherence for ALHIV across 3 domains: (1) as motivation for families and adolescents, (2) to increase adolescent independence and maturity, and (3) to help adolescents accept their HIV status and live successfully with HIV. These data highlight the importance of psychosocial support groups for ALHIV and caregivers, illustrating the benefits of a safe space with trusted relationships and open communication.

Relationship between fluid management, changes in serum sodium and outcome in hypernatraemia associated with gastroenteritis.

OBJECTIVE: To describe the relationship between fluid management, serum sodium and outcome in critically ill children with hypernatraemic gastroenteritis. METHODS: A retrospective study of 57 children with hypernatraemic gastroenteritis admitted to a paediatric intensive care unit in Cape Town, South Africa. Data were collected on fluid management, serum electrolytes and adverse outcome (seizures, new neurological deficit and mortality) and analysed using univariate and multivariate statistics. RESULTS: Median admission sodium was 165 mmol/L (145-199). Median volume of intravenous rehydration fluid was 6 mL/kg/h (144 mL/kg/day), with sodium concentration of 61 mmol/L (0-154 mmol/L), resulting in a median fall in sodium of 0.6 mmol/L/h (14.4 mmol/L/day). Fourteen children (25%) had seizures during rehydration, four children (7%) died and five children (9%) developed neurological deficit. Median admission sodium in children with adverse outcome was 172 mmol/L, with rate of fall of 0.63 mmol/L/h, compared with median admission sodium of 163 mmol/L and rate of fall of 0.48 mmol/L/h, in children with good outcome (P=0.068 and P=0.08, respectively). Median sodium content of intravenous solution was 61 mmol/L in both groups (P=0.68). Multivariate analysis demonstrated that neither sodium content of intravenous solution (P=0.59), nor rate of fall of sodium (P=0.31), was independently associated with adverse outcome. CONCLUSIONS: Rehydration in hypernatraemic gastroenteritis using intravenous solutions containing 61 mmol/L sodium would be expected to correct serum sodium at a rate of approximately 0.6 mmol/L/h. Neither sodium content of the intravenous solution, nor rate of correction of sodium, was independently associated with adverse outcome.