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.

Layering and scaling up chronic non-communicable disease care on existing HIV care systems and acute care settings in Kenya: a cost and budget impact analysis.

INTRODUCTION: Like many countries in sub-Saharan Africa, Kenya is experiencing a rapid rise in the burden of non-communicable diseases (NCDs): NCDs now contribute to over 50% of inpatient admissions and 40% of hospital deaths in the country. The Academic Model Providing Access to Healthcare (AMPATH) Chronic Disease Management (CDM) programme builds on lessons and capacity of HIV care to deliver chronic NCD care layered into both HIV and primary care platforms to over 24,000 patients across 69 health facilities in western Kenya. We conducted a cost and budget impact analysis of scaling up the AMPATH CDM programme in western Kenya using the International Society for Pharmacoeconomics and Outcomes Research guidelines. METHODS: Costs of the CDM programme for the health system were measured retrospectively for 69 AMPATH clinics from 2014 to 2018 using programmatic records and clinic schedules to assign per clinic monthly costs. We quantified the additional costs to provide NCD care above those associated with existing HIV or acute care services, including clinician, staff, training, travel and equipment costs, but do not include drugs or consumables as they would be paid by the patient. We projected the budget impact of increasing CDM coverage to 50% of the eligible population from 2021 to 2025, and compared it with the county budgets from 2019. RESULTS: The per visit cost of providing CDM care was $10.42 (SD $2.26), with costs at facilities added to HIV clinics $1.00 (95% CI: -$2:11 to $0.11) lower than at primary care facilities. The budget impact of adding 26,765 patients from 2021 to 2025 to the CDM programme was 3,088,928 under constant percent growth, and 3,451,732 under steady-state enrolment. Scaling up under the constant percent growth scenario resulted in 12% cost savings in the budget impact. The county programmatic CDM cost in 2025 was <1% of the county healthcare budgets from 2019. CONCLUSIONS: The budget impact of scaling up AMPATH's CDM programme will be driven by annual growth scenarios, and facility/provider mix. By leveraging task shifting, referral systems and partnering with public and non-profit clinics without NCD services, AMPATH's CDM programme can provide critical NCD care to new, rural populations with minimal financial impact.