Community health worker-led versus facility-based type 2 diabetes care in rural Lesotho: a cluster-randomized trial within the ComBaCaL cohort study

BACKGROUND: Type 2 diabetes poses a growing public health burden in low- and middle-income countries, where major gaps in access to chronic care persist. Task-shifting to Community Health Workers (CHWs) and the use of digital clinical decision support systems may bridge these gaps. Randomized trials evaluating CHW-led care models in which CHWs initiate, titrate, and monitor first-line diabetes treatment are lacking. METHODS: , all with type 2 diabetes were enrolled in the trial. In intervention villages, CHWs - guided by a tablet-based clinical decision support system - provided care, including initiation and monitoring of metformin, atorvastatin and aspirin. In control villages, participants were referred to facility-based care. The primary analysis included participants with uncomplicated and uncontrolled type 2 diabetes (fasting glucose ≥7 mmol/l) on glycated haemoglobin (HbA1c) at 12 months. RESULTS: From 13 May 2023 to 31 January 2024, 5'785 cohort participants were screened, 252 (4·4%) diagnosed with type 2 diabetes, and 103 (51 control, 52 intervention) included in the primary analysis (73·8% female, mean age 62·3 ± 12·8 years, mean HbA1c 7·2 ± 1·4%). At 12 months, HbA1c was 7·1 ± 1·9% in the control arm and 6·5 ± 1·3% in the intervention arm (adjusted mean difference -0·46%, 95%CI -1·14 to 0·22). Engagement in care was higher in the intervention arm. No relevant difference in safety outcomes was observed. CONCLUSIONS: CHW-led, clinical decision support system-assisted management of type 2 diabetes, including first-line drug prescription, may improve engagement in care and glycaemic control in rural low-resource settings. Larger studies are required to confirm these findings. TRIAL REGISTRATION: Clinicaltrials.gov: NCT05743387.