Community health worker-led versus facility-based type 2 diabetes care in rural Lesotho: a cluster-randomized trial within the ComBaCaL cohort study
Abstract
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: We conducted a cluster-randomised trial nested within the ComBaCaL (Community-Based Chronic Care Lesotho) cohort (NCT05596773). The cohort spans 103 rural villages in Lesotho, managed by trained, supervised CHWs. After home-based screening of cohort participants ≥40 years old or with body mass index ≥25 kg/m2, 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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 785 participants or records.
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