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Background <p>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.</p> Methods <p>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/m<sup>2</sup>, 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.</p> Results <p>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.</p> Conclusions <p>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.</p> Trial registration <p>Clinicaltrials.gov: NCT05743387</p>

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

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  • 发表日期：

    2026年5月22日

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  • Felix Gerber,
  • Ravi Gupta,
  • Giuliana Sanchez-Samaniego,
  • Thabo Ishmael Lejone,
  • Thesar Tahirsylaj,
  • Fabian Raeber,
  • Elis Belen Saavedra,
  • Iliana Esquivel-Valdés,
  • Mamakhala Chitja,
  • Manthabiseng Molulela,
  • Makhebe Khomolishoele,
  • Mota Mota,
  • Matumaole Bane,
  • Sesale Masike,
  • Mamorontsáne Pauline Sematle,
  • Manthati Mofokeng,
  • Retselisitsoe Makabateng,
  • Madavida Mphunyane,
  • Lebohang Sao,
  • Mosa Tlahali,
  • Malitaba Litaba,
  • Dave Brian Basler,
  • Kevin Kindler,
  • Irene Ayakaka,
  • Pauline Grimm,
  • Eleonora Seelig,
  • Frédérique Chammartin,
  • Niklaus Daniel Labhardt,
  • Alain Amstutz

摘要

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 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