Abstract

BackgroundDiabetes is now a global epidemic, but most cases are now in low- and middle-income countries. Diabetes self-management education (DSME) is key to enabling patients to manage their chronic condition and can reduce the occurrence of costly and devastating complications. However, there is limited evidence on the effectiveness of different DSME programmes in resource limited settings.MethodsWe conducted an unblinded, parallel-group, individually-randomised controlled trial at the University of Calabar Teaching Hospital (Nigeria) to evaluate whether an intensive and systematic DSME programme, using structured guidelines, improved glycaemic control compared to the existing ad hoc patient education (clinical practice was unchanged). Eligible patients (≥18 years, HbA1c > 8.5% and physically able to participate) were randomly allocated by permuted block randomisation to participate for six months in either an intensive or conventional education group. The primary outcome was HbA1c (%) at six-months.ResultsWe randomised 59 participants to each group and obtained six-month HbA1c outcomes from 53 and 51 participants in the intensive and conventional education groups, respectively. Intensive group participants had a mean six-month HbA1c (%) of 8.4 (95% CI: 8 to 8.9), while participants in the conventional education group had a mean six-month HbA1c (%) of 10.2 (95% CI: 9.8 to 10.7). The difference was statistically (P < 0.0001) and clinically significant, with intensive group participants having HbA1c outcomes on average -1.8 (95% CI: -2.4 to -1.2) percentage points lower than conventional group participants. Results were robust to adjustment for a range of covariates and multiple imputation of missing outcome data.ConclusionsThis study demonstrates the effectiveness of a structured, guideline-based DSME intervention in a LMIC setting versus a pragmatic comparator. The intervention is potentially replicable at other levels of the Nigerian healthcare system and in other LMICs, where nurses/diabetes educators can run the programme.Trial RegistrationPan African Clinical Trial Registry PACTR20130200047835

Highlights

  • It is estimated that between 340 and 536 million adults worldwide have diabetes, with the disease accounting for an estimated 14.5% of global all-cause mortality in 2015 [1]

  • Intensive group participants had a mean six-month HbA1c (%) of 8.4, while participants in the conventional education group had a mean six-month HbA1c (%) of 10.2

  • This study demonstrates the effectiveness of a structured, guideline-based Diabetes self-management education (DSME) intervention in a low- and middle-income countries (LMICs) setting versus a pragmatic comparator

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Summary

Introduction

It is estimated that between 340 and 536 million adults (aged 20–79 years) worldwide have diabetes, with the disease accounting for an estimated 14.5% of global all-cause mortality in 2015 [1]. Over the past decade the prevalence of diabetes has risen most rapidly in low- and middle-income countries (LMICs) [2], where it is estimated that around 75% of people with diabetes live [1]. Low- and middle-income countries generally lack the resources with which to adequately deal with this growing diabetes epidemic. Diabetes self-management education (DSME) is seen as “a critical element of care for all people with diabetes and those at risk of developing the disease [6].”. Diabetes is a global epidemic, but most cases are in low- and middle-income countries. Diabetes self-management education (DSME) is key to enabling patients to manage their chronic condition and can reduce the occurrence of costly and devastating complications. There is limited evidence on the effectiveness of different DSME programmes in resource limited settings

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