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孟加拉国社区团体或手机短信预防和控制 2 型糖尿病和中间高血糖(DMagic):一项整群随机对照试验。

Community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycaemia in Bangladesh (DMagic): a cluster-randomised controlled trial.

机构信息

UCL Institute for Global Health, Faculty of Population Health Sciences, University College London, London, UK.

Diabetic Association of Bangladesh, Dhaka, Bangladesh.

出版信息

Lancet Diabetes Endocrinol. 2019 Mar;7(3):200-212. doi: 10.1016/S2213-8587(19)30001-4. Epub 2019 Feb 4.

Abstract

BACKGROUND

Strategies are needed to prevent and control type 2 diabetes and intermediate hyperglycaemia, which together affect roughly a third of adults in Bangladesh. We aimed to assess the effects of mHealth and community mobilisation on the prevalence of intermediate hyperglycaemia and diabetes among the general adult population in rural Bangladesh, and to assess the effect of these interventions on the incidence of type 2 diabetes among people with intermediate hyperglycaemia within the study population.

METHODS

DMagic was a three-arm, cluster-randomised trial of participatory community mobilisation, mHealth mobile phone messaging, and usual care (control) in 96 villages (population roughly 125 000) in Bangladesh. Community mobilisation involved 18 monthly group meetings, led by lay facilitators, applying a participatory learning and action (PLA) cycle focused on diabetes prevention and control. mHealth involved twice-weekly voice messages over 14 months promoting behaviour change to reduce diabetes risk. The primary outcomes were the combined prevalence of type 2 diabetes and intermediate hyperglycaemia in the overall population at the end of the intervention implementation period, and 2-year cumulative incidence of type 2 diabetes in a cohort with intermediate hyperglycaemia at baseline. Primary outcomes were assessed through fasting blood glucose concentrations and 2-h oral glucose tolerance tests among a cross-section of adults aged 30 years and older and a cohort of individuals identified with intermediate hyperglycaemia. Prevalence findings are based on a cross-sectional survey at the end of the study; incidence findings are based on 2-year follow-up survey of a cohort of individuals identified with intermediate hyperglycaemia through a cross-sectional survey at baseline. We also assessed the cost-effectiveness of the interventions. This trial is registered with the ISRCTN registry, number ISRCTN41083256, and is completed.

FINDINGS

The study took place between June 27, 2015, and June 28, 2018, with the PLA intervention running in 32 villages from June, 2016, to December, 2017, and the mHealth intervention running in 32 villages from Oct 21, 2016, to Dec 24, 2017. End-of study prevalence was assessed in 11 454 individuals and incidence in 2100 individuals. There was a large reduction in the combined prevalence of type 2 diabetes and intermediate hyperglycaemia in the PLA group compared with the control group at the end of the study (adjusted [for stratification, clustering, and wealth] odds ratio [aOR] 0·36 [0·27-0·48]), with an absolute reduction of 20·7% (95% CI 14·6-26·7). Among 2470 adults with intermediate hyperglycaemia at baseline, 2100 (85%) were followed-up at 2 years. The 2-year cumulative incidence of diabetes in this cohort was significantly lower in the PLA group compared with control (aOR 0·39, 0·24-0·65), representing an absolute incidence reduction of 8·7% (3·5-14·0). There was no evidence of effect of mHealth on combined prevalence of intermediate hyperglycaemia and diabetes (aOR 0·93, 0·74-1·16) or the incidence of diabetes (1·02, 0·73-1·43). The incremental cost-effectiveness ratios for PLA were INT$316 per case of intermediate hyperglycaemia or type 2 diabetes prevented and $6518 per case of type 2 diabetes prevented among individuals with intermediate hyperglycaemia.

INTERPRETATION

Our data provide strong evidence to support the use of community mobilisation based on PLA to prevent type 2 diabetes in this rural Bangladeshi population. Despite raising knowledge and awareness of diabetes, the mHealth intervention did not change disease outcomes in our population. Replication studies in other populations should be a priority.

FUNDING

UK Medical Research Council.

摘要

背景

需要策略来预防和控制 2 型糖尿病和中间高血糖,这两者共同影响了孟加拉国大约三分之一的成年人。我们旨在评估 mHealth 和社区动员对孟加拉国农村地区普通成年人口中间高血糖和糖尿病患病率的影响,并评估这些干预措施对研究人群中中间高血糖患者 2 型糖尿病发病率的影响。

方法

DMagic 是一项三臂、整群随机试验,在孟加拉国 96 个村庄(约 125000 人)中进行了参与式社区动员、mHealth 手机短信和常规护理(对照组)的干预。社区动员包括由非专业人员领导的 18 次每月小组会议,应用以糖尿病预防和控制为重点的参与式学习和行动(PLA)循环。mHealth 包括在 14 个月内每周两次通过语音信息促进行为改变以降低糖尿病风险。主要结局是在干预实施结束时总体人群中 2 型糖尿病和中间高血糖的合并患病率,以及基线时中间高血糖人群中 2 年累积的 2 型糖尿病发病率。主要结局通过对 30 岁及以上成年人的横断面和基线时通过横断面确定的中间高血糖个体的队列的空腹血糖浓度和 2 小时口服葡萄糖耐量试验进行评估。患病率发现基于研究结束时的横断面调查;发病率发现基于基线时通过横断面调查确定的中间高血糖个体的队列的 2 年随访调查。我们还评估了干预措施的成本效益。这项试验在 ISRCTN 注册表中注册,编号为 ISRCTN41083256,已完成。

结果

研究于 2015 年 6 月 27 日至 2018 年 6 月 28 日进行,PLA 干预于 2016 年 6 月至 2017 年 12 月在 32 个村庄进行,mHealth 干预于 2016 年 10 月 21 日至 2017 年 12 月 24 日在 32 个村庄进行。在研究结束时评估了 11454 人的终末患病率,并在 2100 人身上评估了发病率。与对照组相比,PLA 组的 2 型糖尿病和中间高血糖合并患病率在研究结束时大幅降低(校正[分层、聚类和财富]比值比[aOR]0.36[0.27-0.48]),绝对降低 20.7%(95%CI 14.6-26.7)。在基线时有中间高血糖的 2470 名成年人中,有 2100 人(85%)在 2 年后进行了随访。在该队列中,PLA 组的 2 年累积糖尿病发病率明显低于对照组(aOR 0.39[0.24-0.65]),绝对发病率降低 8.7%(3.5-14.0)。没有证据表明 mHealth 对中间高血糖和糖尿病的合并患病率(aOR 0.93[0.74-1.16])或中间高血糖患者的糖尿病发病率(1.02[0.73-1.43])有影响。PLA 的增量成本效益比分别为预防每例中间高血糖或 2 型糖尿病的费用为 316 国际元,预防每例中间高血糖患者 2 型糖尿病的费用为 6518 国际元。

解释

我们的数据提供了强有力的证据,支持在孟加拉国农村地区使用基于 PLA 的社区动员来预防 2 型糖尿病。尽管提高了对糖尿病的认识和意识,但 mHealth 干预措施并没有改变我们人群的疾病结局。在其他人群中进行复制研究应该是当务之急。

经费

英国医学研究理事会。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e06/6381080/d06664eb0081/gr1.jpg

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