McLeod Melissa, Stanley James, Signal Virginia, Stairmand Jeannine, Thompson Donna, Henderson Kelly, Davies Cheryl, Krebs Jeremy, Dowell Anthony, Grainger Rebecca, Sarfati Diana
Department of Public Health, University of Otago, Wellington, New Zealand.
, Masterton, New Zealand.
Diabetologia. 2020 Dec;63(12):2559-2570. doi: 10.1007/s00125-020-05261-x. Epub 2020 Sep 4.
AIMS/HYPOTHESIS: The aim of this RCT was to evaluate the effectiveness of a digital health programme (BetaMe/Melon) vs usual care in improving the control of type 2 diabetes and prediabetes in a primary care population.
We conducted a randomised parallel-group two-arm single-blinded superiority trial in the primary care setting in two regions of New Zealand. Eligible participants were identified through Primary Health Organisations and participating practices. Eligibility criteria were as follows: age 18-75 years, HbA 41-70 mmol/mol (5.9-8.6%), not taking insulin, and daily access to the internet. BetaMe/Melon is a 12 month mobile-device and web-based programme with four components: health coaching; evidence-based resources; peer support; and goal tracking. Participants were randomised into the intervention or control arm (1:1 allocation) based upon baseline HbA (prediabetes or diabetes range), stratified by practice and ethnicity. Research nurses and the study biostatistician were blind to study arm. Primary outcomes of the study were changes in HbA and weight at 12 months, using an intention-to-treat analysis.
Four hundred and twenty-nine individuals were recruited between 20 June 2017 and 11 May 2018 (n = 215 intervention arm, n = 214 control arm), most of whom were included in analyses of co-primary outcomes (n = 210/215, 97.7% and n = 213/214, 99.5%). HbA levels at 12 months did not differ between study arms: mean difference was -0.9 mmol/mol (95% CI -2.9, 1.1) (-0.1% [95% CI -0.3, 0.1]) for the diabetes group and was 0.0 mmol/mol (95% CI -0.9, 0.9) (0.0% [95% CI -0.1, 0.1]) for the prediabetes group. Weight reduced slightly at 12 months for participants in both study arms, with no difference between arms (mean difference -0.4 kg [95% CI -1.3, 0.5]).
CONCLUSIONS/INTERPRETATION: This study did not demonstrate clinical effectiveness for this particular programme. Given their high costs, technology-assisted self-management programmes need to be individually assessed for their effectiveness in improving clinical outcomes for people with diabetes.
www.anzctr.org.au ACTRN12617000549325 (universal trial number U1111-1189-9094) FUNDING: This study was funded by the Health Research Council of New Zealand, the Ministry of Health New Zealand and the Healthier Lives National Science Challenge. Graphical abstract.
目的/假设：本随机对照试验的目的是评估数字健康计划（BetaMe/瓜）与常规护理相比，在改善基层医疗人群中2型糖尿病和糖尿病前期控制方面的有效性。
我们在新西兰两个地区的基层医疗环境中进行了一项随机平行组双臂单盲优效性试验。通过初级卫生组织和参与机构确定符合条件的参与者。纳入标准如下：年龄18 - 75岁，糖化血红蛋白（HbA）为41 - 70 mmol/mol（5.9 - 8.6%），未使用胰岛素，且每天可上网。BetaMe/瓜是一个为期12个月的移动设备和基于网络的计划，包括四个部分：健康指导；循证资源；同伴支持；以及目标跟踪。根据基线HbA（糖尿病前期或糖尿病范围），按机构和种族分层，将参与者随机分为干预组或对照组（1:1分配）。研究护士和研究生物统计学家对研究分组不知情。本研究的主要结局是12个月时HbA和体重的变化，采用意向性分析。
2017年6月20日至2018年5月11日期间招募了429名个体（n = 215干预组，n = 214对照组），其中大多数纳入了共同主要结局分析（n = 210/215，97.7%和n = 213/214，99.5%）。研究组之间12个月时的HbA水平无差异：糖尿病组的平均差异为 -0.9 mmol/mol（95% CI -2.9，1.1）（-0.1% [95% CI -0.3，0.1]），糖尿病前期组为0.0 mmol/mol（95% CI -0.9，0.9）（0.0% [95% CI -0.1，0.1]）。两个研究组的参与者在12个月时体重均略有下降，组间无差异（平均差异 -0.4 kg [95% CI -1.3，0.5]）。
结论/解读：本研究未证明该特定计划具有临床有效性。鉴于技术辅助自我管理计划成本高昂，需要对其改善糖尿病患者临床结局的有效性进行单独评估。
www.anzctr.org.au ACTRN12617000549325（通用试验编号U1111 - 1189 - 9094） 资金：本研究由新西兰卫生研究委员会、新西兰卫生部和健康生活国家科学挑战基金资助。图形摘要。
