Glucose Lowering through Weight management (GLoW): a randomised controlled trial of the clinical and cost effectiveness of a diabetes education and behavioural weight management programme vs a diabetes education programme in adults with a recent diagnosis of type 2 diabetes

IF 8.4 1区 医学 Q1 ENDOCRINOLOGY & METABOLISM
Julia Mueller, Penny Breeze, Francesco Fusco, Stephen J. Sharp, Katharine Pidd, Alan Brennan, Andrew J. Hill, Stephen Morris, Carly A. Hughes, Sarah E. Bates, Daniel Pollard, Jenny Woolston, Emma Lachassseigne, Marie Stubbings, Fiona Whittle, Rebecca A. Jones, Clare E. Boothby, Robbie Duschinsky, Jennifer Bostock, Nazrul Islam, Simon J. Griffin, Amy L. Ahern
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引用次数: 0

Abstract

Aims/hypothesis

UK standard care for type 2 diabetes is structured diabetes education, with no effects on HbA1c, small, short-term effects on weight and low uptake. We evaluated whether remotely delivered tailored diabetes education combined with commercial behavioural weight management is cost-effective compared with current standard care in helping people with type 2 diabetes to lower their blood glucose, lose weight, achieve remission and improve cardiovascular risk factors.

Methods

We conducted a pragmatic, randomised, parallel two-group trial. Participants were adults (≥18 years) with overweight or obesity (BMI≥25 kg/m2) and recently diagnosed with type 2 diabetes (≤3 years), recruited from 159 primary care practices in England. We randomised participants to a tailored diabetes education and behavioural weight management programme (DEW; delivered by Weight Watchers) or to current standard care diabetes education (DE; Diabetes Education and Self Management for Ongoing and Newly Diagnosed [DESMOND] programme), using a computer-generated randomisation sequence in a 1:1 allocation stratified by gender and diabetes duration, unknown to those collecting and analysing the data. Participants could not be blinded due to the nature of the interventions. Participants completed assessments at 0, 6 and 12 months. The primary outcome was 12 month change from baseline in HbA1c. We also assessed bodyweight, blood pressure, cholesterol (total, HDL, LDL), glucose-lowering medication, behavioural measures (physical activity, food intake), psychosocial measures (eating behaviour, diabetes-related quality of life, wellbeing) and within-trial and modelled lifetime cost effectiveness.

Results

We randomised 577 participants (DEW: 289, DE: 288); 398 (69%) completed 12 month follow-up. We found no evidence for an intervention effect on change in HbA1c from baseline to 12 months (difference: −0.84 [95% CI −2.99, 1.31] mmol/mol, p=0.44) or 6 months (−1.83 [−4.05, 0.40] mmol/mol). We found an intervention effect on weight at 6 (−1.77 [−2.86, −0.67] kg) and 12 months (−1.38 [−2.56, −0.19] kg). Participants in DEW had a higher likelihood of achieving diabetes remission than participants in DE (6 months: RR 2.10 [95% CI 1.03, 4.47]; 12 months: RR 2.53 [1.30, 5.16]). DEW was cost-effective compared with DE in within-trial and lifetime analyses, in the latter generating an incremental cost effectiveness ratio of £2290 per quality-adjusted life year gained.

Conclusions/interpretation

A commercial behavioural weight management programme combined with remote dietary counselling after diagnosis of type 2 diabetes did not improve HbA1c up to 12 months post intervention in this trial. The intervention could help people achieve weight loss and be cost-effective compared with current standard National Health Service care.

Trial registration

ISRCTN 18399564

Funding

National Institute for Health and Care Research (NIHR; RP-PG-0216-20010), Medical Research Council (MC_UU_00006/6), NIHR Cambridge Biomedical Research Centre (NIHR203312).

Graphical Abstract

通过体重管理降低血糖(GLoW):一项随机对照试验,比较糖尿病教育和行为体重管理计划与新近诊断为2型糖尿病的成人糖尿病教育计划的临床和成本效益
目的/假设:英国2型糖尿病的标准治疗是结构化的糖尿病教育,对HbA1c没有影响,对体重的短期影响很小,摄取也很低。我们评估了在帮助2型糖尿病患者降低血糖、减轻体重、达到缓解和改善心血管危险因素方面,与目前的标准治疗相比,远程提供量身定制的糖尿病教育结合商业行为体重管理是否具有成本效益。方法我们进行了一项实用的、随机的、平行的两组试验。参与者是超重或肥胖(BMI≥25kg /m2)且最近诊断为2型糖尿病(≤3年)的成年人(≥18岁),从英格兰159个初级保健诊所招募。我们将参与者随机分配到量身定制的糖尿病教育和行为体重管理计划(DEW;由慧俪轻体(Weight Watchers)提供)或目前的标准护理糖尿病教育(DE;正在进行和新诊断的糖尿病教育和自我管理[DESMOND]项目),使用计算机生成的随机序列,按性别和糖尿病持续时间按1:1分配分层,收集和分析数据的人员不知道。由于干预措施的性质,参与者不能被蒙蔽。参与者分别在第0、6和12个月完成评估。主要终点是12个月HbA1c较基线的变化。我们还评估了体重、血压、胆固醇(总胆固醇、高密度脂蛋白、低密度脂蛋白)、降糖药物、行为测量(身体活动、食物摄入)、社会心理测量(饮食行为、糖尿病相关的生活质量、健康)以及试验内和建模的终身成本效益。我们随机纳入577名受试者(DEW: 289, DE: 288);398例(69%)完成了12个月的随访。我们没有发现干预对HbA1c从基线到12个月(差异:- 0.84 [95% CI - 2.99, 1.31] mmol/mol, p=0.44)或6个月(- 1.83 [- 4.05,0.40]mmol/mol)的变化有影响的证据。我们发现干预在6个月(- 1.77 [- 2.86,- 0.67]kg)和12个月(- 1.38 [- 2.56,- 0.19]kg)时对体重有影响。DEW组患者比DE组患者实现糖尿病缓解的可能性更高(6个月:RR 2.10 [95% CI 1.03, 4.47];12个月:RR 2.53[1.30, 5.16])。在试验内和寿命分析中,与DE相比,DEW具有成本效益,后者每获得质量调整寿命年产生2290英镑的增量成本效益比。结论/解释:在本试验中,2型糖尿病诊断后,商业行为体重管理方案结合远程饮食咨询在干预后12个月内并没有改善HbA1c。与目前标准的国民健康服务相比,这种干预措施可以帮助人们实现减肥,并且具有成本效益。试验注册isrctn 18399564资助国家卫生保健研究所(NIHR);RP-PG-0216-20010),医学研究理事会(MC_UU_00006/6), NIHR剑桥生物医学研究中心(NIHR203312)。图形抽象
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Diabetologia
Diabetologia 医学-内分泌学与代谢
CiteScore
18.10
自引率
2.40%
发文量
193
审稿时长
1 months
期刊介绍: Diabetologia, the authoritative journal dedicated to diabetes research, holds high visibility through society membership, libraries, and social media. As the official journal of the European Association for the Study of Diabetes, it is ranked in the top quartile of the 2019 JCR Impact Factors in the Endocrinology & Metabolism category. The journal boasts dedicated and expert editorial teams committed to supporting authors throughout the peer review process.
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