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
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).
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.