A community-based primary prevention programme for type 2 diabetes mellitus integrating identification and lifestyle intervention for prevention: a cluster randomised controlled trial

Abstract

BackgroundPrevention of type 2 diabetes mellitus (T2DM) is a global priority; however, there is a lack of evidence investigating how to effectively translate prevention research into a primary care setting.Objectives(1) To develop and validate a risk score to identify individuals at high risk of T2DM in the UK; and (2) to establish whether or not a structured education programme targeting lifestyle and behaviour change was clinically effective and cost-effective at preventing progression to T2DM in people with prediabetes mellitus (PDM), identified through a risk score screening programme in primary care.DesignA targeted screening study followed by a cluster randomised controlled trial (RCT), with randomisation at practice level. Participants were followed up for 3 years.SettingA total of 44 general practices across Leicestershire, UK. The intervention took place in the community.ParticipantsA total of 17,972 individuals from 44 practices identified through the risk score as being at high risk of T2DM were invited for screening; of these, 3449 (19.2%) individuals attended. All received an oral glucose tolerance test. PDM was detected in 880 (25.5%) of those screened. Those with PDM were included in the trial; of these, 36% were female, the average age was 64 years and 16% were from an ethnic minority group.InterventionPractices were randomised to receive either standard care or the intervention. The intervention consisted of a 6-hour group structured education programme, with an annual refresher and regular telephone contact.Main outcome measuresThe primary outcome was progression to T2DM. The main secondary outcomes were changes in glycated haemoglobin concentrations, blood glucose levels, cardiovascular risk, the presence of metabolic syndrome, step count and the cost-effectiveness of the intervention.ResultsA total of 22.6% of the intervention group did not attend the education and 29.1% attended all sessions. A total of 131 participants developed T2DM (standard care,n = 67; intervention,n = 64). There was a 26% reduced risk of T2DM in the intervention arm compared with standard care, but this did not reach statistical significance (hazard ratio 0.74, 95% confidence interval 0.48 to 1.14;p = 0.18). There were statistically significant improvements in glycated haemoglobin concentrations, low-density lipoprotein cholesterol levels, psychosocial well-being, sedentary time and step count in the intervention group. The intervention was found to result in a net gain of 0.046 quality-adjusted life-years over 3 years at a cost of £168 per patient, with an incremental cost-effectiveness ratio of £3643 and a probability of 0.86 of being cost-effective at a willingness-to-pay threshold of £20,000.ConclusionsWe developed and validated a risk score for detecting those at high risk of undiagnosed PDM/T2DM. We screened > 3400 people using a two-stage screening programme. The RCT showed that a relatively low-resource pragmatic programme may lead to a reduction in T2DM and improved biomedical and psychosocial outcomes, and is cost-effective.LimitationsOnly 19% of those invited to screening attended, which may limit generalisability. The variation in cluster size in the RCT may have limited the power of the study.Future workFuture work should focus on increasing attendance to both screening and prevention programmes and offering the programme in different modalities, such as web-based modalities. A longer-term follow-up of the RCT participants would be valuable.Trial registrationCurrent Controlled Trials ISRCTN80605705.FundingThe National Institute for Health Research Programme Grants for Applied Research programme.

Cost-effectiveness of a pragmatic structured education intervention for the prevention of type 2 diabetes: economic evaluation of data from the Let's Prevent Diabetes cluster-randomised controlled trial

“…The study design does not permit us to identify reasons for these small differences. However, some qualitative work conducted as part of the study suggests that patients receiving the structured education programme felt they had an increased understanding of the nature and implications of their diagnosis, and better understood key messages about lifestyle changes with regard to diet and physical activity 24. This may have resulted in higher utility levels.…”

Diabetes mellitus and chronic kidney disease in the Eastern Mediterranean Region: findings from the Global Burden of Disease 2015 study

“…Several interventions have been suggested for prevention and control of diabetes. Although the effectiveness and cost-effectiveness of all interventions are not promising, there is evidence of several successful experiences around the world (Davies et al 2017 ; Sun et al 2017 ). For example, the National Diabetes Prevention Program showed successful changes in determinants of diabetes (Ely et al 2017 ).…”

Increase of Oxidants and Antioxidant Consumption in Patients with Type 2 Diabetes Mellitus in Peritoneal Dialysis

“…The authors found a 26% reduction in the risk of type 2 DM of those who received the intervention compared with the standard care. They found no statistical significance, which suggests that the effectiveness of all interventions is not promising [17].…”

“…The patients had a median vintage on PD of 13 months (4-26), without differences between DM and No-DM. In addition, there were no differences in the glucose concentration used in the dialysis solutions, but DM patients were less likely to be on automated peritoneal dialysis (APD) modality (p = 0.016), and the median dwell time was 16 h (QR [16][17][18][19][20][21][22][23][24]. There were no differences in the D/P creatinine or the history of peritonitis between patients.…”