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Aims: This study investigated the ethnic differences in glycaemic levels and clinical characteristics among insulin‐naïve people with type 2 diabetes (T2D) initiating biphasic insulin aspart 30/70 (BIAsp 30) in primary practice in England. Materials and Methods: Retrospective, observational cohort study utilizing data from the Clinical Practice Research Datalink Aurum database, including White, South Asian, Black and Chinese insulin‐naïve adults with T2D, initiating BIAsp 30. The index date was that of the first BIAsp 30 prescription. Endpoints included change in glycated haemoglobin (HbA1c) and body mass index (BMI) 6 months post index. Results: In total, 11 186 eligible people were selected (9443 White, 1116 South Asian, 594 Black, 33 Chinese). HbA1c decreased across all subgroups 6 months post index: estimated %‐point changes [95% CI of −2.32 (−2.36; −2.28) (White); −1.91 (−2.02; −1.80) (South Asian); −2.55 (−2.69; −2.40) (Black); and −2.64 (−3.24; −2.04) (Chinese)]. The BMI increased modestly 6 months post index in all subgroups [estimated changes (95% CI) kg/m2: White, 0.92 (0.86; 0.99); South Asian, 0.60 (0.41; 0.78); Black, 1.41 (1.16; 1.65); and Chinese, 0.32 (−0.67; 1.30)]. In the overall population, hypoglycaemic event rates increased from 0.92 events per 100 patient‐years before the index to 3.37 events per 100 patient‐years post index; event numbers were too low to be analysed by subgroup. Conclusions: Among insulin‐naïve people with T2D initiating BIAsp 30, clinically meaningful HbA1c reductions in all ethnicities were observed. Some ethnic groups had larger reductions than others, but differences were small. In all groups, small BMI increases were seen, with small differences observed between groups. Hypoglycaemia rates were low. [ABSTRACT FROM AUTHOR]

Background Despite generally high coronavirus disease 2019 (COVID-19) vaccination rates in the UK, vaccination hesitancy and lower take-up rates have been reported in certain ethnic minority communities. Methods We used vaccination data from the National Immunisation Management System (NIMS) linked to the 2011 Census and individual health records for subjects aged ≥40 years (n = 24 094 186). We estimated age-standardized vaccination rates, stratified by ethnic group and key sociodemographic characteristics, such as religious affiliation, deprivation, educational attainment, geography, living conditions, country of birth, language skills and health status. To understand the association of ethnicity with lower vaccination rates, we conducted a logistic regression model adjusting for differences in geographic, sociodemographic and health characteristics. Results All ethnic groups had lower age-standardized rates of vaccination compared with the white British population, whose vaccination rate of at least one dose was 94% (95% CI: 94%–94%). Black communities had the lowest rates, with 75% (74–75%) of black African and 66% (66–67%) of black Caribbean individuals having received at least one dose. The drivers of these lower rates were partly explained by accounting for sociodemographic differences. However, modelled estimates showed significant differences remained for all minority ethnic groups, compared with white British individuals. Conclusions Lower COVID-19 vaccination rates are consistently observed amongst all ethnic minorities. [ABSTRACT FROM AUTHOR]

The paired sample t-test of total energy intake showed no significant change in energy intake during lockdown compared to the pre-lockdown period. Keywords: COVID-19; diet; energy; lockdown; type 2 diabetes; weight EN COVID-19 diet energy lockdown type 2 diabetes weight 546 549 4 02/21/22 20220301 NES 220301 COVID-19 and subsequent lockdowns have caused a significant disruption to society. Energy intake and weight during the COVID-19 lockdown were not altered in a sample of older adults with type 2 diabetes in England COVID-19, diet, energy, type 2 diabetes, weight, lockdown. [Extracted from the article]

Obesity and ethnicity are known risk factors for COVID-19 outcomes, but their combination has not been extensively examined. We investigate the association between body mass index (BMI) and COVID-19 mortality across different ethnic groups using linked national Census, electronic health records and mortality data for adults in England from the start of pandemic (January 2020) to December 2020. There were 30,067 (0.27%), 1,208 (0.29%), 1,831 (0.29%), 845 (0.18%) COVID-19 deaths in white, Black, South Asian and other ethnic minority groups, respectively. Here we show that BMI was more strongly associated with COVID-19 mortality in ethnic minority groups, resulting in an ethnic risk of COVID-19 mortality that was dependant on BMI. The estimated risk of COVID-19 mortality at a BMI of 40 kg/m2 in white ethnicities was equivalent to the risk observed at a BMI of 30.1 kg/m2, 27.0 kg/m2, and 32.2 kg/m2 in Black, South Asian and other ethnic minority groups, respectively. Obesity is a known risk factor for severe COVID-19 disease. Here, the authors use linked Census, electronic health records, and mortality data for 12.6 million adults in England and show that the association between COVID-19 mortality and body mass index is stronger in ethnic minority groups. [ABSTRACT FROM AUTHOR]

Objective: To assess trends in primary and specialist care consultation rates and average length of consultation by cardiovascular disease (CVD), type 2 diabetes mellitus (T2DM), or cardiometabolic multimorbidity exposure status. Methods: Observational, retrospective cohort study used linked Clinical Practice Research Datalink primary care data from 01/01/2000 to 31/12/2018 to assess consultation rates in 141,328 adults with newly diagnosed T2DM, with or without CVD. Patients who entered the study with either a diagnosis of T2DM or CVD and later developed the second condition during the study are classified as the cardiometabolic multimorbidity group. Face to face primary and specialist care consultations, with either a nurse or general practitioner, were assessed over time in subjects with T2DM, CVD, or cardiometabolic multimorbidity. Changes in the average length of consultation in each group were investigated. Results: 696,255 (mean 4.9 years [95% CI, 2.02–7.66]) person years of follow up time, there were 10,221,798 primary and specialist care consultations. The crude rate of primary and specialist care consultations in patients with cardiometabolic multimorbidity (N = 11,881) was 18.5 (95% CI, 18.47–18.55) per person years, 13.5 (13.50, 13.52) in patients with T2DM only (N = 83,094) and 13.2 (13.18, 13.21) in those with CVD (N = 57,974). Patients with cardiometabolic multimorbidity had 28% (IRR 1.28; 95% CI: 1.27, 1.31) more consultations than those with only T2DM. Patients with cardiometabolic multimorbidity had primary care consultation rates decrease by 50.1% compared to a 45.0% decrease in consultations for those with T2DM from 2000 to 2018. Specialist care consultation rates in both groups increased from 2003 to 2018 by 33.3% and 54.4% in patients with cardiometabolic multimorbidity and T2DM, respectively. For patients with T2DM the average consultation duration increased by 36.0%, in patients with CVD it increased by 74.3%, and in those with cardiometabolic multimorbidity it increased by 37.3%. Conclusions: Annual primary care consultation rates for individuals with T2DM, CVD, or cardiometabolic multimorbidity have fallen since 2000, while specialist care consultations and average consultation length have both increased. Individuals with cardiometabolic multimorbidity have significantly more consultations than individuals with T2DM or CVD alone. Service redesign of health care delivery needs to be considered for people with cardiometabolic multimorbidity to reduce the burden and health care costs. [ABSTRACT FROM AUTHOR]

Aims/Introduction: The aim of this study was to examine ethnicity‐specific associations between type 2 diabetes mellitus and the risk of a cardiovascular disease (CVD) event as well as risk of specific CVD phenotypes in England. Methods: We obtained data from the Clinical Practice Research Datalink for adults with and without type 2 diabetes mellitus diagnosed 2000–2006. The outcome was the first CVD event during 2007–2017 and the following components: aortic aneurysm, cerebrovascular accidents, heart failure, myocardial infarction, peripheral vascular disease and other CVD‐related conditions. Flexible parametric survival models were used to estimate ethnicity‐specific adjusted hazard ratios. Results: A total of 734,543 people with and without type 2 diabetes mellitus (29,847; 4.1%) were included; most were of white ethnicity (93.0% with and 92.3% without type 2 diabetes mellitus) followed by South Asian (3.2 and 4.6%). During a median follow‐up period of 11.0 years, 67,218 events occurred (6,156 in individuals with type 2 diabetes mellitus). Type 2 diabetes mellitus was associated with a small increase in CVD events (adjusted hazard ratio 1.06, 95% confidence interval 1.02–1.09) in individuals of white ethnicity; whereas the adjusted hazard ratios were considerably higher in individuals of South Asian ethnicity (1.28, 95% confidence interval 1.09–1.51), primarily due to an increased risk of myocardial infarction (1.53, 95% confidence interval 1.08–2.18). Conclusions: Despite universal access to healthcare, there are large disparities in CVD outcomes in people with and without type 2 diabetes mellitus. Other non‐traditional risk factors might play a role in the higher CVD risk associated with type 2 diabetes mellitus in individuals of South Asian ethnicity. [ABSTRACT FROM AUTHOR]

Background: Cardiovascular disease is responsible for 31% of all global deaths. Primary prevention strategies are needed to improve longer-term adherence to statins and healthy lifestyle behaviours to reduce risk in people at risk of cardiovascular disease.Methods: Pragmatic randomised controlled trial recruited between May 2016 and March 2017 from primary care practices, England. Participants (n = 212) prescribed statins for primary prevention of cardiovascular disease with total cholesterol level ≥ 5 mmol/l were randomised: 105 to the intervention group and 107 to the control group, stratified by age and sex. The 3R intervention involved two facilitated, structured group education sessions focusing on medication adherence to statins, lifestyle behaviours and cardiovascular risk, with 44 weeks of medication reminders and motivational text messages and two supportive, coaching phone calls (at approximately 2 weeks and 6 months). The control group continued with usual clinical care. Both groups received a basic information leaflet. The primary outcome was medication adherence to statins objectively measured by a biochemical urine test. Self-reported adherence and practice prescription data provided additional measures. Secondary outcomes included cholesterol profile, blood pressure, anthropometric data, cardiovascular risk score, and self-reported lifestyle behaviours and psychological measures (health/medication beliefs, quality of life, health status). All outcomes were assessed at 12 months.Results: Baseline adherence to statins was 47% (control) and 62% (intervention). No significant difference between the groups found for medication adherence to statins using either the urine test (OR 1.02, 95% CI 0.34 to 3.06, P = 0.968) or other measures. This may have been due to the higher than expected adherence levels at baseline. The adjusted mean difference between the groups (in favour of the intervention group) for diastolic blood pressure (- 4.28 mmHg (95% CI - 0.98 to - 1.58, P = 0.002)) and waist circumference (- 2.55 cm (95% CI - 4.55 to - 0.55, P = 0.012)). The intervention group also showed greater perceived control of treatment and more coherent understanding of the condition.Conclusions: The 3R programme successfully led to longer-term improvements in important clinical lifestyle indicators but no improvement in medication adherence, raising questions about the suitability of such a broad, multiple risk factor approach for improving medication adherence for primary prevention of CVD.Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN16863160), March 11, 2006. [ABSTRACT FROM AUTHOR]

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A correction is presented to the article "COVID-19 vaccination uptake amongst ethnic minority communities in England: a linked study exploring the drivers of differential vaccination rates ."

Background: The prevention of type 2 diabetes is recognised as a health care priority. Lifestyle change has proven effective at reducing the risk of type 2 diabetes, but limitations in the current evidence have been identified in: the promotion of physical activity; availability of interventions that are suitable for commissioning and implementation; availability of evidence-based interventions using new technologies; and physical activity promotion among ethnic minorities. We aim to investigate whether a structured education programme with differing levels of ongoing support, including text-messaging, can increase physical activity over a 4 year period in a multi-ethnic population at high risk of diabetes.Methods/design: A multi-centre randomised controlled trial, with follow-up at 12 and 48 months. The primary outcome is change in ambulatory activity at 48 months. Secondary outcomes include changes to markers of metabolic, cardiovascular, anthropometric and psychological health along with cost-effectiveness. Participants aged 40-74 years for White European, or 25-74 years for South Asians, with an HbA1c value of between 6.0 and < 6.4% (42 and 47 mmol/mol) or with a previously recorded plasma glucose level or HbA1c value within the high risk (prediabetes) range within the last five years, are invited to take part in the trial. Participants are identified through primary care, using an automated diabetes risk score within their practice database, or from a database of previous research participants. Participants are randomly assigned to either: 1) the control group who receive a detailed advice leaflet; 2) the Walking Away group, who receive the same leaflet and attend a 3 hour structured education programme with annual maintenance sessions delivered in groups; or 3) the Walking Away Plus group, who receive the leaflet, attend the structured education programme with annual maintenance sessions, plus receive follow-on support through highly-tailored text-messaging and telephone calls to help to aid pedometer use and behaviour change.Discussion: This study will provide new evidence for the long-term effectiveness of a structured education programme focused on physical activity, conducted within routine care in a multi-ethnic population in the UK. It will also investigate the impact of different levels of ongoing support and the cost-effectiveness of each intervention.Trial Registration: ISRCTN83465245 Trial registration date: 14/06/2012. [ABSTRACT FROM AUTHOR]

Background Cardiovascular disease (CVD) is the leading cause of death globally. Vascular risk assessment is recognized as playing a key role in reducing premature CVD-related morbidity and mortality. The current study evaluated the effectiveness of a pharmacy-led risk assessment service in Leicester City, UK. Methods The vascular risk assessment was offered opportunistically to individuals between 40 and 70 years without any prior diagnosis of CVD on attending their community pharmacist. Individuals were risk stratified using the Framingham score and those classified as high risk were referred to their general practitioner (GP). Results Overall, 2521 individuals were recruited from 39 pharmacies consisting of 1059 (42%) males, 1696 (67%) South Asians and 199 (7.9%) individuals not registered with a GP. A total of 462 (18%) individuals were referred to primary care and 52.6% of a representative subset were subsequently recorded as having attended an appointment with their GP; diagnoses and treatments commenced were recorded. Conclusions Cardiovascular risk assessment led by community pharmacies can successfully assess people from large, multi-ethnic UK populations and identify those at high cardiovascular risk or with undiagnosed cardiovascular disease. The service may improve rates of assessments undertaken by individuals who do not access health care through traditional routes. [ABSTRACT FROM AUTHOR]

We aimed to determine the mortality rates of the main groups of frontline healthcare providers (HCPs) with COVID-19. Of the 147 frontline HCPs in England who died from COVID-19 between 25 March 2020 and 13 May 2020 for whom we had data, doctors accounted for 19.1% ( I n i = 28, including 10 GPs), nurses 42.9% ( I n i = 63), and other HCPs 38.1% ( I n i = 56). Doctors experienced the earliest reported deaths among HCPs, but the cumulative mortality rate for nurses was comparable with doctors by the week of 18 April. [Extracted from the article]

Abstract: We measured body size and composition in 54 South Asian and 17 white European pupils aged 11 and 12 attending secondary schools in Leicester, UK. Body fat percentage, assessed by bio-impedance, was higher in South Asians after adjustment for potential confounders. [Copyright &y& Elsevier]

Aims: To quantify ethnic differences in the risk of all-cause mortality and cardiovascular disease (CVD) events following a first CVD event in people with and without type 2 diabetes.Methods: We identified 5,349,271 subjects with a first CVD between 1 January 2002 and 31 May 2020 in England; CVD included aortic aneurism, cerebrovascular accident, heart failure, myocardial infarction, peripheral vascular disease, and other cardiovascular diseases. We estimated adjusted hazard ratios (HRs) for type 2 diabetes and ethnicity of three outcomes: fatal and nonfatal second CVD event (different phenotype compared to the first) and all-cause mortality.Results: Relative to White, HRs indicated lower rates in all ethnicities and for all outcomes in both men (from 0.64 to 0.79 for all-cause death; 0.78-0.79 for CVD-related death; and 0.85-0.98 for a second CVD event) and women (0.69-0.77; 0.77-0.83; 0.83-0.95, respectively). Irrespective of ethnicity and sex, type 2 diabetes increased rates of all outcomes by around a third.Conclusions: Prognosis following a CVD event was consistently worse in subjects with type 2 diabetes while varied across ethnicities, suggesting the implementation of different strategies for the secondary prevention of CVD in different ethnic groups. [ABSTRACT FROM AUTHOR]

Background: Self-management is a key component of successful chronic kidney disease (CKD) management. Here, we present the findings from the internal pilot of a multicentre randomised controlled trial (RCT) aimed to test the effect of a digital self-management programme ('My Kidneys & Me' (MK&M))., Methods: Participants (aged ≥18 years and CKD stages 3-4) were recruited from hospital kidney services across England. Study processes were completed virtually. Participants were randomised 2:1 to either intervention (MK&M) or control group. The first 60 participants recruited were included in a 10-week internal pilot which assessed study feasibility and acceptability against pre-specified progression criteria: 1) eligibility and recruitment, acceptability of 2) randomisation and 3) outcomes, 4) MK&M activation, and 5) retention and attrition rates. Semi-structured interviews further explored views on trial participation., Results: Of the 60 participants recruited, 41 were randomised to MK&M and 19 to control. All participants completed baseline measures and 62% (n=37) completed post-intervention outcome measures. All progression criteria met the minimum thresholds to proceed. Nine participants were interviewed. The themes identified were satisfaction with study recruitment processes (openness to participate, reading and agreeing to "terms and conditions"), acceptability of study design (remote study participation, acceptability of randomisation, completion of online assessment(s)), and methods to improve recruitment and retention (personalised approach, follow-up communication)., Conclusion: This internal pilot demonstrated the feasibility and acceptability of a virtually run RCT. Progression criteria thresholds to proceed to the definitive RCT were met. Areas for improvement were identified and protocol amendments were made to improve trial delivery., (© 2024 The Authors. Journal of Renal Care published by John Wiley & Sons Ltd on behalf of European Dialysis & Transplant Nurses Association/European Renal Care Association.)

Objective: To examine the associations between age at type 2 diabetes diagnosis and the relative and absolute risk of all-cause and cause-specific mortality in England., Research Design and Methods: In this cohort study using primary care data from the Clinical Practice Research Datalink, we identified 108,061 individuals with newly diagnosed type 2 diabetes (16-50 years of age), matched to 829,946 individuals without type 2 diabetes. We estimated all-cause and cause-specific mortality (cancer, cardiorenal, other [noncancer or cardiorenal]) by age at diagnosis, using competing-risk survival analyses adjusted for key confounders., Results: Comparing individuals with versus without type 2 diabetes, the relative risk of death decreased with an older age at diagnosis: the hazard ratio for all-cause mortality was 4.32 (95% CI 3.35-5.58) in individuals diagnosed at ages 16-27 years compared with 1.53 (95% CI 1.46-1.60) at ages 48-50 years. Smaller relative risks by increasing age at diagnosis were also observed for cancer, cardiorenal, and noncancer or cardiorenal death. Irrespective of age at diagnosis, the 10-year absolute risk of all-cause and cause-specific mortality were higher in individuals with type 2 diabetes; yet, the absolute differences were small., Conclusions: Although the relative risk of death in individuals with versus without type 2 was higher at younger ages, the 10-year absolute risk of all investigated causes of death was small and similar in the two groups. Further multidecade studies could help estimate the long-term risk of complications and death in individuals with early-onset type 2 diabetes., (© 2023 by the American Diabetes Association.)

Objective: To investigate associations of self-reported walking pace (SRWP) with relative and absolute risks of cause-specific mortality., Patients and Methods: In 391,652 UK Biobank participants recruited in 2006-2010, we estimated sex- and cause-specific (cardiovascular disease [CVD], cancer, other causes) mortality hazard ratios (HRs) and 10-year mortality risks across categories of SRWP (slow, average, brisk), accounting for confounders and competing risk. Censoring occurred in September 30, 2021 (England, Wales) and October 31, 2021 (Scotland)., Results: Over a median follow-up of 12.6 years, 22,413 deaths occurred. In women, the HRs comparing brisk to slow SRWP were 0.74 (95% CI: 0.67, 0.82), 0.40 (0.33, 0.49), and 0.29 (0.26, 0.32) for cancer, CVD, and other causes of death, respectively, and 0.71 (0.64, 0.78), 0.38 (0.33, 0.44), and 0.29 (0.26, 0.32) in men. Compared to CVD, HRs were greater for other causes (women: 39.6% [6.2, 72.9]; men: 31.6% [9.8, 53.5]) and smaller for cancer (-45.8% [-58.3, -33.2] and - 45.9% [-54.8, -36.9], respectively). For all causes in both sexes, the 10-year mortality risk was higher in slow walkers, but varied across sex, age, and cause, resulting in different risk reductions comparing brisk to slow: the largest were for other causes of death at age 75 years [women: -6.8% (-7.7, -5.8); men: -9.5% (-10.6, -8.4)]., Conclusion: Compared to slow walkers, brisk SRWP was associated with reduced cancer (smallest reduction), CVD, and other (largest) causes of death and may therefore be a useful clinical predictive marker. As absolute risk reductions varied across age, cause, and SRWP, certain groups may particularly benefit from interventions to increase SRWP., Competing Interests: Declaration of Competing Interest The authors had financial support from the funders listed above for the submitted work. The authors declare that they have no competing interests., (Copyright © 2023. Published by Elsevier Inc.)

Aims: To implement a diabetes prevention programme in primary care METHODS: The programme was implemented for 12 months in two neighbouring towns, served by eight general practices. Practices requested a referral pathway involving an external administrator running electronic searches and sending postal invitations. If interested, people called and booked a place on the programme. Practices were also provided with resources to refer people directly. Six Educators were trained to deliver the programme. The RE-AIM constructs "Adoption", "Reach" and "Uptake" were assessed., Results: All practices engaged in the searches and postal invitations. Overall, 3.9 % of those aged ≥ 25 years had an HbA1c level indicative of non-diabetic hyperglycaemia (NDH) and were invited. Overall uptake (attended as percentage of invited) was 16 % (practice range 10.5-26.6 %) and was highest in two practices where the invitation was followed by a telephone call. Four people were referred directly by their practice. Groups at risk of being excluded were the Bengali population and those unable to attend because of issues such as health, mobility and frailty., Conclusions: Comprehensive electronic searches meant everyone previously diagnosed with NDH was invited to attend. Follow-up telephone call improved uptake and providing practices with resources to make these calls themselves would likely increase uptake further., Competing Interests: Conflicts of Interest An adapted version of the Let’s Prevent Diabetes intervention is on the framework for the NHS Diabetes Prevention Programme. This work was led by Ingeus (main contractor at the time), with Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust providing training and quality assurance for which funding was received. MJD, KK, TY, and LG were involved in the development of this adapted programme. MJD, KK, and TY were members (KK chair) of the NICE PH 38 (Preventing Type 2 diabetes: risk identification and interventions for individuals at high risk) Programme Development Group. KK is a member of the Expert Reference Group of the NHS Diabetes Prevention Programme. JK ad NA were involved in the qualitative evaluation of the programme., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background and Aims: We aimed to evaluate the life expectancy following the first cardiovascular disease (CVD) event by type 2 diabetes (T2D) status and ethnicity., Methods and Results: We used the Clinical Practice Research Datalink database in England (UK), linked to the Hospital Episode Statistics information, to identify individuals with and without T2D who survived a first CVD event between 1st Jan 2007 and 31st Dec 2017; subsequent death events were extracted from the Office for National Statistics database. Ethnicity was categorised as White, South Asian (SA), Black, or other. Flexible parametric survival models were used to estimate survival and predict life expectancy. 59,939 individuals with first CVD event were included: 7596 (12.7%) with T2D (60.9% men; mean age at event: 69.7 years [63.2 years in SA, 65.9 in Black, 70.2 in White]) and 52,343 without T2D (56.7% men; 65.9 years [54.7 in Black, 58.2 in SA, 66.3 in White]). Accounting for potential confounders (sex, deprivation, lipid-lowering medication, current smoking, and pre-existing hypertension), comparing individuals with vs without T2D the mortality rate was 53% higher in White (hazard ratio [HR]: 1.53 [95% CI: 1.44, 1.62]), corresponding to a potential loss of 3.87 (3.30, 4.44) life years at the age of 50 years in individuals with T2D. No evidence of a difference in life expectancy was observed in individuals of SA (HR: 0.82 [0.52, 1.29]; -1.36 [-4.58, 1.86] life years), Black (HR: 1.26 [0.59, 2.70]; 1.21 [-2.99, 5.41] life years); and other (HR: 1.64 [0.80, 3.39]; 3.89 [-2.28, 9.99] life years) ethnic group., Conclusion: Following a CVD event, T2D is associated with a different prognosis and life years lost among ethnic groups., Competing Interests: Declaration of competing interest Professor Khunti is the National Lead for multiple long-term conditions for National Institute for Health Research Applied Research Collaboration (NIHR ARC). Professor Khunti has acted as a consultant, speaker or received grants for investigator-initiated studies for Astra Zeneca, Abbott, Amgen, Bayer, Novartis, Novo Nordisk, Roche, Servier, Sanofi-Aventis, Lilly and Merck Sharp & Dohme, Boehringer Ingelheim, Oramed Pharmaceuticals and Applied Therapeutics. Dr Zaccardi is a speaker fees from Napp Pharmaceuticals and Boehringer Ingelheim. Professor Davies has acted as a consultant, advisory board member and speaker for Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Boehringer Ingelheim, AstraZeneca and Janssen, an advisory board member for Servier and Gilead Sciences Ltd and as a speaker for Napp Pharmaceuticals, Mitsubishi Tanabe Pharma Corporation and Takeda Pharmaceuticals International Inc. Professor Davies has received grants in support of investigator and investigator-initiated trials from Novo Nordisk, Sanofi-Aventis, Lilly, Boehringer Ingelheim, AstraZeneca and Janssen. All other authors have no conflict of interest., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

Aims/hypothesis: The aim of this study was to describe the long-term trends in cancer mortality rates in people with type 2 diabetes based on subgroups defined by sociodemographic characteristics and risk factors., Methods: We defined a cohort of individuals aged ≥35 years who had newly diagnosed type 2 diabetes in the Clinical Practice Research Datalink between 1 January 1998 and 30 November 2018. We assessed trends in all-cause, all-cancer and cancer-specific mortality rates by age, gender, ethnicity, socioeconomic status, obesity and smoking status. We used Poisson regression to calculate age- and calendar year-specific mortality rates and Joinpoint regression to assess trends for each outcome. We estimated standardised mortality ratios comparing mortality rates in people with type 2 diabetes with those in the general population., Results: Among 137,804 individuals, during a median follow-up of 8.4 years, all-cause mortality rates decreased at all ages between 1998 and 2018; cancer mortality rates also decreased for 55- and 65-year-olds but increased for 75- and 85-year-olds, with average annual percentage changes (AAPCs) of -1.4% (95% CI -1.5, -1.3), -0.2% (-0.3, -0.1), 1.2% (0.8, 1.6) and 1.6% (1.5, 1.7), respectively. Higher AAPCs were observed in women than men (1.5% vs 0.5%), in the least deprived than the most deprived (1.5% vs 1.0%) and in people with morbid obesity than those with normal body weight (5.8% vs 0.7%), although all these stratified subgroups showed upward trends in cancer mortality rates. Increasing cancer mortality rates were also observed in people of White ethnicity and former/current smokers, but downward trends were observed in other ethnic groups and non-smokers. These results have led to persistent inequalities by gender and deprivation but widening disparities by smoking status. Constant upward trends in mortality rates were also observed for pancreatic, liver and lung cancer at all ages, colorectal cancer at most ages, breast cancer at younger ages, and prostate and endometrial cancer at older ages. Compared with the general population, people with type 2 diabetes had a more than 1.5-fold increased risk of colorectal, pancreatic, liver and endometrial cancer mortality during the whole study period., Conclusions/interpretation: In contrast to the declines in all-cause mortality rates at all ages, the cancer burden has increased in older people with type 2 diabetes, especially for colorectal, pancreatic, liver and endometrial cancer. Tailored cancer prevention and early detection strategies are needed to address persistent inequalities in the older population, the most deprived and smokers., (© 2023. The Author(s).)

Background: A diagnosis of gestational diabetes (GDM) is associated with an over sevenfold increase in the risk of developing type 2 diabetes (T2D), while among parous women with T2D, up to 30% have a history of GDM. Lifestyle interventions have been shown to reduce the risk of incident T2D in adults with impaired glucose tolerance, including in women with a history of GDM. The aim of this study is to establish whether a group self-management education programme, supported by a mobile web application, can improve levels of physical activity at 12 months in women who have had GDM., Methods: The study is a randomised controlled trial with follow-up at 6 and 12 months. Primary outcome is change in objectively measured average daily physical activity at 12 months. Secondary outcomes include lipid profile, blood pressure, glycated haemoglobin, obesity, smoking and alcohol status, self-reported physical activity, anxiety, depression and quality of life. Participants are recruited from maternity and diabetes departments in hospital trusts in two sites in the UK. Women aged > 18 years, with a diagnosis of GDM during any pregnancy in the previous 60 months are eligible. Participants need to have a good understanding of written and verbal English, be able to give informed consent and have access to a smart-phone. Women who are pregnant or have type 1 or type 2 diabetes are not eligible. In total, 290 participants will be recruited and randomly assigned, with stratification for age and ethnicity, to either the control group, receiving usual care, or the intervention group who are invited to participate in the Baby Steps programme. This comprises a group education programme and access to a mobile web application which provides an education component and interacts with a wrist-worn activity monitor providing automated messages, setting challenges and encouraging motivation., Discussion: If effective, the Baby Steps programme could be translated into a primary care-based intervention that women with GDM are referred to in the postnatal period. This could help them make lifestyle changes that could reduce their future risk of T2D., Trial Registration: ISRCTN, ISRCTN17299860 . Registered on 5 April 2017.

Objectives: To measure the number of people who have identified a behaviour change goal and completed an action-plan to meet their goal on completion of a diabetes self-management education programme (DSME) and level of success in sustaining their action-plan. The DSME people attended was Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (DESMOND)., Methods: Copies of action-plans were collected from participants. Postal questionnaires were sent to participants one week and three months following DESMOND to assess factors associated with setting and sustaining action-plans., Results: 92% (253/275) of participants completed an action-plan. Reducing weight was the area most targeted. Physical activity was the most common goal. 68% (187/275) returned a three month questionnaire. 96% indicated they were still working on their action plan, with 87% reporting they were always/usually meeting their action-plan. 22% said they had discussed their goal with a health care professional (HCP) following DESMOND., Conclusions: Goal-setting as part of a DSME can lead to behaviour change., Practice Implications: Goal-setting as part of a DSME enables participants to set and attain behaviour change goals. Informing HCPs of a person's action-plan following a DSME may further support a person undertaking behaviour change., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: Obesity is twice as common in people with schizophrenia as in the general population. The National Institute for Health and Care Excellence guidance recommends that people with psychosis or schizophrenia, especially those taking antipsychotics, be offered a healthy eating and physical activity programme by their mental health care provider. There is insufficient evidence to inform how these lifestyle services should be commissioned., Objectives: To develop a lifestyle intervention for people with first episode psychosis or schizophrenia and to evaluate its clinical effectiveness, cost-effectiveness, delivery and acceptability., Design: A two-arm, analyst-blind, parallel-group, randomised controlled trial, with a 1 : 1 allocation ratio, using web-based randomisation; a mixed-methods process evaluation, including qualitative case study methods and logic modelling; and a cost-utility analysis., Setting: Ten community mental health trusts in England., Participants: People with first episode psychosis, schizophrenia or schizoaffective disorder., Interventions: Intervention group: (1) four 2.5-hour group-based structured lifestyle self-management education sessions, 1 week apart; (2) multimodal fortnightly support contacts; (3) three 2.5-hour group booster sessions at 3-monthly intervals, post core sessions. Control group: usual care assessed through a longitudinal survey. All participants received standard written lifestyle information., Main Outcome Measures: The primary outcome was change in weight (kg) at 12 months post randomisation. The key secondary outcomes measured at 3 and 12 months included self-reported nutrition (measured with the Dietary Instrument for Nutrition Education questionnaire), objectively measured physical activity measured by accelerometry [GENEActiv (Activinsights, Kimbolton, UK)], biomedical measures, adverse events, patient-reported outcome measures and a health economic assessment., Results: The trial recruited 414 participants (intervention arm: 208 participants; usual care: 206 participants) between 10 March 2015 and 31 March 2016. A total of 341 participants (81.6%) completed the trial. A total of 412 participants were analysed. After 12 months, weight change did not differ between the groups (mean difference 0.0 kg, 95% confidence interval -1.59 to 1.67 kg; p  = 0.964); physical activity, dietary intake and biochemical measures were unchanged. Glycated haemoglobin, fasting glucose and lipid profile were unchanged by the intervention. Quality of life, psychiatric symptoms and illness perception did not change during the trial. There were three deaths, but none was related to the intervention. Most adverse events were expected and related to the psychiatric illness. The process evaluation showed that the intervention was acceptable, with participants valuing the opportunity to interact with others facing similar challenges. Session feedback indicated that 87.2% of participants agreed that the sessions had met their needs. Some indicated the desire for more ongoing support. Professionals felt that the intervention was under-resourced and questioned the long-term sustainability within current NHS settings. Professionals would have preferred greater access to participants' behaviour data to tailor the intervention better. The incremental cost-effectiveness ratio from the health-care perspective is £246,921 per quality-adjusted life-year (QALY) gained and the incremental cost-effectiveness ratio from the societal perspective is £367,543 per QALY gained., Conclusions: Despite the challenges of undertaking clinical research in this population, the trial successfully recruited and retained participants, indicating a high level of interest in weight management interventions; however, the STEPWISE intervention was neither clinically effective nor cost-effective. Further research will be required to define how overweight and obesity in people with schizophrenia should be managed. The trial results suggest that lifestyle programmes for people with schizophrenia may need greater resourcing than for other populations, and interventions that have been shown to be effective in other populations, such as people with diabetes mellitus, are not necessarily effective in people with schizophrenia., Trial Registration: Current Controlled Trials ISRCTN19447796., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 22, No. 65. See the NIHR Journals Library website for further project information., Competing Interests: Richard IG Holt received fees for lecturing, consultancy work and attendance at conferences from the following companies: Boehringer Ingelheim (Ingelheim am Rhein, Germany), Eli Lilly and Company (Indianapolis, IN, USA), Janssen Pharmaceutica (Beerse, Belgium), Lundbeck (Copenhagen, Denmark), Novo Nordisk (Bagsværd, Denmark), Novartis (Basel, Switzerland), Otsuka Pharmaceutical Co., Ltd (Tokyo, Japan), Sanofi-Aventis (Paris, France) and Sunovion Pharmaceuticals, Inc. (Marlborough, MA, USA). Paul French is a member of the National Institute for Health Research (NIHR) Health Technology Assessment Mental, Psychological and Occupational Health funding panel. Melanie J Davies and Kamlesh Khunti are members of a NIHR Clinical Trials Unit. Melanie J Davies reports personal fees from Novo Nordisk, Sanofi-Aventis, Eli Lilly and Company, Merck Sharp & Dohme (Kenilworth, NJ, USA), Boehringer Ingelheim, AstraZeneca (Cambridge, UK), Janssen Pharmaceutica, Servier Laboratories (Neuilly-sur-Seine, France), Mitsubishi Tanabe Pharma Corporation (Tokyo, Japan) and Takeda Pharmaceuticals International Inc. (Canton of Zürich, Switzerland) and grants from Novo Nordisk, Sanofi-Aventis, Eli Lilly and Company, Boehringer Ingelheim and Janssen Pharmaceutica. Kamlesh Khunti has received fees for consultancy and being a speaker for Novartis, Novo Nordisk, Sanofi-Aventis, Eli Lilly and Company, Servier Laboratories and Merck Sharp & Dohme. He has received grants in support of investigator and investigator-initiated trials from Novartis, Novo Nordisk, Sanofi-Aventis, Eli Lilly and Company, Pfizer (New York, NY, USA), Boehringer Ingelheim and Merck Sharp & Dohme. Kamlesh Khunti has also received funds for research and honoraria for speaking at meetings, and has served on advisory boards for Eli Lilly and Company, Sanofi-Aventis, Merck Sharp & Dohme and Novo Nordisk. David Shiers is an expert advisor to the National Institute for Health and Care Excellence (NICE) centre for guidelines, a board member of the National Collaborating Centre for Mental Health (NCCMH) and a clinical advisor (on a paid consultancy basis) to the National Clinical Audit of Psychosis (NCAP); any views given in this report are personal and not those of NICE, NCCMH or NCAP. David Shiers reports personal fees from the Wiley-Blackwell publication Promoting Recovery in Early Psychosis, 2010 (ISBN 978-1-4051-4894-8), as he is a joint editor in receipt of royalties. John Pendelbury received personal fees for involvement in the study from a NIHR grant; he reports personal fees from the Greater Manchester Mental Health NHS foundation trust outside the submitted work and has published papers in the area of weight management and physical health related to mental health. Marian E Carey and Yvonne Doherty report being employed by the Leicester Diabetes Centre, an organisation (employer) jointly hosted by a NHS hospital trust and the University of Leicester and which is the holder (through the University of Leicester) of the copyright of the STEPWISE programme and of the Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (DESMOND) suite of programmes, training and intervention fidelity framework that were used in this study. Fiona Gaughran reports personal fees from Otsuka and Lundbeck and personal fees and non-financial support from Sunovion, outside the submitted work, and has a family member with professional links to Eli Lilly and Company and GlaxoSmithKline (Brentford, UK), including shares.

Background: Coronary heart disease (CHD) represents approximately 13% of deaths worldwide and is the leading cause of death in the UK with considerable associated health care costs. After a CHD event, timely cardiac rehabilitation optimises patient outcomes. However, a high percentage of these services do not meet necessary performance indicators such as course length and follow-up attendance. Uptake of such services is only 50% in UK patients and support provided 12 months after an event is often limited. To delay and prevent further CHD events leading to hospitalisation, supplementary self-management strategies such as group education, are necessary., Methods: This is a single-centre, randomised controlled trial (RCT) recruiting participants (n = 290) aged ≥18 years who are 12 to 48 months post diagnosis of a CHD-related cardiac event (myocardial infarction, angina and any other acute coronary syndrome). The study aims to implement a structured education programme, with text-message support over 12 months, and identify whether delivery of the programme, to individuals who have a history of a cardiac event, would be an effective and cost-effective strategy for increasing walking. The primary outcome, objectively measured average daily physical activity, specifically step count through walking activity, is assessed using the wrist-worn GENEActiv accelerometer at baseline, 6 and 12 months. Secondary outcomes at 12 months include cardiovascular risk factors such as smoking status, blood pressure, lipid profile, glycated haemoglobin (HbA1c), obesity, self-efficacy, quality of life, physical activity and physical function. Participants are randomised to either the control group receiving standard care and a physical activity information leaflet, or the intervention group whose partcipants receive the leaflet and are invited to attend two group-based structured education sessions. These encourage participants to adopt and maintain healthy behaviours and self-manage their lifestyle. They are delivered approximately 2 weeks apart by trained facilitators and reinforced via subsequent text-message support., Discussion: To our knowledge, this is the first trial designed to assess the effectiveness of a group education programme 12 to 48 months after a CHD event diagnosis. If successful, the PACES programme could be translated into effective post-operative cardiac care and complement the current post-operative services available., Trial Registration: ISRCTN, ID: ISRCTN91163727 . The trial was registered on 27 February 2017.

Aims: This paper focuses mainly on explanations and lessons from a research-based programme for identifying undiagnosed type 2 diabetes and high risk. In addition to outlining key quantitative findings, we specifically aim to explore reasons for low uptake from the perspective of primary care staff involved., Methods: The MY-WAIST study was conducted in UK primary care and included the use of oral glucose tolerance tests (OGTTs) and waist measurement. Qualitative data from interviews with healthcare providers and records of meetings were analysed thematically., Results: The key quantitative finding was low uptake of the assessments offered (8.6% overall, 2.6% in inner-city locations with high South Asian residency). In addition to confirming patient-reported barriers including those associated with OGTTs, qualitative findings highlighted a number of primary care provider barriers, including limited staff capacity. Interviewees suggested that those who attended were typically the 'worried well' rather than those from hard-to-reach groups., Conclusions: Implications discussed include the impact of low uptake on the usefulness of the quantitative data obtained, and lessons relevant to research design. Relevance to current guidance regarding early identification strategies is discussed and the importance of addressing the needs of less accessible groups is highlighted., (Copyright © 2013 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.)

Aims: To report the characteristics and treatment of individuals requiring emergency ambulance services for severe hypoglycaemia and estimate associated provider costs., Methods: Retrospective analysis of routinely collected data collected by the East Midlands Ambulance Trust, UK, of episodes of severe hypoglycaemia attended by emergency ambulance services during a four-month period. Standard clinical measures, response time, on-site treatment and transportation were recorded and ambulance services costs calculated., Results: 90,435 emergency calls were recorded, 523 (0.6%) for severe hypoglycaemia, equating to an incidence of to 2.76 per 100 patient years; 74% of individuals were insulin-treated, 28% of events occurred nocturnally (00:00-07:59), and 32% were transported to hospital. Higher respiratory rate was a positive predictor (p=0.03), whereas higher post treatment blood glucose (p=0.05) and insulin treatment (p<0.01) were negative predictors of transport to hospital. Median treatment costs for individuals transported and not transported to hospital were £92 and £176 respectively., Conclusions: Most cases of severe hypoglycaemia requiring assistance from emergency ambulance services are successfully treated at the scene. Individuals not responding to treatment or were non insulin-treated were more likely to be transported to hospital. Further studies are needed to evaluate the effect of prehospital ambulance care by treatment and diabetes type on subsequent outcomes., (Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.)

Background: Chronic kidney disease (CKD) represents a significant and growing health care burden globally. Lifestyle factors, such as physical activity and sitting-related sedentary behavior, have been hypothesized to be directly associated with CKD; however, epidemiologic research is limited., Study Design: Cross-sectional analysis., Setting & Participants: A population-level diabetes screening program conducted across 20 family practices in Leicester, United Kingdom, August 2004 to December 2007., Predictors: Self-reported sitting time and physical activity, obtained using the International Physical Activity Questionnaire., Outcomes & Measurements: CKD, defined using NKF-KDOQI (National Kidney Foundation's Kidney Disease Outcomes Quality Initiative) criteria., Results: 6,379 (52% women) individuals were included. Lower levels of sitting time were associated with lower risk of CKD after controlling for physical activity, body mass index, and other potential confounding variables (OR, 0.74 [95% CI, 0.62-0.92] for lowest vs highest tertile). Interaction analysis showed that women trended toward a significantly higher risk of CKD with higher levels of sitting time compared with men. Participating in levels of physical activity that were at least consistent with the minimum recommendations for health was associated with lower risk of CKD. A significant interaction with sex was observed, with men showing a lower risk of CKD with high levels of physical activity compared with women., Limitations: Cross-sectional design, self-reported lifestyle data, CKD defined at a single time, and estimated glomerular filtration rate and microalbuminuria were the only measures used to define CKD., Conclusions: This study suggests that higher levels of physical activity and lower levels of sitting time are associated with a lower prevalence of CKD independently of each other and other risk factors. However, results may vary by sex, with sitting time being the more important factor in women and physical activity the more important factor in men. These results have important implications for future research., (Copyright © 2012 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Background: The benefit of self-monitoring of blood glucose (SMBG) in people with type 2 diabetes on diet or oral agents other than sulphonylureas remains uncertain. Trials of interventions incorporating education about self-monitoring of blood glucose have reported mixed results. A recent systematic review concluded that SMBG was not cost-effective. However, what was unclear was whether a cheaper method of self-monitoring (such as urine glucose monitoring) could produce comparable benefit and patient acceptability for less cost., Methods/design: The DESMOND SMBG trial is comparing two monitoring strategies (blood glucose monitoring and urine testing) over 18 months when incorporated into a comprehensive self-management structured education programme. It is a multi-site cluster randomised controlled trial, conducted across 8 sites (7 primary care trusts) in England, UK involving individuals with newly diagnosed Type 2 diabetes.The trial has 80% power to demonstrate equivalence in mean HbA1c (the primary end-point) at 18 months of within ± 0.5% assuming 20% drop out and 20% non-consent. Secondary end-points include blood pressure, lipids, body weight and psychosocial measures as well as a qualitative sub-study.Practices were randomised to one of two arms: participants attend a DESMOND programme incorporating a module on self-monitoring of either urine or blood glucose. The programme is delivered by accredited educators who received specific training about equipoise. Biomedical data are collected and psychosocial scales completed at baseline, and 6, 12, and 18 months post programme. Qualitative research with participants and educators will explore views and experiences of the trial and preferences for methods of monitoring., Discussion: The DESMOND SMBG trial is designed to provide evidence to inform the debate about the value of self-monitoring of blood glucose in people with newly diagnosed type 2 diabetes. Strengths include a setting in primary care, a cluster design, a health economic analysis, a comparison of different methods of monitoring while controlling for other components of training within the context of a quality assured structured education programme and a qualitative sub-study., Trial Registration: ISRCTN: ISRCTN95696668.

Background: Recent attention has focused on strategies to combat the forecast epidemic of type-2 diabetes (T2DM) and its major vascular sequelae. Metabolic syndrome (MetS) comprises a constellation of factors that increase the risk of cardiovascular disease (CVD) and T2DM. Our study aims to develop a structured self-management education programme for people with MetS, which includes management of cardiovascular and diabetes risk factors, and to determine its impact. This paper describes the rationale and design of the TRIMS study, including intervention development, and presents baseline data., Methods: Subjects recruited from a mixed-ethnic population with MetS were randomised to intervention or control arms. The intervention arm received structured group education based on robust psychological theories and current evidence. The control group received routine care. Follow-up data will be collected at 6 and 12 months. The primary outcome measure will be reversal of metabolic syndrome in the intervention group subjects compared to controls at 12 months follow-up., Results: 82 participants (44% male, 22% South Asian) were recruited between November 2009 and July 2010. Baseline characteristics were similar for both the intervention (n = 42) and control groups (n = 40). Median age was 63 years (IQR 57 - 67), mean waist size 106 cm (SD ± 11), and prescribing of statins and anti-hypertensives was 51% in each case., Conclusion: Results will provide information on changes in diabetes and CVD risk factors and help to inform primary prevention strategies in people with MetS from varied ethnic backgrounds who are at high risk of developing T2DM and CVD. Information gathered in relation to the programme's acceptability and effectiveness in a multi-ethnic population would ensure that our results are widely applicable., Trial Registration: The study is registered at ClinicalTrials.gov, study identifier: NCT01043770.

Aims: To determine whether a first degree family history (FH) of diabetes and/or a first degree FH of cardiovascular disease (CVD), can predict prevalent cases of metabolic syndrome (MetS). Also, to establish if the association is different for South Asians compared to White Europeans, and for obese compared to non-obese individuals., Methods: Cross-sectional data were analysed for a mixed-ethnic cohort of 3094 at-risk individuals, aged 40-75 years (29% South Asian), who were screened in Leicestershire (UK) for undiagnosed type 2 diabetes using an oral glucose tolerance test. Logistic regression was used to assess the relationship between FH and prevalent MetS, including adjustment for potential confounders., Results: Prevalence of MetS was 39%. Adjusted odds ratios (OR) showed that only a FH of CVD (OR 1.41, 95%CI: 1.18-1.68, p<0.001) was significantly associated with prevalent MetS. Interaction analysis showed no effect modification for obesity and ethnicity. We did not find any association for a FH of diabetes., Conclusions: These findings suggest that a first degree FH of CVD predicts prevalent cases of MetS in a mixed-ethnic population. Evidence of an association may help to identify individuals who should be targeted for screening and early prevention of type 2 diabetes and CVD.