Evaluation of the clinical effectiveness of telephone consultation compared to face-to-face consultation in terms of glycaemic control among patients with suboptimally controlled type 2 diabetes: a retrospective cohort study.

OBJECTIVE: With the COVID-19 pandemic, telemedicine has been increasingly deployed in lieu of face-to-face consultations for management of diabetes in primary care. There was a need to evaluate clinical effectiveness of telephone consultations for diabetes management and this study aimed to show whether one-off telephone consultation was inferior or not to face-to-face consultation in terms of glycaemic control among patients with suboptimally controlled type 2 diabetes. DESIGN: Retrospective cohort study. Data of all patients with type 2 diabetes who had a chronic disease consultation during the period 9 April 2020-18 September 2020, and met the study's inclusion and exclusion criteria was obtained from the electronic medical records. SETTING: A primary care clinic in the north-eastern region of Singapore. The clinic's patient population was representative of Singapore's population in terms of gender and age. PARTICIPANTS: 644 patients with type 2 diabetes and glycated haemoglobin (HbA1c) 7.0% and above, aged 21-80 years old. INTERVENTIONS: Participants either underwent telephone or face-to-face consultation for diabetes management. OUTCOME MEASURE: Mean HbA1c change (∆HbA1c) between preintervention and postintervention. RESULTS: Over 4 months, the mean ∆HbA1c was -0.16 percentage points (p.p.) (95% CI -0.26 to -0.07) and -0.11 p.p. (95% CI -0.20 to -0.02) for face-to-face and telephone consultation groups, respectively. The difference in mean ∆HbA1c between the two groups was +0.05 p.p. (95% CI -∞ to 0.16), with the upper limit of the one-sided 95% CI less than the prespecified non-inferiority margin of 0.5 p.p. (p<0.05). In those with HbA1c≥9%, the difference in mean ∆HbA1c was +0.31 p.p. (95% CI -∞ to 0.79), which exceeded the non-inferiority margin. CONCLUSION: For patients with suboptimally controlled type 2 diabetes, one-time telephone consultation was non-inferior to face-to-face consultation in terms of glycaemic control in the short term. However, more studies are required to investigate the long-term effects of telephone consultations and for those with HbA1c≥9%.

Flash glucose monitoring in young people with type 1 diabetes-a qualitative study of young people, parents and health professionals: 'It makes life much easier'.

OBJECTIVES: Flash glucose monitoring for patients with T1 diabetes avoids frequent painful finger-prick testing, thus potentially improving frequency of glucose self-monitoring. Our study aimed to explore experiences of young people using Freestyle Libre sensors and their parents, and to identify benefits and challenges to National Health Service (NHS) staff of its adoption in their care provision. PARTICIPANTS: Young people with T1 diabetes, their parents and healthcare professionals were interviewed between February and December 2021. Participants were recruited via social media and through NHS diabetes clinic staff. DESIGN: Semistructured interviews were conducted online and analysed using thematic methods. Staff themes were mapped onto normalisation process theory (NPT) constructs. RESULTS: Thirty-four participants were interviewed: 10 young people, 14 parents and 10 healthcare professionals. Young people reported that life was much easier since changing to flash glucose monitoring, increasing confidence and independence to manage their condition. Parents' quality of life improved and they appreciated access to real-time data. Using the NPT concepts to understand how technology was integrated into routine care proved useful; health professionals were very enthusiastic about flash glucose monitoring and coped with the extra data load to facilitate more tailored patient support within and between clinic visits. CONCLUSION: This technology empowers young people and their parents to understand their diabetes adherence more completely; to feel more confident about adjusting their own care between clinic appointments; and provides an improved interactive experience in clinic. Healthcare teams appear committed to delivering improving technologies, acknowledging the challenge for them to assimilate new information required to provide expert advice.

Associations of the built environment with type 2 diabetes in Asia: a systematic review.

OBJECTIVES: Our study aimed to systematically review the literature and synthesise findings on potential associations of built environment characteristics with type 2 diabetes (T2D) in Asia. DESIGN: Systematic review of the literature. DATA SOURCES: Online databases Medline, Embase and Global Health were used to identify peer-reviewed journal articles published from inception to 23 January 2023. ELIGIBILITY CRITERIA: Eligible studies included cohort, cross-sectional and case-control studies that explored associations of built environment characteristics with T2D among adults 18 years and older in Asia. DATA EXTRACTION AND SYNTHESIS: Covidence online was used to remove duplicates and perform title, abstract and full-text screening. Data extraction was carried out by two independent reviewers using the OVID database and data were imported into MS Excel. Out of 5208 identified studies, 28 studies were included in this systematic review. Due to heterogeneity in study design, built environment and outcome definitions, a semiqualitative analysis was conducted, which synthesised results using weighted z-scores. RESULTS: Five broad categories of built environment characteristics were associated with T2D in Asia. These included urban green space, walkability, food environment, availability and accessibility of services such as recreational and healthcare facilities and air pollution. We found very strong evidence of a positive association of particulate matter (PM2.5, PM10), nitrogen dioxide and sulfur dioxide (p<0.001) with T2D risk. CONCLUSION: Several built environment attributes were significantly related to T2D in Asia. When compared with Western countries, very few studies have been conducted in Asia. Further research is, therefore, warranted to establish the importance of the built environment on T2D. Such evidence is essential for public health and planning policies to (re)design neighbourhoods and help improve public health across Asian countries. PROSPERO REGISTRATION NUMBER: CRD42020214852.

Retrospective study on the impact of COVID-19 lockdown on patients with type 2 diabetes in Northern Jordan.

OBJECTIVE: During COVID-19 pandemic, complete lockdown of cities was one of the measures implemented by governments worldwide. Lockdown had a significant impact on people's lifestyles and access and utilisation of health services. This study aimed to assess the impact of the lockdown on glycaemic control among patients with type 2 diabetes mellitus (T2DM). DESIGN AND SETTING: This was a retrospective study, electronic medical records at a leading University Hospital in Northern Jordan were used to extract study data. PARTICIPANTS: All outpatients with T2DM. PRIMARY AND SECONDARY OUTCOME MEASURES: Glycated haemoglobin (HbA1c), blood glucose and lipid profile for patients with T2DM, 6 months before and 6 months after the full COVID-19 lockdown. RESULTS: A total of 639 patients (289 (45.2%) males and 350 (54.8%) females) were included in this study. Their age ranged from 18 to 91 years, with a mean (SD) of 59.9 (13.8) years. The overall means of HbA1c (8.41 vs 8.20, <0.001), high-density lipoprotein (1.16 vs 1.12, <0.001), low-density lipoprotein (2.81 vs 2.49, <0.001) and total cholesterol (4.45 vs 4.25, p<0.001) levels were significantly higher in the period before lockdown compared with the period after the lockdown. However, triglyceride and fasting blood glucose levels were not affected significantly after the lockdown. CONCLUSIONS: The glycaemic control and lipid profile had significantly improved after COVID-19 pandemic lockdown. The availability of medication and medical advice delivery systems (monthly medicine deliveries) during the lockdown in Jordan might have positive impact on patients with diabetes.

Process evaluation of in-person, news and social media engagement of a community-based programme Brown Buttabean Motivation (BBM): a research protocol.

INTRODUCTION: The community group Brown Buttabean Motivation (BBM) initially began to assist Auckland Pasifika and Maori to manage weight problems, predominantly through community-based exercise sessions and social support. BBM's activities expanded over time to include many other components of healthy living in response to community need. With advent of the COVID-19 pandemic, BBM outreach grew to include a foodbank distributing an increasing amount of donated healthy food to families in need, a community kitchen and influenza and COVID-19 vaccine drives. A strong social media presence has served as the main means of communication with the BBM community as well as use of traditional news media (written, radio, television) to further engage with vulnerable members of the community. METHODS AND ANALYSIS: The study aims to conduct mixed method process evaluation of BBM's community engagement through in-person, social and news media outreach activities with respect to the health and well-being of Pasifika and Maori over time. The project is informed by theoretical constructs including Pacific Fa'afaletui and Fonofale and Maori Te Whare Tapa Wha Maori research frameworks and principles of Kaupapa Maori. It is further framed using the concept of community-driven diffusion of knowledge and engagement through social networks. Data sources include in-person community engagement databases, social and news media outreach data from archived documents and online resources. Empirical data will undergo longitudinal and time series statistical analyses. Qualitative text thematic analyses will be conducted using the software NVivo, Leximancer and AntConc. Image and video visual data will be randomly sampled from two social media platforms. The social media dataset contains almost 8000 visual artefacts. ETHICS AND DISSEMINATION: Ethics approval obtained from University of Auckland Human Participants Ethics Committee UAHPEC 23456. Findings will be published in peer-reviewed publications, disseminated through community meetings and conferences and via BBM social network platforms. TRIAL REGISTRATION NUMBER: ACTRN 12621 00093 1875.

SPUR: psychometric properties of a patient-reported outcome measure of medication adherence in type 2 diabetes.

INTRODUCTION: Poor medication adherence is associated with worsening patient health outcomes and increasing healthcare costs. A holistic tool to assess both medication adherence and drivers of adherence behaviour has yet to be developed. This study aimed to examine SPUR, a multifactorial patient-reported outcome measure of medication adherence in patients living with type 2 diabetes, with a view to develop a suitable model for psychometric analysis.Furthermore, the study aimed to explore the relationship between the SPUR model and socio-clinical factors of medication adherence. RESEARCH DESIGN AND METHODS: The study recruited 378 adult patients living with type 2 diabetes from a mix of community and secondary-care settings to participate in this non-interventional cross-sectional study. The original SPUR-45 tool was completed by participants with other patient-reported outcome measures for comparison, in addition to the collection of two objective adherence measures; HbA1c and the medication possession ratio (MPR). RESULTS: Factor and reliability analysis conducted on SPUR-45 produced a revised and more concise version (27-items) of the tool, SPUR-27, which was psychometrically assessed. SPUR-27 observed strong internal consistency with significant correlations to the other psychometric measures (Beliefs about Medication Questionnaire, Diabetes Treatment Satisfaction Questionnaire, Medicine Adherence Rating Scale) completed by participants. Higher SPUR-27 scores were associated with lower HbA1c values and a higher MPR, as well as other predicted socio-clinical factors such as higher income, increased age and lower body mass index. CONCLUSIONS: SPUR-27 demonstrated strong psychometric properties. Further work should look to examine the test-retest reliability of the model as well as examine transferability to other chronic conditions and broader population samples. Overall, the initial findings suggest that SPUR-27 is a reliable model for the multifactorial assessment of medication adherence among patients living with type 2 diabetes.

COVID-19 pandemic unmasking cardiovascular risk factors and non-communicable diseases among migrant workers: a cross-sectional study in Singapore.

OBJECTIVES: This study aims to report the prevalence of cardiovascular risk factors (CVRFs) and other non-communicable diseases among migrant workers in Singapore admitted for COVID-19 infection, to highlight disease burden and the need for changes in health screening and healthcare delivery in this unique population. SETTING: The study was conducted in the largest tertiary hospital in Singapore. DESIGN: Retrospective cross-sectional study. PARTICIPANTS: 883 migrant workers who had mild or asymptomatic COVID-19 infection admitted to three isolation wards between 6 April 2020 and 31 May 2020 were included in this study. OUTCOME MEASURES: The outcome measures were the prevalence of pre-existing and newly diagnosed comorbid conditions and the prevalence of CVRFs-diabetes mellitus, hypertension and hyperlipidaemia-and non-communicable diseases at the time of discharge. The OR of having specific CVRFs depending on country of origin was generated via multivariate logistic regression analysis. RESULTS: The median age of our study population was 45 years. 17.0% had pre-existing conditions and 25.9% received new diagnoses. Of the new diagnoses, 15.7% were acute medical conditions and 84.3% chronic medical conditions. The prevalence of CVRFs was higher in Southeast Asian and South Asian migrant workers compared with Chinese. The prevalence of non-communicable diseases on discharge was highest among Southeast Asians (49.4%). CONCLUSIONS: The COVID-19 outbreak in a large number of migrant workers in Singapore unmasked a significant disease burden among them, increasing stakeholders' interests in their welfare. Moving forward, system-level changes are necessary to deliver healthcare sustainably and effect improvements in migrant workers' health.

Protocol for updated systematic review and meta-analysis on the burden of non-communicable diseases among people living with HIV in sub-Saharan Africa.

INTRODUCTION: Sub-Saharan Africa (SSA) is faced with the dual epidemics of HIV/AIDS and non-communicable diseases (NCDs). Cardiovascular diseases, cancers, chronic respiratory diseases, diabetes and mental illnesses are the five major NCDs, causing death globally with low-income and middle-income countries, contributing 78% of all NCD deaths and 85% of premature deaths. There has been increased interest in the integration of HIV and NCDs care, especially in SSA that accounts for 55% of people living with HIV (PLHIV) globally. This systematic review and meta-analysis will estimate the overall prevalence or incidence of NCDs (or its risk factors) among adults living with HIV in SSA. METHODS AND ANALYSIS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be used. Two authors will independently screen the title and abstracts of the articles identified from the search. Study participants will be any adult (≥18 years old) living with HIV in SSA. Exposure of interest will be HIV (with or without ART). Outcomes of interest are prevalence or incidence of any NCD/NCD risk factors. A random-effects meta-analysis will be used to estimate pooled prevalence or incidence of the five major NCDs among PLHIV, using Stata software. χ2 test and I2 statistic will be used to measure statistical heterogeneity between studies. If there is significant heterogeneity, subgroup analysis will be used to investigate potential sources. Publication bias will be assessed using funnel plots and the Stata 'metabias' command. ETHICS AND DISSEMINATION: Ethical review will not be required because it is a systematic review. Data will be kept in the institutional data repository. Study findings will be disseminated through peer-reviewed publications and conference presentations. PROSPERO REGISTRATION NUMBER: CRD42021258769.

ARCADIA study protocol: a phase II, randomised, double-blind, placebo-controlled clinical trial to assess the safety and efficacy of AZD1656 in patients with diabetes hospitalised with suspected or confirmed COVID-19.

INTRODUCTION: COVID-19, caused by SARS-CoV-2, remains a global pandemic that has affected more than 100 million people worldwide with over 4.8 million deaths as of October 2021. Patients with diabetes have both an increased susceptibility to SARS-CoV-2 infection, enhanced disease severity and increased risk of mortality. The challenge presented in these patients is both to improve glycaemic control-which itself may confer a survival advantage-and to help maintain or restore immunological homeostasis. The specific glucokinase activator AZD1656 may address both of these challenges via its glucose-lowering effect and its immunological mechanism of action. The aim of the Alleviation of cardioRespiratory complications in patients with COVID-19 And DIAbetes (ARCADIA) trial is to investigate this hypothesis and determine whether AZD1656 can improve clinical outcomes for these patients. METHODS AND ANALYSIS: ARCADIA is a double-blind, placebo-controlled, interventional study of AZD1656 in 150 patients with either type 1 or type 2 diabetes who have been admitted to hospital with COVID-19. Eligible, consented patients will be randomised in a 1:1 manner to receive either active drug or matched placebo tablets while they are in hospital. All patients will receive the usual and current standard of care for patients with COVID-19 in that hospital. Clinical and laboratory data will be collected and assessed at baseline and throughout their participation in the study. Data will be captured in the case report form, which will be electronically archived at the end of the trial in the trial master file. The WHO 8-point Ordinal Scale for Clinical Improvement will be used to measure clinical outcome for the primary endpoint of the trial. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the East Midlands-Leicester South Ethics Committee (REC 20/EM/0198) in the UK, from the National Bioethics Committee of Medicines and Medical Devices in Bucharest, Romania, and from the Ethics Committee IKEM a TN in Prague, Czech Republic. All study-related data will be used by the sponsor in accordance with local data protection law. In the UK, all patient identifiable data will be stored on a password-protected National Health Service N3 network with full audit trail. Anonymised data will be stored in an ISO27001 certificated data warehouse. TRIAL REGISTRATION NUMBER: EudraCT 2020-002211-21, NCT04516759.

Diabetes Prevention Education Program in a population with pre-diabetes in Nepal: a study protocol of a cluster randomised controlled trial (DiPEP).

INTRODUCTION: Evidence suggests that diabetes burden can be reduced by implementing early lifestyle intervention programmes in population with pre-diabetes in high-income countries. However, little is known in developing nations like Nepal. This study aims to assess effectiveness of community-based Diabetes Prevention Education Program (DiPEP) on haemoglobin A1c (HbA1c) level, proportion of pre-diabetes reverting to normoglycaemia, diet, physical activity, weight reduction, diabetes knowledge and health literacy after 6 months of follow-up. Furthermore, we will also conduct qualitative studies to explore experiences of participants of intervention sessions and perception of healthcare workers/volunteers about DiPEP. METHODS AND ANALYSES: This is a community-based two-arm, open-label, cluster randomised controlled trial. We will randomise 14 clusters into intervention arm and control arm. Estimated total sample size is 448. We will screen individuals without diabetes, aged 18-64 years, and permanent residents of study sites. HbA1c test will be only performed if both Indian Diabetes Risk Score and random blood sugar value are ≥60 and 140-250 mg/dL, respectively. At baseline, participants in intervention arm will receive DiPEP package (including intensive intervention classes, diabetes prevention brochure, exercise calendar and food record booklet), and participants in control arm will be provided only with diabetes prevention brochure. The change in outcome measures will be compared between intervention to control arm after 6 months of follow-up by linear mixed models. Also, we will conduct individual interviews among participants and healthcare workers as part of a qualitative study. We will use thematic analysis to analyse qualitative data. ETHICS AND DISSEMINATION: Regional Committee for Medical and Health Research Ethics, Norway; Nepal Health Research Council, Nepal and Institutional Review Committee, Kathmandu University School of Medical Sciences have approved the study. The DiPEP package can be implemented in other communities of Nepal if it is effective in preventing diabetes. TRIAL REGISTRATION NUMBER: NCT04074148, 2019/783.

Awareness and readiness to use telemonitoring to support diabetes care among care providers at teaching hospitals in Ethiopia: an institution-based cross-sectional study.

OBJECTIVES: This survey aimed to assess the awareness and readiness of healthcare providers to use telemonitoring (TM) technologies for managing diabetes patients as well as to identify associated factors in Ethiopia. DESIGN: An institution-based cross-sectional quantitative survey was conducted by using a pretested self-administered questionnaire from February to March 2020. Data analysis used a binary logistic regression and partial proportional odds model for factor identification. PARTICIPANTS: Randomly selected 423 study physicians and nurses. SETTING: This study was conducted at the University of Gondar and Tibebe Ghion specialised teaching referral hospitals. OUTCOME MEASURES: Awareness and readiness towards TM in diabetes care. RESULT: Out of 406 healthcare providers (69.7%, n=283 nurses and 30.3%, n=123 physicians) who completed the survey, 345 (38.7%) heard about TM, when it came to readiness, 321 (25.1%) and 121 (65.5%) of respondents had average and low readiness towards TM, respectively. The result of regression analysis shows that awareness towards TM was higher among respondents who had access to a computer (adjusted OR (AOR): 2.8 (95% CI 1.1 to 7.1)), computer-related training (AOR: 4.6 (95% CI 1.63 to 12.95)) and those who had the experience of supporting patients through digital tools (AOR: 1.7 (95% CI 1.0 to 2.8)). Self-perceived innovators and those who had access to a computer, computer-related training and favourable attitude towards TM had significantly higher readiness to use TM. CONCLUSION: The findings of this survey revealed low awareness and readiness of participant's towards TM. However, this study suggests the need of improving participant's attitudes, access to smartphones and computers and technical skills to fill this gap.

Diabetes, hypertension, body mass index, smoking and COVID-19-related mortality: a systematic review and meta-analysis of observational studies.

OBJECTIVES: We conducted a systematic literature review and meta-analysis of observational studies to investigate the association between diabetes, hypertension, body mass index (BMI) or smoking with the risk of death in patients with COVID-19 and to estimate the proportion of deaths attributable to these conditions. METHODS: Relevant observational studies were identified by searches in the PubMed, Cochrane library and Embase databases through 14 November 2020. Random-effects models were used to estimate summary relative risks (SRRs) and 95% CIs. Certainty of evidence was assessed using the Cochrane methods and the Grading of Recommendations, Assessment, Development and Evaluations framework. RESULTS: A total of 186 studies representing 210 447 deaths among 1 304 587 patients with COVID-19 were included in this analysis. The SRR for death in patients with COVID-19 was 1.54 (95% CI 1.44 to 1.64, I2=92%, n=145, low certainty) for diabetes and 1.42 (95% CI 1.30 to 1.54, I2=90%, n=127, low certainty) for hypertension compared with patients without each of these comorbidities. Regarding obesity, the SSR was 1.45 (95% CI 1.31 to 1.61, I2=91%, n=54, high certainty) for patients with BMI ≥30 kg/m2 compared with those with BMI <30 kg/m2 and 1.12 (95% CI 1.07 to 1.17, I2=68%, n=25) per 5 kg/m2 increase in BMI. There was evidence of a J-shaped non-linear dose-response relationship between BMI and mortality from COVID-19, with the nadir of the curve at a BMI of around 22-24, and a 1.5-2-fold increase in COVID-19 mortality with extreme obesity (BMI of 40-45). The SRR was 1.28 (95% CI 1.17 to 1.40, I2=74%, n=28, low certainty) for ever, 1.29 (95% CI 1.03 to 1.62, I2=84%, n=19) for current and 1.25 (95% CI 1.11 to 1.42, I2=75%, n=14) for former smokers compared with never smokers. The absolute risk of COVID-19 death was increased by 14%, 11%, 12% and 7% for diabetes, hypertension, obesity and smoking, respectively. The proportion of deaths attributable to diabetes, hypertension, obesity and smoking was 8%, 7%, 11% and 2%, respectively. CONCLUSION: Our findings suggest that diabetes, hypertension, obesity and smoking were associated with higher COVID-19 mortality, contributing to nearly 30% of COVID-19 deaths. TRIAL REGISTRATION NUMBER: CRD42020218115.

Benefits of the addition of continuous or flash glucose monitoring versus standard practice using self-monitored blood glucose and haemoglobin A1c in the primary care of diabetes mellitus: a systematic review protocol.

INTRODUCTION: Studies demonstrate that optimal glycaemic control reduces morbidity from diabetes mellitus but remains elusive in a significant portion of patients. Although research shows that continuous glucose monitoring (CGM) and flash glucose monitoring (FGM) improves glycaemic control in selected subsets of patients with diabetes in specialty practices, we found no systematic reviews evaluating the use of CGM/FGM in primary care, where the majority of patients with diabetes are cared for.This systematic review aims to answer the questions: 'compared with usual care of self-monitoring blood glucose and haemoglobin A1c (HbA1c), does the addition of CGM/FGM use in the primary care of patients with diabetes improve glycaemic control, decrease rates of hypoglycaemia, and improve patient and physician satisfaction?' and if so, 'what subgroups of primary care patients with diabetes are most likely to benefit?'. METHODS AND ANALYSIS: Aligning with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines, a search will be conducted in PubMed, EMBASE, Scopus, CINAHL, Cochrane Central Register of Controlled Trials and Web of Science. We will include studies investigating CGM/FGM use and reporting the primary outcome measure of HbA1c and secondary outcome measures of hypoglycaemia, time in range, time below range, time above range and patient/staff satisfaction. We will examine which patient populations appear to benefit from CGM/FGM. Three independent researchers will use the Covidence systematic review software for blinded screening and study selection. The National Heart, Lung, and Blood Institute quality assessment tool and Grading of Recommendations Assessment, Development and Evaluation will be used to assess the risk of bias and quality of evidence. ETHICS AND DISSEMINATION: The systematic review methodology does not require ethics approval due to the nature of the study design. Study findings will be publicly available to a wide readership across disciplines and will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42021229416.

Effect of routinely assessing and addressing depression and diabetes distress using patient-reported outcome measures in improving outcomes among adults with type 2 diabetes: a systematic review protocol.

INTRODUCTION: Type 2 diabetes is a global health priority. People with diabetes are more likely to experience mental health problems relative to people without diabetes. Diabetes guidelines recommend assessment of depression and diabetes distress during diabetes care. This systematic review will examine the effect of routinely assessing and addressing depression and diabetes distress using patient-reported outcome measures in improving outcomes among adults with type 2 diabetes. METHODS AND ANALYSIS: MEDLINE, Embase, CINAHL Complete, PsycInfo, The Cochrane Library and Cochrane Central Register of Controlled Trials will be searched using a prespecified strategy using a prespecified Population, Intervention, Comparator, Outcomes, Setting and study design strategy. The date range of the search of all databases will be from inception to 3 August 2020. Randomised controlled trials, interrupted time-series studies, prospective and retrospective cohort studies, case-control studies and analytical cross-sectional studies published in peer-reviewed journals in the English language will be included. Two review authors will independently screen abstracts and full texts with disagreements resolved by a third reviewer, if required, using Covidence software. Two reviewers will undertake risk of bias assessment using checklists appropriate to study design. Data will be extracted using prespecified template. A narrative synthesis will be conducted, with a meta-analysis, if appropriate. ETHICS AND DISSEMINATION: Ethics approval is not required for this review of published studies. Presentation of results will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidance. Findings will be disseminated via peer-reviewed publication and conference presentations. PROSPERO REGISTRATION NUMBER: CRD42020200246.

COVID-19 hinterland: surveilling the self-reported impacts of the pandemic on diabetes management in the USA (cross-sectional results of the iNPHORM study).

MAIN OBJECTIVE: To determine how and to what extent COVID-19 has affected real-world, self-reported glycaemic management in Americans with type 1 or type 2 diabetes taking insulin and/or secretagogues, with or without infection. DESIGN: A cross-sectional substudy using data from the Investigating Novel Predictions of Hypoglycemia Occurrence using Real-world Models panel survey. SETTING: USA. PARTICIPANTS: Americans 18-90 years old with type 1 or 2 diabetes taking insulin and/or secretagogues were conveniently sampled from a probability-based internet panel. PRIMARY OUTCOME MEASURE: A structured, COVID-19-specific questionnaire was administered to assess the impact of the pandemic (irrespective of infection) on socioeconomic, behavioural/clinical and psychosocial aspects of glycaemic management. RESULTS: Data from 667 respondents (type 1 diabetes: 18%; type 2 diabetes: 82%) were analysed. Almost 25% reported A1c values ≥8.1%. Rates of severe and non-severe hypoglycaemia were 0.68 (95% CI 0.5 to 0.96) and 2.75 (95% CI 2.4 to 3.1) events per person-month, respectively. Ten respondents reported a confirmed or probable COVID-19 diagnosis. Because of the pandemic, 24% of respondents experienced difficulties affording housing; 28% struggled to maintain sufficient food to avoid hypoglycaemia; and 19% and 17% reported challenges accessing diabetes therapies and testing strips, respectively. Over one-quarter reported issues retrieving antihyperglycaemics from the pharmacy and over one-third reported challenges consulting with diabetes providers. The pandemic contributed to therapeutic non-adherence (14%), drug rationing (17%) and reduced monitoring (16%). Many struggled to keep track, and in control, of hypoglycaemia (12%-15%) and lacked social support to help manage their risk (19%). Nearly half reported decreased physical activity. Few statistically significant differences were observed by diabetes type. CONCLUSIONS: COVID-19 was found to cause substantial self-reported deficiencies in glycaemic management. Study results signal the need for decisive action to restabilise routine diabetes care in the USA. TRIAL REGISTRATION NUMBER: NCT04219514.

Risk factors for severe outcomes in people with diabetes hospitalised for COVID-19: a cross-sectional database study.

AIM: This study's objective was to assess the risk of severe in-hospital complications of patients admitted for COVID-19 and diabetes mellitus (DM). DESIGN: This was a cross-sectional study. SETTINGS: We used pseudonymised medical record data provided by six general hospitals from the HM Hospitales group in Spain. OUTCOME MEASURES: Multiple logistic regression analyses were used to identify variables associated with mortality and the composite of mortality or invasive mechanical ventilation (IMV) in the overall population, and stratified for the presence or absence of DM. Spline analysis was conducted on the entire population to investigate the relationship between glucose levels at admission and outcomes. RESULTS: Overall, 1621 individuals without DM and 448 with DM were identified in the database. Patients with DM were on average 5.1 years older than those without. The overall in-hospital mortality was 18.6% (N=301), and was higher among patients with DM than those without (26.3% vs 11.3%; p<0.001). DM was independently associated with death, and death or IMV (OR=2.33, 95% CI: 1.7 to 3.1 and OR=2.11, 95% CI: 1.6 to 2.8, respectively; p<0.001). In subjects with DM, the only variables independently associated with both outcomes were age >65 years, male sex and pre-existing chronic kidney disease. We observed a non-linear relationship between blood glucose levels at admission and risk of in-hospital mortality and death or IMV. The highest probability for each outcome (around 50%) was at random glucose of around 550 mg/dL (30.6 mmol/L), and the risks flattened above this value. CONCLUSION: The results confirm the high burden associated with DM in patients hospitalised with COVID-19 infection, particularly among men, the elderly and those with impaired kidney function. Moreover, hyperglycaemia on admission was strongly associated with poor outcomes, suggesting that personalised optimisation could help to improve outcome during the hospital stay.

Flash glucose monitoring with the FreeStyle Libre 2 compared with self-monitoring of blood glucose in suboptimally controlled type 1 diabetes: the FLASH-UK randomised controlled trial protocol.

INTRODUCTION: Optimising glycaemic control in type 1 diabetes (T1D) remains challenging. Flash glucose monitoring with FreeStyle Libre 2 (FSL2) is a novel alternative to the current standard of care self-monitoring of blood glucose (SMBG). No randomised controlled trials to date have explored the potential benefits of FSL2 in T1D. We aim to assess the impact of FSL2 in people with suboptimal glycaemic control T1D in comparison with SMBG. METHODS: This open-label, multicentre, randomised (via stochastic minimisation), parallel design study conducted at eight UK secondary and primary care centres will aim to recruit 180 people age ≥16 years with T1D for >1 year and glycated haemoglobin (HbA1c) 7.5%-11%. Eligible participants will be randomised to 24 weeks of FSL2 (intervention) or SMBG (control) periods, after 2-week of blinded sensor wear. Participants will be assessed virtually or in-person owing to the COVID-19 pandemic. HbA1c will be measured at baseline, 12 and 24 weeks (primary outcome). Participants will be contacted at 4 and 12 weeks for glucose optimisation. Control participants will wear a blinded sensor during the last 2 weeks. Psychosocial outcomes will be measured at baseline and 24 weeks. Secondary outcomes include sensor-based metrics, insulin doses, adverse events and self-report psychosocial measures. Utility, acceptability, expectations and experience of using FSL2 will be explored. Data on health service resource utilisation will be collected. ANALYSIS: Efficacy analyses will follow intention-to-treat principle. Outcomes will be analysed using analysis of covariance, adjusted for the baseline value of the corresponding outcome, minimisation factors and other known prognostic factors. Both within-trial and life-time economic evaluations, informed by modelling from the perspective of the National Health Service setting, will be performed. ETHICS: The study was approved by Greater Manchester West Research Ethics Committee (reference 19/NW/0081). Informed consent will be sought from all participants. TRIAL REGISTRATION NUMBER: NCT03815006. PROTOCOL VERSION: 4.0 dated 29 June 2020.

Hypertension is the major predictor of poor outcomes among inpatients with COVID-19 infection in the UK: a retrospective cohort study.

OBJECTIVE: To assess the impact of diabetes, hypertension and cardiovascular diseases on inpatient mortality from COVID-19, and its relationship to ethnicity and social deprivation. DESIGN: Retrospective, single-centre observational study SETTING: Birmingham, UK. PARTICIPANTS: 907 hospitalised patients with laboratory-confirmed COVID-19 from a multi-ethnic community, admitted between 1 March 2020 and 31 May 2020. MAIN OUTCOME MEASURES: The primary analysis was an evaluation of cardiovascular conditions and diabetes in relation to ethnicity and social deprivation, with the end-point of inpatient death or death within 30 days of discharge. A multivariable logistic regression model was used to calculate HRs while adjusting for confounders. RESULTS: 361/907 (39.8%) died in hospital or within 30 days of discharge. The presence of diabetes and hypertension together appears to confer the greatest mortality risk (OR 2.75; 95% CI 1.80 to 4.21; p<0.001) compared with either condition alone. Age >65 years (OR 3.32; 95% CI 2.15 to 5.11), male sex (OR 2.04; 95% CI 1.47 to 2.82), hypertension (OR 1.69; 95% CI 1.10 to 2.61) and cerebrovascular disease (OR 1.87; 95% CI 1.31 to 2.68) were independently associated with increased risk of death. The mortality risk did not differ between the quintiles of deprivation. High-sensitivity troponin I was the best predictor of mortality among biomarkers (OR 4.43; 95% CI 3.10 to 7.10). Angiotensin-receptor blockers (OR 0.57; 95% CI 0.33 to 0.96) and ACE inhibitors (OR 0.65; 95% CI 0.43 to 0.97) were not associated with adverse outcome. The Charlson Index of Comorbidity scores were significantly higher in non-survivors. CONCLUSIONS: The combined prevalence of hypertension and diabetes appears to confer the greatest risk, where diabetes may have a modulating effect. Hypertension and cerebrovascular disease had a significant impact on inpatient mortality. Social deprivation and ethnicity did not have any effect once the patient was in hospital.

Protocol for a randomised controlled trial on the feasibility and effects of 10-hour time-restricted eating on cardiometabolic disease risk among career firefighters doing 24-hour shift work: the Healthy Heroes Study.

INTRODUCTION: Career firefighters experience chronic circadian rhythm disruption, increasing their risk of cardiometabolic disease. The recent discovery that eating patterns regulate circadian rhythmicity in metabolic organs has raised the hypothesis that maintaining a consistent daily cycle of eating and fasting can support circadian rhythms and reduce disease risks. Preclinical animal studies and preliminary clinical trials have shown promising effects of time-restricted eating (TRE) to reduce disease risk without compromising physical performance. However, there is a lack of research on TRE in shift workers including firefighters. This study aims to investigate the feasibility and efficacy of 10-hour TRE on health parameters that contribute to cardiometabolic disease risks among career firefighters who work on a 24-hour shift schedule. METHODS AND ANALYSES: The Healthy Heroes Study is a randomised controlled parallel open-label clinical trial with 150 firefighters over 1 year. Firefighters are randomised with a 1:1 ratio to either the control or intervention group. The control group receives Mediterranean diet nutritional counselling (standard of care, 'SOC'). The intervention group receives the same SOC and a self-selected 10-hour TRE window. After the 2-week baseline, participants enter a 3-month monitored intervention, followed by a 9-month self-guided period with follow-up assessments. The impact of TRE on blood glucose, body weight, body composition, biomarkers (neuroendocrine, inflammatory and metabolic), sleep and mood is evaluated. These assessments occur at baseline, at the end of intervention and at 6, 9 and 12-month follow-ups. Temporal calorie intake is monitored with the smartphone application myCircadianClock throughout the study. Continuous glucose monitors, wrist-worn actigraphy device and questionnaires are used to monitor glucose levels, activity, sleep and light exposure. ETHICS AND DISSEMINATION: The study was approved by the Institutional Review Boards of the University of California San Diego and the Salk Institute for Biological Studies. Results will be disseminated through peer-reviewed manuscripts, reports and presentations. TRIAL REGISTRATION NUMBER: NCT03533023; Pre result.

Study protocol for resolution of organ injury in acute pancreatitis (RESORP): an observational prospective cohort study.

INTRODUCTION: Survivors of acute pancreatitis (AP) have shorter overall survival and increased incidence of new-onset cardiovascular, respiratory, liver and renal disease, diabetes mellitus and cancer compared with the general population, but the mechanisms that explain this are yet to be elucidated. Our aim is to characterise the precise nature and extent of organ dysfunction following an episode of AP. METHODS AND ANALYSIS: This is an observational prospective cohort study in a single centre comprising a University hospital with an acute and emergency receiving unit and clinical research facility. Participants will be adult patient admitted with AP. Participants will undergo assessment at recruitment, 3 months and 3 years. At each time point, multiple biochemical and/or physiological assessments to measure cardiovascular, respiratory, liver, renal and cognitive function, diabetes mellitus and quality of life. Recruitment was from 30 November 2017 to 31 May 2020; last follow-up measurements is due on 31 May 2023. The primary outcome measure is the incidence of new-onset type 3c diabetes mellitus during follow-up. Secondary outcome measures include: quality of life analyses (SF-36, Gastrointestinal Quality of Life Index); montreal cognitive assessment; organ system physiological performance; multiomics predictors of AP severity, detection of premature cellular senescence. In a nested cohort within the main cohort, individuals may also consent to multiparameter MRI scan, echocardiography, pulmonary function testing, cardiopulmonary exercise testing and pulse-wave analysis. ETHICS AND DISSEMINATION: This study has received the following approvals: UK IRAS Number 178615; South-east Scotland Research Ethics Committee number 16/SS/0065. Results will be made available to AP survivors, caregivers, funders and other researchers. Publications will be open-access. TRIAL REGISTRATION NUMBERS: ClinicalTrials.gov Registry (NCT03342716) and ISRCTN50581876; Pre-results.