Feasibility and acceptability of the use of flash glucose monitoring encountered by Indigenous Australians with type 2 diabetes mellitus: initial experiences from a pilot study.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is highly prevalent within the Indigenous Australian community. Novel glucose monitoring technology offers an accurate approach to glycaemic management, providing real-time information on glucose levels and trends. The acceptability and feasibilility of this technology in Indigenous Australians with T2DM has not been investigated. OBJECTIVE: This feasibility phenomenological study aims to understand the experiences of Indigenous Australians with T2DM using flash glucose monitoring (FGM). METHODS: Indigenous Australians with T2DM receiving injectable therapy (n = 8) who used FGM (Abbott Freestyle Libre) for 6-months, as part of a clinical trial, participated in semi-structured interviews. Thematic analysis of the interviews was performed using NVivo12 Plus qualitative data analysis software (QSR International). RESULTS: Six major themes emerged: 1) FGM was highly acceptable to the individual; 2) FGM's convenience was its biggest benefit; 3) data from FGM was a tool to modify lifestyle choices; 4) FGM needed to be complemented with health professional support; 5) FGM can be a tool to engage communities in diabetes management; and 6) cost of the device is a barrier to future use. CONCLUSIONS: Indigenous Australians with T2DM had positive experiences with FGM. This study highlights future steps to ensure likelihood of FGM is acceptable and effective within the wider Indigenous Australian community.

A scoping review of cardiovascular risk factor screening rates in general or family practice attendees living with severe mental ill-health.

BACKGROUND: Primary care is essential to address the unmet physical health needs of people with severe mental ill-health. Continued poor cardiovascular health demands improved screening and preventive care. No previous reviews have examined primary care cardiovascular screening rates for people living with severe mental ill-health; termed in the literature "severe mental illness". METHODS: A scoping review following Joanna Briggs Institute methodology was conducted. Cardiovascular risk factor screening rates in adults with severe mental ill-health were examined in general or family practices (as the main delivery sites of primary care). Literature published between 2001 and 2023 was searched using electronic databases including Medline, Embase, Web of Science, PsychINFO and CINAHL. Two reviewers independently screened titles and abstracts and conducted a full-text review. The term "severe mental illness" was applied as the term applied in the literature over the past decades. Study information, participant details and cardiovascular risk factor screening rates for people with 'severe mental illness' were extracted and synthesised. RESULTS: Thirteen studies were included. Nine studies were from the United Kingdom and one each from Canada, Spain, New Zealand and the Netherlands. The general and/or family practice cardiovascular disease screening rates varied considerably across studies, ranging from 0 % to 75 % for people grouped within the term "severe mental illness". Lipids and blood pressure were the most screened risk factors. CONCLUSIONS: Cardiovascular disease screening rates in primary care settings for adults living with severe mental ill-health varied considerably. Tailored and targeted cardiovascular risk screening will enable more comprehensive preventive care to improve heart health outcomes and address this urgent health inequity.

The impact of structured self-monitoring of blood glucose on clinical, behavioral, and psychosocial outcomes among adults with non-insulin-treated type 2 diabetes: a systematic review and meta-analysis.

Background: Self-monitoring of blood glucose (SMBG) is considered of little clinical benefit for adults with non-insulin-treated type 2 diabetes, but no comprehensive review of a structured approach to SMBG has been published to date. Purpose: To conduct a systematic review and meta-analysis of the impact of sSMBG on HbA1c, treatment modifications, behavioral and psychosocial outcomes, and; examine the moderating effects of sSMBG protocol characteristics on HbA1c. Data sources: Four databases searched (November 2020; updated: February 2022). Study selection: Inclusion criteria: non-randomized and randomized controlled trials (RCTs) and prospective observational studies; reporting effect of sSMBG on stated outcomes; among adults (≥18 years) with non-insulin-treated type 2 diabetes. Studies excluded if involving children or people with insulin-treated or other forms of diabetes. Data extraction and analysis: Outcome data extracted, and risk of bias/quality assessed independently by two researchers. Meta-analysis was conducted for RCTs, and moderators explored (HbA1c only). Data synthesis: From 2,078 abstracts, k=23 studies were included (N=5,372). Risk of bias was evident and study quality was low. Outcomes assessed included: HbA1c (k=23), treatment modification (k=16), psychosocial/behavioral outcomes (k=12). Meta-analysis revealed a significant mean difference favoring sSMBG in HbA1c (-0·29%, 95% CI: -0·46 to -0·11, k=13) and diabetes self-efficacy (0.17%, 95% CI: 0.01 to 0.33, k=2). Meta-analysis revealed no significant moderating effects by protocol characteristics. Limitations: Findings limited by heterogeneity in study designs, intervention characteristics, and psychosocial assessments. Conclusion: A small positive effect of sSMBG on HbA1c and diabetes self-efficacy was observed. Narrative synthesis of sSMBG intervention characteristics may guide future implementation. PROSPERO registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020208857, identifier CRD42020208857.

'Is Insulin Right for Me?': Web-based intervention to reduce psychological barriers to insulin therapy among adults with non-insulin-treated type 2 diabetes-A randomised controlled trial.

AIMS: To test 'Is Insulin Right for Me?', a theory-informed, self-directed, web-based intervention designed to reduce psychological barriers to insulin therapy among adults with type 2 diabetes. Further, to examine resource engagement and associations between minimum engagement and outcomes. METHODS: Double-blind, two-arm randomised controlled trial (1:1), comparing the intervention with freely available online information (control). Eligible participants were Australian adults with type 2 diabetes, taking oral diabetes medications, recruited primarily via national diabetes registry. EXCLUSION CRITERIA: prior use of injectable medicines; being 'very willing' to commence insulin. Data collections were completed online at baseline, 2-week and 6-month follow-up. PRIMARY OUTCOME: negative insulin treatment appraisal scale (ITAS) scores; secondary outcomes: positive ITAS scores and hypothetical willingness to start insulin. ANALYSES: intention-to-treat (ITT); per-protocol (PP) examination of outcomes by engagement. TRIAL REGISTRATION: ACTRN12621000191897. RESULTS: No significant ITT between-arm (intervention: n = 233; control: n = 243) differences were observed in primary (2 weeks: Mdiff [95% CI]: -1.0 [-2.9 to 0.9]; 6 months: -0.01 [-1.9 to 1.9]), or secondary outcomes at either follow-up. There was evidence of lower Negative ITAS scores at 2-week, but not 6-month, follow-up among those with minimum intervention engagement (achieved by 44%) compared to no engagement (-2.7 [-5.1 to -0.3]). CONCLUSIONS: Compared to existing information, 'Is insulin right for me?' did not improve outcomes at either timepoint. Small intervention engagement effects suggest it has potential. Further research is warranted to examine whether effectiveness would be greater in a clinical setting, following timely referral among those for whom insulin is clinically indicated.

Site-specific factors associated with clinical trial recruitment efficiency in general practice settings: a comparative descriptive analysis.

BACKGROUND: Recruitment of participants is crucial to the success of randomised control trials (RCTs) but can be challenging and expensive. Current research on trial efficiency is often focused at the patient-level with an emphasis on effective recruitment strategies. Less is known about selection of study sites to optimise recruitment. We examine site-level factors that are associated with patient recruitment and cost efficiency using data from an RCT conducted across 25 general practices (GP) in Victoria, Australia. METHODS: Data on number of participants screened, excluded, eligible, recruited, and randomised from each study site were extracted from a clinical trial. Details regarding site characteristics, recruitment practices, and staff time commitment were collected using a three-part survey. The key outcomes assessed were recruitment efficiency (ratio of screened to randomised), average time, and cost for each participant recruited and randomised. To identify practice-level factors associated with efficient recruitment and lower cost, outcomes were dichotomised (25th percentile vs others) and each practice-level factor assessed against the outcomes to determine its association. RESULTS: Across 25 GP study sites, 1968 participants were screened of which 299 (15.2%) were recruited and randomised. The mean recruitment efficiency was 7.2, varying from 1.4 to 19.8 across sites. The strongest factor associated with efficiency was assigning clinical staff to identify potential participants (57.14% vs. 22.2%). The more efficient sites were smaller practices and were more likely to be rural locations and in areas of lower socioeconomic status. The average time used for recruitment was 3.7 h (SD2.4) per patient randomised. The mean cost per patient randomised was $277 (SD161), and this varied from $74 to $797 across sites. The sites identified with the 25% lowest recruitment cost (n = 7) were more experienced in research participation and had high levels of nurse and/or administrative support. CONCLUSION: Despite the small sample size, this study quantified the time and cost used to recruit patients and provides helpful indications of site-level characteristics that can help improve feasibility and efficiency of conducting RCT in GP settings. Characteristics indicative of high levels of support for research and rural practices, which often tends to be overlooked, were observed to be more efficient in recruiting.

Web-based intervention to reduce psychological barriers to insulin therapy among adults with non-insulin-treated type 2 diabetes: study protocol for a two-armed randomised controlled trial of 'Is insulin right for me?'.

INTRODUCTION: Psychological barriers to insulin therapy are associated with the delay of clinically indicated treatment intensification for people with type 2 diabetes (T2D), yet few evidence-based interventions exist to address these barriers. We describe the protocol for a randomised controlled trial (RCT) examining the efficacy of a novel, theoretically grounded, psychoeducational, web-based resource designed to reduce psychological barriers to insulin among adults with non-insulin treated T2D: 'Is insulin right for me?'. METHODS AND ANALYSIS: Double-blind, parallel group RCT. A target sample of N=392 participants (n=196/arm) will be randomised (1:1) to 'Is insulin right for me?' (intervention) or widely available online resources (control). Eligible participants include adults (18-75 years), residing in Australia, currently taking oral hypoglycaemic agents to manage T2D. They will be primarily recruited via invitations and reminders from the national diabetes registry (from a purposefully selected sample of N≥12 000). EXCLUSION CRITERIA: experience of self-administered injectable; previously enrolled in pilot RCT; 'very willing' to start insulin as baseline. Outcomes will be assessed via online survey at 2 weeks and 6 months. Primary outcome between-group: difference in mean negative Insulin Treatment Appraisal Scores (ITAS negative) at 2-week and 6-month follow-up. SECONDARY OUTCOMES: between-group differences in mean positive insulin appraisals (ITAS positive) and percentage difference in intention to commence insulin at follow-up time points. All data analyses will be conducted according to the intention-to-treat principle. ETHICS AND DISSEMINATION: Deakin University Human Research Ethics Committee (2020-073). Dissemination via peer-reviewed journals, conferences and a plain-language summary. TRIAL REGISTRATION NUMBER: ACTRN12621000191897; Australian and New Zealand Clinical Trials Registry.

'For me, it didn't seem as drastic a step as being controlled by insulin': A qualitative investigation of expectations and experiences of non-insulin injectable therapy among adults with type 2 diabetes.

AIMS: This qualitative study aims to explore beliefs, attitudes and experiences of injectable glucagon-like-peptide-1 receptor agonists (GLP-1RAs) use and discontinuation, as well as attitudes to further injectable treatment intensification, among adults with type 2 diabetes (T2D). METHODS: Nineteen in-depth semi-structured interviews lasting (mean ± standard deviation) 45 ± 18 min were conducted, face-to-face (n = 14) or via telephone (n = 5). Transcripts were analysed using inductive template analyses. Eligible participants were English-speaking adults with T2D who had recently initiated (≤3 years) GLP-1RA treatment. RESULTS: Participants were aged 28-72 years, who predominantly lived in metropolitan areas (n = 15), and had an experience of daily (n = 11) and/or once-weekly (n = 13) GLP-1RA formulations. Six participants had discontinued treatment and seven had trialled two or more formulations. Expectations and experiences of GLP-1RA were related to the perceived: (1) symbolism and stigma of injectable diabetes treatment; (2) ease of injectable administration and device preferences; (3) treatment convenience and social impact; (4) treatment efficacy and benefits, and; (5) negative treatment side effects. Some participants reported increased receptiveness to insulin therapy following their GLP-1RA experience, others emphasised unique concerns about insulin beyond injectable administration. CONCLUSIONS: This study provides a novel understanding of expectations and experience of non-insulin injectables among Australian adults with T2D. Our data suggest expectations may be informed by attitudes to insulin therapy, while perceived treatment benefits (e.g. weight-related benefits, administration frequency) may motivate uptake and ongoing use despite concerns. Experience of GLP-1RA injections may impact receptiveness to future insulin use.

Cost-effectiveness of professional-mode flash glucose monitoring in general practice among adults with type 2 diabetes: Evidence from the GP-OSMOTIC trial.

AIM: To assess the cost-effectiveness of professional-mode flash glucose monitoring in adults with type 2 diabetes in general practice compared with usual clinical care. METHODS: An economic evaluation was conducted as a component of the GP-OSMOTIC trial, a pragmatic multicentre 12-month randomised controlled trial enrolling 299 adults with type 2 diabetes in Victoria, Australia. The economic evaluation was conducted from an Australian healthcare sector perspective with a lifetime horizon. Health-related quality of life (EQ-5D) and total healthcare costs were compared between the intervention and the usual care group within the trial period. The 'UKPDS Outcomes Model 2' was used to simulate post-trial lifetime costs, life expectancy and quality-adjusted life years (QALYs). RESULTS: No significant difference in health-related quality of life and costs was found between the two groups within the trial period. Professional-mode flash glucose monitoring yielded greater QALYs (0.03 [95% CI: 0.02, 0.04]) and a higher cost (A$3807 [95% CI: 3604, 4007]) compared with usual clinical care using a lifetime horizon under the trial-based monitoring frequency, considered not cost-effective (incremental cost-effectiveness ratio = A$120,228). The intervention becomes cost-effective if sensor price is reduced to lower than 50%, or monitoring frequency is decreased to once per year while maintaining the same treatment effect on HbA1c . CONCLUSIONS: Including professional-mode flash glucose monitoring every 3 months as part of a management plan for people with type 2 diabetes in general practice is not cost-effective, but could be if the sensor price or monitoring frequency can be reduced.

'Is insulin right for me?': Feasibility of a pilot randomised controlled trial and acceptability of a web-based intervention to reduce psychological barriers to insulin therapy among adults with type 2 diabetes.

AIMS: Acceptable and accessible interventions are needed to address 'psychological insulin resistance', which is a common barrier to insulin uptake among adults with type 2 diabetes (T2D). Our aim was to test the feasibility of a randomised controlled trial (RCT) study design and acceptability of a theoretically grounded, psycho-educational, web-based resource to reduce negative insulin appraisals among adults with T2D. METHODS: A double-blinded, parallel group, two-arm pilot RCT (1:1), comparing intervention with active control (existing online information about insulin). Eligible participants were Australian adults with T2D, taking oral diabetes medications. EXCLUSION CRITERIA: prior use of injectable medicines; being 'very willing' to commence insulin. Primary outcomes: study feasibility (recruitment ease, protocol fulfilment, attrition, data completeness); secondary outcomes: intervention acceptability (intervention engagement, user feedback) and likely efficacy (negative Insulin Treatment Appraisal Scale [ITAS] scores at follow-up). Online surveys completed at baseline and 2 weeks. RESULTS: During 4-week recruitment, 76 people expressed interest: 51 eligible and 35 enrolled (intervention = 17, control = 18; median[interquartile range] age = 62[53, 69] years; 17 women). Protocol fulfilment achieved by 26 (74%) participants (n = 13 per arm), with low participant attrition (n = 6, 17%). Intervention acceptability was high (>80% endorsement, except format preference = 60%). ITAS negative scores differed between-groups at follow-up (M diff = -6.5, 95% confidence interval: -10.7 to -2.4), favouring the intervention. CONCLUSIONS: This novel web-based resource ("Is insulin right for me?") is acceptable and associated with a likely reduction in negative insulin appraisals, relative to existing resources. This pilot shows the study design is feasible and supports conduct of a fully powered RCT.

'Is Insulin Right for Me?' Development of a theory-informed, web-based resource for reducing psychological barriers to insulin therapy in type 2 diabetes.

OBJECTIVE: To develop a theory and evidence-based web intervention to reduce psychological barriers towards insulin therapy among adults with non-insulin-treated type 2 diabetes (T2D). METHODS: Salient psychological barriers towards insulin were identified from the literature and classified using the Theoretical Domains Framework (TDF). Relevant TDF domains were mapped to evidence-based behaviour change techniques (BCTs), which informed the content for each barrier. Acceptability was explored using cognitive debriefing interviews (n=6 adults with T2D). RESULTS: 'Is Insulin Right for Me' addresses eight barriers, phrased as common questions: Does insulin mean my diabetes is more serious? Do insulin injections cause complications? Is it my fault I need to inject insulin? Will I gain weight? Will injecting hurt? What about hypos? Will injecting insulin be a burden? What will others think of me? BCTs, including persuasive communication and modelling/demonstration, were delivered using appropriate methods (eg, demonstration of the injection process). Participant suggestions for improvement included clear and direct messages, normalising insulin and avoiding confronting images. CONCLUSIONS: 'Is Insulin Right for Me' is the first theory and evidence-based, web intervention designed to reduce psychological barriers towards insulin therapy for adults with T2D. Evaluation is needed to determine its impact on negative appraisals and receptiveness towards insulin.

The CORE study-An adapted mental health experience codesign intervention to improve psychosocial recovery for people with severe mental illness: A stepped wedge cluster randomized-controlled trial.

BACKGROUND: Mental health policies outline the need for codesign of services and quality improvement in partnership with service users and staff (and sometimes carers), and yet, evidence of systematic implementation and the impacts on healthcare outcomes is limited. OBJECTIVE: The aim of this study was to test whether an adapted mental health experience codesign intervention to improve recovery-orientation of services led to greater psychosocial recovery outcomes for service users. DESIGN: A stepped wedge cluster randomized-controlled trial was conducted. SETTING AND PARTICIPANTS: Four Mental Health Community Support Services providers, 287 people living with severe mental illnesses, 61 carers and 120 staff were recruited across Victoria, Australia. MAIN OUTCOME MEASURES: The 24-item Revised Recovery Assessment Scale (RAS-R) measured individual psychosocial recovery. RESULTS: A total of 841 observations were completed with 287 service users. The intention-to-treat analysis found RAS-R scores to be similar between the intervention (mean = 84.7, SD= 15.6) and control (mean = 86.5, SD= 15.3) phases; the adjusted estimated difference in the mean RAS-R score was -1.70 (95% confidence interval: -3.81 to 0.40; p = .11). DISCUSSION: This first trial of an adapted mental health experience codesign intervention for psychosocial recovery outcomes found no difference between the intervention and control arms. CONCLUSIONS: More attention to the conditions that are required for eight essential mechanisms of change to support codesign processes and implementation is needed. PATIENT AND PUBLIC INVOLVEMENT: The State consumer (Victorian Mental Illness Awareness Council) and carer peak bodies (Tandem representing mental health carers) codeveloped the intervention. The adapted intervention was facilitated by coinvestigators with lived-experiences who were coauthors for the trial and process evaluation protocols, the engagement model and explanatory model of change for the trial.

Impact of quarterly professional-mode flash glucose monitoring in adults with type 2 diabetes in general practice (GP-OSMOTIC): Secondary psychological and self-care outcomes of a pragmatic, open-label, 12-month, randomised controlled trial.

AIMS: To investigate the impact of quarterly professional-mode flash glucose monitoring on psychological outcomes in adults with type 2 diabetes in primary care. METHODS: The GP-OSMOTIC trial randomised 299 adults with type 2 diabetes in 25 general practices to quarterly use of professional-mode flash glucose monitoring (sensor worn for 14 days; data discussed at clinic visit) or usual care. At baseline and 12 months, participants completed validated measures: general emotional well-being (WHO-5), diabetes-specific quality of life (DIDP), satisfaction with glucose monitoring (GME-Q), self-care activities (SDSCA) and perceived involvement in clinical care (PICS). Linear mixed-effects models examined between-group differences at 12 months. RESULTS: At 12 months, there were no clinically important between-arm differences in any secondary psychological or self-care outcomes. Per protocol analyses showed no clinically significant between-group differences. CONCLUSIONS: The GP-OSMOTIC intervention had no significant impact, at 12 months, on general emotional well-being, diabetes-specific quality of life or satisfaction with glucose monitoring, suggesting no added psychological burden. Lack of positive impact on self-reported self-care activities or perceived involvement in clinical care may warrant closer attention to the fidelity of intervention delivery, the context (e.g. the nature of clinician-patient interactions) and/or the sensitivity of the measures, as these will help plan future studies.

Women, clinician and IT staff perspectives on telehealth for enhanced gestational diabetes mellitus management in an Australian rural/regional setting.

INTRODUCTION: Women in rural and regional areas encounter challenges when accessing care for gestational diabetes mellitus (GDM). A telehealth initiative for GDM care in an urban setting demonstrated positive effects on achieving glycaemic targets without compromising quality of care, but consumer and health service staff perspectives have not been explored. This research aimed to identify the profiles of women accessing care for GDM in a large regional hospital with a rural catchment in Victoria, Australia as well as gain insight into the views of the women with GDM, clinicians and IT staff on the acceptability and feasibility of a GDM telehealth in this setting. METHODS: Clinical and demographic characteristics of women accessing the GDM service between October 2016 and October 2017 were audited. Semi-structured interviews were completed with nine patients, three clinical staff and two IT service staff. Quantitative and qualitative data were analysed descriptively and thematically, respectively. RESULTS: Telehealth was viewed favourably by women and staff, with many perceived benefits identified around mitigating challenges of accessing care, and service capacity and provision. Concerns were raised around potential costs incurred by women and health services in accessing telehealth initiatives. Staff highlighted that moderation of workloads and coordination of telehealth services would be essential to the success of a future telehealth initiative. CONCLUSION: This article contributes important knowledge around GDM care in rural and regional settings and the perspectives of women with GDM, clinicians and technical support staff. Women and health services staff consider telehealth a feasible and acceptable alternative to current GDM care and address many of the barriers and impacts of attending care in person. Perceived benefits to patients and health services need to be balanced against the concerns around the work and costs to deliver GDM telehealth services.

Managing Severe Chronic Breathlessness in Chronic Obstructive Pulmonary Disease Is Challenging for General Practitioners.

CONTEXT: Patients with advanced chronic obstructive pulmonary disease (COPD) can develop increasing breathlessness, which can persist despite optimal medical management-refractory breathlessness. Management can be challenging for all clinicians and requires a broad approach that includes optimization of disease directed therapies, non-pharmacological strategies to manage breathlessness and for some patients opioids. OBJECTIVES: To explore the approaches to breathlessness management and palliative care undertaken by Australian General Practitioners (GP) for patients with severe COPD and refractory breathlessness. METHODS: A case-vignette based survey was conducted with Australian GPs to determine their approaches to breathlessness management and palliative care in COPD. RESULTS: Of the 137 GPs, 66% recommended commencing an additional medication to manage refractory breathlessness. Thirty-eight GPs (28%) recommended opioids and 26 (19%) recommended guideline discordant treatments. Two-thirds of GPs had concerns regarding the use of opioids in COPD. Half (55%) of GPs were comfortable providing general palliative care to patients with COPD and 62 (45%) had referred patients with COPD to specialist palliative care services. Most respondents wanted further training to manage severe COPD and severe chronic breathlessness. CONCLUSION: Most GPs recognized and were willing to add specific treatments for severe chronic breathlessness. However, experience prescribing opioids for severe chronic breathlessness was low, with many practitioners holding significant concerns regarding adverse effects. Many GPs are uncomfortable offering a palliative approach to their COPD patients, yet these patients are not routinely referred to specialist palliative care services despite their immense needs. GPs therefore desire education and support to overcome these barriers.

Professional flash glucose monitoring and health service utilisation in type 2 diabetes: A secondary analysis of the GP-OSMOTIC study.

AIM: Professional flash glucose monitoring involves people with diabetes wearing a glucose monitor for up to two weeks, with the data downloaded by their health professional, and the information used to help guide treatment. This study describes if professional flash glucose monitoring was associated with a change in health services utilisation. METHODS: Administrative claims data from three data sources were linked to 288 participants from the GP-OSMOTIC study, a randomised controlled trial evaluating the use of professional flash glucose monitoring versus usual care in people with type 2 diabetes in primary care. Generalised linear models with the Poisson family specified and log link function were used to compare general practice consultations between the intervention and control groups at 0-6- and 6-12-month time points, with adjustment for baseline health services utilisation. RESULTS: GP consultations increased in the flash glucose monitoring group in the 6 months following initial flash glucose monitoring sensor application from a median (IQR) 6 (4,9) to 8 (5,11); (P < 0.001). Participants in the professional FGM group were 1.2 times (95 % CI 1.1-1.4 (P = 0.0014)) more likely at 6-12 months to have GP consultation visits. CONCLUSIONS: Administrative claims data identified changes in health services utilisation associated with professional flash glucose monitoring, despite minimal changes in glycaemic control.

Associations between multimorbidity and glycaemia (HbA1c) in people with type 2 diabetes: cross-sectional study in Australian general practice.

OBJECTIVES: To explore the prevalence of multimorbidity as well as individual and combinations of long-term conditions (LTCs) in people with type 2 diabetes (T2D) attending Australian general practice, using electronic health record (EHR) data. We also examine the association between multimorbidity condition count (total/concordant(T2D related)/discordant(unrelated)) and glycaemia (glycated haemoglobin, HbA1c). DESIGN: Cross-sectional study. SETTING: Australian general practice. PARTICIPANTS: 69 718 people with T2D with a general practice encounter between 2013 and 2015 captured in the MedicineInsight database (EHR Data from 557 general practices and >3.8 million Australian patients). PRIMARY AND SECONDARY OUTCOME MEASURES: Prevalence of multimorbidity, individual and combinations of LTCs. Multivariable linear regression models used to examine associations between multimorbidity counts and HbA1c (%). RESULTS: Mean (SD) age 66.42 (12.70) years, 46.1% female and mean (SD) HbA1c 7.1 (1.4)%. More than 90% of participants with T2D were living with multimorbidity. Discordant conditions were more prevalent (83.4%) than concordant conditions (69.9 %). The three most prevalent discordant conditions were: painful conditions (55.4%), dyspepsia (31.6%) and depression (22.8%). The three most prevalent concordant conditions were hypertension (61.4%), coronary heart disease (17.1%) and chronic kidney disease (8.5%). The three most common combinations of conditions were: painful conditions and hypertension (38.8%), painful conditions and dyspepsia (23.1%) and hypertension and dyspepsia (22.7%). We found no associations between any multimorbidity counts (total, concordant and discordant) or combinations and HbA1c. CONCLUSIONS: Multimorbidity was common in our cohort of people with T2D attending Australian general practice, but was not associated with glycaemia. Although we did not explore mortality in this study, our results suggest that the increased mortality in those with multimorbidity and T2D observed in other studies may not be linked to glycaemia. Interestingly, discordant conditions were more prevalent than concordant conditions with painful conditions being the second most common comorbidity. Better understanding of the implications of different patterns of multimorbidity in people with T2D will allow more effective tailored care.

Metabolic Score for Visceral Fat (METS-VF) Estimation - A Novel Cost-Effective Obesity Indicator for Visceral Adipose Tissue Estimation.

BACKGROUND: Visceral adipose tissue (VAT) assessment is limited in clinical practice due to expensive, time consuming and limited availability of MRI and DXA machines. We explored the utility of a recently developed Metabolic Score for Visceral Fat (METS-VF) to assess VAT in south Asian individuals with morbid obesity. PATIENTS AND METHODS: Individuals with BMI ≥35 kg/m2 aged between 30 and 60 years were randomly selected from a database of individuals with morbid obesity, attending a multi-disciplinary bariatric clinic in a tertiary care teaching hospital in southern India. Body composition was assessed by using a Hologic Discovery A dual-energy X-ray absorptiometry (DXA) machine. METS-VF was used to estimate VAT by using a previously published algorithm. RESULTS: The mean age and body mass index of the study subjects (N=350) were 38.2 years and 40.1 kg/m2. The MET-VF score performed satisfactorily (AUC of 0.78 (95% CI 0.72-0.85)) for predicting an increased visceral adipose tissue (VAT area ≥ 163 cm2) as detected by DXA. A METS-VF value of 7.3 was found to have a good sensitivity and reasonable specificity in predicting elevated VAT in this population. CONCLUSION: This is the first study to validate the utility of METS-VF as a surrogate measure of visceral adiposity in south Indian individuals with morbid obesity. Given the simplicity, easy availability, reliability and inexpensive nature of this obesity indicator, it may find its widespread use in lower middle-income countries.

The assertive cardiac care trial: A randomised controlled trial of a coproduced assertive cardiac care intervention to reduce absolute cardiovascular disease risk in people with severe mental illness in the primary care setting.

BACKGROUND: Cardiovascular disease (CVD) accounts for 40% of the excess mortality identified in people with severe mental illness (SMI). Modifiable CVD risk factors are higher and can be exacerbated by the cardiometabolic impact of psychotropic medications. People with SMI frequently attend primary care presenting a valuable opportunity for early identification, prevention and management of cardiovascular health. The ACCT Healthy Hearts Study will test a coproduced, nurse-led intervention delivered with general practitioners to reduce absolute CVD risk (ACVDR) at 12 months compared with an active control group. METHODS/DESIGN: ACCT is a two group (intervention/active control) individually randomised (1:1) controlled trial (RCT). Assessments will be completed baseline (pre-randomisation), 6 months, and 12 months. The primary outcome is 5-year ACVDR measured at 12 months. Secondary outcomes include 6-month ACVDR; and blood pressure, lipids, HbA1c, BMI, quality of life, physical activity, motivation to change health behaviour, medication adherence, alcohol use and hospitalisation at 6 and 12 months. Linear mixed-effects regression will estimate mean difference between groups for primary and secondary continuous outcomes. Economic cost-consequences analysis will be conducted using quality of life and health resource use information and routinely collected government health service use and medication data. A parallel process evaluation will investigate implementation of the intervention, uptake and outcomes. DISCUSSION: ACCT will deliver a coproduced and person-centred, guideline level cardiovascular primary care intervention to a high need population with SMI. If successful, the intervention could lead to the reduction of the mortality gap and increase opportunities for meaningful social and economic participation. Trial registration ANZCTR Trial number: ACTRN12619001112156.

Multimorbidity, glycaemic variability and time in target range in people with type 2 diabetes: A baseline analysis of the GP-OSMOTIC trial.

AIMS: To explore associations between multimorbidity condition counts (total; concordant (diabetes-related); discordant (unrelated to diabetes)) and glycaemia (HbA1c; glycaemic variability (GV); time in range (TIR)) using data from a randomised controlled trial examining effectiveness of continuous glucose monitoring (CGM) in people with type 2 diabetes (T2D). METHODS: Cross-sectional study: 279 people with T2D using baseline data from the General Practice Optimising Structured MOnitoring To Improve Clinical outcomes (GP-OSMOTIC) trial from 25 general practices in Australia. Number of long-term conditions (LTCs) in addition to T2D used to quantify total/concordant/discordant multimorbidity counts. GV (measured by coefficient of variation (CV)) and TIR derived from CGM data. Multivariable linear regression models used to examine associations between multimorbidity counts, HbA1c (%), GV and TIR. RESULTS: Mean (SD) age of participants 60.4 (9.9) years; 40.9% female. Multimorbidity was present in 89.2% of participants. Most prevalent comorbid LTCs: hypertension (57.4%), painful conditions (29.8%), coronary heart disease (22.6%) and depression (19.0%). No evidence of associations between multimorbidity counts, HbA1c, GV and TIR. CONCLUSIONS: While multimorbidity was common in this T2D cohort, it was not associated with HbA1c, CV or TIR. Future studies should explore factors other than glycaemia that contribute to the increased mortality observed in those with multimorbidity and T2D.

Guiding Glucose Management Discussions Among Adults With Type 2 Diabetes in General Practice: Development and Pretesting of a Clinical Decision Support Tool Prototype Embedded in an Electronic Medical Record.

BACKGROUND: Managing type 2 diabetes (T2D) requires progressive lifestyle changes and, sometimes, pharmacological treatment intensification. General practitioners (GPs) are integral to this process but can find pharmacological treatment intensification challenging because of the complexity of continually emerging treatment options. OBJECTIVE: This study aimed to use a co-design method to develop and pretest a clinical decision support (CDS) tool prototype (GlycASSIST) embedded within an electronic medical record, which uses evidence-based guidelines to provide GPs and people with T2D with recommendations for setting glycated hemoglobin (HbA1c) targets and intensifying treatment together in real time in consultations. METHODS: The literature on T2D-related CDS tools informed the initial GlycASSIST design. A two-part co-design method was then used. Initial feedback was sought via interviews and focus groups with clinicians (4 GPs, 5 endocrinologists, and 3 diabetes educators) and 6 people with T2D. Following refinements, 8 GPs participated in mock consultations in which they had access to GlycASSIST. Six people with T2D viewed a similar mock consultation. Participants provided feedback on the functionality of GlycASSIST and its role in supporting shared decision making (SDM) and treatment intensification. RESULTS: Clinicians and people with T2D believed that GlycASSIST could support SDM (although this was not always observed in the mock consultations) and individualized treatment intensification. They recommended that GlycASSIST includes less information while maintaining relevance and credibility and using graphs and colors to enhance visual appeal. Maintaining clinical autonomy was important to GPs, as they wanted the capacity to override GlycASSIST's recommendations when appropriate. Clinicians requested easier screen navigation and greater prescribing guidance and capabilities. CONCLUSIONS: GlycASSIST was perceived to achieve its purpose of facilitating treatment intensification and was acceptable to people with T2D and GPs. The GlycASSIST prototype is being refined based on these findings to prepare for quantitative evaluation.