Clinician Perspectives of Barriers and Enablers to Implementing the Mediterranean Dietary Pattern in Routine Care for Coronary Heart Disease and Type 2 Diabetes: A Qualitative Interview Study.

BACKGROUND: Practice guidelines for coronary heart disease and type 2 diabetes recommend promoting the Mediterranean dietary pattern (MDP), which improves cardiometabolic risk markers and may prevent disease progression and complications. It is unknown to what extent the MDP is recommended in routine care for patients with these conditions, particularly in multiethnic settings. OBJECTIVE: The study aim was to explore multidisciplinary health care professionals' perspectives on recommending the MDP in routine care for patients with coronary heart disease or type 2 diabetes and barriers and enablers to its implementation. DESIGN: A qualitative description design was employed, utilizing semistructured individual interviews to collect data. PARTICIPANTS AND SETTING: Fifty-seven clinicians (21 nurses, 19 doctors, 13 dietitians, and 4 physiotherapists) routinely managing relevant patients across hospital and community settings in a metropolitan health service in Australia participated in interviews between November 2019 and March 2020. STATISTICAL ANALYSIS PERFORMED: Interviews were audiorecorded, transcribed verbatim, and analyzed using thematic analysis. RESULTS: Four overarching themes were identified highlighting that the MDP was not routinely recommended: current dietary practices (all clinicians perceived they had a role in dietary care but prioritization varied. There was a legacy of single nutrient-based strategies and disease silos); clinician-centered barriers to recommending MDP (limited MDP knowledge and practice skills and variable understanding and acceptance of evidence supporting its use. This was related to lack of education and training about the diet and personal interest/experience); organizational culture and resources influence dietary care (MDP not embedded in service culture or current clinic tools and resources, with limited dietary knowledge exchange within and across multidisciplinary teams); and perceived patient-centered barriers to implementation of MDP (socioeconomic challenges in a multicultural setting, and a lack of belief in patient capabilities to improve diet adherence). CONCLUSIONS: Clinician and organizational factors, compounded by perceptions about patient acceptance, influence recommendations of the MDP for patients with coronary heart disease or type 2 diabetes. These factors should be addressed to improve translation of MDP evidence into practice.

Digital interventions to improve safety and quality of inpatient diabetes management: A systematic review.

IMPORTANCE: Diabetes is common amongst hospitalised patients and contributes to increased length of stay and poorer outcomes. Digital transformation, particularly the implementation of electronic medical records (EMRs), is rapidly occurring across the healthcare sector and provides an opportunity to improve the safety and quality of inpatient diabetes care. Alongside this revolution has been a considerable and ongoing evolution of digital interventions to optimise care of inpatients with diabetes including optimisation of EMRs, digital clinical decision support systems (CDSS) and solutions utilising data visibility to allow targeted patient review. OBJECTIVE: To systematically appraise the recent literature to determine which digitally-enabled interventions including EMR, CDSS and data visibility solutions improve the safety and quality of non-critical care inpatient diabetes management. METHODS: Pubmed, Embase and Cochrane databases were searched for suitable articles. Selected articles underwent quality assessment and analysis with results grouped by intervention type. RESULTS: 1202 articles were identified with 42 meeting inclusion criteria. Four key interventions were identified; computerised physician order entry (n = 4), clinician decision support systems (n = 21), EMR driven active case finding (data visibility solutions) and targeted patient review (n = 10) and multicomponent system interventions (n = 7). Studies reported on glucometric outcomes, evidence-based medication ordering including medication errors, and patient and user outcomes. An improvement in glucometric measures particularly mean blood glucose and proportion of target range blood glucose levels and rates of evidence-based insulin prescribing were consistently demonstrated. CONCLUSION: Digitally-enabled interventions utilised to improve quality and safety of inpatient diabetes care were heterogenous in design. The majority of studies across all intervention types reported positive effects for evidence-based prescribing and glucometric outcomes. There was less evidence for digital interventions reducing diabetes medication administration errors or impacting patient outcomes (length of stay).

Predicting Liver-Related Outcomes in People With Nonalcoholic Fatty Liver Disease: The Prognostic Value of Noninvasive Fibrosis Tests.

It remains unclear whether screening for advanced fibrosis in the community can identify the subgroup of people with nonalcoholic fatty liver disease (NAFLD) at higher risk for development of liver-related complications. We aimed to determine the prognostic value of baseline noninvasive fibrosis tests for predicting liver-related outcomes and mortality in patients with NAFLD from type 2 diabetes (T2D) clinics or primary care. Patients (n = 243) who were screened for NAFLD with advanced fibrosis by using NAFLD fibrosis score (NFS), fibrosis 4 score (FIB-4), enhanced liver fibrosis (ELF) test, and liver stiffness measurements (LSMs) were followed up for clinical outcomes by review of electronic medical records. During a median follow-up of 50 months, decompensated liver disease or primary liver cancer occurred in 6 of 35 (17.1%) patients with baseline LSM > 13 kPa, 1 of 17 (5.9%) patients with LSM 9.5-13 kPa, and in no patients with LSM < 9.5 kPa. No patient with low-risk NFS developed liver decompensation or liver-related mortality. Following repeat NFSs at the end of follow-up, all patients with a liver-related complication were in the high-risk NFS category. Patients who developed liver-related complications were also more likely to have baseline high-risk FIB-4 scores or ELF test ≥9.8 compared to patients who did not develop liver outcomes. Conclusion: Liver fibrosis risk stratification in non-hepatology settings can identify the subset of patients at risk of liver-related complications. Although the rate of development of a decompensation event or hepatocellular carcinoma was low (2.1% per year) in our patients with compensated cirrhosis (LSM > 13 kPa), these events are projected to lead to a substantial increase in NAFLD-related disease burden over the next decade due to the high prevalence of NAFLD in people with obesity and T2D.

Electronic consultations (eConsults): a proof of concept trial in Australia.

BACKGROUND: Electronic consultations (eConsults) allow general practitioners (GP) to seek the advice of a specialist via secure asynchronous digital communication. AIMS: To report the outcomes of a proof of concept (POC) trial of eConsults for patients with diabetes and endocrine disorders. METHODS: A prospective observational study conducted from November 2020 to May 2021. eConsults were provided by endocrinologists from the Princess Alexandra Hospital, Brisbane. The requests for advice were from GP in Brisbane South. An online questionnaire was completed by the GP and endocrinologist after each eConsult. RESULTS: Forty eConsults were performed over 7 months. The majority were in relation to type 2 diabetes (30%) or thyroid conditions (30%). All eConsult responses were performed within the target of 72 h with 92.5% responses provided within 24 h. The average time taken for the endocrinologist to perform the eConsult was 14.2 ± 4.4 min. The GP rated the value of eConsults as excellent 97% of the time. The eConsult resulted in a new or additional course of action 68% (19/28) of the time and confirmed a course of action 32% (9/28) of the time. The eConsult avoided the need for referral of the patient for a face-to-face specialist review in 55% of the eConsults. CONCLUSION: An eConsult service was able to be delivered by endocrinologists from a tertiary hospital to GP in Brisbane South. With an appropriate funding model, the broader implementation and adoption of eConsults has the potential to address specialist waiting lists and facilitate models of integrated care.

CoMET: a randomised controlled trial of co-commencement of metformin versus placebo as an adjunctive treatment to attenuate weight gain in patients with schizophrenia newly commenced on clozapine.

BACKGROUND: There is limited evidence on interventions to minimise weight gain at clozapine commencement. We compared the effect of adjunctive metformin versus placebo at clozapine initiation. METHODS: People with schizophrenia commencing on clozapine were randomised to either metformin or placebo for 24 weeks. The primary outcome was difference in the change of body weight. Secondary outcomes included comparative rates of weight gain of more than 5%, overall weight gain/loss, and differences in metabolic and psychosis outcomes. RESULTS: The study was closed prematurely in March 2020 due to COVID-19 restrictions. Ten participants were randomised to each of the metformin and placebo groups. Eight metformin group and five placebo group participants completed the trial and were included in the analysis. The study was insufficiently powered to detect difference between the metformin and placebo groups for the primary outcome of change in weight (0.09 kg vs 2.88 kg, p = 0.231). In terms of secondary outcomes, people in the metformin group were significantly less likely to gain >5% of their body weight (12.5% vs 80%, p = 0.015) and were more likely to lose weight (37.5% vs 0% p = 0.024) compared to placebo. There was no difference between the groups in terms of adverse drug reactions (ADRs). CONCLUSION: While limited by the forced premature closure of the trial due to COVID19, the findings from this randomised controlled trial are promising. Clozapine and metformin co-commencement may be a promising treatment to prevent clozapine-associated weight gain, especially given the low rates of ADRs associated with metformin. This supports the consideration of use of metformin to prevent weight gain in people initiated on clozapine; however, further studies are needed to confirm this finding. TRIAL REGISTRATION: ACTRN12617001547336.

Toilet Paper, Minced Meat and Diabetes Medicines: Australian Panic Buying Induced by COVID-19.

The COVID-19 pandemic has impacted the management of non-communicable diseases in health systems around the world. This study aimed to understand the impact of COVID-19 on diabetes medicines dispensed in Australia. Publicly available data from Australia's government subsidised medicines program (Pharmaceutical Benefits Scheme), detailing prescriptions by month dispensed to patients, drug item code and patient category, was obtained from January 2016 to November 2020. This study focused on medicines used in diabetes care (Anatomical Therapeutical Chemical code level 2 = A10). Number of prescriptions dispensed were plotted by month at a total level, by insulins and non-insulins, and by patient category (general, concessional). Total number of prescriptions dispensed between January and November of each year were compared. A peak in prescriptions dispensed in March 2020 was identified, an increase of 35% on March 2019, compared to average growth of 7.2% in previous years. Prescriptions dispensed subsequently fell in April and May 2020 to levels below the corresponding months in 2019. These trends were observed across insulins, non-insulins, general and concessional patient categories. The peak and subsequent dip in demand have resulted in a small unexpected overall increase for the period January to November 2020, compared to declining growth for the same months in prior years. The observed change in consumer behaviour prompted by COVID-19 and the resulting public health measures is important to understand in order to improve management of medicines supply during potential future waves of COVID-19 and other pandemics.

Community-based integrated care versus hospital outpatient care for managing patients with complex type 2 diabetes: costing analysis.

Objective This study compared the cost of an integrated primary-secondary care general practitioner (GP)-based Beacon model with usual care at hospital outpatient departments (OPDs) for patients with complex type 2 diabetes. Methods A costing analysis was completed alongside a non-inferiority randomised control trial. Costs were calculated using information from accounting data and interviews with clinic managers. Two OPDs and three GP-based Beacon practices participated. In the Beacon practices, GPs with a special interest in advanced diabetes care worked with an endocrinologist and diabetes nurse educator to care for referred patients. The main outcome was incremental cost saving per patient course of treatment from a health system perspective. Uncertainty was characterised with probabilistic sensitivity analysis using Monte Carlo simulation. Results The Beacon model is cost saving: the incremental cost saving per patient was A$365 (95% confidence interval -A$901, A$55) and was cost saving in 93.7% of simulations. The key contributors to the variance in the cost saving per patient course of treatment were the mean number of patients seen per site and the number of additional presentations per course of treatment associated with the Beacon model. Conclusions Beacon clinics were less costly per patient course of treatment than usual care in hospital OPDs for equivalent clinical outcomes. Local contractual arrangements and potential variation in the operational cost structure are of significant consideration in determining the cost-efficiency of Beacon models. What is known about this topic? Despite the growing importance of achieving care quality within constrained budgets, there are few costing studies comparing clinically-equivalent hospital and community-based care models. What does this paper add? Costing analyses comparing hospital-based to GP-based health services require considerable effort and are complex. We show that GP-based Beacon clinics for patients with complex chronic disease can be less costly per patient course of treatment than usual care offered in hospital OPDs. What are the implications for practitioners? In addition to improving access and convenience for patients, transferring care from hospital to the community can reduce health system costs.

An Experimental Series Investigating the Effects of Hyperinsulinemic Euglycemia on Myocardial Blood Flow Reserve in Healthy Individuals and on Myocardial Perfusion Defect Size following ST-Segment Elevation Myocardial Infarction.

BACKGROUND: Incomplete restoration of myocardial blood flow (MBF) is reported in up to 30% of ST-segment elevation myocardial infarction (STEMI) despite prompt mechanical revascularization. Experimental hyperinsulinemic euglycemia (HE) increases MBF reserve (MBFR). If fully exploited, this effect may also improve MBF to ischemic myocardium. Using insulin-dextrose infusions to induce HE, we conducted four experiments to determine (1) how insulin infusion duration, dose, and presence of insulin resistance affect MBFR response; and (2) the effect of an insulin-dextrose infusion given immediately following revascularization of STEMI on myocardial perfusion. METHODS: The MBFR was determined using myocardial contrast echocardiography. Experiment 1 (insulin duration): 12 participants received an insulin-dextrose or saline infusion for 120 minutes. MBFR was measured at four time intervals during infusion. Experiment 2 (insulin dose): 22 participants received one of three insulin doses (0.5, 1.5, 3.0 mU/kg/minute) for 60 minutes. Baseline and 60-minute MBFRs were determined. Experiment 3 (insulin resistance): five metabolic syndrome and six type 2 diabetes (T2DM) participants received 1.5 mU/kg/minute of insulin-dextrose for 60 minutes. Baseline and 60-minute MBFRs were determined. Experiment 4 (STEMI): following revascularization for STEMI, 20 patients were randomized to receive either 1.5 mU/kg/minute insulin-dextrose infusion for 120 minutes or standard care. Myocardial contrast echocardiography was performed at four time intervals to quantify percentage contrast defect length. RESULTS: Experiment 1: MBFR increased with time through to 120 minutes in the insulin-dextrose group and did not change in controls. Experiment 2: compared with baseline, MBFR increased in the 1.5 (2.42 ± 0.39 to 3.25 ± 0.77, P = .002), did not change in the 0.5, and decreased in the 3.0 (2.64 ± 0.25 to 2.16 ± 0.33, P = .02) mU/kg/minute groups. Experiment 3: compared with baseline, MBFR increase was only borderline significant in metabolic syndrome and T2DM participants (1.98 ± 0.33 to 2.59 ± 0.45, P = .04, and 1.67 ± 0.35 to 2.14 ± 0.21, P = .05). Experiment 4: baseline percentage contrast defect length was similar in both groups but with insulin decreased with time and was significantly lower than in controls at 60 minutes (2.8 ± 5.7 vs 13.7 ± 10.6, P = .02). CONCLUSIONS: Presence of T2DM, insulin infusion duration, and dose are important determinants of the MBFR response to HE. When given immediately following revascularization for STEMI, insulin-dextrose reduces perfusion defect size at one hour. Hyperinsulinemic euglycemia may improve MBF following ischemia, but further studies are needed to clarify this.

Urea treatment in fluid restriction-refractory hyponatraemia.

OBJECTIVE: Hyponatraemia in hospitalized patients is common and associated with increased mortality. International guidelines give conflicting advice regarding the role of urea in the treatment of SIADH. We hypothesized that urea is a safe, effective treatment for fluid restriction-refractory hyponatraemia. DESIGN: Review of urea for the treatment of hyponatraemia in patients admitted to a tertiary hospital during 2016-2017. Primary end-point: proportion of patients achieving a serum sodium ≥130 mmol/L at 72 hours. PATIENTS: Urea was used on 78 occasions in 69 patients. The median age was 67 (IQR 52-76), 41% were female. Seventy (89.7%) had hyponatraemia due to SIADH-CNS pathology (64.3%) was the most common cause. The duration was acute in 32 (41%), chronic in 35 (44.9%) and unknown in the rest. RESULTS: The median nadir serum sodium was 122 mmol/L (IQR 118-126). Fluid restriction was first-line treatment in 65.4%. Urea was used first line in 21.8% and second line in 78.2%. Fifty treatment episodes (64.1%) resulted in serum sodium ≥130 mmol/L at 72 hours. In 56 patients who received other prior treatment, the mean sodium change at 72 hours (6.9 ± 4.8 mmol/L) was greater than with the preceding treatments (-1.0 ± 4.7 mmol/L; P < 0.001). Seventeen patients (22.7%) had side effects (principally distaste), none were severe. No patients developed hypernatraemia, overcorrection (>10 mmol/L in 24 hours or >18 mmol/L in 48 hours), or died. CONCLUSIONS: Urea is safe and effective in fluid restriction-refractory hyponatraemia. We recommend urea with a starting dose of ≥30 g/d, in patients with SIADH and moderate to profound hyponatraemia who are unable to undergo, or have failed fluid restriction.

Clinical outcomes of an integrated primary-secondary model of care for individuals with complex type 2 diabetes: a non-inferiority randomised controlled trial.

AIMS/HYPOTHESIS: The aim of the study was to determine if a Beacon model of integrated care utilising general practitioners (GPs) with special interests could achieve similar clinical outcomes to a hospital-based specialist diabetes outpatient clinic. METHODS: This pragmatic non-inferiority multisite randomised controlled trial assigned individuals with complex type 2 diabetes to care delivered by a Beacon clinic or to usual care delivered by a hospital outpatient department, in a 3:1 ratio. Owing to the nature of the study, researchers were only blinded during the allocation process. Eligible participants were aged 18 or over, had been referred by their usual GP to the hospital central referral hub with type 2 diabetes and had been triaged to be seen within 30 or 90 days. The intervention consisted of diabetes management in primary care by GPs with a special interest who had been upskilled in complex diabetes under the supervision of an endocrinologist. The primary outcome was HbA1c at 12 months post-recruitment. The non-inferiority margin was 4.4 mmol/mol (0.4%). Both per-protocol and intention-to-treat analyses are reported. RESULTS: Between 27 November 2012 and 14 July 2015, 352 individuals were recruited and 305 comprised the intention-to-treat sample (71 in usual care group and 234 in the Beacon model group). The Beacon model was non-inferior to usual care for both the per-protocol (difference -0.38 mmol/mol [95% CI -4.72, 3.96]; -0.03% [95% CI -0.43, 0.36]) and the intention-to-treat (difference -1.28 mmol/mol [95% CI -5.96, 3.40]; -0.12% [95% CI -0.55, 0.31]) analyses. Non-inferiority was sustained in a sensitivity analysis at 12 months. There were no statistically or clinically significant differences in the secondary outcomes of BP, lipids or quality of life as measured by the 12 item short-form health survey (SF-12v2) and the diabetes-related quality of life (DQoL-Brief) survey. Safety indicators did not differ between groups. Participant satisfaction on the eight-item client satisfaction questionnaire (CSQ-8) was good in both groups, but scores were significantly higher in the Beacon model group than the usual care group (mean [SD] 28.4 [4.9] vs 25.6 [4.9], respectively, p < 0.001). CONCLUSIONS/INTERPRETATION: In individuals with type 2 diabetes, a model of integrated care delivered in the community by GPs with a special interest can safely achieve clinical outcomes that are not inferior to those achieved with gold-standard hospital-based specialist outpatient clinics. Individuals receiving care in the community had greater satisfaction. Further studies will determine the cost of delivering this model of care. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12612000380897 FUNDING: The study was funded by the Australian National Health and Medical Research Council (GNT1001157).

Glucagon-like peptide-1 receptor agonists for antipsychotic-associated cardio-metabolic risk factors: A systematic review and individual participant data meta-analysis.

AIMS: To evaluate if glucagon-like peptide-1 receptor agonists (GLP-1RAs) reduce antipsychotic-associated body weight gain in patients with schizophrenia, when compared to controls. MATERIALS AND METHODS: We systematically searched PubMed/EMBASE/PsycINFO/Cochrane using the search terms '(antipsychotic and GLP-1RA)'. Individual participant data from studies randomizing patients to GLP-1RA or control were meta-analysed. The primary outcome was difference in body weight between GLP-1RA and control; secondary outcomes included cardio-metabolic variables and adverse drug reactions (ADRs). Multiple linear regression was conducted including sex, age, psychosis severity, metabolic variable, ADRs, and GLP-1RA agent. RESULTS: Three studies (exenatide once-weekly = 2; liraglutide once-daily = 1) provided participant-level data (n = 164, age = 40.0 ± 11.1 years, body weight = 105.8 ± 20.8 kg). After 16.2 ± 4.0 weeks of treatment, body weight loss was 3.71 kg (95% CI = 2.44-4.99 kg) greater for GLP-1RA versus control (p < 0.001), number-needed-to-treat ≥5% body weight loss = 3.8 (95% CI = 2.6-7.2). Waist circumference, body mass index, HbA1c, fasting glucose and visceral adiposity were each significantly lower with GLP-1RA. Sex, age, psychosis severity, nausea, any ADR, and GLP-1RA agent did not significantly impact outcomes. Body weight loss with GLP-1RAs was greater for clozapine/olanzapine-treated patients (n = 141) than other antipsychotics (n = 27) (4.70 kg, 95% CI = 3.13-6.27 vs. 1.5 kg, 95% CI = -1.47-4.47) (p < 0.001). Nausea was more common with GLP-1RAs than control (53.6% vs. 27.5%, p = 0.002, number-needed-to-harm = 3.8). CONCLUSION: GLP-1RAs are effective and tolerable for antipsychotic-associated body weight gain, particularly clozapine/olanzapine-treated patients. With few included patients, further studies are required before making routine use recommendations for GLP-1RAs.

Treatment of clozapine-associated obesity and diabetes with exenatide in adults with schizophrenia: A randomized controlled trial (CODEX).

Clozapine causes obesity and type 2 diabetes (T2DM). Glucagon-like peptide-1 (GLP-1) receptor agonists (e.g. exenatide) can counter clozapine-associated GLP-1 dysregulation in animals, and may be beneficial in people on clozapine. This randomized, controlled, open-label, pilot trial evaluated weekly exenatide for weight loss among clozapine-treated obese adults with schizophrenia, with or without T2DM. A total of 28 outpatients were randomized to once-weekly extended-release subcutaneous exenatide or usual care for 24 weeks. The primary outcome was proportion of participants with >5% weight loss. All 28 participants completed the study; 3/14 in the exenatide group and 2/14 in the usual care group had T2DM. Six people on exenatide achieved >5% weight loss vs one receiving usual care (P = .029). Compared with usual care, participants on exenatide had greater mean weight loss (-5.29 vs -1.12 kg; P = .015) and body mass index reduction (-1.78 vs -0.39 kg/m2 ; P = .019), and reduced fasting glucose (-0.34 vs 0.39 mmol/L; P = .036) and glycated haemoglobin levels (-0.21% vs 0.03%; P = .004). There were no significant differences in other metabolic syndrome components. Exenatide may be a promising therapeutic agent for glycaemic control and weight loss in clozapine-treated people with obesity, and could assist in reducing clozapine-associated cardio-metabolic morbidity and mortality.

Underappreciation of non-alcoholic fatty liver disease by primary care clinicians: limited awareness of surrogate markers of fibrosis.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is a common cause of incidental liver test abnormalities. General practitioners (GP) have a key role in identifying people with NAFLD at risk of significant liver disease. Recent specialist guidelines emphasise the use of fibrosis algorithms or serum biomarkers rather than routine liver tests, to assess advanced fibrosis. AIM: To evaluate primary care clinicians' current approach to diagnosis, management and referral of NAFLD. METHODS: A cross-sectional survey of primary care clinicians was undertaken through a structured questionnaire about NAFLD. A convenience sample of general practice clinics and general practice conferences in Metropolitan Brisbane and regional south east Queensland was selected. RESULTS: A total of 108 primary care clinicians completed the survey (participation rate 100%). Fifty-one percent of respondents considered the prevalence of NAFLD in the general population to be ≤10%. Twenty-four percent of respondents felt that liver enzymes were sufficiently sensitive to detect underlying NAFLD. Most respondents were unsure whether the Fibrosis 4 score (62.7% unsure) or Enhanced Liver Fibrosis score (63.7% unsure) could help to identify advanced fibrosis or cirrhosis. Although 47% of respondents said they would refer a patient to a Gastroenterologist/Hepatologist if they suspect the patient has NAFLD, 44.1% do not make any referrals. Of concern, 70.6% of clinicians said they were unlikely to refer a patient to Hepatology unless liver function tests are abnormal. CONCLUSION: Our findings demonstrate that many primary care clinicians underestimate the prevalence of NAFLD and under-recognise the clinical spectrum of NAFLD and how this is assessed.

Ophthalmic and clinical factors that predict four-year development and worsening of diabetic retinopathy in type 1 diabetes.

AIMS: To investigate the role of ophthalmic imaging markers - namely retinal thickness measures and corneal nerve morphology - in predicting four-year development and worsening of diabetic retinopathy (DR) in type 1 diabetes (T1DM). METHODS: 126 eyes of 126 participants with T1DM were examined at baseline and after four years. Diabetic retinopathy (DR) was graded using the Early Treatment Diabetic Retinopathy Study scale. HbA1c, nephropathy, neuropathy, cardiovascular factors, and retinal thickness using optical coherence tomography (OCT) and corneal nerve fiber length (CNFL) using corneal confocal microscopy at baseline were assessed by univariate and step-wise multiple logistic regression, and their diagnostic capabilities for single and combined measures. RESULTS: Four-year development of DR was 19% (13 of 68 without DR at baseline). Worsening of DR was seen in 43% (25 of 58 with DR at baseline). When adjusted for potential confounders, a lower CNFL (AUC=0.637, p=0.040, 64% sensitivity and 64% specificity at 14.9mm/mm2 cut-off), higher triglycerides (AUC=0.669, p=0.012, 64% sensitivity, 62% specificity at 0.85mmol/L) and an elevated vibration threshold (AUC=0.708, p=0.002, 96% sensitivity, 40% specificity at 3.55Hz) were significant predictors for four-year worsening of DR. CONCLUSIONS: Reduced CNFL, elevated vibration perception threshold and higher triglycerides can predict future worsening of DR.

User Experience of an Innovative Mobile Health Program to Assist in Insulin Dose Adjustment: Outcomes of a Proof-Of-Concept Trial.

BACKGROUND: Many patients with diabetes require insulin therapy to achieve optimal glycemic control. Initiation and titration of insulin often require an insulin dose adjustment (IDA) program, involving frequent exchange of blood glucose levels (BGLs) and insulin prescription advice between the patient and healthcare team. This process is time consuming with logistical barriers. OBJECTIVE: To develop an innovative mobile health (m-Health) mobile-based IDA program (mIDA) and evaluate the user adherence and experience through a proof-of-concept trial. METHODS: In the program, an m-Health system was designed to be integrated within a clinical IDA service, comprising a Bluetooth-enabled glucose meter, smartphone application, and clinician portal. Insulin-requiring patients with type-2 diabetes mellitus and stable BGL were recruited to use the m-Health system to record and exchange BGL entries, insulin dosages, and clinical messages for 2 weeks. The user experience was evaluated by a Likert scale questionnaire. RESULTS: Nine participants, aged 58 ± 14 years (mean ± SD), completed the trial with average daily records of 3.1 BGL entries and 1.2 insulin dosage entries. The participants recognized the potential value of the clinical messages. They felt confident about managing their diabetes and were positive regarding ease of use and family support of the system, but disagreed that there were no technical issues. Finally, they were satisfied with the program and would continue to use it if possible. CONCLUSIONS: The m-Health system for IDA showed promising levels of adherence, usability, perception of usefulness, and satisfaction. Further research is required to assess the feasibility and cost-effectiveness of using this system in outpatient settings.

Establishing a new model of integrated primary and secondary care based around general practice: a case study of lessons learned and challenges.

This case study describes the development and implementation of an innovative integrated primary-secondary model of care for people with complex diabetes. The aim of the paper is to present the experiences of clinicians and researchers involved in implementing the 'Beacon' model by providing a discussion of the contextual factors, including lessons learned, challenges and solutions. Beacon-type models of community care for people with chronic disease are well placed to deliver on Australia's health care reform agenda, and this commentary provides rich contextual information relevant to the translation of such models into policy and practice.

Alcohol Consumption in Diabetic Patients with Nonalcoholic Fatty Liver Disease.

AIM: To examine the association between lifetime alcohol consumption and significant liver disease in type 2 diabetic patients with NAFLD. METHODS: A cross-sectional study assessing 151 patients with NAFLD at risk of clinically significant liver disease. NAFLD fibrosis severity was classified by transient elastography; liver stiffness measurements ≥8.2 kPa defined significant fibrosis. Lifetime drinking history classified patients into nondrinkers, light drinkers (always ≤20 g/day), and moderate drinkers (any period with intake >20 g/day). RESULT: Compared with lifetime nondrinkers, light and moderate drinkers were more likely to be male (p = 0.008) and to be Caucasian (p = 0.007) and to have a history of cigarette smoking (p = 0.000), obstructive sleep apnea (p = 0.003), and self-reported depression (p = 0.003). Moderate drinkers required ≥3 hypoglycemic agents to maintain diabetic control (p = 0.041) and fibrate medication to lower blood triglyceride levels (p = 0.044). Compared to lifetime nondrinkers, light drinkers had 1.79 (95% CI: 0.67-4.82; p = 0.247) and moderate drinkers had 0.91 (95% CI: 0.27-3.10; p = 0.881) times the odds of having liver stiffness measurements ≥8.2 kPa (adjusted for age, gender, and body mass index). CONCLUSIONS: In diabetic patients with NAFLD, light or moderate lifetime alcohol consumption was not significantly associated with liver fibrosis. The impact of lifetime alcohol intake on fibrosis progression and diabetic comorbidities, in particular obstructive sleep apnea and hypertriglyceridemia, requires further investigation.

Corneal and Retinal Neuronal Degeneration in Early Stages of Diabetic Retinopathy.

Purpose: To examine the neuronal structural integrity of cornea and retina as markers for neuronal degeneration in nonproliferative diabetic retinopathy (NPDR). Methods: Participants were recruited from the broader Brisbane community, Queensland, Australia. Two hundred forty-one participants (187 with diabetes and 54 nondiabetic controls) were examined. Diabetic retinopathy (DR) was graded according to the Early Treatment Diabetic Retinopathy Study (ETDRS) scale. Corneal nerve fiber length (CNFL), corneal nerve branch density (CNBD), corneal nerve fiber tortuosity (CNFT), full retinal thickness, retinal nerve fiber layer (RNFL), ganglion cell complex (GCC), focal (FLV) and global loss volumes (GLV), hemoglobin A1c (HbA1c), nephropathy, neuropathy, and cardiovascular measures were examined. Results: The central zone (P = 0.174), parafoveal thickness (P = 0.090), perifovea (P = 0.592), RNFL (P = 0.866), GCC (P = 0.798), and GCC GLV (P = 0.338) did not differ significantly between the groups. In comparison to the control group, those with very mild NPDR and those with mild NPDR had significantly higher focal loss in GCC volume (P = 0.036). CNFL was significantly lower in those with mild NPDR (P = 0.004) in comparison to the control group and those with no DR. The CNBD (P = 0.094) and CNFT (P = 0.458) did not differ between the groups. Conclusions: Both corneal and retinal neuronal degeneration may occur in early stages of diabetic retinopathy. Further studies are required to examine these potential markers for neuronal degeneration in the absence of clinical signs of DR.

Diagnostic capability of retinal thickness measures in diabetic peripheral neuropathy / Capacidad diagnóstica de las mediciones del grosor de la retina en la neuropatía periférica diabética

Purpose: To examine the diagnostic capability of the full retinal and inner retinal thickness measures in differentiating individuals with diabetic peripheral neuropathy (DPN) from those without neuropathy and non-diabetic controls. Methods: Individuals with (n=44) and without (n=107) diabetic neuropathy and non-diabetic control (n=42) participants underwent spectral domain optical coherence tomography (SDOCT). Retinal thickness in the central 1mm zone (including the fovea), parafovea and perifovea was assessed in addition to ganglion cell complex (GCC) global loss volume (GCC GLV) and focal loss volume (GCC FLV), and retinal nerve fiber layer (RNFL) thickness. Diabetic neuropathy was defined using a modified neuropathy disability score (NDS) recorded on a 0-10 scale, wherein, NDS ≥3 indicated neuropathy and NDS indicated <3 no neuropathy. Diagnostic performance was assessed by areas under the receiver operating characteristic curves (AUCs), 95 per cent confidence intervals (CI), sensitivities at fixed specificities, positive likelihood ratio (+LR), negative likelihood ratio (-LR) and the cut-off points for the best AUCs obtained. Results: The AUC for GCC FLV was 0.732 (95% CI: 0.624-0.840, p<0.001) with a sensitivity of 53% and specificity of 80% for differentiating DPN from controls. Evaluation of the LRs showed that GCC FLV was associated with only small effects on the post-test probability of the disease. The cut-off point calculated using the Youden index was 0.48% (67% sensitivity and 73% specificity) for GCC FLV. For distinguishing those with neuropathy from those without neuropathy, the AUCs of retinal parameters ranged from 0.508 for the central zone to 0.690 for the inferior RNFL thickness. For distinguishing those with moderate or advanced neuropathy from those with mild or no neuropathy, the inferior RNFL thickness demonstrated the highest AUC of 0.820, (95% CI: 0.731-0.909, p<0.001) with a sensitivity of 69% and 80% specificity. The cut-off-point for the inferior RNFL thickness was 97μm, with 81% sensitivity and 72% specificity. Conclusions: The GCC FLV can differentiate individuals with diabetic neuropathy from healthy controls, while the inferior RNFL thickness is able to differentiate those with greater degrees of neuropathy from those with mild or no neuropathy, both with an acceptable level of accuracy. Optical coherence tomography represents a non-invasive technology that aids in detection of retinal structural changes in patients with established diabetic neuropathy. Further refinement of the technique and the analytical approaches may be required to identify patients with minimal neuropathy (AU)

Objetivo: Examinar la capacidad diagnóstica de las mediciones del grosor total e interno de la retina, con diferenciación entre individuos con neuropatía periférica diabética (DPN), aquellos que no la padecen, y controles no diabéticos. Métodos: Cuarenta y cuatro individuos con (n=44) y sin (n=107) neuropatía diabética y participantes de control no diabéticos (n=42) fueron sometidos a una tomografía de coherencia óptica de dominio espectral (SDOCT). Se evaluó el grosor de la retina en la zona central de 1mm (incluyendo la fóvea), parafóvea y perifóvea, además del complejo de células ganglionares (GCC), el volumen de pérdida global (GCC GLV) y el volumen de pérdida focal (GCC FLV), y el espesor de la capa de fibras nerviosas de la retina (RNFL). Se definió la neuropatía diabética utilizando la versión modificada del «Neuropathy Disability Score (NDS)», sobre una escala de 0 a 10, donde el valor de NDS ≥3 indicaba neuropatía y NDS <3 ausencia de la misma. El desempeño diagnóstico se evaluó mediante las áreas bajo las curvas características operativas del receptor (AUC), intervalos de confianza del 95% (IC), sensibilidades a especificidades fijas, cociente de probabilidad positiva (CP+), y cociente de probabilidad negativa (CP-) y los puntos de corte para los mejores AUC obtenidos. Resultados: El AUC para GCC FLV fue de 0,732, 95% IC: 0,624-0,840, p<0,001 con una sensibilidad del 53% y una especificidad del 80% para la diferenciación entre DPN y los controles. La evaluación de los CP reflejó que el GCC FLV se asociaba únicamente a unos pequeños efectos en la prueba posterior de probabilidad de la enfermedad. El punto de corte calculado utilizando el índice de Youden fue del 0,48% (67% de sensibilidad y 73% de especificidad) para GCC FLV. Para distinguir a aquellos individuos con neuropatía de los que no la padecían, las AUC de los parámetros retinianos oscilaron entre 0,508 para el grosor RNFL de la zona central y 0,690 para el de la zona inferior. Para distinguir a aquellas personas con neuropatía moderada o avanzada, de aquellas con neuropatía leve, o ausencia de ella, el grosor RNFL de la zona inferior reflejó una AUC superior de 0,820, 95% IC: 0,731-0,909, p<0,001, con una sensibilidad del 69% y una especificidad del 80%. El punto de corte para el grosor RNFL inferior fue de 97μm, con un 81% de sensibilidad y un 72% de especificidad. Conclusiones: El GCC FLV puede diferenciar entre aquellos individuos con neuropatía diabética y los controles sanos, mientras que el grosor RNFL de la zona inferior es capaz de diferenciar entre aquellas personas con grados superiores de neuropatía y aquellas con neuropatía leve o ausencia de neuropatía, en ambos casos con un nivel aceptable de precisión. La tomografía de coherencia óptica supone una tecnología no invasiva que ayuda a la detección de los cambios estructurales retinianos en pacientes con neuropatía diabética establecida. Se precisa un mayor refinamiento de esta técnica, así como enfoques analíticos, para identificar a aquellos pacientes con una neuropatía mínima (AU)

A comparison of characteristics of patients seen in a tertiary hospital diabetes telehealth service versus specialist face-to-face outpatients.

This study aimed to describe patient-related characteristics of those attending the diabetes telehealth service delivered from a tertiary hospital and compare these with the characteristics of patients attending face-to-face visits at the same hospital's diabetes outpatient service. This analysis could inform diabetes telehealth service improvements. To our knowledge, there has been no prior evaluation of a diabetes telehealth service in Australia. A cross-sectional survey was conducted as part of the Australian National Diabetes Audit in May 2016 for all patients attending the diabetes telehealth service and diabetes outpatient service. The diabetes telehealth service was serving a greater proportion of females, indigenous people and patients with a longer mean duration of type 2 diabetes mellitus. Type 2 diabetes mellitus patients in the diabetes telehealth service group had a higher average glycated haemoglobin of 9.1% (76 mmol/mol) vs 8.1% (65 mmol/mol) in the diabetes outpatient service group. The diabetes telehealth service had more people with initial visits; had higher self-reported smoking rates in type 2 diabetes mellitus patients; and had adequate access to allied health supports as recommended for diabetes management. Diabetes telehealth service patients had more complex diabetes as evidenced by a higher proportion of indigenous clients, higher glycated haemoglobin and longer mean duration of diabetes.