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Aim: To report the first study of temelimab, a monoclonal antibody neutralizing the pathogenic human endogenous retrovirus type W envelope, in patients with type 1 diabetes (T1D). Materials and Methods: This double-blind, placebo-controlled, randomized clinical trial recruited adult patients with T1D within 4 years postdiagnosis and remaining C-peptide secretion. Sixty-four patients were randomized (2:1) to monthly temelimab 6 mg/kg or placebo during 24 weeks, followed by a 24-week, open-label extension, during which all patients received temelimab. The primary objective was the safety and tolerability of temelimab. The secondary objective was to assess the pharmacodynamics response such as C-peptide levels, insulin use, HbA1c, hypoglycaemia and autoantibodies. Results: Temelimab was well tolerated without any group difference in the frequency or severity of adverse events. Concerning exploratory endpoints, there was no difference in the levels of C-peptide, insulin use or HbA1c between treatment groups at weeks 24 and 48. The frequency of hypoglycaemia events was reduced with temelimab (P = 0.0004) at week 24 and the level of anti-insulin antibodies was lower with temelimab (P < 0.01); the other autoantibodies did not differ between groups. Conclusions: Temelimab appeared safe in patients with T1D. Pharmacodynamics signals (hypoglycaemia and anti-insulin antibodies) under temelimab were observed. Markers of β-cell functions were not modified by treatment. These results need to be further explored in younger patients with T1D with earlier disease onset.

To examine if there is an association between a low-carbohydrate diet (LCD), glycemic control, and quality of life (QoL) in Australian adults with type 1 diabetes.This single-group, pre-post, mixed methods (quantitative and qualitative) study was conducted in an outpatient tertiary hospital. Eligible participants were those aged ≥18 years, with type 1 diabetes for ≥1 year, and using multiple daily insulin injections. Participants followed a 12-week individualized LCD (100 g/d). Daily glucose levels were monitored using a continuous glucose monitor. Glycated hemoglobin (HbA1c) and QoL were measured preintervention and postintervention. A post-hoc exploratory regression analysis determined whether changes in carbohydrate intake was associated with changes in HbA1c and QoL. Qualitative data collected postintervention explored participants' perceptions relating to a LCD, glycemic control, and QoL.Participants (n = 22) completed the 12-week LCD intervention. An LCD provided a statistically, significant improvement in HbA1c 0.83% (95% CI 0.32%-1.33%), P = .003 but did not impact QoL: estimated change 1.14 units (95% CI: -5.34 to 7.61); P = .72. The post-hoc exploratory regression analysis showed that participants with poorer baseline glycemic control were more likely to respond to an LCD resulting in significant reductions in HbA1c. Participant perceptions relating to the study variables were mixed.An LCD (100 g/d) is a potentially effective and safe strategy to improve glycemic control without negatively effecting QoL in Australian adults with type 1 diabetes.

BACKGROUND Globally, the prevalence of type 1 diabetes mellitus (T1DM) is rising. In 2020, a total of 124,652 Australians had T1DM. Maintaining optimal glycemic control (hemoglobin A1c ≤7.0%, ≤53 mmol/mol) on a standard carbohydrate diet can be a challenge for people living with T1DM. The Diabetes Complications and Control Trial established that macrovascular and microvascular complications could be reduced by improving glycemic control. Recent studies have found that a very low or low carbohydrate diet can improve glycemic control. However, the overall evidence relating to an association between a very low or low carbohydrate diet and glycemic control in people living with T1DM is both limited and mixed. In addition, research has suggested that a reduced quality of life due to anxiety and depression adversely influences glycemic control. Despite a potential link between a very low or low carbohydrate diet and optimal glycemic control, to our knowledge, no research has examined an association between a low carbohydrate diet, quality of life, and glycemic control, making this study unique in its approach. OBJECTIVE The study aims to develop a validated diabetes-specific quality of life questionnaire for use in Australian adults with T1DM and to determine if an association exists between a low carbohydrate diet, quality of life, and glycemic control in Australian adults living with T1DM. METHODS This cross-sectional study will be conducted in a tertiary hospital outpatient setting and will consist of 3 phases: phase 1, online Australian diabetes-specific quality of life questionnaire development and piloting (25-30 adults with T1DM); phase 2, questionnaire validation (364 adults with T1DM); and phase 3, a 12-week dietary intervention to determine if an association exists between a low carbohydrate diet, quality of life, and glycemic control in adults with T1DM (16-23 adults with T1DM). The validation of the study-developed Australian diabetes-specific quality of life questionnaire, and changes in hemoglobin A1c and quality of life in adults with T1DM while undertaking a low carbohydrate diet over 12 weeks will be the primary outcomes of this study. RESULTS Phase 1 of the study is currently open for recruitment and has recruited 12 participants to date. It is anticipated that the first results will be submitted for publication in November 2021. Presently, no results are available. CONCLUSIONS This study is the first of its kind in that it will be the first to generate a new validated instrument, which could be used in evidence-based practice and research to understand the quality of life of Australian adults with T1DM. Second, the low carbohydrate dietary intervention outcomes could be used to inform clinicians about an alternative approach to assist T1DM adults in improving their quality of life and glycemic control. Finally, this study could warrant the development of an evidence-based low carbohydrate dietary guideline for adults living with T1DM with the potential to have a profound impact on this population. CLINICALTRIAL ClinicalTrials.gov NCT04213300; https://clinicaltrials.gov/ct2/show/NCT04213300 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/25085

Objective: Obesity is a predictor of adverse outcomes in patients undergoing adrenalectomy. Pre-adrenalectomy weight reduction is becoming an increasingly common challenge in view of the rising prevalence of obesity. This case report describes the clinical course of a morbidly obese gentleman who underwent bariatric surgery prior to pheochromocytoma resection.Methods: A morbidly obese man with a body mass index of 43 kg/m2 had an incidental finding of an 8.5 cm right-sided pheochromocytoma. Dietary and pharmacologic methods of weight loss lead to a 6 kg weight loss over a 12-month period. Multidisciplinary discussion concluded that weight loss and tumor resection were priority and the patient proceeded to laparoscopic sleeve gastrectomy with appropriate peri-operative alpha- and beta-blockade.Results: Laparoscopic sleeve gastrectomy proceeded without complication and lead to a further 23 kg of weight loss and the pheochromocytoma was resected 2 months later.Conclusion: Bariatric surgery for pre-operative weight loss in medically prepared patients with pheochromocytoma should be considered for morbidly obese patients in whom nonsurgical weight loss is unsuccessful.Abbreviations: BMI = body mass index

Background Globally, the prevalence of type 1 diabetes mellitus (T1DM) is rising. In 2020, a total of 124,652 Australians had T1DM. Maintaining optimal glycemic control (hemoglobin A1c ≤7.0%, ≤53 mmol/mol) on a standard carbohydrate diet can be a challenge for people living with T1DM. The Diabetes Complications and Control Trial established that macrovascular and microvascular complications could be reduced by improving glycemic control. Recent studies have found that a very low or low carbohydrate diet can improve glycemic control. However, the overall evidence relating to an association between a very low or low carbohydrate diet and glycemic control in people living with T1DM is both limited and mixed. In addition, research has suggested that a reduced quality of life due to anxiety and depression adversely influences glycemic control. Despite a potential link between a very low or low carbohydrate diet and optimal glycemic control, to our knowledge, no research has examined an association between a low carbohydrate diet, quality of life, and glycemic control, making this study unique in its approach. Objective The study aims to develop a validated diabetes-specific quality of life questionnaire for use in Australian adults with T1DM and to determine if an association exists between a low carbohydrate diet, quality of life, and glycemic control in Australian adults living with T1DM. Methods This cross-sectional study will be conducted in a tertiary hospital outpatient setting and will consist of 3 phases: phase 1, online Australian diabetes-specific quality of life questionnaire development and piloting (25-30 adults with T1DM); phase 2, questionnaire validation (364 adults with T1DM); and phase 3, a 12-week dietary intervention to determine if an association exists between a low carbohydrate diet, quality of life, and glycemic control in adults with T1DM (16-23 adults with T1DM). The validation of the study-developed Australian diabetes-specific quality of life questionnaire, and changes in hemoglobin A1c and quality of life in adults with T1DM while undertaking a low carbohydrate diet over 12 weeks will be the primary outcomes of this study. Results Phase 1 of the study is currently open for recruitment and has recruited 12 participants to date. It is anticipated that the first results will be submitted for publication in November 2021. Presently, no results are available. Conclusions This study is the first of its kind in that it will be the first to generate a new validated instrument, which could be used in evidence-based practice and research to understand the quality of life of Australian adults with T1DM. Second, the low carbohydrate dietary intervention outcomes could be used to inform clinicians about an alternative approach to assist T1DM adults in improving their quality of life and glycemic control. Finally, this study could warrant the development of an evidence-based low carbohydrate dietary guideline for adults living with T1DM with the potential to have a profound impact on this population. Trial Registration ClinicalTrials.gov NCT04213300; https://clinicaltrials.gov/ct2/show/NCT04213300 International Registered Report Identifier (IRRID) PRR1-10.2196/25085

Background: Hypertriglyceridaemia is an oft-forgotten cause of acute pancreatitis, which can lead to delayed appropriate therapy and increased morbidity. Uncontrolled diabetes and acute alcohol ingestion can exacerbate this. There are no definite guidelines on management, and there is limited evidence supporting current treatment methods. Objective: A two-centre retrospective audit was conducted of acute pancreatitis presentations over three-years, and management reviewed of those with elevated triglyceride levels (≥6mmol/L). Results: Of 1628 presentations of pancreatitis between 01- Jan-2016 to 31-Dec-2018 to either Gold Coast University Hospital or Robina Hospital, 27 presentations (1.64%) from 20 patients are attributed to hypertriglyceridaemia on admission (mean 67.4mmol/L). 92.6% required admission into hospital (mean 11.5day). 36% had insulin infusion, 12% had apheresis, and 28% required intensive care admission. Only 84% were discharged on statins and/or fibrates. 72% of patients had further episodes hypertriglyceridaemia-induced pancreatitis. Pre-existing diabetes affected 44%, and HbA1c was measured in only 63.6% of these. Acute alcohol intake was relevant for 22.2% of presentations. Endocrinologist opinion was sought in 51.8%. Conclusion: Whilst hypertriglyceridaemia-induced pancreatitis is uncommon, it is undertreated and specialist opinion under-utilised. This increases risk of recurrence, morbidity, and further hospital presentations.

Background The incidence of thyroid cancer is increasing worldwide without a simultaneous rise in mortality. It is thought that the incidence of non-clinically significant thyroid cancers are on the rise as a result of more sensitive diagnostic imaging. Aim To determine the number of inappropriate requests for thyroid ultrasound (US), the quality of radiology reporting for thyroid nodules based on accepted guidelines and the resultant number of thyroid cancers identified because of these investigations. Methods Electronic medical records of patients who underwent thyroid US imaging and thereafter referred to the Endocrine Department at Gold Coast University Hospital, Queensland, between July 2014 and July 2017 were reviewed. Data for 251 patients who had thyroid US were analysed and the final 201 patients who were found to have thyroid nodules were evaluated using descriptive statistics. Indications for thyroid US imaging among referring clinicians were assessed and we compared both clinical management and radiology reporting practices of thyroid nodules to the published 2009 and 2015 American Thyroid Association (ATA) guidelines. Results There were 50.2% of patients with initial thyroid US imaging deemed outside of expert recommendations where 42% of these patients required further surveillance imaging and 25.4% required fine needle aspiration of their thyroid nodules. A definite recommendation whether to evaluate thyroid nodules further was provided in 44.8% of radiology reports. There were no radiology reports that described thyroid nodules findings based on patterns as recommended by the 2015 ATA guidelines. Two cases of thyroid cancer were detected including one patient with prior history of thyroid cancer and a second patient with hypothyroidism. Conclusion Routine use of US thyroid imaging outside expert recommendation is common. There is lack of standardised reporting when assessing thyroid nodules on US. Limiting the initial use of US in cases of palpable neck lumps and the use of systematic reporting according to the 2017 guidelines published by the American College of Radiology Thyroid Imaging Reporting and Data System may reduce unnecessary investigations for thyroid nodules in the future.

Exercise is an important element to optimize health and well-being, though navigating exercise safely can be challenging for exercise specialists working with people with diabetes. Measuring glucose levels before an exercise session assists in the determination of whether exercise is safe for a person with diabetes. A number of organizations have recently developed guidelines to provide exercise and diabetes recommendations based on glucose levels and other relevant factors. However, there are limited easy-to-use resources to assist exercise specialists to determine whether exercise should be started and continued by people with diabetes. The type of diabetes, pre-exercise glucose level, medications and their timing, recent food intake and general sense of wellness all warrant consideration when determining the approach to each exercise session. An expert group was convened to review the published literature and develop resources to guide exercise specialists in assessing the safety of an adult with diabetes starting exercise, and indications to cease exercise, based upon glucose levels and other factors. Contraindications to people with diabetes starting or continuing exercise are (1) glucose 15.0 mmol/L with symptoms of weakness/tiredness, or with ketosis; (3) hypoglycaemic event within the previous 24 h that required assistance from another person to treat and (4) feeling unwell. To optimize diabetes and exercise safety, recommendations (stratified by pre-exercise glucose level) are provided regarding carbohydrate ingestion, glucose monitoring and medication adjustment.

There is an increasing array of medicines available to improve blood glucose control in type 2 diabetes. Finding the best combination for an individual patient requires an assessment of the patient's characteristics and understanding the mechanism of action for each drug.The aim of this article is to provide a rational approach for choosing between the various blood glucose-lowering medicines available for treatment of patients with type 2 diabetes mellitus.Metformin is the first choice of glucose-lowering medicines for most patients with type 2 diabetes. Sulphonylureas have proven benefits in long-term trials. Insulin is required in patients with symptoms of insulin deficiency. Glucagon-like peptide 1 agonists and sodium-glucose co-transporter 2 inhibitors provide some assistance in weight loss as well as improving blood glucose control. Dipeptidyl peptidase 4 inhibitors provide an alternative to metformin and sulphonylureas, especially when side effects of those drugs limit their use. Re-assessing blood glucose control after an appropriate trial period before deciding on continuing use is appropriate.

Background Current clinical practice widely regards deep tissue biopsy as the gold standard for identification of wound bacterial bio-burden. This study aims to establish whether fine needle aspiration biopsy (FNAB) is as accurate as deep tissue biopsy and therefore offers a more accurate, cheaper and suitable alternative to routinely used superficial swab in diabetic wounds of varying depth and severity.

A 44-year-old man presented with extreme hypernatraemia. The case is unique in three respects: the patient's plasma sodium concentration was 208mmol/L; the aetiology was multifactorial, including essential hypernatraemia, hypodipsia and high ambient temperature; and the patient survived with full neurological recovery. We briefly review various disorders of thirst and osmorecepters.

Chronic administration of nicotinic acid (NA) has been shown to cause a deterioration in glycemic control in diabetic patients (1,2). Acute use of NA inhibits lipolysis in adipose tissue suppressing circulating nonesterfied fatty acid (NEFA) levels. Once the effect of NA abates, NEFA levels increase above baseline (3). According to the Randle cycle hypothesis, when NEFA availability increases, NEFA oxidation occurs at the expense of glucose oxidation with a resultant reduction in glucose uptake by skeletal muscle and an increase in blood glucose levels (4). Some patients with type 1 diabetes have frequent and often unpredictable hypoglycemic episodes. We hypothesized that the addition of regular oral NA to deliberately …