A systematic review: Cost-effectiveness of continuous glucose monitoring compared to self-monitoring of blood glucose in type 1 diabetes.

Continuous glucose monitoring (CGM) is rapidly becoming a vital tool in the management of type 1 diabetes. Its use has been shown to improve glycaemic management and reduce the risk of hypoglycaemic events. The cost of CGM remains a barrier to its widespread application. We aimed to identify and synthesize evidence about the cost-effectiveness of utilizing CGM in patients with type 1 diabetes. Studies were identified from MEDLINE, Embase and Cochrane Library from January 2010 to February 2022. Those that assessed the cost-effectiveness of CGM compared to self-monitored blood glucose (SMBG) in patients with type 1 diabetes and reported lifetime incremental cost-effectiveness ratio (ICER) were included. Studies on critically ill or pregnant patients were excluded. Nineteen studies were identified. Most studies compared continuous subcutaneous insulin infusion and SMBG to a sensor-augmented pump (SAP). The estimated ICER range was [$18,734-$99,941] and the quality-adjusted life year (QALY) gain range was [0.76-2.99]. Use in patients with suboptimal management or greater hypoglycaemic risk revealed more homogenous results and lower ICERs. Limited studies assessed CGM in the context of multiple daily injections (MDI) (n = 4), MDI and SMBG versus SAP (n = 2) and three studies included hybrid closed-loop systems. Most studies (n = 17) concluded that CGM is a cost-effective tool. This systematic review suggests that CGM appears to be a cost-effective tool for individuals with type 1 diabetes. Cost-effectiveness is driven by reducing short- and long-term complications. Use in patients with suboptimal management or at risk of severe hypoglycaemia is most cost-effective.

Functional MRI in assessment of diabetic kidney disease in people with type 1 diabetes.

AIMS: To compare levels of renal hypoxia measured by Blood Oxygen Level Dependent (BOLD) magnetic resonance imaging (MRI) with measured transverse relaxation rate (R2*) and renal structural changes including apparent diffusion coefficient (ADC) and fractional anisotropy (FA) in patients with type 1 diabetes and healthy controls. METHODS: Cohort study comparing MRI metrics in type 1 diabetes (n = 32, GFR 105 (77, 120) ml/min.1.73m2) and controls (n = 10). Renal function and selected inflammatory renal biomarkers were also measured. RESULTS: For BOLD, we found reduced cortical [14.7 (13.7,15.8) (1/s) vs 15.7 (15.1,16.6) (1/s), p < 0.001] and medullary [24.8 (21.8,28.2) (1/s) vs. 29.3 (24.3,32.4) (1/s), p < 0.001] R2*, indicating more oxygenated parenchyma, in type 1 diabetes vs. controls, respectively. We observed reduced cortical FA, indicating decreased structural integrity in type 1 diabetes -0.04 (-0.07, -0.01), (p = 0.02). We found reduced cortical ADC, reflecting reduced water diffusion, in non-hyperfiltering [2.40 (2.29,2.53) (103mm2/s)] versus hyperfiltering [2.61 (2.53,2.74) (103mm2/s)] type 1 diabetes patients. MRI parameters correlated with renal function and inflammatory renal biomarkers. CONCLUSIONS: MRI derived indices of renal function and structure differed between (i) type 1 diabetes and healthy controls, and (ii) between non-hyperfiltering and hyperfiltering type 1 diabetes patients, providing insight into the role of hypoxia and renal structural, and functional changes in DKD.

Culturally Adaptive Governance-Building a New Framework for Equity in Aboriginal and Torres Strait Islander Health Research: Theoretical Basis, Ethics, Attributes and Evaluation.

Indigenous health inequities persist in Australia due to a system of privilege and racism that has political, economic and social determinants, rather than simply genetic or behavioural causes. Research involving Aboriginal and Torres Strait Islander ('Indigenous') communities is routinely funded to understand and address these health inequities, yet current ethical and institutional conventions for Indigenous health research often fall short of community expectations. Typically, mainstream research projects are undertaken using traditional "top-down" approaches to governance that hold inherent tensions with other dominant governance styles and forms. This approach perpetuates long-held power imbalances between those leading the research and those being researched. As an alternative, Indigenous governance focuses on the importance of place, people, relationships and process for addressing power imbalances and achieving equitable outcomes. However, empowering principles of Indigenous governance in mainstream environments is a major challenge for research projects and teams working within organisations that are regulated by Western standards and conventions. This paper outlines the theoretical basis for a new Culturally Adaptive Governance Framework (CAGF) for empowering principles of Indigenous governance as a prerequisite for ethical conduct and practice in Indigenous health research. We suggest new orientations for mainstream research project governance, predicated on translating theoretical and practical attributes of real-world ethics, adaptive governance and critical allyship frameworks to Indigenous health research. The CAGF is being implemented in a national Indigenous multicenter trial evaluating the use of continuous blood glucose monitors as a new technology with the potential to improve diabetes care and treatment for Indigenous Australians-the FlashGM Study. The CAGF is a governance framework that identifies the realities of power, acknowledges the complexities of culture and emerging health technologies, and foregrounds the principle of equity for mainstream Indigenous health research.

Comparison of two questionnaires for assessment of emotional eating in people undergoing treatment for obesity.

PURPOSE: Emotional eating may contribute to weight gain and difficulty with weight loss. Questionnaires are currently the primary method used to identify this behaviour but there is no gold standard for detecting emotional eating, making it difficult to know which questionnaire to use for this purpose. This study assesses two questionnaires validated for assessment of emotional eating in patients with obesity, with the aim of investigating their interchangeability in the clinical setting. METHODS: 387 adult participants were recruited from the obesity treatment service at a tertiary metropolitan hospital. Responses were obtained for the 25-item Emotional Eating Scale (EES) and the 4-item coping subscale of the Palatable Eating Motives Scale (PEMS). Agreement was analysed using quadratically weighted Cohen's κ scores. Substantial agreement was defined as κ 0.61-0.80. RESULTS: The median (interquartile range) body mass index and age of participants was 42.1 kg/m2 (36.4-48.9 kg/m2) and 51.6 years (41.1-61.4 years), respectively, and 70.5% of participants were female. The EES and PEMS were found to have substantial agreement (κ 0.71; 95% CI 0.65-0.76). Agreement remained substantial when analysing responses from men (0.61; 95% CI 0.47-0.73), women (0.73; 95% CI 0.67-0.79) and post-bariatric surgery patients (0.72; 95% CI 0.62-0.82) separately. CONCLUSION: Despite focusing on different elements of emotional eating behaviour, the substantial agreement between the EES and PEMS coping subscale suggests that they identify respondents' susceptibility to emotional eating with consistency, including in people who have undergone bariatric surgery. LEVEL V: Opinions of respected authorities, based on descriptive studies, narrative reviews, clinical experience, or reports of expert committees. CLINICAL TRIAL REGISTRATION: This observational study has not been registered as a clinical trial.

Continuous glucose monitoring: A review of the evidence in type 1 and 2 diabetes mellitus.

CONTEXT AND AIM: Continuous glucose monitoring (CGM) is becoming widely accepted as an adjunct to diabetes management. Compared to standard care, CGM can provide detailed information about glycaemic variability in an internationally standardised ambulatory glucose profile, enabling more informed user and clinician decision making. We aimed to review the evidence, user experience and cost-effectiveness of CGM. METHODS: A literature search was conducted by combining subject headings 'CGM' and 'flash glucose monitoring', with key words 'type 1 diabetes' and 'type 2 diabetes', limited to '1999 to current'. Further evidence was obtained from relevant references of retrieved articles. RESULTS: There is a strong evidence for CGM use in people with type 1 diabetes, with benefits of reduced glycated haemoglobin and hypoglycaemia, and increased time in range. While the evidence for CGM use in type 2 diabetes is less robust, similar benefits have been demonstrated. CGM can improve diabetes-related satisfaction in people with diabetes (PWD) and parents of children with diabetes, as well as the clinician experience. However, CGM does have limitations including cost, accuracy and perceived inconvenience. Cost-effectiveness analyses have indicated that CGM is a cost-effective adjunct to type 1 diabetes management that is associated with reduced diabetes-related complications and hospitalisation. CONCLUSIONS: Continuous glucose monitoring is revolutionising diabetes management. It is a cost-effective adjunct to diabetes management that has the potential to improve glycaemic outcomes and quality of life in PWD, especially type 1 diabetes.

Lipoprotein apheresis and PCSK9 inhibitors for severe familial hypercholesterolaemia: Experience from Australia and New Zealand.

INTRODUCTION: Severe familial hypercholesterolaemia (FH) causes premature disability and death due to atherosclerotic cardiovascular disease and is refractory to standard lipid-lowering therapies. Lipoprotein apheresis (LA) has long been a standard of care for patients with severe FH, but is invasive, expensive and time-consuming for patients and their caregivers. Newer drug therapies, including the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, may reduce the need for LA. MATERIALS AND METHODS: We audited the records of 16 patients (eight homozygous, eight heterozygous) treated with LA in Australia and New Zealand, 14 of whom subsequently commenced PCSK9 inhibitor therapy. LA was performed by cascade filtration in all centres. RESULTS: LDL-cholesterol was acutely lowered by 69 ± 7% in patients with homozygous FH and by 72 ± 9% in those with heterozygous FH, representing time-averaged reductions of 36 ± 12% and 34 ± 5%, respectively. LA was well-tolerated, and patients reported comparable quality of life to population and disease-related norms. After commencement of PCSK9 inhibitors, four of seven patients with homozygous FH had meaningful biochemical responses, with a reduction in the frequency of LA permitted in one patient and complete cessation in another. Four of seven patients with heterozygous FH were able to be managed without LA after commencing PCSK9 inhibitors. CONCLUSION: While PCSK9 inhibitors have reduced the need for LA, some patients with severe FH continue to require LA, and will require it for the foreseeable future. However, emerging therapies, including angiopoetin-like 3 inhibitors, may further reduce the need for LA.

Continuous glucose monitoring: a review of the evidence, opportunities for future use and ongoing challenges.

The advent of devices that can track interstitial glucose levels, which are closely related to blood glucose levels, on a near continuous basis, has facilitated better insights into patterns of glycaemia. Continuous glucose monitoring (CGM) therefore allows for more intensive monitoring of blood glucose levels and potentially improved glycaemic control. In the context of the announcement on 1 April 2017 that the Australian Government will fund CGM monitoring for people with type 1 diabetes under the age of 21 years, this paper provides a review of the evidence for CGM and some of the ongoing challenges. There is evidence that real-time CGM in type 1 diabetes improves HbA1c and hypoglycaemia, while in type 2 diabetes, the evidence is less robust. Initial barriers to widespread implementation of CGM included issues with accuracy and user friendliness; however, as the technology has evolved, these issues have largely improved. Ongoing barriers include cost, and weaker evidence for their benefit in certain populations such as those with type 2 diabetes and less glycaemic variability. CGM has the potential to reduce healthcare costs, although real-world studies, including cost-effectiveness analyses, are needed in this area.

Liberal Versus Conventional Glucose Targets in Critically Ill Diabetic Patients: An Exploratory Safety Cohort Assessment.

OBJECTIVES: To assess the feasibility, safety, and impact on relative hypoglycemia of liberal versus conventional blood glucose concentration targets in critically ill diabetic patients. DESIGN: Prospective, open-label, sequential-period exploratory study. SETTING: A 22-bed multidisciplinary ICU of a tertiary care hospital in Australia. PATIENTS: Eighty adult diabetic patients, 40 from the conventional before period and 40 from the liberal after period. INTERVENTIONS: Blood glucose concentration targets were 6-10 mmol/L during the before period and 10-14 mmol/L during the after period. MEASUREMENTS AND MAIN RESULTS: We used admission glycated hemoglobin to estimate premorbid baseline blood glucose concentration. We defined glycemic distance as the difference between blood glucose concentration in ICU and baseline blood glucose concentration. During the first 48 ICU hours, we recorded absolute (blood glucose concentration, < 3.9 mmol/L) and relative (glycemic distance, > 30% below baseline) hypoglycemia rates, insulin administration, and outcomes. The groups had similar baseline characteristics. We observed a negative glycemic distance in 248 of 488 blood glucose concentrations (50.8%) during the before period and 164 of 485 (33.8%) during the after period (p < 0.001). We detected relative hypoglycemia in 20 (50.0%) and nine (22.5%) patients in the before and after periods, respectively (p = 0.01). On day 1, 50.0% and 16.7% received insulin in the before and after periods (p = 0.007). ICU and hospital length of stay and mortality were similar between groups. CONCLUSIONS: In a safety cohort of critically ill diabetic patients, a blood glucose concentration target of 10-14 mmol/L resulted in fewer episodes of negative glycemic distance or relative hypoglycemia and reduced insulin administration compared with a target of 6-10 mmol/L.

The high burden of inpatient diabetes mellitus: the Melbourne Public Hospitals Diabetes Inpatient Audit.

OBJECTIVE: To determine the prevalence of diabetes in inpatients in Melbourne hospitals. DESIGN: Point prevalence survey of all inpatients in each hospital on a single day between 30 November 2010 and 22 November 2012. SETTING: 11 hospitals in metropolitan Melbourne including community, secondary and tertiary hospitals and one aged care and rehabilitation centre. PARTICIPANTS: 2308 adult inpatients in all wards apart from intensive care, emergency, obstetrics and psychiatry. MAIN OUTCOME MEASURES: Point prevalence of self-reported diabetes, details of current medication, self-reported frequency of complications. RESULTS: Diabetes status was obtained in 2273 of 2308 inpatients (98.5%). Of these, 562 (24.7%) had diabetes (95% CI, 22.9%-26.5%). Diabetes prevalence ranged from 15.7% to 35.1% in different hospitals (P < 0.001). Patients with diabetes were older, heavier and more likely to be taking lipid-lowering, antihypertensive and blood-thinning medications. Of 388 patients with complete medication information, 270 (69.6%) were taking oral hypoglycaemic agents alone or in combination with insulin, 158 (40.7%) were treated with insulin (67 [17.3%] with insulin alone) and 51 (13.1%) were not taking medication for diabetes. The frequency of diabetes complications was very high: 207/290 (71.4%) for any microvascular complication, 275/527 (52.2%) for any macrovascular complication and 227/276 (82.2%) for any complication. CONCLUSION: The high burden of diabetes in Melbourne hospital inpatients has major implications for patient health and health care expenditure. Optimising care of these high-risk patients has the potential to decrease inpatient morbidity and length of stay as well as preventing or delaying future complications. A formal Australian national audit of inpatient diabetes would determine its true prevalence and consequences, allowing rational planning to deal with shortcomings in its management.

Longitudinal assessment of thyroid function in pregnancy.

BACKGROUND: Trimester-specific reference intervals (RIs) for thyroid function tests are lacking for Beckman Dxl 800 analysers. We aimed to establish RIs for thyroid stimulating hormone (TSH), free thyroxine (fT4) and to track intraindividual changes in thyroid function throughout pregnancy. METHODS: One hundred and thirty healthy women without antithyroid peroxidase antibodies were followed longitudinally. Thyroid function was determined at trimester-1 (T1): 9-13 weeks; trimester-2 (T2): 22-26 weeks; trimester-3 (T3): 35-39 weeks and postpartum (PP): 8-12 weeks. A subgroup (n = 47) was used to track intraindividual changes using PP as non-pregnant state (baseline). RESULTS: For trimesters 1-3, TSH (median (2.5th, 5th, 95th and 97.5th percentile)) was 0.77 (0.03, 0.05, 2.33, 3.05), 1.17 (0.42, 0.47, 2.71, 3.36) and 1.35 (0.34, 0.42, 2.65, 2.83) mIU/L, respectively. Free T4 (mean (95%CI)) was 10.7 (5.9-15.5), 8.1 (4.9-11.3), 7.8 (4.5-11.0) pmol/L, respectively. In T2 and T3, 36% and 41% of the fT4 values, respectively, fell below the non-pregnancy lower normal limit. In the subgroup assessed for longitudinal changes, of the women with baseline TSH ≤ median, 71-75% remained at or below the corresponding median for trimesters 1-3. Of the women with baseline fT4 ≤ median, 69-81% also remained at or below the corresponding median for trimesters 1-3. High correlation was observed at different trimesters and baseline for TSH (Spearman's r: 0.593-0.846, P < 0.001) and for fT4 (r: 0.480-0.739, P < 0.001). CONCLUSIONS: Use of trimester-specific RIs would prevent misclassification of thyroid function during pregnancy. In the majority of women, TSH and fT4 tracked on the same side of the median distribution, from a non-pregnant baseline, throughout pregnancy.