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.

Improved metabolic parameters of people with diabetes attending an Aboriginal health service in regional Victoria.

BACKGROUND: Aboriginal and Torres Strait Islander people have higher rates of diabetes and its complications than non-Aboriginal people. Rumbalara Aboriginal Co-operative is the major primary healthcare provider for Aboriginal people in the Greater Shepparton region. AIMS: To evaluate the baseline metabolic parameters and presence of diabetes complications in people with type 2 diabetes attending Rumbalara Aboriginal Co-operative in 2017 and compare it with other Aboriginal and Torres Strait Islander studies and Australian specialist diabetes services. METHODS: Clinical and biochemical characteristics, including diabetes type, age, weight, body mass index (BMI), blood pressure, micro- and macrovascular complications, glycosylated haemoglobin (HbA1c), haemoglobin, renal function, lipid profile, urine albumin:creatinine ratio, diabetes medications, renin angiotensin system inhibition therapies, HMG-CoA reductase inhibitors and antiplatelet agents, were determined. RESULTS: One hundred and twenty-six individuals had diabetes, 121 had type 2 diabetes. One hundred and thirteen identified as Aboriginal and/or Torres Strait Islander. Median age was 57.5 (48-68) years, median HbA1c was 7.8% (6.8-9.6) and median BMI was 33.4 kg/m2 (29-42.3). Compared with other Australian Aboriginal and Torres Strait Islander populations, this population was older and had more obesity, but with better glycaemia management. Compared with specialist diabetes services, this population was of similar age, with greater BMI but comparable HbA1c. CONCLUSIONS: Aboriginal people living with type 2 diabetes attending this regional Aboriginal health service have comparable glycaemic management to specialist diabetes services in Australia, managed largely by primary care physicians with limited access to specialist care for the past 5 years.

Efficacy of Flash Glucose Monitoring in Type 1 and Type 2 Diabetes: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.

Objective: Flash glucose monitoring (FlashGM) is a sensor-based technology that displays glucose readings and trends to people with diabetes. In this meta-analysis, we assessed the effect of FlashGM on glycaemic outcomes including HbA1c, time in range, frequency of hypoglycaemic episodes and time in hypo/hyperglycaemia compared to self-monitoring of blood glucose, using data from randomised controlled trials. Methods: A systematic search was conducted on MEDLINE, EMBASE and CENTRAL for articles published between 2014 and 2021. We selected randomised controlled trials comparing flash glucose monitoring to self-monitoring of blood glucose that reported change in HbA1c and at least one other glycaemic outcome in adults with type 1 or type 2 diabetes. Two independent reviewers extracted data from each study using a piloted form. Meta-analyses using a random-effects model was conducted to obtain a pooled estimate of the treatment effect. Heterogeneity was assessed using forest plots and the I2 statistic. Results: We identified 5 randomised controlled trials lasting 10 - 24 weeks and involving 719 participants. Flash glucose monitoring did not lead to a significant reduction in HbA1c. However, it resulted in increased time in range (mean difference 1.16 hr, 95% CI 0.13 to 2.19, I2 = 71.7%) and decreased frequency of hypoglycaemic episodes (mean difference -0.28 episodes per 24 hours, 95% CI -0.53 to -0.04, I2 = 71.4%). Conclusions: Flash glucose monitoring did not lead to a significant reduction in HbA1c compared to self-monitoring of blood glucose, however, it improved glycaemic management through increased time in range and decreased frequency of hypoglycaemic episodes. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/, identifier PROSPERO (CRD42020165688).

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.

Feasibility of once weekly exenatide-LAR and enhanced diabetes care in Indigenous Australians with type 2 diabetes (Long-acting-Once-Weekly-Exenatide laR-SUGAR, 'Lower SUGAR' study).

BACKGROUND: Diabetes is 3-4 times more prevalent in Indigenous Australians with blood glucose levels often above target range. Once weekly formulations of exenatide(exenatide-LAR) have demonstrated significantly greater improvements in glycaemic management with no increased risk of hypoglycaemia and with reductions in bodyweight but have not been studied in Indigenous Australians. AIMS: To assess the feasibility and metabolic effects of once weekly supervised injection of exenatide-LAR in addition to standard care in Indigenous Australians with type 2 diabetes. METHODS: Two communities in Central Australia with longstanding specialist clinical outreach services were allocated by random coin toss to receive once-weekly exenatide-LAR injection with weekly nurse review and adjustment of medication for 20 weeks (community with exenatide-LAR) or to weekly nurse review in addition to standard care over 20 weeks (community without exenatide-LAR). The primary outcome was the feasibility of an intensive diabetes management model of care with and without weekly supervised exenatide-LAR. Secondary outcomes included change in HbA1c. RESULTS: Thirteen participants from the community with exenatide-LAR and nine participants from the community without exenatide-LAR were analysed. Eighty-five percent of individuals in the community with exenatide-LAR and 67% in the community without exenatide-LAR attended more than half of clinic visits. Median difference in the change in HbA1c from baseline to final visit, adjusted for baseline HbA1c, between the community with exenatide-LAR and the community without exenatide-LAR was -3.1%, 95% CI (-5.80%, -0.38%; P = 0.03). CONCLUSIONS: Weekly exenatide-LAR combined with weekly nurse review demonstrated greater improvements in HbA1c, highlighting its potential for use in remote communities.

Feasibility trial of metformin XR in people with pre-diabetes and stroke (MIPPS)-randomised open blinded endpoint controlled trial.

AIMS: Pre-diabetes is a common condition that affects about 16.4% of Australian adults. Hyperglycaemia is a strong risk factor for the development of stroke. Metformin XR is an approved medication to treat type 2 diabetes in Australia but not pre-diabetes. Additionally, whether it is tolerated following a stroke is unclear. In this pilot study, we aimed to assess the feasibility of Metformin XR in people with stroke and pre-diabetes. METHODS: In this PROBE design trial, people who had recent stroke (within 3 months) with pre-diabetes were randomized to either the active arm (n = 13) receiving usual care plus Metformin XR (500 mg daily increased to a total daily dose of 1500 mg) or the control group receiving only usual care (n = 13). At baseline & after four months of intervention, clinical and biomedical characteristics, cardiovascular risk factors and medication data were recorded. At one month and 2.5 months into the study, compliance rateandside effects were determined. RESULTS: This trial showed that it is feasible to recruit, retain and monitor participants. However, the compliance rate was low. Adherence to metformin XR was 52% (IQR:42% to 61%) based on the remaining tablets in the container after 4 months of intervention. None of the reported side effects were deemed to be related to the study treatment and no significant differences were observed between the metformin XR and the control group. CONCLUSION: Treatment with Metformin XR in participants admitted with stroke and with pre-diabetes is feasible and safe. Strategies are needed to improve adherence in future trials.

Routine HbA1c among hematology and oncology inpatients: Diabetes-status and hospital-outcomes.

AIMS: Using routine HbA1c measurement to determine the prevalence of diabetes mellitus (known and previously unrecognized) and their hospital outcomes among hematology and oncology inpatients. METHODS: This was a prospective, observational study. Routine automated HbA1c testing was performed in all hematology and oncology inpatients aged ≥54 years at a tertiary hospital, July 2013-January 2015. The outcome measures were: (i) prevalence of known and previously unrecognized diabetes, and (ii) hospital outcomes: length-of-stay (LOS), intensive-care-unit (ICU) admission, 30-day/18-month readmission, and 18-month mortality. RESULTS: Over the 18-month study period, 1076 inpatients aged ≥54 years were admitted to hematology (n = 298) and oncology (n = 778) units: 21% had known diabetes and 7% had previously unrecognized diabetes. Patients with known diabetes had a longer LOS (IRR: 1.18, 95%CI: 1.02-1.37, p = 0.03), compared to those without diabetes, adjusting for age, hemoglobin level, estimated-glomerular-filtration-rate, admission specialty unit, Charlson's comorbidity index score, and glucocorticoid exposure. No significant differences were observed in ICU admission, 30-day/18-month readmission, and 18-month mortality among patients with known, previously unrecognized and no diabetes (p ≥ 0.05). CONCLUSIONS: Approximately one in five hematology or oncology inpatients aged ≥54 years had known diabetes, and one in fourteen had previously unrecognized diabetes. Those with known diabetes had a longer hospital stay. Routine HbA1c measurement is can be useful for identifying previously unrecognized diabetes, particularly among patients with high glucocorticoid exposure. Further study is required to determine cost-effectiveness in screening for unrecognized diabetes and optimal management of these patients.

Long-term intra-individual variability of albuminuria in type 2 diabetes mellitus: implications for categorization of albumin excretion rate.

BACKGROUND: Diabetic kidney disease (DKD) is the leading cause of end-stage renal disease in the Western world. Early and accurate identification of DKD offers the best chance of slowing the progression of kidney disease. An important method for evaluating risk of progressive DKD is abnormal albumin excretion rate (AER). Due to the high variability in AER, most guidelines recommend the use of more than or equal to two out of three AER measurements within a 3- to 6-month period to categorise AER. There are recognised limitations of using AER as a marker of DKD because one quarter of patients with type 2 diabetes may develop kidney disease without an increase in albuminuria and spontaneous regression of albuminuria occurs frequently. Nevertheless, it is important to investigate the long-term intra-individual variability of AER in participants with type 2 diabetes. METHODS: Consecutive AER measurements (median 19 per subject) were performed in 497 participants with type 2 diabetes from 1999 to 2012 (mean follow-up 7.9 ± 3 years). Baseline clinical characteristics were collected to determine associations with AER variability. Participants were categorised as having normo-, micro- or macroalbuminuria according to their initial three AER measurements. Participants were then categorised into four patterns of AER trajectories: persistent, intermittent, progressing and regressing. Coefficients of variation were used to measure intra-individual AER variability. RESULTS: The median coefficient of variation of AER was 53.3%, 76.0% and 67.0% for subjects with normo-, micro- or macroalbuminuria at baseline. The coefficient of variation of AER was 37.7%, 66% and 94.8% for subjects with persistent, intermittent and progressing normoalbuminuria; 43%, 70.6%, 86.1% and 82.3% for subjects with persistent, intermittent, progressing and regressing microalbuminuria; and 55.2%, 67% and 82.4% for subjects with persistent, intermittent and regressing macroalbuminuria, respectively. CONCLUSION: High long-term variability of AER suggests that two out of three AER measurements may not always be adequate for the optimal categorisation and prediction of AER.

Using Routine Hemoglobin A1c Testing to Determine the Glycemic Status in Psychiatric Inpatients.

AIM: Using routine hemoglobin A1c (HbA1c) testing to describe the prevalence, characteristics, and length of stay (LOS) of psychiatry inpatients with type 2 diabetes compared to those with pre-diabetes and those without diabetes. METHODS: In this prospective observational study, all inpatients aged greater than 30 years admitted to the Austin Health Psychiatry Unit, a major tertiary hospital, affiliated with the University of Melbourne, between February 2014 and April 2015 had routine HbA1c testing as part of the Diabetes Discovery Initiative. Patients were divided into three groups: diabetes (HbA1c ≥ 6.5%, 48 mmol/mol), pre-diabetes (HbA1c 5.7-6.4%, 39-46 mmol/mol), or no diabetes (HbA1c ≤ 5.6%, 38 mmol/mol). Baseline characteristics, co-morbidities, psychiatric illnesses, and treatment were recorded. RESULTS: There were a total of 335 psychiatry inpatients (median age 41 years). The most prevalent diagnoses were schizophrenia, depression, and substance abuse. Of the 335 psychiatric inpatients, 14% (n = 46) had diabetes and 19% (n = 63) had pre-diabetes, a prevalence threefold greater than in the aged matched general population. Compared to inpatients with pre-diabetes and no diabetes, those with diabetes were older and were at least twice as likely to have hypertension, obesity, and hyperlipidemia (all p ≤ 0.002). In multivariable analyses, diabetes was associated with increasing age (p = 0.02), substance abuse (p = 0.04), dyslipidaemia (p = 0.03), and aripiprazole use (p = 0.01). Patients with diabetes also had a 70% longer expected LOS (95% CI: 20-130%; p = 0.001), compared to those with pre-diabetes and no diabetes. CONCLUSION: Despite relative youth, one-third of all psychiatric inpatients above the age of 30 have diabetes or pre-diabetes. Presence of diabetes in psychiatric inpatients is associated with older age, substance abuse, and longer LOS. Routine inpatient HbA1c testing provides an opportunity for early detection and optimization of diabetes care.

Serum uric acid and the relationship with subclinical organ damage in adults.

AIMS: Elevated serum uric acid (SUA) is often present in conditions associated with increased cardiovascular risk yet it is not recognized as a marker of risk. We evaluated whether SUA was associated with evidence of early markers of cardiovascular risk factor including subclinical early organ damage, sympathetic tone and metabolic profile in a healthy population with a high prevalence of obesity. MATERIAL AND METHODS: Data from 281 patients (175 women and 106 men, mean age: 35.5 ±â€Š0.8 years, mean BMI: 33.2 ±â€Š0.5 kg/m) were retrieved from a database. All participants were healthy, nonsmoker and free of medication. Available data included metabolic profile, muscle sympathetic nervous activity (MSNA, microneurography), endothelial function (pulse amplitude tonometry, augmentation index), estimated glomerular filtration rate (eGFR) and echocardiography. RESULTS: With participants grouped into sex-adjusted tertiles of SUA, those in the third tertile of SUA had increased waist circumference, worse metabolic profile (fasting glucose, total cholesterol, triglycerides and HDL), elevated MSNA, decreased endothelial function, increased augmentation index and decreased eGFR compared with those in the first tertile of SUA. In multiple regression analysis adjusted for age, sex, BMI and ethnicity, SUA was independently associated with waist circumference, low-density lipoprotein, triglycerides, augmentation index, MSNA and eGFR, providing a combined adjusted R = 0.599 or 60% of the overall variance. CONCLUSION: In a healthy population with a high proportion of obesity, SUA is associated with measures of metabolic, end-organ damage and sympathetic tone indicating the potential value of SUA as a marker of early cardiovascular disease development.