Medicine (St Vincent's) - Research Publications
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ItemEvaluation of an Algorithm to Guide Patients With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion on How to Respond to Real-Time Continuous Glucose Levels A randomized controlled trial(AMER DIABETES ASSOC, 2010-06)OBJECTIVE: To evaluate an algorithm guiding responses of continuous subcutaneous insulin infusion (CSII)-treated type 1 diabetic patients using real-time continuous glucose monitoring (RT-CGM). RESEARCH DESIGN AND METHODS: Sixty CSII-treated type 1 diabetic participants (aged 13-70 years, including adult and adolescent subgroups, with A1C
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ItemAsymmetric changes in circulating insulin levels after an increase compared with a reduction in insulin pump basal rate in people with Type 1 diabetes(WILEY, 2017-08)AIMS: To investigate circulating insulin profiles after a clinically relevant insulin pump basal rate increase vs a reduction, and the associated glucose responses. METHODS: A cohort of 12 adults with Type 1 diabetes undertook this two-stage university hospital study using Accu-Chek pumps (Roche Diagnostics, Mannheim, Germany) and insulin aspart. An insulin basal rate change of 0.2 unit/h (increase in first stage, reduction in second stage) was implemented at ~09:30 h, after a single overnight basal rate (without bolus insulin), while fasting participants rested. Frequent venous samples for the assessment of plasma free insulin, glucose and cortisol were collected from 60 min before until 300 min after rate change. The primary outcome was time to steady-state insulin. RESULTS: The 0.2-unit/h rate change represented a mean ± sd alteration of 23 ± 6%. After the rate increase, the median (interquartile range) times to 80% and 90% steady-state insulin were 170 (45) min and 197 (87) min, respectively. By contrast, after rate reduction, 80% steady-state insulin was not achieved. After the rate increase, mean ± se insulin levels increased by 4.3 ± 3.1%, 12.0 ± 2.9% and 25.6 ± 2.6% at 60, 120 and 300 min, respectively (with no significant difference until 180 min). After the rate reduction, insulin decreased by 8.3 ± 3.0% at 300 min (with no significant difference until 300 min). After rate reduction, glucose levels paradoxically declined by 17.4 ± 3.7% after 300 min; cortisol levels also fell during observation (P = 0.0003). CONCLUSIONS: The time to circulating insulin change after a 0.2-unit/h basal rate change was substantial, and was greater after a reduction than after an increase. Counter-regulatory hormone circadian variation may affect glycaemia when implementing minor changes at low basal rates. Both direction of basal rate change, and time of day, warrant consideration when anticipating the clinical effects of basal rate changes.
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ItemHealth-related behaviours in a remote Indigenous population with Type 2 diabetes: a Central Australian primary care survey in the Telehealth Eye and Associated Medical Services Network [TEAMSnet] project(WILEY, 2019-12)AIM: There is a wealth of data concerning the health behaviours of Indigenous Australians, but the health behaviours of Indigenous Australians with diabetes are not systematically documented. At the clinical level, understanding a person's health behaviours can help identify and address barriers to diabetes care and promote good clinical outcomes. METHODS: We used a novel survey tool to systematically collect health behaviour data on Smoking, Nutrition, Alcohol consumption, Physical activity and Emotional well-being (SNAPE) from Indigenous Australians with Type 2 diabetes in a remote primary care setting in Alice Springs. RESULTS: At least one of the five surveys in the SNAPE tool was completed by 210 participants: 30% male, mean age 52.6 years (range 22.9 - 87.4). Fifty per cent of men and 23% of women were current smokers (P < 0.001). None of the participants reported an adequate intake of vegetables. Only 9.6% reported an adequate fruit intake. Some 49% of men and 32% of women consumed alcohol in the past year (P = 0.022), and 46% of drinkers were considered high-risk or likely-dependent drinkers. On average, participants walked 10 min or more at a time 6.0 days a week and spent 4.8 h sitting on a weekday. Mean adapted Patient Health Questionnaire 9 score was 4.61, with 34% of participants having mild depressive symptoms and 11% having moderate-severe depressive symptoms. CONCLUSIONS: Our SNAPE survey tool results present a high-risk, disadvantaged Indigenous population with Type 2 diabetes. More resources will be needed to sustainably implement interventions with the goal of improving health behaviours and subsequent long-term health.
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ItemSuboptimal behaviour and knowledge regarding overnight glycaemia in adults with type 1 diabetes is common(WILEY, 2018-09)BACKGROUND: In people with type 1 diabetes (T1D), nocturnal hypoglycaemia (NH) can be slept through and can cause seizures, arrhythmias and death. Hypoglycaemia avoidance can induce hyperglycaemia and ketosis. Patient behaviour impacts clinical outcomes and may be changed by education. AIM: To develop and utilise a survey to evaluate patient self-management of overnight glycaemia in adults with T1D. METHODS: Adults with T1D attending two Australian tertiary referral diabetes clinics completed a survey about their diabetes self-management and glycaemic control, including responses to hypothetical pre-bed blood glucose (BG) levels (4-20 mmol/L). Statistical analyses included t-tests, Chi square tests and ANOVA with significance considered at P < 0.05. RESULTS: There were 205 participants (103 females), with a mean (SD) age of 41 (17) years, T1D duration of 20 (16) years, HbA1c of 7.8(1.4)%, (61.3(8.2) mmol/mol), 38% on insulin pump therapy (CSII) and 36% with impaired hypoglycaemia awareness (IHA). Mean (SD) number of BG tests/day was 5.4 (2.7). Patients set higher BG target levels at bedtime and overnight: 7.5(1.4) and 7.1(1.3) mmol/L, respectively, compared to daytime (6.9(1.0); P < 0.0001 and P = 0.002 respectively). Only 36% of participants reported treating nocturnal hypoglycaemia (NH) with the recommended refined, then complex, carbohydrate. Only 28% of patients made safe choices in all bedtime BG scenarios, with higher rates for CSII users, P = 0.0005. Further education was desired by 32% of respondents, with higher rates in those with (44%) versus without IHA (25%), P = 0.006. CONCLUSIONS: Many adults with T1D have suboptimal knowledge and behaviour regarding overnight BG self-management. A survey, piloted herein, may facilitate the identification of patients who could benefit from further education.
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ItemIncreased serum kallistatin levels in type 1 diabetes patients with vascular complications(BIOMED CENTRAL LTD, 2010)BACKGROUND: Kallistatin, a serpin widely produced throughout the body, has vasodilatory, anti-angiogenic, anti-oxidant, and anti-inflammatory effects. Effects of diabetes and its vascular complications on serum kallistatin levels are unknown. METHODS: Serum kallistatin was quantified by ELISA in a cross-sectional study of 116 Type 1 diabetic patients (including 50 with and 66 without complications) and 29 non-diabetic controls, and related to clinical status and measures of oxidative stress and inflammation. RESULTS: Kallistatin levels (mean(SD)) were increased in diabetic vs. control subjects (12.6(4.2) vs. 10.3(2.8) μg/ml, p = 0.007), and differed between diabetic patients with complications (13.4(4.9) μg/ml), complication-free patients (12.1(3.7) μg/ml), and controls; ANOVA, p = 0.007. Levels were higher in diabetic patients with complications vs. controls, p = 0.01, but did not differ between complication-free diabetic patients and controls, p > 0.05. On univariate analyses, in diabetes, kallistatin correlated with renal dysfunction (cystatin C, r = 0.28, p = 0.004; urinary albumin/creatinine, r = 0.34, p = 0.001; serum creatinine, r = 0.23, p = 0.01; serum urea, r = 0.33, p = 0.001; GFR, r = -0.25, p = 0.009), total cholesterol (r = 0.28, p = 0.004); LDL-cholesterol (r = 0.21, p = 0.03); gamma-glutamyltransferase (GGT) (r = 0.27, p = 0.04), and small artery elasticity, r = -0.23, p = 0.02, but not with HbA1c, other lipids, oxidative stress or inflammation. In diabetes, geometric mean (95%CI) kallistatin levels adjusted for covariates, including renal dysfunction, were higher in those with vs. without hypertension (13.6 (12.3-14.9) vs. 11.8 (10.5-13.0) μg/ml, p = 0.03). Statistically independent determinants of kallistatin levels in diabetes were age, serum urea, total cholesterol, SAE and GGT, adjusted r2 = 0.24, p < 0.00001. CONCLUSIONS: Serum kallistatin levels are increased in Type 1 diabetic patients with microvascular complications and with hypertension, and correlate with renal and vascular dysfunction.
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ItemHbA1c variability in adults with type 1 diabetes on continuous subcutaneous insulin infusion (CSII) therapy compared to multiple daily injection (MDI) treatment.(BMJ, 2019-12-29)OBJECTIVE: To determine if continuous subcutaneous insulin infusion (CSII) therapy is associated with lower glycated haemoglobin (HbA1c) variability (long-term glycaemic variability; GV) relative to multiple daily injection (MDI) treatment in adults with type 1 diabetes mellitus (T1DM). DESIGN: Retrospective audit. SETTING AND PARTICIPANTS: Clinic records from 506 adults with T1DM from two tertiary Australian hospitals. OUTCOME MEASURES: Long-term GV was assessed by HbA1c SD and coefficient of variation (CV) in adults on established MDI or CSII therapy, and in a subset changing from MDI to CSII. RESULTS: Adults (n=506, (164 CSII), 50% women, mean±SD age 38.0±15.3 years, 17.0±13.7 years diabetes, mean HbA1c 7.8%±1.2% (62±13 mmol/mol) on CSII, 8.0%±1.5% (64±16 mmol/mol) on MDI) were followed for 4.1±3.6 years. CSII use was associated with lower GV (HbA1c SD: CSII vs MDI 0.5%±0.41% (6±6 mmol/mol) vs 0.7%±0.7% (9±8 mmol/mol)) and CV: CSII vs MDI 6.7%±4.6% (10±10 mmol/mol) vs 9.3%±7.3% (14±13 mmol/mol), both p<0.001. Fifty-six adults (73% female, age 36±13 years, 16±13 years diabetes, HbA1c 7.8%±0.8% (62±9 mmol/mol)) transitioned from MDI to CSII. Mean HbA1c fell by 0.4%. GV from 1 year post-CSII commencement decreased significantly, HbA1c SD pre-CSII versus post-CSII 0.7%±0.5% (8±5 mmol/mol) vs 0.4%±0.4% (5±4 mmol/mol); p<0.001, and HbA1c CV 9.2%±5.5% (13±8 mmol/mol) vs 6.1%±3.9% (9±5 mmol/mol); p<0.001. CONCLUSIONS: In clinical practice with T1DM adults relative to MDI, CSII therapy is associated with lower HbA1c GV.
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ItemAn exploratory trial of insulin initiation and titration among patients with type 2 diabetes in the primary care setting with retrospective continuous glucose monitoring as an adjunct: INITIATION study protocol(BMC, 2014-05-03)BACKGROUND: Insulin initiation and titration in primary care is necessary to respond to the growing epidemic of type 2 diabetes (T2D). The INITIATION study aims to evaluate the impact of implementing a new model of care with Primary Care Physician and Practice Nurse (PN) teams supported by a Credentialed Diabetes Educator-Registered Nurse (CDE-RN) and endocrinologist in initiating and titrating basal and prandial insulin for T2D patients in the Australian healthcare system over 24 weeks. This study also explores the feasibility and efficacy of retrospective continuous glucose monitoring (r-CGM) in comparison with self-monitoring of blood glucose (SMBG) among people with T2D in primary care. METHODS/DESIGN: The study employs a before and after design with a nested exploratory trial of SMBG and r-CGM. A total of 102 insulin naïve T2D patients with a glycated haemoglobin (HbA1c) level of >7.5% in the previous 6 months while treated with maximal oral therapy will be recruited and screened from 22 primary care practices in Melbourne, Australia. All patients will be commenced on a basal insulin regimen following randomization into one of the two blood glucose monitoring arms, with intensification to a "basal plus" regimen if required. The outcomes of the new model of care will be benchmarked with data collected over the same period from a specialist setting in Melbourne, Australia. DISCUSSION: This article describes the study protocol and insulin treatment algorithm employed in the first study to explore r-CGM use among T2D in primary care. Findings from the INITIATION study will inform development of a larger randomized controlled trial. TRIAL REGISTRATION: ACTRN12610000797077.
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ItemSocioeconomic status and time in glucose target range in people with type 2 diabetes: a baseline analysis of the GP-OSMOTIC study(BMC, 2018-07-21)BACKGROUND: Optimal glycaemia, reflected by glycated haemoglobin (HbA1c) levels, is key in reducing type 2 diabetes (T2D) complications. However, most people with T2D have suboptimal recall and understanding of HbA1c. Continuous glucose monitoring (CGM) measures glucose levels every 5 to 15-min over days and may be more readily understood. Given that T2D is more common in lower socioeconomic settings, we aim to study relationships between socioeconomic status (SES) and percentage time in glucose target range (TIR) which is a key metric calculated from CGM. METHODS: Analysis of baseline data from the General Practice Optimising Structured MOnitoring To Improve Clinical outcomes (GP-OSMOTIC) randomised controlled trial (October 2016 - November 2017) of 300 people with T2D from 25 Victorian General Practices. FreeStyle Libre Pro® sensor patch was used for this study. SES was defined by the Index of Relative Socio-economic Disadvantage (IRSD) and educational attainment. Univariable and multivariable mixed-effects linear regression analyses controlling for age, BMI, diet, exercise and study arm were performed. RESULTS: One hundred and sixty-seven (60.1%) participants were male, the mean (SD) participant age was 61.0 (9.7) years, and the mean (SD) duration of CGM use was 12.3 (2.5) days. The 10th IRSD decile (least disadvantaged) was associated with a 15% higher TIR vs. the 1st decile (most disadvantaged) (95% CI 5, 25; p = 0.003) and a 0.6% lower HbA1c (95% CI 0.1, 1; p = 0.03). There was no evidence of an association between educational attainment and TIR/HbA1c. CONCLUSION: Higher SES measured at an area level is associated with better achievement of glycaemic target using complementary measures of HbA1c and TIR in the GP-OSMOTIC cohort. Given that TIR may be more easily used in patient education and self-management support compared to HbA1c values, the social gradient identified in TIR provides an opportunity for clinicians and policy makers to address health inequities in T2D. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry Trial ACTRN12616001372471 , prospective, Date registered 4/10/2016.
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ItemPrescribing of diabetes medications to people with type 2 diabetes and chronic kidney disease: a national cross-sectional study(BMC, 2019-02-18)BACKGROUND: Previous studies in general practice and hospital settings have identified that prescribing of non-insulin diabetes medications may be sub-optimal in people with type 2 diabetes (T2D) and renal impairment. Since these publications, a number of new medications have become available for the management of T2D. Study aims were to, in a cohort of Australians with T2D and renal impairment attending general practice, (1) investigate whether the prescribing of non-insulin diabetes medications is consistent with dosing adjustments recommended within current Australian Diabetes Society (ADS) guidelines; and (2) identify patient socio-demographic and clinical factors associated with at least one prescription of a non-insulin diabetes medication inconsistent with current ADS guidelines for medication doses. METHODS: Cross-sectional study using data from the MedicineInsight general practice database managed by NPS MedicineWise. Patients with T2D who were aged 18 years and over, with an average eGFR< 60 ml/min/1.73m2 and at least one prescription of a non-insulin diabetes medication between 1st January 2015 and 30th June 2017 were included. Descriptive statistics were used to summarise patient characteristics and medication use. Marginal logistic regression models were used to estimate associations between sociodemographic and clinical factors and prescribing of ≥1non-insulin diabetes medicine not consistent with ADS guidelines. RESULTS: The majority of the 3505 patients included (90.4%) had an average eGFR of 30-59 ml/min/1.73m2. In terms of absolute numbers, metformin was the medication most frequently prescribed at a dose not consistent with current ADS guidelines for dosing in renal impairment (n = 1601 patients), followed by DPP4 inhibitors (n = 611) and sulphonylureas (n = 278). The drug classes with the highest proportion of prescriptions with dosage not consistent with ADS guidelines were SGLT2 inhibitors (83%), followed by biguanides (58%) and DPP4 inhibitors (46%). Higher HbA1c, longer known diabetes duration and diagnosis of retinopathy were associated with receiving ≥1prescription with a dosage not consistent with guidelines. CONCLUSIONS: Prescribing of non-insulin diabetes medications at doses inconsistent with current ADS guideline recommendations for dosing adjustments for people with renal impairment was common. Further research is needed to understand how general practitioners access, interpret and apply the ADS guidelines and the impact this may have on patient outcomes.
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ItemEffect of 6 months of hybrid closed-loop insulin delivery in adults with type 1 diabetes: a randomised controlled trial protocol(BMJ PUBLISHING GROUP, 2018-06)INTRODUCTION: Manual determination of insulin dosing largely fails to optimise glucose control in type 1 diabetes. Automated insulin delivery via closed-loop systems has improved glucose control in short-term studies. The objective of the present study is to determine the effectiveness of 6 months' closed-loop compared with manually determined insulin dosing on time-in-target glucose range in adults with type 1 diabetes. METHODS AND ANALYSIS: This open-label, seven-centre, randomised controlled parallel group clinical trial will compare home-based hybrid closed-loop versus standard diabetes therapy in Australia. Adults aged ≥25 years with type 1 diabetes using intensive insulin therapy (via multiple daily injections or insulin pump, total enrolment target n=120) will undertake a run-in period including diabetes and carbohydrate-counting education, clinical optimisation and baseline data collection. Participants will then be randomised 1:1 either to 26 weeks of MiniMed 670G hybrid closed-loop system therapy (Medtronic, Northridge, CA, USA) or continuation of their current diabetes therapy. The hybrid closed-loop system delivers insulin automatically to address basal requirements and correct to target glucose level, while bolus doses for meals require user initiation and carbohydrate estimation. Analysis will be intention to treat, with the primary outcome time in continuous glucose monitoring (CGM) target range (3.9-10.0 mmol/L) during the final 3 weeks of intervention. Secondary outcomes include: other CGM parameters, HbA1c, severe hypoglycaemia, psychosocial well-being, sleep, cognition, electrocardiography, costs, quality of life, biomarkers of vascular health and hybrid closed-loop system performance. Semistructured interviews will assess the expectations and experiences of a subgroup of hybrid closed-loop users. ETHICS AND DISSEMINATION: The study has Human Research Ethics Committee approval. The study will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. Results will be disseminated at scientific conferences and via peer-reviewed publications. TRIAL REGISTRATION NUMBER: ACTRN12617000520336; Pre-results.