Study protocol for a randomised open-label clinical trial examining the safety and efficacy of the Android Artificial Pancreas System (AAPS) with advanced bolus-free features in adults with type 1 diabetes: the 'CLOSE IT' (Closed Loop Open SourcE In Type 1 diabetes) trial.

INTRODUCTION: Multiple automated insulin delivery (AID) systems have become commercially available following randomised controlled trials demonstrating benefits in people with type 1 diabetes (T1D). However, their real-world utility may be undermined by user-associated burdens, including the need to carbohydrate count and deliver manual insulin boluses. There is an important need for a 'fully automated closed loop' (FCL) AID system, without manual mealtime boluses. The (Closed Loop Open SourcE In Type 1 diabetes) trial is a randomised trial comparing an FCL AID system to the same system used as a hybrid closed loop (HCL) in people with T1D, in an outpatient setting over an extended time frame. METHODS AND ANALYSIS: Randomised, open-label, parallel, non-inferiority trial comparing the Android Artificial Pancreas System (AAPS) AID algorithm used as FCL to the same algorithm used as HCL. Seventy-five participants aged 18-70 will be randomised (1:1) to one of two treatment arms for 12 weeks: (a) FCL-participants will be advised not to bolus for meals and (b) HCL-participants will use the AAPS AID algorithm as HCL with announced meals. The primary outcome is the percentage of time in target sensor glucose range (3.9-10.0 mmol/L). Secondary outcomes include other glycaemic metrics, safety, psychosocial factors, platform performance and user dietary factors. Twenty FCL arm participants will participate in a 4-week extension phase comparing glycaemic and dietary outcomes using NovoRapid (insulin aspart) to Fiasp (insulin aspart and niacinamide). ETHICS AND DISSEMINATION: Approvals are by the Alfred Health Ethics Committee (615/22) (Australia) and Health and Disability Ethics Committees (2022 FULL 13832) (New Zealand). Each participant will provide written informed consent. Data protection and confidentiality will be ensured. Study results will be disseminated by publications, conferences and patient advocacy groups. TRIAL REGISTRATION NUMBERS: ACTRN12622001400752 and ACTRN12622001401741.

Hybrid Closed Loop Using a Do-It-Yourself Artificial Pancreas System in Adults With Type 1 Diabetes.

OBJECTIVE: There is increasing use of open-source artificial pancreas systems (APS) in the management of Type 1 diabetes. Our aim was to assess the safety and efficacy of the automated insulin delivery system AndroidAPS (AAPS), compared with stand-alone pump therapy in people with type 1 diabetes. The primary outcome was the difference in the percentage of time in range (TIR, 70-180 mg/dL). Secondary aims included mean sensor glucose value and percent continuous glucose monitor (CGM) time below range (TBR, <70 mg/dL). RESEARCH DESIGN AND METHODS: This open-label single-center randomized crossover study (ANZCTR, Australian New Zealand clinical trial registry, ANZCTR-ACTRN12620001191987) comprised 20 participants with type 1 diabetes on established pump therapy, assigned to either stand-alone insulin pump therapy or the open-source AAPS hybrid closed-loop system for four weeks, with crossover to the alternate arm for the following four weeks. The CGM outcome parameters were measured by seven-day CGM at baseline and the final week of each four-week study arm. RESULTS: Twenty participants were recruited (60% women), aged 45.8 ± 15.9 years, with mean diabetes duration of 23.9 ± 13.2 years, baseline glycated hemoglobin (HbA1c) 7.5% ± 0.5% (58 ± 6 mmol/mol) and mean TIR 62.3% ± 12.9%. The change in TIR from baseline for AAPS compared with stand-alone pump therapy was 18.6% (11.4-25.9), (P < .001), TIR 76.6% ± 11.7%, 58.0% ± 15.6%, for AAPS and stand-alone pump, respectively. Time glucose <54 mg/dL was not increased (mean = -2.0%, P = .191). No serious adverse events or episodes of severe hypoglycemia were recorded. CONCLUSIONS: This clinical trial of the open-source AAPS hybrid closed-loop system performed in an at-home setting demonstrated comparable safety to stand-alone pump therapy. The glycemic outcomes of AAPS were superior with improved TIR, and there was no significant difference in TBR compared with stand-alone pump therapy.

Impact of age at type 2 diabetes mellitus diagnosis on mortality and vascular complications: systematic review and meta-analyses.

AIMS/HYPOTHESIS: Few studies examine the association between age at diagnosis and subsequent complications from type 2 diabetes. This paper aims to summarise the risk of mortality, macrovascular complications and microvascular complications associated with age at diagnosis of type 2 diabetes. METHODS: Data were sourced from MEDLINE and All EBM (Evidence Based Medicine) databases from inception to July 2018. Observational studies, investigating the effect of age at diabetes diagnosis on macrovascular and microvascular diabetes complications in adults with type 2 diabetes were selected according to pre-specified criteria. Two investigators independently extracted data and evaluated all studies. If data were not reported in a comparable format, data were obtained from authors, presented as minimally adjusted ORs (and 95% CIs) per 1 year increase in age at diabetes diagnosis, adjusted for current age for each outcome of interest. The study protocol was recorded with PROSPERO International Prospective Register of Systematic Reviews (CRD42016043593). RESULTS: Data from 26 observational studies comprising 1,325,493 individuals from 30 countries were included. Random-effects meta-analyses with inverse variance weighting were used to obtain the pooled ORs. Age at diabetes diagnosis was inversely associated with risk of all-cause mortality and macrovascular and microvascular disease (all p < 0.001). Each 1 year increase in age at diabetes diagnosis was associated with a 4%, 3% and 5% decreased risk of all-cause mortality, macrovascular disease and microvascular disease, respectively, adjusted for current age. The effects were consistent for the individual components of the composite outcomes (all p < 0.001). CONCLUSIONS/INTERPRETATION: Younger, rather than older, age at diabetes diagnosis was associated with higher risk of mortality and vascular disease. Early and sustained interventions to delay type 2 diabetes onset and improve blood glucose levels and cardiovascular risk profiles of those already diagnosed are essential to reduce morbidity and mortality. Graphical abstract.

Development, Relative Validity and Reproducibility of the Aus-SDS (Australian Short Dietary Screener) in Adults Aged 70 Years and Above.

The aim of this study was to assess the relative validity and reproducibility of a six-item Australian Short Dietary Screener (Aus-SDS). The Aus-SDS assessed the daily intake of core food groups (vegetables, fruits, legumes and beans, cereals, protein sources and dairy sources) in 100 Australians (52 males and 48 females) aged ≥70 years. Relative validity was assessed by comparing intakes from the Aus-SDS1 with an average of three 24-hour recalls (24-HRs), and reproducibility using two administrations of the Aus-SDS (Aus-SDS1 and Aus-SDS2). Cohen's kappa statistic between the Aus-SDS1 and 24-HRs showed moderate to good agreement, ranging from 0.44 for fruits and dairy to 0.64 for protein. There was poor agreement for legume intake (0.12). Bland-Altman plots demonstrated acceptable limits of agreement between the Aus-SDS1 and 24-HRs for all food groups. Median intakes obtained from Aus-SDS1 and Aus-SDS2 did not differ. For all food groups, Cohen's kappa statistic ranged from 0.68 to 0.89, indicating acceptable agreement between the Aus-SDS1 and Aus-SDS2. Spearman's correlation coefficient between Aus-SDS1 and 24-HRs across all food groups ranged from 0.64 for fruit to 0.83 for protein. We found the Aus-SDS to be a useful tool in assessing daily intake of core food groups in this population.

Association between Dietary Intake and Lipid-Lowering Therapy: Prospective Analysis of Data from Australian Diabetes, Obesity, and Lifestyle Study (AusDiab) Using a Quantile Regression Approach.

Lipid-lowering therapy (LLT) should be accompanied by dietary guidance for cardiovascular risk reduction; however, current evidence suggests sub-optimal dietary behaviors in those on LLT. We examined the associations between the dietary intake of key food groups (vegetables, fruit, cereal, protein, and dairy) and LLT use in Australian adults using quantile regression. We used data from the Australian Diabetes, Obesity and Lifestyle Study (AusDiab), a prospective population-based study of adults aged ≥25 years, conducted over 5 years (1999-2005). Measurements included a 121-item food frequency questionnaire and LLT use. LLT use was categorized as: LLT users (n = 446), commenced LLT (n = 565), ceased LLT (n = 71), and non-users (n = 4813). Less than 1% of the cohort met recommended intakes of all food groups at the baseline and follow up. The median daily dietary intake at the follow up among LLT users was 2.2 serves of vegetables, 1.4 serves of fruit, 2.8 serves of cereal, 2.0 serves of protein, and 1.4 serves of dairy. Adjusted analysis showed no differences across the quantiles of intake of key food groups in LLT users and commenced LLT compared to non-users. The LLT medication status is not associated with any difference in meeting recommended intakes of key foods.

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.

The Effects of Statins on Physical Activity or Physical Fitness Among Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

This review examines the effects of statins on physical activity and/or fitness, as statins can have adverse muscle effects. A search was done of MEDLINE, Embase, and EBMR databases up to July 2018 for randomized controlled trials comparing statin with placebo or control, measuring physical activity and/or fitness in adults. Sixteen randomized controlled trials (total participants [N] = 2,944) were included, 6 randomized controlled trials contributed data for meta-analysis. Random effects meta-analysis examined differences in physical fitness, maximal exercise time (in seconds) in exercise testing, and maximal heart rate (in beats per minute) between statins and control. No significant difference between statin and control for maximal heart rate (mean difference = 2.8 beats per minute, 95% confidence interval [-7.4, 13.0]; p = .59) nor exercise time (mean difference = 82.8 s, 95% confidence interval [-31.9, 197.4]; p = .516) were seen. There were insufficient studies reporting habitual physical activity to perform a meta-analysis. This review found no evidence for an effect of statins on physical activity or fitness, but data availability is limited.

Age-related differences in glycaemic control, cardiovascular disease risk factors and treatment in patients with type 2 diabetes: a cross-sectional study from the Australian National Diabetes Audit.

OBJECTIVE: To compare the glycaemic control and cardiovascular risk factor profiles of younger and older patients with type 2 diabetes. Cross-sectional analysis of data from the 2015 Australian National Diabetes Audit was undertaken. METHODS: Data were obtained from adults with type 2 diabetes presenting to Australian secondary/tertiary diabetes centres. Logistic regression examined associations with glycated haemoglobin A1c (HbA1c) >7% (53 mmol/mol) and cardiovascular risk factors. RESULTS: Data from 3492 patients were analysed. Mean (±SD) age was 62.9±12.5 years, mean diabetes duration 13.5±9.4 years and mean HbA1c 8.2%±1.8%. Mean HbA1c was 8.6%±2.1% and 8.0%±1.6% for the younger (<60 years) and older subgroups (≥60 years), respectively (p<0.001). The adjusted OR (aOR) of HbA1c above >7.0% was 1.5 times higher (95% CI 1.22 to 1.84) for younger patients compared with older patients after adjustment for gender, smoking, diabetes duration, renal function and body mass index. Younger patients were also more likely to have dyslipidaemia (aOR 2.02, 95% CI 1.53 to 2.68; p<0.001), be obese (aOR 1.25, 95% CI 1.05 to 1.49; p<0.001) and be current smokers (aOR 2.13 95% CI 1.64 to 2.77; p<0.001) than older patients. CONCLUSIONS: Younger age was associated with poorer glycaemic control and adverse cardiovascular risk factor profiles. It is imperative to optimise and monitor treatment in order to improve long-term outcomes.

Risk-adjustment of diabetes health outcomes improves the accuracy of performance benchmarking.

Benchmarking clinical performance by comparing diabetes health outcomes across healthcare providers drives quality improvement. Non-care related patient risk factors are likely to confound clinical performance, but few studies have tested this. This cross-sectional study is the first Australian investigation to analyse the effect of risk-adjustment for non-care related patient factors on benchmarking. Data from 4,670 patients with type 2 (n = 3,496) or type 1 (n = 1,174) were analysed across 49 diabetes centres. Diabetes health outcomes (HbA1c levels, LDL-cholesterol levels, systolic blood pressure and rates of severe hypoglycaemia) were risk-adjusted for non-care related patient factors using multivariate stepwise linear and logistic regression models. Unadjusted and risk-adjusted funnel plots were constructed for each outcome to identify low-performing and high-performing outliers. Unadjusted funnel plots identified 27 low-performing outliers and 15 high-performing outliers across all diabetes health outcomes. After risk-adjustment, 22 (81%) low-performing outliers and 13 (87%) high-performing outliers became inliers. Additionally, one inlier became a low-performing outlier. Risk-adjustment of diabetes health outcomes significantly reduced false positives and false negatives for outlier performance, hence providing more accurate information to guide quality improvement activity.

Burden of cardiovascular risk factors and disease among patients with type 1 diabetes: results of the Australian National Diabetes Audit (ANDA).

BACKGROUND: Cardiovascular risk stratification is complex in type 1 diabetes. We hypothesised that traditional and diabetes-specific cardiovascular risk factors were prevalent and strongly associated with cardiovascular disease (CVD) among adults with type 1 diabetes attending Australian diabetes centres. METHODS: De-identified, prospectively collected data from patients with type 1 diabetes aged ≥ 18 years in the 2015 Australian National Diabetes Audit were analysed. The burden of cardiovascular risk factors [age, sex, diabetes duration, glycated haemoglobin (HbA1c), blood pressure, lipid profile, body mass index, smoking status, retinopathy, renal function and albuminuria] and associations with CVD inclusive of stroke, myocardial infarction, coronary artery bypass graft surgery/angioplasty and peripheral vascular disease were assessed. Restricted cubic splines assessed for non-linearity of diabetes duration and likelihood ratio test assessed for interactions between age, diabetes duration, centre type and cardiovascular outcomes of interest. Discriminatory ability of multivariable models were assessed with area under the receiver operating characteristic (ROC) curves. RESULTS: Data from 1169 patients were analysed. Mean (± SD) age and median diabetes duration was 40.0 (± 16.7) and 16.0 (8.0-27.0) years respectively. Cardiovascular risk factors were prevalent including hypertension (21.9%), dyslipidaemia (89.4%), overweight/obesity (56.4%), ever smoking (38.5%), albuminuria (31.1%), estimated glomerular filtration rate < 60 mL/min/1.73 m2 (10.3%) and HbA1c > 7.0% (53 mmol/mol) (81.0%). Older age, longer diabetes duration, smoking and antihypertensive therapy use were positively associated with CVD, while high density lipoprotein-cholesterol and diastolic blood pressure were negatively associated (p < 0.05). Association with CVD and diabetes duration remained constant until 20 years when a linear increase was noted. Longer diabetes duration also had the highest population attributable risk of 6.5% (95% CI 1.4, 11.6). Further, the models for CVD demonstrated good discriminatory ability (area under the ROC curve 0.88; 95% CI 0.84, 0.92). CONCLUSIONS: Cardiovascular risk factors were prevalent and strongly associated with CVD among adults with type 1 diabetes attending Australian diabetes centres. Given the approximate J-shaped association between type 1 diabetes duration and CVD, the impact of cardiovascular risk stratification and management before and after 20 years duration needs to be further assessed longitudinally. Diabetes specific cardiovascular risk stratification tools incorporating diabetes duration should be an important consideration in future guideline development.

Depression and diabetes distress in adults with type 2 diabetes: results from the Australian National Diabetes Audit (ANDA) 2016.

This study explores the prevalence of, and factors associated with, likely depression and diabetes distress in adults with type 2 diabetes in a large, national sample. Australian National Diabetes Audit data were analysed from adults with type 2 diabetes attending 50 diabetes centres. The Brief Case find for Depression and Diabetes Distress Score 17 were administered to screen for likely depression and diabetes-related distress, respectively. A total of 2,552 adults with type 2 diabetes participated: (mean ± SD) age was 63 ± 13 years, diabetes duration was 12 ± 10 years, and HbA1c was 8 ± 2%. Twenty-nine percent of patients had likely depression, 7% had high diabetes distress, and 5% had both. Difficulty following dietary recommendations, smoking, forgetting medications, and diabetes distress were all associated with greater odds of depression whereas higher own health rating was associated with lower odds (all p < 0.02). Female gender, increasing HbA1c, insulin use, difficulty following dietary recommendations and depression were all associated with greater odds of diabetes distress & older age, higher own health rating and monitoring blood glucose levels as recommended were associated with lower odds (all p < 0.04). Depression was associated with sub-optimal self-care, while diabetes distress was associated with higher HbA1c and sub-optimal self-care.

Impact of age at diagnosis and duration of type 2 diabetes on mortality in Australia 1997-2011.

AIMS/HYPOTHESIS: Current evidence suggests that type 2 diabetes may have a greater impact on those with earlier diagnosis (longer duration of disease), but data are limited. We examined the effect of age at diagnosis of type 2 diabetes on the risk of all-cause and cause-specific mortality over 15 years. METHODS: The data of 743,709 Australians with type 2 diabetes who were registered on the National Diabetes Services Scheme (NDSS) between 1997 and 2011 were examined. Mortality data were derived by linking the NDSS to the National Death Index. All-cause mortality and mortality due to cardiovascular disease (CVD), cancer and all other causes were identified. Poisson regression was used to model mortality rates by sex, current age, age at diagnosis, diabetes duration and calendar time. RESULTS: The median age at registration on the NDSS was 60.2 years (interquartile range [IQR] 50.9-69.5) and the median follow-up was 7.2 years (IQR 3.4-11.3). The median age at diagnosis was 58.6 years (IQR 49.4-67.9). A total of 115,363 deaths occurred during 7.20 million person-years of follow-up. During the first 1.8 years after diabetes diagnosis, rates of all-cause and cancer mortality declined and CVD mortality was constant. All mortality rates increased exponentially with age. An earlier diagnosis of type 2 diabetes (longer duration of disease) was associated with a higher risk of all-cause mortality, primarily driven by CVD mortality. A 10 year earlier diagnosis (equivalent to 10 years' longer duration of diabetes) was associated with a 1.2-1.3 times increased risk of all-cause mortality and about 1.6 times increased risk of CVD mortality. The effects were similar in men and women. For mortality due to cancer (all cancers and colorectal and lung cancers), we found that earlier diagnosis of type 2 diabetes was associated with lower mortality compared with diagnosis at an older age. CONCLUSIONS/INTERPRETATION: Our findings suggest that younger-onset type 2 diabetes increases mortality risk, and that this is mainly through earlier CVD mortality. Efforts to delay the onset of type 2 diabetes might, therefore, reduce mortality.

Age, age at diagnosis and diabetes duration are all associated with vascular complications in type 2 diabetes.

BACKGROUND: Type 2 diabetes (T2DM) is increasingly diagnosed in younger patients. The trajectory of complications in patients diagnosed at a younger or older age is not well understood. We examine the associations between age, age at diagnosis and diabetes duration and vascular complications in patients with T2DM. METHODS: A cross-sectional study of pre-specified demographic and clinical data, from 3419 adults with T2DM participating in the Australian National Diabetes Audit (2015). Factors associated with diabetes complications were analysed using logistic regression. RESULTS: Mean (±SD) current age was 62.9±12.5years, age at diagnosis was 49.4±12.3years and mean diabetes duration was 13.5±9.4years. Macrovascular complications were more prevalent in patients who were older at diabetes diagnosis whereas microvascular complications were more prevalent in patients who were younger at diabetes diagnosis. Age, age at diagnosis and diabetes duration were all independently associated with increased risk of macrovascular complications after adjustment for sex, smoking, BMI and microvascular complications (all p<0.001). In contrast, only diabetes duration was independently associated with microvascular complications after adjustment for sex, smoking, BMI and macrovascular complications (p<0.001). CONCLUSIONS: Age, age at diagnosis, and diabetes duration were all independently associated with macrovascular complications whereas only diabetes duration was independently associated with microvascular complications.

Utilisation of prehospital emergency medical services for hyperglycaemia: A community-based observational study.

AIMS: This study examines prehospital Emergency Medical Service (EMS) utilisation and patterns of demand for hyperglycaemia management, including characteristics of individuals and factors related to hospital transport. MATERIALS AND METHODS: A state-wide, community-based observational study of all patients requiring prehospital EMS for hyperglycaemia during a 7 year study period (Jan 2009-Dec 2015) using electronic data from the Ambulance Victoria data warehouse was conducted. Pre-specified variables related to patient demographics, comorbidities, examination findings, paramedic treatment and transport outcomes were obtained. Logistic regression was used to assess factors associated with transport to hospital. RESULTS: There were 11,417 cases of hyperglycaemia attended by paramedics during the study period, accounting for 0.3-0.4% of the total annual EMS caseload, and equating to 0.54 attendances per 100 people with diabetes in the state of Victoria, Australia, per year. There was a significant increase in annual utilisation, with a rate ratio of 1.62 between 2009 (2.42 cases per 10,000 population) and 2015 (3.91 cases per 10,000 population). Fifty-one percent of cases had type 2 diabetes, 37% had type 1 diabetes, 4% had diabetes with the type unspecified and 8% had no recorded history of diabetes. Ninety percent of cases were transported to hospital. Factors associated with increased odds of transport to hospital included no known history of diabetes, regional/rural locations, case time between 0600 and <1800 hours, increasing number of comorbidities and increasingly unstable vital sign observations. CONCLUSION: There is substantial utilisation of prehospital EMS for hyperglycaemia. With increased population prevalence of diabetes predicted, further research on opportunities for prevention, as well as optimal management in the prehospital environment is warranted.

Time series modelling to forecast prehospital EMS demand for diabetic emergencies.

BACKGROUND: Acute diabetic emergencies are often managed by prehospital Emergency Medical Services (EMS). The projected growth in prevalence of diabetes is likely to result in rising demand for prehospital EMS that are already under pressure. The aims of this study were to model the temporal trends and provide forecasts of prehospital attendances for diabetic emergencies. METHODS: A time series analysis on monthly cases of hypoglycemia and hyperglycemia was conducted using data from the Ambulance Victoria (AV) electronic database between 2009 and 2015. Using the seasonal autoregressive integrated moving average (SARIMA) modelling process, different models were evaluated. The most parsimonious model with the highest accuracy was selected. RESULTS: Forty-one thousand four hundred fifty-four prehospital diabetic emergencies were attended over a seven-year period with an increase in the annual median monthly caseload between 2009 (484.5) and 2015 (549.5). Hypoglycemia (70%) and people with type 1 diabetes (48%) accounted for most attendances. The SARIMA (0,1,0,12) model provided the best fit, with a MAPE of 4.2% and predicts a monthly caseload of approximately 740 by the end of 2017. CONCLUSIONS: Prehospital EMS demand for diabetic emergencies is increasing. SARIMA time series models are a valuable tool to allow forecasting of future caseload with high accuracy and predict increasing cases of prehospital diabetic emergencies into the future. The model generated by this study may be used by service providers to allow appropriate planning and resource allocation of EMS for diabetic emergencies.

Correction: Using Automated HbA1c Testing to Detect Diabetes Mellitus in Orthopedic Inpatients and Its Effect on Outcomes.

[This corrects the article DOI: 10.1371/journal.pone.0168471.].

Using Automated HbA1c Testing to Detect Diabetes Mellitus in Orthopedic Inpatients and Its Effect on Outcomes.

AIMS: The prevalence of diabetes is rising, and people with diabetes have higher rates of musculoskeletal-related comorbidities. HbA1c testing is a superior option for diabetes diagnosis in the inpatient setting. This study aimed to (i) demonstrate the feasibility of routine HbA1c testing to detect the presence of diabetes mellitus, (ii) to determine the prevalence of diabetes in orthopedic inpatients and (iii) to assess the association between diabetes and hospital outcomes and post-operative complications in orthopedic inpatients. METHODS: All patients aged ≥54 years admitted to Austin Health between July 2013 and January 2014 had routine automated HbA1c measurements using automated clinical information systems (CERNER). Patients with HbA1c ≥6.5% were diagnosed with diabetes. Baseline demographic and clinical data were obtained from hospital records. RESULTS: Of the 416 orthopedic inpatients included in this study, 22% (n = 93) were known to have diabetes, 4% (n = 15) had previously unrecognized diabetes and 74% (n = 308) did not have diabetes. Patients with diabetes had significantly higher Charlson comorbidity scores compared to patients without diabetes (median, IQR; 1 [0,2] vs 0 [0,0], p<0.001). After adjusting for age, gender, comorbidity score and estimated glomerular filtration rate, no significant differences in the length of stay (IRR = 0.92; 95%CI: 0.79-1.07; p = 0.280), rates of intensive care unit admission (OR = 1.04; 95%CI: 0.42-2.60, p = 0.934), 6-month mortality (OR = 0.52; 95%CI: 0.17-1.60, p = 0.252), 6-month hospital readmission (OR = 0.93; 95%CI: 0.46-1.87; p = 0.828) or any post-operative complications (OR = 0.98; 95%CI: 0.53-1.80; p = 0.944) were observed between patients with and without diabetes. CONCLUSIONS: Routine HbA1c measurement using CERNER allows for rapid identification of inpatients admitted with diabetes. More than one in four patients admitted to a tertiary hospital orthopedic ward have diabetes. No statistically significant differences in the rates of hospital outcomes and post-operative complications were identified between patients with and without diabetes.

Utilisation of emergency medical services for severe hypoglycaemia: An unrecognised health care burden.

AIMS: Diabetes is associated with several acute, life-threatening complications yet there are limited data on the utilisation of prehospital services for their management. This study aimed to examine the utilisation of emergency medical services (EMS) for prehospital hypoglycaemia, including patient characteristics and factors related to hospital transportation. METHODS: An observational study of patients requiring EMS for hypoglycaemia across Victoria, Australia over three years was conducted. Pre-specified data including patient demographics, comorbidities, examination findings and transport outcomes were obtained. Logistic regression was used to assess factors associated with transportation. RESULTS: During the study period, 12,411 hypoglycaemia events were attended by paramedics for people with diabetes. The majority were individuals with type 1 diabetes (58.8%), followed by type 2 diabetes (35.2%) and unspecified diabetes type (5.9%). Thirty-eight percent of patients were transported to hospital by EMS following hypoglycaemia. Factors associated with transport by EMS included extremes of age (<15 and >75years), female gender, type 2 diabetes, event at a nursing home or hospital/community clinic, presence of comorbidities and time of day. CONCLUSIONS: Examination of the utilisation of EMS for hypoglycaemia has identified a previously unquantified need for emergency care for people with diabetes as well as factors related to hospital transportation.

Obesity, polycystic ovary syndrome and breastfeeding: an observational study.

INTRODUCTION: Polycystic ovary syndrome (PCOS) affects 9-21% of reproductive-age women. The relations between PCOS, body mass index (BMI) and breastfeeding are unclear. Our aim was to examine breastfeeding in women with and without PCOS and the relation with BMI. MATERIAL AND METHODS: This is a cross-sectional study set in the general community. Participants are women, aged 31-36 years, from the Australian Longitudinal Study on Women's Health (ALSWH), a large community-based study. Data was analyzed from the first child of respondents to Survey five (2009) reporting at least one live born child. Logistic regression analysis was used to examine factors associated with breastfeeding. The main outcome measures studied were breastfeeding initiation and duration and the main explanatory variables included self-reported PCOS and BMI. RESULTS: Of the 4898 women, 6.5% reported PCOS (95% confidence interval 5.8-7.2%). Median duration of breastfeeding was lower in women reporting PCOS (6 months, range 2-10 months) than in women not reporting PCOS (7 months, range 3-12 months) (p = 0.001). On multivariable regression analysis, there was no association between PCOS and breastfeeding outcomes. However, being overweight or obese was associated with not initiating breastfeeding and with breastfeeding for less than 6 months, after adjusting for confounders. CONCLUSIONS: High BMI is negatively associated with breastfeeding, whereas PCOS status per se does not appear to be related to breastfeeding initiation and duration, after adjusting for BMI.

Inpatient HbA1c testing: a prospective observational study.

OBJECTIVE: To use admission inpatient glycated hemoglobin (HbA1c) testing to help investigate the prevalence of unrecognized diabetes, the cumulative prevalence of unrecognized and known diabetes, and the prevalence of poor glycemic control in both. Moreover, we aimed to determine the 6-month outcomes for these patients. Finally, we aimed to assess the independent association of diabetes with these outcomes. RESEARCH DESIGN AND METHODS: Prospective observational cohort study conducted in a tertiary hospital in Melbourne, Australia. PATIENTS: A cohort of 5082 inpatients ≥54 years admitted between July 2013 and January 2014 underwent HbA1c measurement. A previous diagnosis of diabetes was obtained from the hospital medical record. Patient follow-up was extended to 6 months. RESULTS: The prevalence of diabetes (known and unrecognized) was 34%. In particular, we identified that unrecognized but HbA1c-confirmed diabetes in 271 (5%, 95% CI 4.7% to 6.0%) patients, previously known diabetes in 1452 (29%, 95% CI 27.3% to 29.8%) patients; no diabetes in 3359 (66%, 95% CI 64.8-67.4%) patients. Overall 17% (95% CI 15.3% to 18.9%) of patients with an HbA1c of >6.5% had an HbA1c ≥8.5%. After adjusting for age, gender, Charlson Index score, estimated glomerular filtration rate, and hemoglobin levels, with admission unit treated as a random effect, patients with previously known diabetes had lower 6-month mortality (OR 0.69, 95% CI 0.56 to 0.87, p=0.001). However, there were no significant differences in proportions of intensive care unit admission, mechanical ventilation or readmission within 6 months between the 3 groups. CONCLUSIONS: Approximately one-third of all inpatients ≥54 years of age admitted to hospital have diabetes of which about 1 in 6 was previously unrecognized. Moreover, poor glycemic control was common. Proportions of intensive care unit admission, mechanical ventilation, or readmission were similar between the groups. Finally, diabetes was independently associated with lower 6-month mortality.