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This guide is designed for tutors and teachers of literacy in rural locations in Australia, and their trainers, to help them respond appropriately to the language and literacy needs of adults of non-English-speaking background. It is divided into five sections. The first is an introduction. The second addresses the general topics of language learning and literacy development in a second language, particularly in adults, and the relationship between oral and written language. The third discusses literacy skills assessment procedures and principles, and contains some reading and writing assessment materials. The fourth section outlines steps in curriculum development, instructional material selection, teaching methodologies and strategies, objective-writing, and classroom activity planning. Sources of additional information are provided in the final section, including a contact list for referral and advice, a glossary of technical terms, and a number of brief related readings. A number of forms for first language literacy assessment are appended; they are in Arabic, Chinese, Croatian, Farsi, Italian, Khmer, Korean, Lao, Polish, Portuguese, Spanish, Tagalog, Thai, Turkish, and Vietnamese. (MSE) (Adjunct ERIC Clearinghouse on Literacy Education)

Aims: To assess the effect of early intervention with electronic-based proactive specialist diabetes care in surgical inpatients on glycaemia and clinical outcomes. Methods: The Specialist Treatment of Inpatients: Caring for Diabetes (STOIC-D) Surgery randomised controlled trial (RCT) recruited consecutive adults admitted to surgical units of the Royal Melbourne Hospital (Australia) in 2021 with diabetes or blood glucose ≥200 mg/dL and length of stay (LOS) ≥24 hours. Intervention arm patients received remote proactive consultation by the inpatient diabetes service (IDS) in the electronic medical record (Epic®) within 24 hours of admission and, if escalation criteria were met, received a bedside consultation. Patients receiving standard care were reviewed by the IDS at the bedside only following referral. Insulin and non-insulin agents were used to target glucose 90-180 mg/dL. Outcomes included glucometrics, healthcare-associated infection (HAI), and mortality. Registration: ACTRN12620001303932. Results: 1,383 admissions met inclusion criteria; 689 received the intervention. The primary outcome of mean patient-day mean glucose was lower in the active (158.4 mg/dL, standard deviation [SD] 48.6) vs. control arm (162.0 mg/dL, SD 46.8, p<0.001). HAI (most commonly pneumonia) was lower in the active vs. control arm (11% vs. 16%, p=0.02). Mortality (2.4% vs. 4.2%, p=0.08) and LOS (10.7 vs. 10.0 days, p=0.26) were no different. The number needed to treat for HAI prevention was 22. Hypoglycaemia <72 mg/dL was not increased (1.0% active vs. 0.9% control, p=0.23). The IDS performed a bedside consultation in 333 (49%) of the active vs. 93 (14%) of the control arm. Conclusion: The STOIC-D Surgery trial is the largest RCT of a diabetes model-of-care intervention in non-critical care. Early, electronic-based specialist diabetes intervention significantly reduced patient-day mean glucose and HAIs in a surgical population.

Objectives: To assess the clinical and demographic characteristics of children and adolescents across Australia and New Zealand (NZ) with type 2 diabetes. Method(s): We performed a descriptive audit of data prospectively reported to the Australasian Diabetes Data Network (ADDN) registry. Data were collected from six tertiary pediatric diabetes centers across Australia (New South Wales, Queensland, South Australia, Western Australia, and Victoria) and NZ (Auckland). Children and adolescents diagnosed with type 2 diabetes aged <= 18 years with data reported to ADDN between 2012 and 2017 were included. Age, sex, ethnicity, HbA1c, blood pressure, BMI, waist circumference and lipid profile at first visit were assessed. Result(s): There were 269 cases of type 2 diabetes in youth reported to ADDN between 2012 and 2017. The most common ethnicities were Indigenous Australian in 56/243 (23%) and NZ Maori or Pacifica in 47 (19%). Median age at diagnosis was 13.7 years and 94% of participants were overweight or obese. Indigenous Australian and Maori/Pacifica children were younger at diagnosis compared with nonindigenous children: median 13.3 years (indigenous Australian); 13.1 years (Maori/Pacifica); 14.1 years (nonindigenous), p = 0.005. HbA1c was higher in indigenous Australian (9.4%) and Maori/Pacifica youth (7.8%) compared with nonindigenous (6.7%) p < 0.001. BMI-SDS was higher in Maori/Pacifica youth (2.3) compared with indigenous Australian (2.1) and nonindigenous (2.2) p = 0.011. Conclusion(s): Indigenous Australian and Maori/Pacifica youth in ADDN were younger and had worse glycaemic control at diagnosis of type 2 diabetes. Our findings underscore the need to consider targeted and earlier screening in these "high-risk" populations.Copyright © 2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

Introduction: We aimed to compare the mental health of mothers, with and without type 1 diabetes (T1D), during pregnancy and postpartum, and to examine the relationship between glycaemic control and mental health in T1D. Objective(s): We hypothesised that mental health in trimester 3 (T3) and post-partum is less favourable in mothers with T1D, and that poorer mental health scores relate directly to glycaemic control. Method(s): Participants were 800/946 women enrolled in the Environmental Determinants of Islet Autoimmunity (ENDIA) study, an Australiawide pregnancy-birth prospective cohort following children with a first-degree relative with T1D, from 2016-2020.Women with and without T1D (n=518, 282) completed the Edinburgh Postnatal Depression Scale (EPDS) and Perceived Stress Scale (PSS) during T3, (median [IQR], 34 [32, 36] weeks) and early post-partum (median 14 [13, 16] weeks). Linear mixed regression models were adjusted for parity. Result(s): Women without T1D were aged mean (SD) 33.1 (4.4) years; 31.9 (4.4) years with T1D. Pre-existing mental health issues requiring psychotropic medications were of similar number in non-T1D n=17 [6%] and T1D n=41 [8%]. EPDS and PSS scores did not differ between non-T1D and T1D mothers at T3 or post-partum (all p>=0.5; Table 1). EPDS scores were less favourable at T3 compared with postpartum (p=0.01), independent of T1D status, and by post-partum 12/47 women had improved to below the threshold (=12) recommended for intervention. HbA1c during pregnancy in 398/518 women (76.8%) with T1D did not relate to EPDS (r2=0.01, p=0.2) or PSS (r2=0.02, p=0.4) scores. Median [IQR] HbA1c was 6.3% [5.8-6.9]. Conclusion(s): Overall, mental health in late pregnancy and postpartum was not adversely impacted by T1D. Glycaemic control did not relate to mental health scores in mothers with T1D. A generalised improvement in mental health between T3 and post-partum was independent of T1D status.

Context: Cardiovascular disease occurs prematurely in type 1 diabetes. The additional risk of overweight is not well characterized. Objective(s): The primary aim was to measure the impact of body mass index (BMI) in youth with type 1 diabetes on cardiovascular risk factors. The secondary aim was to identify other determinants of cardiovascular risk. Design(s): Observational longitudinal study of 7061 youth with type 1 diabetes followed for median 7.3 (interquartile range [IQR] 4-11) years over 41 (IQR 29-56) visits until March 2019. Setting(s): 15 tertiary care diabetes centers in the Australasian Diabetes Data Network. Participants were aged 2 to 25 years at baseline, with at least 2 measurements of BMI and blood pressure. Main Outcome Measure(s): Standardized systolic and diastolic blood pressure scores and non-high-density lipoprotein (HDL) cholesterol were co-primary outcomes. Urinary albumin/creatinine ratio was the secondary outcome. Result(s): BMI z-score related independently to standardized blood pressure z- scores and non-HDL cholesterol. An increase in 1 BMI z-score related to an average increase in systolic/diastolic blood pressure of 3.8/1.4 mmHg and an increase in non-HDL cholesterol (coefficient + 0.16 mmol/L, 95% confidence interval [CI], 0.13-0.18; P < 0.001) and in low-density lipoprotein (LDL) cholesterol. Females had higher blood pressure z-scores, higher non-HDL and LDL cholesterol, and higher urinary albumin/creatinine than males. Indigenous youth had markedly higher urinary albumin/creatinine (coefficient + 2.15 mg/mmol, 95% CI, 1.27-3.03; P < 0.001) and higher non-HDL cholesterol than non-Indigenous youth. Continuous subcutaneous insulin infusion was associated independently with lower non-HDL cholesterol and lower urinary albumin/creatinine. Conclusion(s): BMI had a modest independent effect on cardiovascular risk. Females and Indigenous Australians in particular had a more adverse risk profile.Copyright © 2020 The Author(s).

OBJECTIVES: To study the prevalence and clinical characteristics of islet antibody-negative (idiopathic) type 1 diabetes mellitus (T1DM) among Indian children and adolescents at the time of diagnosis of illness. METHODS: In a hospital-based cross-sectional study, we studied 110 patients with T1DM aged ≤18 years. This included 61 patients with duration of diabetes ≤2 weeks (mean ± SD age of onset 9.9 ± 4.4 years) and 49 patients with duration 2 to 12 weeks. Antibodies against GAD65 (GADA), IA-2 (IA-2A) and zinc transporter 8 (ZnT8A), detected by radio-binding assay, were measured in all patients. Insulin autoantibody (IAA) was measured only in subjects with duration ≤2 weeks, using a competitive radio-binding assay. RESULTS: The prevalence of GADA, IA-2A, and ZnT8A was 53%, 34%, and 29% respectively, while IAA (measured in 61 patients) was detected in 31%. All four antibodies were absent in 17 of 61 (28%) patients. The prevalence of islet antibody-negative patients was similar among both sexes and in children with onset younger and older than 10 years. ZnT8A was the only antibody detected in four patients, and its measurement resulted in 6% reduction in islet antibody-negative patients. Patients with idiopathic T1DM did not differ in their clinical features or fasting plasma C-peptide at the onset and after follow-up of 1 year. Compared with idiopathic T1DM, antibody-positive patients had an increased allele frequency of HLA DRB1*0301 (46% vs 14%, OR = 5.10 [confidence interval = 1.61-16.16], P = .003). CONCLUSION: Nearly 30% of Indian patients were negative for all islet antibodies at the onset of T1DM. Patients with idiopathic T1DM had similar clinical features to antibody-positive subjects.

AIM: To determine advantages conferred by a youth-specific transition clinic model for young adults with type 1 diabetes (T1D) at Westmead Hospital (WH) as compared with Australian registry data. METHODS: Prospectively collected data included age, diabetes duration, visit frequency, post code, BMI, mode of insulin delivery, continuous glucose monitoring, HbA1c, albumin creatinine ratio, BP, retinopathy and diabetic ketoacidosis (DKA) for all WH T1D clinic attendees aged 16-25 between January 2017 and June 2018 (n = 269). Results were compared with data collected during the same time period from 2 separate Australian data registries, one longitudinal (Australasian Diabetes Data Network, ADDN) and one a spot survey (the Australian National Diabetes Audit, ANDA). RESULTS: Across the three cohorts, HbA1c was similar (respectively, WH, ADDN, ANDA; 8.7%[72mmol/mol], 8.7%[72mmol/mol], 8.5%[69mmol/mol]) and HbA1c was significantly higher in young adults <21 years (8.7-8.9%[73-75mmol/mol]) as compared with ≥21 years (8.5%[69mmol/mol], p < .002). In the WH cohort, median interval between visits was shorter than in ADDN (4.5 vs. 9.0 months) and DKA was lower (respectively, 3.6 and 9.2/100 patient years; p < .001). CONCLUSIONS: While suboptimal HbA1c was recorded in all centres, the WH model of care saw increased attendance and reduced admissions with DKA as compared with other Australian adult centres.

Primary aim was to measure the impact of BMI in youth with type 1 diabetes on cardiovascular risk factors. We also identified other independent determinants of risk. Method(s): Inclusion criteria were youth with type 1 diabetes followed by the Australasian Diabetes Data Network (ADDN), aged 2 -25 years at all visits, with at least (i) two measures of BMI (ii)two measures of blood pressure at rest and/or (iii) one measure of total and HDL cholesterol. Exclusion criteria were anti- hypertensive or statin medications. A two way random intercept model was fitted at the patient and centre level, and a random slope for BMI z-score. Outcomes in multivariate analyses were blood pressure z-score, non -HDL cholesterol, and urinary albumin/creatinine. Result(s): An increase of 1 BMI z-score related independently to an increase in systolic (coefficient +0.26, 95% CI 0.24, 0.28, p< 0.001) and diastolic blood pressure z-scores (+0.13, 95% CI 0.11,0.14, p< 0.001) and higher non- HDL cholesterol (+0.16 mmol/L, 95% CI 0.13, 0.18, p< 0.001) and LDL cholesterol. Females had higher non -HDL cholesterol (coeff + 0.27 mmol/L, 95% CI 0.24- 0.31, p< 0.001) and higher ACR (coeff+0.63 mg/mmol, 95% CI 0.40, 0.86, p< 0.001). Indigenous Australians (1.8%) had higher non- HDL cholesterol (+0.21 mmol/L, 95% CI 0.04, 0.39, p=0.02) and markedly higher ACR (+ 2.37 mg/mmol, 95% CI 1.47, 3.27, p< 0.001). CSII participants had lower systolic and diastolic blood pressure z-scores (p< 0.001), lower ACR (-0.29 mg/mmol, 95%CI -0.53, -0.05, p< 0.001) and lower non-HDL cholesterol (-0.07mM, 95% CI-0.10,-0.03, p< 0.001), compared with MDI and independent of HbA1c's effect on non-HDL cholesterol (+0.13 mmol/L, 95% CI 0.12-0.14, p< 0.001). Conclusion(s): BMI had an independent adverse effect on cardiovascular risk. CSII had a modest independent benefit on cardiovascular risk profile. Females and indigenous Australians in particular had a more adverse risk profile.

Introduction: Many adolescents and young adults with type 1 diabetes (T1D) move away from supportive parental homes, have less structure in their lives and engage in behaviors which may be detrimental to their diabetes care. Objective(s): We examined the glycemic control of young people with T1D across Australasia, on whom there is a paucity of published data. Method(s): We used data from ADDN (addn.org.au), a collaboration among pediatric and adult diabetes centers across Australasia. Longitudinal data were extracted on all healthcare visits attended by young people with T1D who were aged 16-25 yrs at their last visit. Clinical data were extracted from 1st Jan 2014-31st Dec 2018 inclusive. Result(s): A cohort of 4651 young people attending 17 diabetes centers across Australasia met the inclusion criteria; 2433 (52%) were male. Mean+SD T1D duration was 8.6+4.9 yrs (range 0-24); BMI SDS 0.61 +0.97; mean aggregated HbA1c from all visits in the 5-yr period was 8.7+1.8% (71.9+19 mmol/L); only 530 (11%) achieved an aggregated HbA1c< 7.0% (53mmol/mol). At their last visit, mean HbA1c was 8.8 +1.9% (72.6+20.7 mmol/L); 569 (13%) had HbA1c< 7.0%; 54% (n=2,231) used multiple-daily injections (MDI), 39% (n=1,606) CSII and 8% (n=335) twice-daily (BD) injections. HbA1c was slightly higher in females vs males (8.9 vs 8.7%, 73.3 vs 71.9mmol/mol, p=0.02) and in those diagnosed < age 10 yrs vs >10 yrs (8.9 vs 8.7%, 73.3 vs 71.9mmol/mol, p< 0.001). In multivariable linear regression, higher HbA1c was associated with younger age at T1D diagnosis (p< 0.001), female gender (p=0.03) and BD therapy vs MDI/CSII (p< 0.001). Conclusion(s): The glycemic control of adolescents and young adults with T1D across Australasia is persistently sub-optimal across this age range, particularly among those with young onset of T1D. There is a need to better understand factors that contribute to these observations, and how healthcare services can support achievement of improved glycemic control in this pop

Introduction: In April 2017 the Australian Government initiated funding for continuous glucose monitoring (CGM) for eligible under 21 year olds resulting in an acute increase in CGM use in young people in Australia. Although clinical trials have demonstrated a positive effect of CGM use on glycaemic and psychosocial outcomes in T1DM there are as yet few data to describe its impact in real world use. Objective(s): The Australasian Diabetes Data Network (ADDN) is a centralised database capturing de-identified coded clinical data from people living with T1DM on a single purpose-built platform. A total of 17 centres are now incorporated into the database, including regional and adult centres in five States. Following the initiation of CGM funding, ADDN was expanded to include a CGM module. This has provided a unique opportunity to evaluate CGM uptake on clinical outcomes for young people with T1DM. Method(s): Analysis of CGM outcomes in ADDN participants between 1 April 2017 to 31 December 2018, inclusive, captured 2,724 of the 10,644 youth < 21 years who registered for CGM with the National Diabetes Services Scheme (NDSS) . Result(s): Of those with documented usage data, HbA1C reduced significantly from 8.3+/-1.5% at the start of CGM use to 7.9+/-1.4% at 12 months (p< 0.001) and 7.8%+/-1.3% at 18 months (p< 0.001) from CGM start. This was associated with an increase in the proportion of patients achieving the recommended HbA1c target of < 7.0%: from 13.1% at start of CGM use to 26.0% 18 months post CGM start. No significant change in severe (coma/convulsion) hypoglycaemia rates (3.08 vs 3.69 events/100 patient years, pre vs 12 months post use) or DKA rates (3.99 vs 4.3 events/100 patient years, pre vs 12 months post use) were observed. Conclusion(s): This preliminary analysis of the early impact of general availability of CGM for young people with T1DM indicates a positive impact on key glycaemic outcomes in those using the technology.

Introduction Automated insulin delivery (also known as closed loop, or artificial pancreas) has shown potential to improve glycaemic control and quality of life in people with type 1 diabetes (T1D). Automated insulin delivery devices incorporate an insulin pump with continuous glucose monitoring(CGM) and an algorithm, and adjust insulin in real time. This study aims to establish the safety and efficacy of a hybrid closed-loop (HCL) system in a long-term outpatient trial in people with T1D aged 12 -<25 years of age, and compare outcomes with standard therapy for T1D as used in the contemporary community. Methods and analysis This is an open-label, multicentre, 6-month, randomised controlled home trial to test the MiniMed Medtronic 670G system (HCL) in people with T1D aged 12 -<25 years, and compare it to standard care (multiple daily injections or continuous subcutaneous insulin infusion (CSII), with or without CGM). Following a run-in period including diabetes and carbohydrate counting education, dosage optimisation and baseline glucose control data collection, participants are randomised to either HCL or to continue on their current treatment regimen. The primary aim of the study is to compare the proportion of time spent in target sensor glucose range (3.9-10.0 mmol/L) on HCL versus standard therapy. Secondary aims include a range of glucose control parameters, psychosocial measures, health economic measures, biomarker status, user/technology interactions and healthcare professional expectations. Analysis will be intention to treat. A study in adults with an aligned design is being conducted in parallel to this trial. Ethics and dissemination Ethics committee permissions were gained from respective institutional review boards. The findings of the study will provide high-quality evidence on the role of HCL in clinical practice.

OBJECTIVE: We assessed dysglycemia and a T1D Diagnostic Index60 (Index60) ≥1.00 (on the basis of fasting C-peptide, 60-min glucose, and 60-min C-peptide levels) as prediagnostic end points for type 1 diabetes among Type 1 Diabetes TrialNet Pathway to Prevention Study participants. RESEARCH DESIGN AND METHODS: Two cohorts were analyzed: 1) baseline normoglycemic oral glucose tolerance tests (OGTTs) with an incident dysglycemic OGTT and 2) baseline Index60 <1.00 OGTTs with an incident Index60 ≥1.00 OGTT. Incident dysglycemic OGTTs were divided into those with (DYS/IND+) and without (DYS/IND-) concomitant Index60 ≥1.00. Incident Index60 ≥1.00 OGTTs were divided into those with (IND/DYS+) and without (IND/DYS-) concomitant dysglycemia. RESULTS: The cumulative incidence for type 1 diabetes was greater after IND/DYS- than after DYS/IND- (P < 0.01). Within the normoglycemic cohort, the cumulative incidence of type 1 diabetes was higher after DYS/IND+ than after DYS/IND- (P < 0.001), whereas within the Index60 <1.00 cohort, the cumulative incidence after IND/DYS+ and after IND/DYS- did not differ significantly. Among nonprogressors, type 1 diabetes risk at the last OGTT was greater for IND/DYS- than for DYS/IND- (P < 0.001). Hazard ratios (HRs) of DYS/IND- with age and 30- to 0-min C-peptide were positive (P < 0.001 for both), whereas HRs of type 1 diabetes with these variables were inverse (P < 0.001 for both). In contrast, HRs of IND/DYS- and type 1 diabetes with age and 30- to 0-min C-peptide were consistent (all inverse [P < 0.01 for all]). CONCLUSIONS: The findings suggest that incident dysglycemia without Index60 ≥1.00 is a suboptimal prediagnostic end point for type 1 diabetes. Measures that include both glucose and C-peptide levels, such as Index60 ≥1.00, appear better suited as prediagnostic end points.

We describe three cases of severe hyponatraemia in the setting of primary polydipsia that were managed in our centre in 2016. Despite receiving different solute loads, large volume diuresis and rapid correction of serum sodium occurred in all cases. Given the potentially catastrophic consequence of osmotic demyelination, we highlight the judicious use of desmopressin and hypotonic fluid infusion to mitigate sodium overcorrection in this setting.

The Bcl-2 family regulates induction of apoptosis at the mitochondria. Essential to this regulation are the interactions between Bcl-2 family members, which are mediated by Bcl-2 homology (BH) domains. Vaccinia virus F1L is a unique inhibitor of apoptosis that lacks significant sequence similarity with the Bcl-2 family and does not contain obvious BH domains. Despite this, F1L inhibits cytochrome c release from mitochondria by preventing Bak and Bax activation. Although F1L constitutively interacts with Bak to prevent Bak activation, the precise mechanism of this interaction remains elusive. We have identified highly divergent BH domains in F1L that were verified by the recent crystal structure of F1L (Kvansakul, M., Yang, H., Fairlie, W. D., Czabotar, P. E., Fischer, S. F., Perugini, M. A., Huang, D. C., and Colman, P. M. (2008) Cell Death Differ. 15, 1564-1571). Here we show that F1L required these BH domains to interact with ectopically expressed and endogenous Bak. The interaction between F1L and Bak was conserved across species, and both F1L and the cellular antiapoptotic protein Mcl-1 required the Bak BH3 domain for interaction. Moreover, F1L replaced Mcl-1 during infection, as the Bak x Mcl-1 complex was disrupted during vaccinia virus infection. In contrast to UV irradiation, vaccinia virus infection did not result in rapid degradation of Mcl-1, consistent with our observation that vaccinia virus did not initiate a DNA damage response. Additionally, Mcl-1 expression prevented Bak activation and apoptosis during infection with a proapoptotic vaccinia virus devoid of F1L. Our data suggest that F1L replaces the antiapoptotic activity of Mcl-1 during vaccinia virus infection by interacting with Bak using highly divergent BH domains.

Objective: The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study is examining the effects of long-term fibrate therapy on coronary heart disease (CHD) event rates in patients with diabetes mellitus. This article describes the trial's run-in phase and patients' baseline characteristics. Research design and methods: FIELD is a double-blind, placebo-controlled trial in 63 centres in 3 countries evaluating the effects of fenofibrate versus placebo on CHD morbidity and mortality in 9795 patients with type 2 diabetes mellitus. Patients were to have no indication for lipid-lowering therapy on randomization, but could start these or other drugs at any time after randomization. Follow-up in the study was to be for a median duration of not less than 5 years and until 500 major coronary events (fatal coronary heart disease plus nonfatal myocardial infarction) had occurred. Results: About 2100 patients (22%) had some manifestation of cardiovascular disease (CVD) at baseline and thus high risk status. Less than 25% of patients without CVD had a (UKPDS determined) calculated 5-year CHD risk of <5%, but nearly all had a 5-year stroke risk of <10%. Despite this, half of the cohort were obese (BMI >30), most were men, two-thirds were aged over 60 years, and substantial proportions had NCEP ATP III features of the metabolic syndrome independent of their diabetes, including low HDL (60%), high blood pressure measurement (41%), high waist measurement (65%), and raised triglycerides (52%). After a 6-week run-in period before randomisation with all participants receiving 200 mg comicronized fenofibrate, there were declines in total and LDL cholesterol (10%) and triglycerides (26%) and an increase in HDL cholesterol (6.5%). Conclusion: The study will show the effect of PPAR-alpha agonist action on CHD and other vascular outcomes in patients with type 2 diabetes including substantial numbers with low to moderate CVD risk but with the various components of the metabolic

Background: Fibrates correct the typical lipid abnormalities of type 2 diabetes mellitus, yet no study, to date, has specifically set out to evaluate the role of fibrate therapy in preventing cardiovascular events in this setting. Methods: Subjects with type 2 diabetes, aged 50-75 years, were screened for eligibility to participate in a long-term trial of comicronized fenofibrate 200 mg daily compared with matching placebo to assess benefits of treatment on the occurrence of coronary and other vascular events. People with total cholesterol levels 3.0-6.5 mmol/L plus either a total-to-HDLc ratio >4.0 or triglyceride level >1.0 mmol /L with no clear indication for lipid-modifying therapy were eligible. Results: A total of 9795 people were randomized into the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) trial. All received dietary advice, followed by a 6-week single-blind placebo run-in, then a 6-week active run-in period before randomization. Participants are being followed up every 6 months for outcome events and safety assessments. The study is designed to yield at least 500 coronary events (primary endpoint: first nonfatal myocardial infarction or coronary death) over 5 years, to have 80% power to identify as statistically significant at 2P = 0.05 a 22% reduction in such events, using intention-to-treat methods. Conclusions: Type 2 diabetes is the most common endocrine disorder worldwide, and its prevalence is increasing. The current evidence about use of fibrates in type 2 diabetes, from around 2000 people treated, will increase with FIELD to evidence from around 12000. FIELD will establish the role of fenofibrate treatment in reducing cardiovascular risk in people with type 2 diabetes. The main results are expected to be available in late 2005.

[No abstract available]