Trends in diabetic retinopathy screening attendance and associations with vision impairment attributable to diabetes in a large nationwide cohort.

AIMS: To investigate diabetic retinopathy screening attendance and trends in certified vision impairment caused by diabetic eye disease. METHODS: This was a retrospective study of attendance in three urban UK diabetic eye screening programmes in England. A survival analysis was performed to investigate time from diagnosis to first screen by age and sex. Logistic regression analysis of factors influencing screening attendance during a 15-month reporting period was conducted, as well as analysis of new vision impairment certifications (Certificate of Vision Impairment) in England and Wales from 2009 to 2019. RESULTS: Of those newly registered in the Routine Digital Screening pathway (n = 97 048), 80% attended screening within the first 12 months and 88% by 36 months. Time from registration to first eye screening was longer for people aged 18-34 years, and 20% were unscreened after 3 years. Delay in first screen was associated with increased risk of referable retinopathy. Although 95% of participants (n = 291 296) attended during the 15-month reporting period, uptake varied considerably. Younger age, social deprivation, ethnicity and duration of diabetes were independent predictors of non-attendance and referable retinopathy. Although the last 10 years has seen an overall reduction in vision impairment certification attributable to diabetic eye disease, the incidence of vision impairment in those aged <35 years was unchanged. CONCLUSIONS: Whilst the majority of participants are screened in a timely manner, there is considerable variation in uptake. Young adults, have sub-optimal attendance, and levels of vision impairment in this population have not changed over the last 10 years. There is an urgent need to explore barriers to/enablers of attendance in this group to inform policy initiatives and tailored interventions to address this issue.

Utility of HbA1c assessment in people with diabetes awaiting liver transplantation.

AIMS: To investigate the relationship between HbA1c and glucose in people with co-existing liver disease and diabetes awaiting transplant, and in those with diabetes but no liver disease. METHODS: HbA1c and random plasma glucose data were collected for 125 people with diabetes without liver disease and for 29 people awaiting liver transplant with diabetes and cirrhosis. Cirrhosis was caused by non-alcoholic fatty liver disease, hepatitis C, alcoholic liver disease, hereditary haemochromatosis, polycystic liver/kidneys, cryptogenic/non-cirrhotic portal hypertension and α-1-antitrypsin-related disease. RESULTS: The median (interquartile range) age of the diabetes with cirrhosis group was 55 (49-63) years compared to 60 (50-71) years (P=0.13) in the group without cirrhosis. In the diabetes with cirrhosis group there were 21 men (72%) compared with 86 men (69%) in the group with diabetes and no cirrhosis (P=0.82). Of the group with diabetes and cirrhosis, 27 people (93%) were of white European ethnicity, two (7%) were South Asian and none was of Afro-Caribbean/other ethnicity compared with 94 (75%), 16 (13%), 10 (8%)/5 (4%), respectively, in the group with diabetes and no cirrhosis (P=0.20). Median (interquartile range) HbA1c was 41 (32-56) mmol/mol [5.9 (5.1-7.3)%] vs 61 (52-70) mmol/mol [7.7 (6.9-8.6)%] (P<0.001), respectively, in the diabetes with cirrhosis group vs the diabetes without cirrhosis group. The glucose concentrations were 8.4 (7.0-11.2) mmol/l vs 7.3 (5.2-11.5) mmol/l (P=0.17). HbA1c was depressed by 20 mmol/mol (1.8%; P<0.001) in 28 participants with cirrhosis but elevated by 28 mmol/mol (2.6%) in the participant with α-1-antitrypsin disorder. Those with cirrhosis and depressed HbA1c had fewer larger erythrocytes, and higher red cell distribution width and reticulocyte count. This was reflected in the positive association of glucose with mean cell volume (r=0.39) and haemoglobin level (r=0.49) and the negative association for HbA1c (r=-0.28 and r=-0.26, respectively) in the diabetes group with cirrhosis. CONCLUSION: HbA1c is not an appropriate test for blood glucose in people with cirrhosis and diabetes awaiting transplant as it reflects altered erythrocyte presentation.

Factors determining uptake of diabetic retinopathy screening in Oxfordshire.

AIMS: To investigate variables at the demographic and primary care practice levels that influence the uptake of diabetic retinopathy screening. METHODS: Data were extracted from the management software of one screening programme for 21 797 people registered with 79 general practices. Uptake was examined by gender, age group, modality of screening (mobile unit at general practice versus high-street optometrist), and by general practice. A telephone survey of high-street optometrists provided information on the availability of screening appointments. RESULTS: Uptake was 82.4% during the study period, and was higher for men (83.2%) than for women (81.5%) (P = 0.001). Uptake varied by age group (P < 0.001), being lowest in those aged 12-39 years (67%). Uptake was higher for people invited to a general practice for screening by a mobile unit (83.5%) than for those invited for screening by a high-street optometrist (82%) (P = 0.006). After adjusting for these factors and for socio-economic deprivation score at the location of the general practice, heterogeneity in uptake rate was still observed between some practices. Our survey of optometrists indicated wide variation in the availability of time slots for screening during the week and of screening appointment provision. CONCLUSIONS: Diabetic retinopathy screening services do not achieve high uptake among the youngest or oldest age groups. Practices in the least deprived areas had the highest uptake. Variation in uptake between general practices after adjustment for individual-level variables and deprivation suggests that practice-level factors may have an important role in determining rates of screening attendance.

Risk of diabetic retinopathy at first screen in children at 12 and 13 years of age.

AIMS: To investigate the relationships between age at diagnosis of diabetes, age at diabetic eye screening and severity of diabetic retinopathy at first and subsequent screenings in children aged 12 or 13 years. METHODS: Data were extracted from four English screening programmes and from the Scottish, Welsh and Northern Irish programmes on all children with diabetes invited for their first and subsequent screening episodes from the age of 12 years. Retinopathy levels at first and subsequent screens, time from diagnosis of diabetes to first screening and age at diagnosis in years were calculated. RESULTS: Data were available for 2125 children with diabetes screened for the first time at age 12 or 13 years. In those diagnosed with diabetes at 2 years of age or less, the proportion with retinopathy in one or both eyes was 20% and 11%, respectively, decreasing to 8% and 2% in those diagnosed between 2 and 12 years (P < 0.0001). Only three children (aged 8, 10 and 11 years at diagnosis of diabetes) had images graded with referable retinopathy and, of these, two had non-referable diabetic retinopathy at all subsequent screenings. Of 1703 children with subsequent images, 25 were graded with referable diabetic retinopathy over a mean follow-up of 3.1 years, an incidence rate of 4.7 (95% confidence interval, 3.1-7.0) per 1000 per year. CONCLUSIONS: In this large cohort of children, the low prevalence and incidence rates of referable diabetic retinopathy suggest that screening earlier than age 12 is not necessary.

System-level and patient-level explanations for non-attendance at diabetic retinopathy screening in Sutton and Merton (London, UK): a qualitative analysis of a service evaluation.

OBJECTIVES: Non-attendance at diabetic retinopathy screening has financial implications for screening programmes and potential clinical costs to patients. We sought to identify explanations for why patients had never attended a screening appointment (never attendance) in one programme. DESIGN: Qualitative analysis of a service evaluation. SETTING: One South London (UK) diabetic eye screening programme. PARTICIPANTS AND PROCEDURE: Patients who had been registered with one screening programme for at least 18 months and who had never attended screening within the programme were contacted by telephone to ascertain why this was the case. Patients' general practices were also contacted for information about why each patient may not have attended. Framework analysis was used to interpret responses. RESULTS: Of the 296 patients, 38 were not eligible for screening and of the 258 eligible patients, 159 were not contactable (31 of these had phone numbers that were not in use). We obtained reasons from patients/general practices/clinical notes for non-attendance for 146 (57%) patients. A number of patient-level and system-level factors were given to explain non-attendance. Patient-level factors included having other commitments, being anxious about screening, not engaging with any diabetes care and being misinformed about screening. System-level factors included miscommunication about where the patient lives, their clinical situation and practical problems that could have been overcome had their existence been shared between programmes. CONCLUSIONS: This service evaluation provides unique insight into the patient-level and system-level reasons for never attendance at diabetic retinopathy screening. Improved sharing of relevant information between providers has the potential to facilitate increased uptake of screening. Greater awareness of patient-level barriers may help providers offer a more accessible service.

Screening attendance, age group and diabetic retinopathy level at first screen.

AIMS: To report on the relationships between age at diagnosis of diabetes, time from registration with the screening programme to first diabetic eye screening and severity of diabetic retinopathy. METHODS: Data were extracted from four English screening programmes and from the Scottish, Welsh and Northern Irish programmes. Time from diagnosis of diabetes to first screening and age at diagnosis were calculated. RESULTS: Time from registration with the screening programme to first screening episode is strongly related to age at registration. Within 18 months of registration 89% of 3958 young people under 18 years of age and 81% of 391 293 people over 35 years of age were seen. In 19 058 people between 18 and 34 years of age, 80% coverage was not reached until 2 years and 9 months. The time from diagnosis of diabetes to first screening is positively associated with severity of disease (P < 0.0001). CONCLUSIONS: This report is the first that to demonstrate that those in the 18-34 year age group are least likely to attend promptly for screening after registration with a higher risk of referable diabetic retinopathy being present at the time of first screen. Date of diagnosis should be recorded and prodigious efforts made to screen all people promptly after diagnosis. Screening programmes should collect data on those who have not attended within one year of registration.

The use of statistical methodology to determine the accuracy of grading within a diabetic retinopathy screening programme.

AIMS: We aimed to use longitudinal data from an established screening programme with good quality assurance and quality control procedures and a stable well-trained workforce to determine the accuracy of grading in diabetic retinopathy screening. METHODS: We used a continuous time-hidden Markov model with five states to estimate the probability of true progression or regression of retinopathy and the conditional probability of an observed grade given the true grade (misclassification). The true stage of retinopathy was modelled as a function of the duration of diabetes and HbA1c . RESULTS: The modelling dataset consisted of 65 839 grades from 14 187 people. The median number [interquartile range (IQR)] of examinations was 5 (3, 6) and the median (IQR) interval between examinations was 1.04 (0.99, 1.17) years. In total, 14 227 grades (21.6%) were estimated as being misclassified, 10 592 (16.1%) represented over-grading and 3635 (5.5%) represented under-grading. There were 1935 (2.9%) misclassified referrals, 1305 were false-positive results (2.2%) and 630 were false-negative results (1.0%). Misclassification of background diabetic retinopathy as no detectable retinopathy was common (3.4% of all grades) but rarely preceded referable maculopathy or retinopathy. CONCLUSION: Misclassification between lower grades of retinopathy is not uncommon but is unlikely to lead to significant delays in referring people for sight-threatening retinopathy.

The use of weighted health-related Quality of Life scores in people with diabetic macular oedema at baseline in a randomized clinical trial.

AIMS: To examine the relationship between visual acuity in each eye and Quality of Life (QoL) outcomes in people with diabetic macular oedema. METHODS: Cross sectional retrospective analysis of data collected at baseline in 289 people entered into a randomized clinical trial with diabetic macular oedema which investigated the safety and efficacy of a vascular endothelial growth factor inhibitor, pegaptanib sodium. At the baseline visit, visual acuity was measured through refraction and using retro-illuminated modified Early Treatment Diabetic Retinopathy Study Log MAR charts, and patient health-related QoL was determined using the European Quality of Life EQ-5D-3L and the Visual Functioning Questionnaire-25 (NEI-VFQ25). A regression analysis with QoL score from each vision-related domain as the dependent variable was fitted using linear and quadratic terms of the better and worse eye, age, gender, adjusted for number of concurrent conditions, ethnicity and level of diabetes control. RESULTS: For all vision-related QoL domains from NEI-VFQ25 and EQ-5D-3L except ocular pain, both visual acuity in the better-seeing and the worse-seeing eye gave a significant increase in correlation coefficient over that obtained from clinical and demographic data. The NEI-VFQ25 correlation was most closely associated with a weighted visual acuity measure of 0.75 in the better and 0.25 in the worse eye or 0.60 in the better and 0.40 in the worse eye. CONCLUSIONS: We recommend that a weighted visual acuity measure from both eyes is considered in future diabetic macular oedema trials.

Delay in diabetic retinopathy screening increases the rate of detection of referable diabetic retinopathy.

AIMS: To assess whether there is a relationship between delay in retinopathy screening after diagnosis of type 2 diabetes and level of retinopathy detected. METHODS: Patients were referred from 88 primary care practices to an English National Health Service diabetic eye screening programme. Data for screened patients were extracted from the primary care databases using semi-automated data collection algorithms supplemented by validation processes. The programme uses two-field mydriatic digital photographs graded by a quality assured team. RESULTS: Data were available for 8183 screened patients with diabetes newly diagnosed in 2005, 2006 or 2007. Only 163 with type 1 diabetes were identified and were insufficient for analysis. Data were available for 8020 with newly diagnosed type 2 diabetes. Of these, 3569 were screened within 6 months, 2361 between 6 and 11 months, 1058 between 12 and 17 months, 366 between 18 and 23 months, 428 between 24 and 35 months, and 238 at 3 years or more after diagnosis. There were 5416 (67.5%) graded with no retinopathy, 1629 (20.3%) with background retinopathy in one eye, 753 (9.4%) with background retinopathy in both eyes and 222 (2.8%) had referable diabetic retinopathy. There was a significant trend (P = 0.0004) relating time from diagnosis to screening detecting worsening retinopathy. Of those screened within 6 months of diagnosis, 2.3% had referable retinopathy and, 3 years or more after diagnosis, 4.2% had referable retinopathy. CONCLUSIONS: The rate of detection of referable diabetic retinopathy is elevated in those who were not screened promptly after diagnosis of type 2 diabetes.

United Kingdom National Ophthalmology Database Study: Diabetic Retinopathy; Report 1: prevalence of centre-involving diabetic macular oedema and other grades of maculopathy and retinopathy in hospital eye services.

AIMS: To report estimates of the prevalence of diabetic retinopathy (DR) and maculopathy grades for a large cohort of patients managed by the UK hospital eye service (HES). METHODS: Anonymised data were extracted from 30 UK NHS hospital trusts using a single ophthalmic electronic medical record (EMR) for the period from April 2000 to November 2010 to create the National Ophthalmology Database (NOD). From 2007, the EMR facilitated capture of a nationally agreed-upon standardised data set (DR Structured Assessment) relating to the presence or absence of clinical signs of DR and maculopathy. An algorithm in the software automatically calculated the Early Treatment of Diabetic Retinopathy Study grades of retinopathy and maculopathy. RESULTS: Between 2007 and 2010, 307,538 patients had data on the NOD, with 76,127 (24.8%) patients having been recorded as having diabetes. The proportion of patients with diabetes who had a structured assessment increased from 50.7% (2007) to 86.8% (2010). In each NHS year, 12.6-20.6% of eyes with structured assessments had no DR; 59.6-67.3% had non-proliferative DR; and 18.3-20.9% had active or regressed proliferative DR. Clinically significant macular oedema was present in 15.8-18.1% of eyes, and in 8.7-10.0% of eyes, this involved the central macula. CONCLUSION: This study provides contemporary estimates of the prevalence of retinopathy and maculopathy grades in a large cohort of patients with diabetes managed by the UK HES. Centre-involving diabetic macular oedema, potentially amenable to anti-VEGF therapy, is present in the eyes of almost 10% of these patients. This information is useful for clinicians, health-care economists, and commissioners involved in planning and delivering diabetic eye services.

Updating diabetic retinopathy screening lists using automatic extraction from GP patient records.

OBJECTIVES: Diabetic Retinopathy screening services aim to reduce the risk of sight loss amongst patients with diabetes. The rising incidence of diabetes in England and the operational need to ensure the accuracy and timeliness of screening lists led to a pilot study of electronic extraction of data from primary care. This study aimed to evaluate the effectiveness of updating the single collated list of patients eligible for diabetic eye screening using extracts from electronic patient records in primary care. SETTING AND METHODS: The Gloucestershire Diabetic Eye Screening Programme (GDESP) provides screening for 85 General Practices in the county. Of these, 54 using Egton Medical Information Systems (EMIS) practice management system software agreed to participate in this study. The screening list held in 2009 by the Gloucestershire DESP of 14,209 patients known to have diabetes was audited against a list created with automatic extraction from General Practice records of patients marked with the diabetes Read Code C10. Those subsequently screened and referred to the Hospital Eye service were followed up. RESULTS: The Gloucestershire DESP manual list covering the 54 EMIS practices comprised 14,771 people with diabetes. The audit process identified an additional 709 (4.8%) patients coded C10, including 23 diagnosed more than 5 years ago, and 20 patients under the age of 20 who were diagnosed more than a year ago. CONCLUSION: Automatic extraction of data from General Practice identified 709 patients coded as having diabetes not previously known to the Gloucestershire DESP.

Which visual acuity measurements define high-quality care for patients with neovascular age-related macular degeneration treated with ranibizumab?

PURPOSE: The purpose of this study is to define which visual acuity (VA) measurements are the best indicators of high-quality care for patients receiving intravitreal ranibizumab for neovascular age-related macular degeneration (nAMD). METHODS: Analysis of prospectively collected data recorded within an electronic medical record system on treatment-naive, first-eligible eyes with nAMD, treated with ranibizumab using an as-needed treatment regimen with a minimum follow-up of 1 year. Data collection included the following: age, gender, laterality, type of nAMD, VA, central 1 mm OCT retinal thickness, number of intravitreal injections, and number of follow-up assessments. RESULTS: Data were available on the first-treated eye from 406 patients with at least 1 year follow-up; of these, 198 had data at 2 years. The mean baseline VA of 54.4 Early Treatment Diabetic Retinopathy Study letters improved to 58.5 letters at 12 months and to 56.8 letters at 24 months. The mean VA changes from baseline to 1 year were +6.5, +7.5, +1.7, and -1.5 letters, respectively, for baseline VA categories of 23-35, 36-55, 56-70, and >70 letters. Change in mean VA from the end of the loading phase to year 1 ranged from -2.9 to +1.4 letters for the different baseline VA categories. The mean number of injections were similar across baseline VA categories ranging from 5.7 to 6.0 injections in year 1 and from 3.3 to 3.8 in year 2. CONCLUSIONS: This large, real-world series demonstrates that mean change in VA is largely a function of selection criteria and baseline VA. The quality of a service is therefore better judged by actual VA outcomes and maintenance of vision after the loading phase.

Lack of confidence among trainee doctors in the management of diabetes: the Trainees Own Perception of Delivery of Care (TOPDOC) Diabetes Study.

BACKGROUND: There is an increased prevalence of diabetes. Doctors in training, irrespective of specialty, will have patients with diabetes under their care. AIM: To determine levels of confidence of doctors in training in the management of diabetes and establish their training needs in this area of clinical practice. DESIGN: A national online survey of trainee doctors in the UK using a pre-validated questionnaire. METHODS: A four-point confidence rating scale was used to rate confidence in the management of diabetes and comparators. A six-point scale was used to quantify how often trainees would contribute to the management of patients with diabetes and trainees were asked about their training in managing diabetes. RESULTS: A total of 2149 doctors completed the survey. The percentage 'fully confident' in diagnosing diabetes was 27%, diagnosing and managing hypoglycaemia 55%, diagnosing and managing diabetic ketoacidosis 43%, managing intravenous (IV) insulin 27%, prescribing IV fluids for patients with diabetes 39% and altering diabetes therapy prior to surgery/other procedure 18%. In comparison, 66% and 65% were 'fully confident' in the management of angina and asthma, respectively (P < 0.05). Forty-one percent would take the initiative to optimize glycaemic control for patients under their care >80% of the time. Respectively, 19% and 35% of respondents reported that their undergraduate and postgraduate training had prepared them adequately to optimize treatment of diabetes. The majority (>70%) wanted further training in managing all aspects of diabetes care. CONCLUSIONS: Trainee doctors in the UK lack confidence in the management of diabetes, are unlikely to take the initiative to optimize glycaemic control and report a need for further training.

Agreement and reasons for disagreement between photographic and hospital biomicroscopy grading of diabetic retinopathy.

AIMS: To compare agreement level and identify reasons for disagreement between grading of mydriatic digital photographs in a diabetic retinopathy screening service and hospital eye service biomicroscopy grading. METHODS: Structured examination findings leading to automatically calculated National Screening Committee grades recorded on an electronic medical record system in the hospital eye service at the first clinic visit after diabetic retinopathy screening service referral between April 2006 and November 2007 were retrospectively compared with the grade at the screening visit that prompted referral. In cases of disagreement, screening images were reviewed. RESULTS: Data on 452 eyes (226 patients) were analysed. For retinopathy, hospital eye service slit-lamp biomicroscopy grades were: R0 (no diabetic retinopathy) in 63 eyes; R1 (background retinopathy) in 251 eyes; R2 (pre-proliferative) in 129 eyes and R3 (proliferative) in nine eyes. Diabetic retinopathy screening service grades were in agreement in 350 eyes (77.4%), showed a lower grade in 59 eyes and a higher grade in 43. Agreement was moderate (κ=0.60). The most common reason for disagreement was overgrading of R1 by clinicians. Hospital eye service biomicroscopy maculopathy grades were: M0 (no maculopathy) in 366 eyes and M1 (maculopathy) in 86 eyes. Diabetic retinopathy screening service grades were in agreement in 327 eyes (72.3%), showed a lower grading in five eyes and a higher grade in 120 eyes. Agreement was moderate (κ=0.41). The commonest cause for disagreement was clinicians failing to identify fine macular exudates. CONCLUSIONS: This study of routine clinical services demonstrates moderate agreement between non-medical grading of mydriatic digital retinal photography images and hospital slit-lamp biomicroscopy grading of patients referred with diabetic retinopathy. The majority of errors in grading were attributable to errors by hospital doctors, usually in the direction of under-grading which could be a potential source of clinical risk if treatment is delayed.

Validation of an algorithm combining haemoglobin A(1c) and fasting plasma glucose for diagnosis of diabetes mellitus in UK and Australian populations.

AIM: To determine whether glycated haemoglobin (HbA(1c)) can be used in combination with fasting plasma glucose (FPG) for the diagnosis of diabetes in patients with impaired fasting glucose (IFG) and in a broader spectrum of patients. METHODS: An algorithm was derived from oral glucose tolerance test (OGTT) capillary samples in 500 consecutive UK patients with IFG by World Health Organization criteria. It was validated in a further 500 UK patients and, with venous specimens, in 1175 unselected Australian patients. RESULTS: The derivation cohort was aged 61 years (50-69 years) (median IQ range) with 52% male and 12% South Asian. Diabetes Control and Complications Trial-aligned HbA(1c) was 6.2% (5.8-6.6%) (reference interval < 6.0%) and FPG 6.7 mmol/l (6.3-7.2 mmol/l). FPG was in the diabetes range in 36% of patients, with an OGTT identifying a further 12% with diabetes. The derived algorithm, (HbA(1c) >or= 6.0% with FPG < 7.0 mmol/l) identified those patients requiring an OGTT to diagnose diabetes. When applied to the UK validation cohort, sensitivity was 97% and specificity 100%. The algorithm was equally effective in the unselected group, aged 59 years (49-68 years) and 54% male, with sensitivity 93% and specificity 100%. HbA(1c) was 6.0% (5.6-6.6%) and FPG 6.0 mmol/l (5.3-6.8 mmol/l), with 26% having IFG. Use of the algorithm would reduce the number of OGTTs performed in the UK validation cohort by 33% and by 66% in the Australian patients studied. CONCLUSIONS: Use of this algorithm would simplify procedures for diagnosis of diabetes and could also be used for monitoring pre-diabetes. Validation is now required in other populations and patient groups.

Atorvastatin in Factorial with Omega-3 EE90 Risk Reduction in Diabetes (AFORRD): a randomised controlled trial.

AIMS/HYPOTHESIS: The aim of the study was to examine the impact of statin or omega-3-acid ethyl esters 90 (omega-3 EE90; omega-3-acid ethyl esters 90 refers to a mixture of ethyl esters of n-3 fatty acids) on estimated cardiovascular disease (CVD) risk in community-based people with type 2 diabetes but without known CVD and not taking lipid-lowering therapy. METHODS: A central computer randomised 800 patients in 59 UK general practices to atorvastatin (n = 401, 20 mg/day) or placebo (n = 399) and omega-3 EE90 (n = 397, 2 g/day) or placebo (n = 403) in a concealed factorial manner. Participants with LDL-cholesterol <2.6 mmol/l, triacylglycerol <1.5 mmol/l and estimated 10-year CVD risk <20% were compared at 4 months. RESULTS: Mean (SD) age was 63.5 (11.7) years, HbA(1c) 6.9 (1.1) % and known diabetes duration (median [interquartile range]) was 4 (2-8) years. Fifty-seven per cent were men, 90% white and 74% had an estimated 10-year CVD risk >or=20%. Of 732 patients with 4-month data, more allocated atorvastatin (n = 371) compared with placebo (n = 361) achieved LDL-cholesterol <2.6 mmol/l (91% vs 24%, p < 0.001) and had estimated 10-year CVD risks <20% (38% vs 26%, p < 0.001). No differences were seen between those allocated omega-3 EE90 (n = 371) compared with placebo (n = 361) for participants achieving triacylglycerol <1.5 mmol/l (65% vs 60%, p = 0.18) or estimated 10-year CVD risks <20% (34% vs 30%, p = 0.18). There were no side effects of note. CONCLUSIONS/INTERPRETATION: Many community-based diabetic patients without known CVD remain at high CVD risk despite statin treatment and require additional risk-reduction strategies. The impact of omega-3 EE90 on CVD risk will remain uncertain until clinical endpoint trial results are available. TRIAL REGISTRATION: ISRCT no. 76737502.