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Aim To test how certain patient factors would influence the decision of Dutch care providers regarding insulin dose adjustments. We hypothesize that some of these decisions would diverge from recent evidence and consensus statements. Methods We developed narrative vignettes describing clinical scenarios of patients receiving basal insulin therapy. For each vignette, the respondents were asked to indicate whether they would advise a change in insulin dose. A total of 520 paper questionnaires were distributed among physicians and nurses in primary and secondary care in the Netherlands. Multivariate linear and logistic regression analyses were performed to identify factors associated with dosing decisions. Results A total of 190 (37%) questionnaires were returned. In cases of a severe rather than mild hypoglycaemic event, care providers were nearly five times more likely to decrease the dose (odds ratio 4.77, 95% CI 1.65-13.75). Care providers were six times more likely to increase the dose when the patient's current dose was low (30 units) rather than high (90 units) (odds ratio 6.38, 95% CI 3.04-13.37). The plasma glucose concentration during a hypoglycaemic event and a known history of cardiovascular disease did not influence the care providers' dosing decisions. Conclusion Evidence regarding the optimum insulin titration is not always translated into clinical practice. When formulating guidelines, misconceptions should be identified and addressed. [ABSTRACT FROM AUTHOR]

Aims To assess the effect of mobile phone intervention on glycaemic control in diabetes self-management. Methods We searched three electronic databases (PubMed, EMBASE and Cochrane Library) using the following terms: diabetes or diabetes mellitus and mobile phone or cellular phone, or text message.We also manually searched reference lists of relevant papers to identify additional studies. Clinical studies that used mobile phone intervention and reported changes in glycosylated haemoglobin (HbA1c) values in patients with diabetes were reviewed. The study design, intervention methods, sample size and clinical outcomes were extracted from each trial. The results of the HbA1c change in the trials were pooled using meta-analysis methods. Results A total of 22 trials were selected for the review. Meta-analysis among 1657 participants showed that mobile phone interventions for diabetes self-management reduced HbA1c values by amean of 0.5% [6 mmol / mol; 95% confidence interval, 0.3-0.7% (4-8 mmol/ mol)] over a median of 6 months follow-up duration. In subgroup analysis, 11 studies among Type 2 diabetes patients reported significantly greater reduction in HbA1c than studies among Type 1 diabetes patients [0.8 (9 mmol/ mol) vs. 0.3% (3 mmol / mol); P = 0.02]. The effect of mobile phone intervention did not significantly differ by other participant characteristics or intervention strategies. Conclusions Results pooled from the included trials provided strong evidence that mobile phone intervention led to statistically significant improvement in glycaemic control and self-management in diabetes care, especially for Type 2 diabetes patients. [ABSTRACT FROM AUTHOR]

Aim To use continuous glucose monitoring to examine the effects of insulin initiation with glargine, with or without glulisine, on glycaemic variability and glycaemia in a cohort of people with Type 2 diabetes receiving maximum oral hypoglycaemic agents in primary healthcare. Methods We conducted a post hoc analysis of continuous glucose monitoring data from 89 participants at baseline and at 24 weeks after insulin commencement. Indicators of glycaemic variability (standard deviation, J-index and mean amplitude of glycaemic excursion) and glycaemia (HbA1c, mean glucose, area under the glucose-time curve) were assessed. Multi-level regression analysis was used to identify the predictors of change. Results Complete glycaemic variability data were available for 78 participants. Of these participants, 41% were women, their mean ( sd) age was 59.2 (10.4) years, the median (interquartile range) diabetes duration was 10.4 (6.5, 13.3) years and the median (interquartile range) baseline HbA1c was 82.5 (71.6, 96.7) mmol/mol [9.7 (8.7, 11.0)%]. At baseline, BMI correlated negatively with standard deviation ( r = −0.30) and mean amplitude of glycaemic excursion ( r = −0.26), but not with J-index; HbA1c correlated with J-index ( r = 0.61) but not with mean amplitude of glycaemic excursion and standard deviation. After insulin initiation the mean ( sd) glucose level decreased [from 12.0 (3.0) to 8.5 (1.6) mmol/l; P < 0.001], as did the median (interquartile range) J-index [from 66.9 (47.7, 95.1) to 36.9 (27.6, 49.8) mmol/l; P < 0.001]. Baseline HbA1c correlated with a greater J-index reduction ( r = −0.45; P < 0.001). The mean amplitude of glycaemic excursion and standard deviation values were unchanged. The baseline temporal profile, showing elevated postprandial morning glucose levels, was unchanged after insulin initiation, despite an overall reduction in glycaemia. Conclusion Insulin initiation reduced hyperglycaemia but did not alter glycaemic variability in adults with Type 2 diabetes receiving maximum oral hypoglycaemic agents. The most significant postprandial excursions were seen in the morning, which identifies prebreakfast as the most effective target for short-acting insulin therapy. [ABSTRACT FROM AUTHOR]

Aims To examine whether patients using sitagliptin at the time of an acute coronary syndrome event are at increased risk of incident heart failure compared with those not exposed. Methods Using US claims data, people with diabetes without a history of heart failure in the 3 years before hospitalization for acute coronary syndrome were identified for the period 2004 to 2010. We used a nested case-control design, whereby cases were patients who developed incident heart failure <30 days after admission to hospital for acute coronary syndrome and were matched by age and sex with up to 10 controls with no heart failure. Subjects exposed or not exposed to sitagliptin in the 90 days before acute coronary syndrome admission were compared using conditional logistic regression after adjustment for clinical and laboratory data, healthcare utilization and propensity scores. Results In total, 457 cases of heart failure developing de novo after diagnosis of acute coronary syndrome were matched to 4570 controls. The average age of the subjects was 55 years and 65% were male. Overall, 11 of 147 (7%) people exposed to sitagliptin developed heart failure compared with 446 of the 4880 people not exposed (9%, adjusted odds ratio 0.75, 95% CI 0.38-1.46; P=0.40). Sitagliptin exposure before acute coronary syndrome was not associated with an increased risk of death or heart failure combined (7% vs 9%, adjusted odds ratio 0.66, 95% CI 0.34-1.28). Conclusions In our sample of patients who are at high risk of heart failure after acute coronary syndrome, sitagliptin exposure was not associated with an increased risk of de novo heart failure. [ABSTRACT FROM AUTHOR]

Aims To investigate the long-term efficacy and safety of empagliflozin as add-on to metformin in people with Type 2 diabetes. Methods Of 637 participants treated with empagliflozin 10 mg, empagliflozin 25 mg, or placebo once daily for 24 weeks, 463 (72.7%) were treated in a double-blind extension trial for ≥ 52 weeks. Prespecified exploratory endpoints included changes from baseline in HbA1c, weight and blood pressure at week 76. Results Compared with placebo, adjusted mean changes from baseline in HbA1c (overall baseline mean ± sd 63 ± 9 mmol/mol [7.9 ± 0.9%]) were â'7 mmol/mol [(â'0.6%) 95% CI â'8, â'5 mmol/mol (â'0.8, â'0.5%); P < 0.001] and â'8 mmol/mol [(â'0.7%) 95% CI â'10, â'6 mmol/mol (â'0.9, â'0.6%); P < 0.001], for empagliflozin 10 mg and 25 mg, respectively. Compared with placebo, adjusted mean changes from baseline in weight were â'1.9 kg (95% CI â'2.5, â'1.3; P < 0.001) and â'2.2 kg (95% CI â'2.8, â'1.6; P < 0.001) for empagliflozin 10 mg and 25 mg, respectively. Empagliflozin led to sustained reductions in systolic blood pressure vs. placebo. Adverse events were reported in 77.7, 80.2 and 72.0% of participants on placebo, empagliflozin 10 mg and empagliflozin 25 mg, respectively. Confirmed hypoglycaemic adverse events (glucose ≥ 3.9 mmol/l and/or event requiring assistance) were reported in 3.4, 4.1 and 4.2% of participants in these groups, respectively. Conclusions In people with Type 2 diabetes, empagliflozin 10 mg and 25 mg given as add-on to metformin for 76 weeks were well tolerated and led to sustained reductions in HbA1c, weight and systolic blood pressure. [ABSTRACT FROM AUTHOR]

Aim To examine prescribing practices and predictors of glucose-lowering therapy within the first year following diagnosis of Type 2 diabetes mellitus in a clinical care setting. Methods We followed people enrolled in the Danish Centre for Strategic Research in Type 2 Diabetes (DD2) cohort from outpatient hospital clinics and general practices throughout Denmark in 2010-2013. We used Poisson regression to compute age- and gender-adjusted risk ratios (RRs). Results Among 1158 new Type 2 diabetes mellitus patients, 302 (26%) did not receive glucose-lowering therapy within the first year, 723 (62%) received monotherapy [685 (95%) with metformin], and 133 (12%) received more than one drug. Predictors of receiving any vs. no therapy and combination vs. monotherapy were: age < 40 years [RR: 1.29 (95% CI: 1.16-1.44) and 3.60 (95% CI: 2.36-5.50)]; high Charlson Comorbidity Index [RRs: 1.20 (95% CI: 1.05-1.38) and 2.08 (95% CI: 1.16-3.72)]; central obesity [RRs: 1.23 (95% CI: 1.04-1.44) and 1.93 (95% CI: 0.76-4.94)]; fasting blood glucose of ≥ 7.5 mmol/l [RRs: 1.25 (95% CI: 1.10-1.42) and 1.94 (95% CI: 1.02-3.71)]; and HbA1c = 59 mmol/mol (≥ 7.5%) [RR: 1.26 (95% CI: 1.20-1.32) and 2.86 (95% CI: 1.97-4.14)]. Weight gain = 30 kg since age 20, lack of physical exercise and C-peptide of < 300 pmol/l also predicted therapy. Conclusions Comorbidity, young age, central obesity and poor baseline glycaemic control are important predictors of therapy one year after Type 2 diabetes mellitus debut. [ABSTRACT FROM AUTHOR]

Aim The evidence for self-management programmes in older adults varies in methodological approaches, and disease criteria. Using predetermined methodological criteria, we evaluated the effect of diabetes-specific self-management programme interventions in older adults. Methods The EMBASE, MEDLINE and Cochrane Central Register of Controlled Trials databases were searched from January 1980 to November 2013, as were reference lists from systematic reviews, meta-analyses and clinical practice guidelines. A total of 13 trials met the selection criteria, which included 4517 older adult participants; 2361 participants randomized to a diabetes self-management programme and 2156 to usual care. Results The pooled effect on HbA1c was a reduction of -2 mmol/mol (-0.2%; 95% CI -0.3 to -0.1); tailored interventions [-3 mmol/mol (-0.2%; 95% CI -0.4 to -0.1)] or programmes with a psychological emphasis [-3 mmol/mol (-0.2; 95% CI -0.4 to -0.1)] were most effective. A pooled treatment effect on total cholesterol was a 5.81 mg/dl reduction (95% CI -10.33 to -1.29) and non-significant reductions in systolic and diastolic blood pressure. Conclusions Diabetes self-management programmes for older adults demonstrate a small reduction in HbA1c, lipids and blood pressure. These findings may be of greater clinical relevance when offered in conjunction with other therapies. [ABSTRACT FROM AUTHOR]

Aim To investigate the association between pulse pressure and risk of hospitalization for cardiovascular events among people with Type 2 diabetes. Methods A population-based case-control study was carried out using data from medical databases. A total of 588 people with Type 2 diabetes from 18 general practices in Cambridgeshire recorded a first hospitalization for a cardiovascular event between 2009 and 2011, and a total of 2920 age-matched, gender-matched and practice-matched control subjects with Type 2 diabetes were selected based on risk-set sampling. Pulse pressure was assessed before admission in 2008-2009. Further dose-response relationships between pulse pressure and risks were explored using spline models. Results There was a non-linear relationship between pulse pressure and the risk of hospitalization for a cardiovascular event ( P < 0.001 for linearity test). The pulse pressure associated with the lowest risk of hospitalization for a cardiovascular event was 61 (95% CI 57-63) mmHg. Conclusion In people with Type 2 diabetes, pulse pressure is a good predictor of risk of hospitalization for cardiovascular events. The risk is lowest with a pulse pressure of 57-63 mmHg. [ABSTRACT FROM AUTHOR]

Aim This study investigates the relationship between basal insulin regimen and glycaemic outcomes 12 months after skills-based structured education in the UK Dose Adjustment for Normal Eating ( DAFNE) programme for Type 1 diabetes mellitus. Method Retrospective analysis of data from 892 DAFNE participants from 11 UK centres. Results Mean HbA1c 12 months after DAFNE was lower in those using twice- rather than once-daily basal insulin after correcting for differences in baseline HbA1c, age and duration of diabetes; difference -2 (95% CI -3 to -1) mmol/mol [-0.2 (-0.3 to -0.1)%], P = 0.009. The greatest fall in HbA1c of -5 (-7 to -3) mmol/mol [-0.4 (-0.6 to -0.3)%], P < 0.001 occurred in those with less good baseline control, HbA1c ≥ 58 mmol/mol, who switched from once- to twice-daily basal insulin. There was no difference in the 12-month HbA1c between users of glargine, detemir and NPH insulin after correcting for other variables. Relative risk of severe hypoglycaemia fell by 76% and ketoacidosis by 63% 12 months after DAFNE. The rate of severe hypoglycaemia fell from 0.82 to 0.23 events/patient year in twice-daily basal insulin users. In the group with greatest fall in HbA1c, the estimated relative risk for severe hypoglycaemia in twice-daily basal insulin users versus once daily at 12 months was 1.72 (0.88-3.36, P = 0.110). Conclusion After structured education in adults with Type 1 diabetes mellitus, use of basal insulin twice rather than once daily was associated with lower HbA1c, independent of insulin type, with significant reductions in severe hypoglycaemia and ketoacidosis in all groups. [ABSTRACT FROM AUTHOR]

Aim To explore the gender differences, along with the relationships between BMI, glycaemic control, cardiovascular risk factors and the prevalence of diabetes complications, in a representative population-based group of people with Type 1 and Type 2 diabetes. Methods Data were obtained from general practices in Ayrshire and Arran, Scotland for 15 351 patients. Results In the cohort with Type 1 diabetes, after adjustment for age, men had a significantly lower BMI ( P = 0.007) and significantly lower total cholesterol ( P = 0.005), HDL-cholesterol ( P = 2.5*10-17) and HbA1c levels ( P = 0.003) than women. By contrast, men had higher blood pressure, both systolic ( P = 0.034) and diastolic ( P = 0.0003), and higher non-fasting triglyceride levels ( P = 0.001). Men with Type 1 diabetes had a higher prevalence of neuropathy ( P = 0.021). Among people with Type 2 diabetes, men had a significantly lower BMI ( P = 4.26*10-37), and significantly lower total cholesterol ( P = 2.96*10-62) and HDL-cholesterol levels ( P = 8.25*10-141) but higher non-fasting triglyceride levels ( P = 0.0002). In Type 2 diabetes, men had a higher prevalence of ischaemic heart disease ( P = 1.66*10-25), stroke ( P = 0.002) and peripheral vascular disease ( P = 1.68*10-12), while women were older ( P = 4.83*10-23), heavier and had a higher prevalence of hypertension ( P = 5.32*10-12). More people with Type 2 diabetes were on lipid-lowering treatment (84.7 vs 52.4%; P = 5.51*10-8) than were those with Type 1 diabetes. The prevalence of retinopathy was higher among non-smokers thank smokers in people with both Type 1 and Type 2 diabetes (Type 1, P = 0.016; Type 2, P = 0.001). Conclusions The study shows gender differences between Type 1 and 2 diabetes that are of clinical significance and require further investigation. Follow-up of the patients included in the present study should give us much greater understanding of the importance of gender in the development of metabolic abnormalities and diabetes complications. [ABSTRACT FROM AUTHOR]

Aim To develop and test a format of delivery of diabetes self-management education by paired professional and lay educators. Methods We conducted an equivalence trial with non-randomized participant allocation to a Diabetes Education and Self Management for Ongoing and Newly Diagnosed Type 2 diabetes (DESMOND) course, delivered in the standard format by two trained healthcare professional educators (to the control group) or by one trained lay educator and one professional educator (to the intervention group). A total of 260 people with Type 2 diabetes diagnosed within the previous 12 months were referred for self-management education as part of routine care and attended either a control or intervention format DESMOND course. The primary outcome measure was change in illness coherence score (derived from the Diabetes Illness Perception Questionnaire-Revised) between baseline and 4 months after attending education sessions. Secondary outcome measures included change in HbA1c level. The trial was conducted in four primary care organizations across England and Scotland. Results The 95% CI for the between-group difference in positive change in coherence scores was within the pre-set limits of equivalence (difference = 0.22, 95% CI 1.07 to 1.52). Equivalent changes related to secondary outcome measures were also observed, including equivalent reductions in HbA1c levels. Conclusion Diabetes education delivered jointly by a trained lay person and a healthcare professional educator with the same educator role can provide equivalent patient benefits. This could provide a method that increases capacity, maintains quality and is cost-effective, while increasing access to self-management education. [ABSTRACT FROM AUTHOR]

Aim To predict mortality risk and life expectancy for patients with Type 2 diabetes after a major diabetes-related complication. Methods The study sample, taken from the Swedish National Diabetes Register, consisted of 20 836 people with Type 2 diabetes who had their first major complication (myocardial infarction, stroke, heart failure, amputation or renal failure) between January 2001 and December 2007. A Gompertz proportional hazards model was derived which determined significant risk factors associated with mortality and was used to estimate life expectancies. Results Risk of death changed over time according to type of complication, with myocardial infarction initally having the highest initial risk of death, but after the first month, the risk was higher for heart failure, renal failure and amputation. Other factors that increased the risk of death were male gender (hazard ratio 1.06, 95% CI 1.02-1.12), longer duration of diabetes (hazard ratio 1.07 per 10 years, 95% CI 1.04-1.10), smoking (hazard ratio 1.51, 95% CI 1.40-1.63) and macroalbuminuria (hazard ratio 1.14, 95% CI 1.06-1.22). Low BMI, low systolic blood pressure and low estimated GFR also increased mortality risk. Life expectancy was highest after a stroke, myocardial infarction or heart failure, lower after amputation and lowest after renal failure. Smoking and poor renal function were the risk factors which had the largest impact on reducing life expectancy. Conclusions Risk of death and life expectancy differs substantially among the major complications of diabetes, and factors significantly increasing risk included smoking, low estimated GFR and albuminuria. [ABSTRACT FROM AUTHOR]

Aims To determine the impact of structured education promoting flexible intensive insulin therapy on rates of diabetic ketoacidosis, and the costs associated with emergency treatment for severe hypoglycaemia and ketoacidosis in adults with Type 1 diabetes. Methods Using the Dose Adjustment For Normal Eating research database we compared the rates of ketoacidosis and severe hypoglycaemia during the 12 months preceding Dose Adjustment For Normal Eating training with the rates during the 12-month follow-up after this training. Emergency treatment costs were calculated for associated paramedic assistance, Accident and Emergency department attendance and hospital admissions. Results Complete baseline and 1-year data were available for 939/1651 participants (57%). The risk of ketoacidosis in the 12 months after Dose Adjustment For Normal Eating training, compared with that before training, was 0.39 (95% CI: 0.23 to 0.65, P < 0.001), reduced from 0.07 to 0.03 episodes/patient/year. For every 1 mmol/mol unit increase in HbA1c concentration, the risk of a ketoacidosis episode increased by 6% (95% CI: 5 to 7%; 88% for a 1% increase), and for each 5-year increase in diabetes duration, the relative risk reduced by 20% (95% CI: 19 to 22%). The number of emergency treatments decreased for ketoacidosis ( P < 0.001), and also for severe hypoglycaemia, including paramedic assistance ( P < 0.001), Accident and Emergency department attendance ( P = 0.029) and hospital admission ( P = 0.001). In the study cohort, the combined cost of emergency treatment for ketoacidosis and severe hypoglycaemia fell by 64%, from £119,470 to £42,948. Conclusions Structured training in flexible intensive insulin therapy is associated with a 61% reduction in the risk of ketoacidosis and with 64% lower emergency treatment costs for ketoacidosis and severe hypoglycaemia. [ABSTRACT FROM AUTHOR]

Aim's The aim was to To study the relationship between BMI and hospitalization for heart failure in people with Type 2 diabetes. Methods We identified 83 021 individuals with Type 2 diabetes from the Swedish National Diabetes Registry during 1998-2003, who were followed until hospitalization for heart failure, death or end of follow-up on 31 December 2009. Cox regression analyses were performed, adjusting for age, sex, HbA1c, blood pressure, diabetes duration, smoking, microalbuminuria, cardiac co-morbidities, glucose-lowering and anti-hypertensive medications. Results During a median follow-up of 7.2 years, 10 969 patients (13.2%) were hospitalized with heart failure. By categories of BMI, with BMI 20 to < 25 kg/m2 as the reference, hazard ratios for patients during follow-up were 1.07 (95% CI 0.91-1.26) for a mean BMI of < 20 kg/m2, 1.04 (95% CI 0.98-1.11) for BMI 25 to < 27.5 kg/m2, 1.22 (95% CI 1.15-1.30) for BMI 27.5 to < 30 kg/m2, 1.54 (95% CI 1.45-1.63) for BMI 30 to < 35 kg/m2, 2.16 (95% CI 2.00-2.33) for BMI 35 to < 40 kg/m2 and 3.22 (95% CI 2.88-3.60) for BMI 40 kg/m2 or higher. There was a significant interaction between BMI and sex ( P = 0.0006), with numerically higher hazard ratios for hospitalization for heart failure within each BMI category for men than for women. Conclusions Obesity is strongly related to hospitalization for heart failure in people with Type 2 diabetes, and the relationship is somewhat stronger for men than for women. Preventing weight gain and promoting weight loss may be crucial in reducing the incidence of future hospitalizations for heart failure in this population. [ABSTRACT FROM AUTHOR]

Aim To investigate the relationship between HbA1c and the 2-year risk of hospitalization among people with Type 2 diabetes. Methods In total, 4704 patients from 18 general practices in Cambridgeshire were included. Glycaemic exposure was assessed in 2008-2009. The primary outcome was all-cause hospital admissions in 2010-2011. Adjusted relative risks for each HbA1c quintile were estimated using Cox models. Further relationships between HbA1c and risks were explored using spline models. Results There was a non-linear relationship between HbA1c and the risk of all-cause, diabetes and vascular admissions (all P < 0.001 for linearity test) with an HbA1c threshold of 61 (95% CI 55-66) mmol/mol [7.7 (95% CI 7.2-8.2)%]. For every 11 mmol/mol (1%) HbA1c above the threshold, the risks increased by 6.3% for all-cause admission, 6.4% for a diabetes admission and 15.9% for a cardiovascular admission (all P < 0.001). The overall hospitalization risks of having an HbA1c above, rather than at, the threshold, were 19.1 16.3 and 54.3% greater, respectively. There were non-significantly greater risks of hospital admission below the threshold. Conclusion In people with Type 2 diabetes, a non-linear relationship exists between HbA1c and the risk of hospitalization. A threshold of 61 mmol/mol (7.7%) was associated with the lowest rate of all-cause hospital admissions. Further research should investigate the causes of admissions below and above this threshold, with a view to developing strategies to reduce the excess hospitalization among patients with diabetes. [ABSTRACT FROM AUTHOR]

Aims To determine the prevalence of foot ulcers and the incidence of amputations in patients with Type 2 diabetes observed for 19 years after diagnosis. We investigated the role of gender, age and co-morbidities. Methods From the Diabetes Care in General Practice study, 1381 patients were included and examined at diabetes diagnosis, at 6 years and at 14 years after diagnosis. Register-based follow-up was for 19 years. Foot ulcers and amputations were related to gender, age and co-morbidities by odds and hazard ratios from logistic and Cox regression models, respectively. Results The incidence of any amputation and major amputation was 400 (95% CI 307-512) and 279 (95% CI 203-375) per 100 000 patient-years, respectively. At the three observation points, the foot ulcer prevalences were 2.76% (95% CI 1.89-3.63), 2.93% (95% CI 1.86-4.00) and 4.96% (95% CI 3.10-6.82). Multivariate analyses showed associations between foot ulcers and peripheral neuropathy, peripheral arterial disease, male gender, retinopathy and myocardial infarction. After multivariate adjustment, significant predictors (hazard ratio; 95% CI) of any amputation were peripheral neuropathy (hazard ratio 2.09; 95% CI 1.19-3.69), peripheral arterial disease (hazard ratio 3.43; 95% CI 1.65-7.12), microalbuminuria (hazard ratio 2.11; 95% CI 1.21-3.67), retinopathy (hazard ratio 6.42; 95% CI 2.59-15.90), impaired vision (hazard ratio 6.92; 95% CI 2.35-20.38) and male gender (hazard ratio 2.40; 95% CI 1.31-4.41). For women, the risk of amputation increased with age, but for men the risk was higher when diagnosed with diabetes at a younger age. Conclusions Despite improved treatment regimens, the incidence of amputations is still high in this population-based patient sample. Men diagnosed with diabetes before age 65 years and patients with diabetes-related co-morbidities are at particularly high risk of foot ulcers and amputations. [ABSTRACT FROM AUTHOR]

Aims This 52-week, randomized, multinational, open-label, parallel-group, non-inferiority trial investigated the efficacy and safety of basal-bolus treatment with insulin detemir vs. NPH (neutral protamine Hagedorn) insulin, in combination with insulin aspart, in subjects aged 2-16 years with Type 1 diabetes mellitus. Methods Of the 347 randomized and exposed subjects, 177 received insulin detemir and 170 NPH insulin, both administered once or twice daily in combination with mealtime insulin aspart. Glycaemic measurements and weight were followed over 52 weeks. Results After 52 weeks, insulin detemir was shown to be non-inferior to NPH insulin with regard to HbA1c [mean difference insulin detemir-NPH: 1.30 mmol/mol, 95% CI -1.32 to 3.92 (0.12%, 95% CI -0.12 to 0.36) in the full analysis set and 1.41 mmol/mol, 95% CI -1.26 to 4.08 (0.13%, 95% CI -0.12 to 0.37) in the per protocol analysis set]. Hypoglycaemic events per subject-year of exposure of 24-h and nocturnal hypoglycaemia were significantly lower with insulin detemir than with NPH insulin (rate ratio 0.76, 95% CI 0.60-0.97, P = 0.028 and 0.62, 95% CI 0.47-0.84, P = 0.002, respectively). Weight standard deviation ( sd) scores (body weight standardized by age and gender) decreased with insulin detemir, but increased slightly with NPH insulin (change: -0.12 vs. 0.04, P < 0.001). At end of the trial, median insulin doses were similar in both treatment groups. Conclusions Insulin detemir was non-inferior to NPH insulin after 52 weeks' treatment of children and adolescents aged 2-16 years, and was associated with a significantly lower risk of hypoglycaemia, together with significantly lower weight sd score when compared with NPH insulin. [ABSTRACT FROM AUTHOR]

Diabet. Med. 29, 488-491 (2012) Abstract Aims To determine the prevalence and distribution of abnormal plasma liver enzymes in a representative sample of older adults with Type 2 diabetes. Methods Plasma concentrations of alanine aminotransferase, aspartate aminotransferase and γ-glutamyltransferase were measured in a randomly selected, population-based cohort of 1066 men and women aged 60-75 years with Type 2 diabetes (the Edinburgh Type 2 Diabetes Study). Results Overall, 29.1% (95% CI 26.1-31.8) of patients had one or more plasma liver enzymes above the upper limit of the normal reference range. Only 10.1% of these patients had a prior history of liver disease and a further 12.4% reported alcohol intake above recommended limits. Alanine aminotransferase was the most commonly raised liver enzyme (23.1% of patients). The prevalence of abnormal liver enzymes was significantly higher in men (odds ratio 1.40, 95% CI 1.07-1.83), in the youngest 5-year age band (odds ratio 2.02, 95% CI 1.44-2.84), in patients with diabetes duration < 5 years (odds ratio 1.38, 95% CI 1.01-1.90), plasma HbA1c≥ 58 mmol/mol (7.5%) (odds ratio 1.43, 95% CI 1.09-1.88), obese BMI (odds ratio 2.84, 95% CI 1.59-3.06) and secondary care management for their diabetes (odds ratio 1.40, 95% CI 1.05-1.87). However, all these factors combined accounted for only 7.6% of the variation in liver enzyme abnormality. Conclusions The prevalence of elevated liver enzymes in people with Type 2 diabetes is high, with only modest variation between clinically defined patient groups. Further research is required to determine the prognostic value of raised, routinely measured liver enzymes to inform decisions on appropriate follow-up investigations. [ABSTRACT FROM AUTHOR]

Diabet. Med. 29, 266-271 (2012) Abstract Aims Glycated haemoglobin (HbA1c) is monitored to guide treatment decisions in relation to glycaemic goals over time. Changes between two consecutive HbA1c tests result not only from deterioration or improvement in glycaemic control, but also from biovariability and measurement error. We model how this short-term variability impacts on HbA1c monitoring. Methods Using data from a randomized trial of non-insulin treated patients with Type 2 diabetes we fitted a random-effects model for progression and variability of HbA1c. We estimated how many tests where HbA1c ≥ 7.5% (58.5 mmol/mol) would be false-positive (underlying HbA1c < 7.5% but test ≥ 7.5% owing to variability) vs. true-positive, in people with initial HbA1c between 6.5% and 7.3% (48 mmol/mol and 56 mmol/mol). Results Participants ( n = 320) had mean (SD) age 66 (10) years, BMI 31.3 (6.0) kg/m2 and median HbA1c was 7.1% (54 mmol/mol) with interquartile range 6.6% (49 mmol/mol) to 7.7% (61 mmol/mol). Mean (95% CI) change in HbA1c was 0.1% (1 mmol/mol) with 95% confidence interval 0.05% (0.5 mmol/mol) to 0.15% (2 mmol/mol) per 6 months. The minimum interval at which a true-positive test is more likely than a false positive test is 270 days for a starting HbA1c of 6.9% (52 mmol/mol) and 360 days at a starting value of 6.5% (48 mmol/mol). Conclusion In patients with initial HbA1c close to treatment goal, retesting at 6 months would yield more true-positive than false-positive tests. For patients with lower initial HbA1c, retesting at 6 months would yield more false than true-positive tests. In all patients, retesting at 12 months yields more true than false-positive tests. In very few patients would retesting at 3 months be justified. [ABSTRACT FROM AUTHOR]

Diabet. Med. 28, 1425-1432 (2011) Abstract Aims To estimate the prevalence of diagnosed Type 2 diabetes mellitus in Greenland and to evaluate the quality of the diabetes care before and after implementation of a new diabetes programme. Methods In this observational and cross-sectional study, data from the medical records were collected in Greenland in 2008 and 2010. Information about age, gender, most recently measured HbA1c, blood pressure and serum cholesterol and from the examination of eyes, feet and urine was obtained. The prevalence was estimated using the whole adult population in Greenland as background population. The quality of the diabetes care was monitored by six process, three biological and three treatment indicators. A diabetes concept based on national guidelines, systematized recording in an electronic medical record and feedback to the clinics were used to improve diabetes care. Results Four hundred and sixty-five patients were included in the 2008 sample and 691 in the 2010 sample. The total prevalence increased from 2.3 (95% CI 2.1-2.5) % in 2008 to 2.7 (95% CI 2.5-3.0) among Greenlanders aged 40 years old or above, corresponding to an increase of 19% ( P = 0.006). All process indicators improved significantly between the two observations. Conclusions Along with an increasing prevalence of diagnosed Type 2 diabetes, all six process quality indicators increased. It is strongly recommended that focus on the quality of diabetes care in Greenland should be maintained in order to benefit from the programme in the longer term. [ABSTRACT FROM AUTHOR]

Background: We examined associations between patient and practice characteristics and exclusions fromquality indicators for diabetes during the first 3 years of the Quality and Outcomes Framework, a major pay-for-performance scheme in the UK. Methods: Three cross-sectional analyses, conducted using data from the electronicmedical records of all patients with diabetes registered in 23 general practices in Brent, NorthWestLondon between 2004 ⁄ 2005 and 2006 ⁄ 2007. Patterns of exclusionswere examined for three intermediate outcome indicators. Results: Excluded patients were less likely to achieve treatment targets for HbA1c (2004 ⁄ 2005, 2006 ⁄ 2007), blood pressure (2005 ⁄ 2006, 2006 ⁄ 2007) and cholesterol (2005 ⁄ 2006). Black and South Asian patients were more likely to be excluded from the HbA1c indicator than White patients [adjusted odds ratio = 1.64 (1.17-2.29) in 2005 ⁄ 2006]. Patients diagnosed with diabetes duration of > 10 years [adjusted odds ratio = 2.01 (1.65-2.45) forHbA1c in2006-2007] andthosewith co-morbidities (adjusted odds ratio, ‡ 3 co-morbidities compared with no co-morbidity for HbA1c adjusted odds ratio = 1.90 (1.24-2.90) in 2004⁄ 2005] were more likely to be excluded. Larger practices excluded more patients from theHbA1c indicator [adjusted odds ratio, practice ‡ 7000 comparedwith < 3000, 3.52 (2.35-5.27) in 2005-2006].More deprived practices consistently excluded more patients from all indicators, whilst in 2007 older patients were excluded to a larger degree [adjusted odds ratio = 2.52 (1.21-5.28) ‡ 75 compared with 18-44 for blood pressure control]. Conclusions: Patients excluded from pay-for performance programmes may be less likely to achieve treatment goals and disproportionately come from disadvantaged groups. Permitting physicians to exclude patients from pay for-performance programmes may worsen health disparities. [ABSTRACT FROM AUTHOR]

Aims To assess perinatal outcome in women with pregestational diabetes mellitus according to the sex of the fetus. Methods A retrospective review of all singleton pregnancies of women with pregestational diabetes progressing to a gestational age of 22 weeks or more who attended the diabetes and pregnancy clinic from 1981 to 2006 (n = 455). We compared maternal characteristics and perinatal outcomes (perinatal mortality, major congenital malformations, small and large for gestational age newborns, preterm birth and a composite of the former) according to the sex of the fetus. A logistic regression analysis was performed using the composite perinatal outcome as the dependent variable and all maternal variables and sex of fetus as potential predictors. Results Maternal characteristics did not differ in mothers of male and female newborns. In the whole cohort, the composite perinatal outcome was significantly higher in male fetuses; adjusted OR 1.61 (95% CI 1.04-2.50). Conclusions In women with pregestational diabetes, perinatal outcome was poorer in male newborns despite similar maternal characteristics. [ABSTRACT FROM AUTHOR]

Aim The aim of this study was to address the controversy over the influence of intensive glucose control on the risk for cardiovascular events in patients with Type 2 diabetes. Methods FRENA is an ongoing registry of stable outpatients with symptomatic coronary artery disease, cerebrovascular disease or peripheral artery disease.We compared the incidence of subsequent ischaemic events (myocardial infarction, stroke or critical limb ischaemia) in patients with Type 2 diabetes and mean HbA1c levels < 7.0% (< 53 mmol / mol) vs. those with HbA1c levels > 7.0%(> 53 mmol /mol). Results Of 974 patients with Type 2 diabetes, 480 (49%) had mean HbA1c levels < 7%(< 53 mmol/ mol). Over a mean follow-up of 14 months, 126 patients (13%) had subsequent ischaemic events: myocardial infarction (43), stroke (29) and critical limb ischaemia (64). The incidence of subsequent ischaemic eventswas significantly lower in patients with mean HbA1c levels < 7.0% (< 53 mmol / mol) than in those with HbA1c levels > 7.0%(> 53 mmol / mol) (8.6 vs. 14 per 100 patient-years; rate ratio 0.6; 95% CI 0.4-0.9). These differences persisted after adjusting for potential confounders. However, this better outcome was only found in patients presenting with coronary artery disease (rate ratio 0.4; 95% CI 0.2-0.8), not in those with cerebrovascular disease (rate ratio 0.9; 95% CI 0.4-2.0) or peripheral artery disease (rate ratio 0.8; 95% CI 0.5-1.3). Patients with mean HbA1c levels < 7.0% (< 53 mmol / mol) also had a lower mortality (rate ratio 0.6; 95% CI 0.3-0.99). Conclusions In secondary prevention, patients with diabetes and HbA1c levels < 7.0% (< 53 mmol /mol) had a lower incidence of subsequent ischaemic events and a lower mortality than those with HbA1c levels > 7.0% (> 53 mmol /mol). These differences appeared only in patients with coronary artery disease. [ABSTRACT FROM AUTHOR]

Diabet. Med. 29, 628-631 (2012) Abstract Aims To examine whether high-dose statin therapy in Dutch European patients with Type 2 diabetes and dyslipidaemia influenced variables of glycaemic control. Methods The CORALL study, which was a 24-week, open-label, randomized, parallel-group, phase IIIb, multi-centre study, was designed to compare the cholesterol-lowering effects of rosuvastatin compared with atorvastatin in patients with Type 2 diabetes. Fasting plasma glucose levels and HbA1c levels were collected at baseline and at 6 and 18 weeks. Results Treatment with the highest dose of statins, i.e. atorvastatin 80 mg and rosuvastatin 40 mg at 18 weeks from baseline, was associated with increase in HbA1c levels; baseline 57 ± 11 mmol/l (7.4 ± 1.0%) to 61 ± 14 mmol/mol (7.7 ± 1.3%) (range 5.0-11.9) for atorvastatin ( P = 0.003) and from baseline 60 ± 11 mmol/mol (7.6 ± 1.0%) to 63 ± 13 mmol/mol (7.9 ± 1.2%) (range 5.7-12.3) for rosuvastatin ( P < 0.001). Mean fasting plasma glucose increased from baseline 8.7 ± 2.4 mmol/l to 9.5 ± 3.0 mmol/l upon treatment with atorvastatin 20 mg ( P = 0.002) and 9.0 ± 3.0 mmol/l after treatment with 80 mg (not significant compared with baseline). The mean fasting plasma glucose did not change after treatment with rosuvastatin (9.1 ± 2.7 mmol/l at baseline, 8.9 ± 2.7 mmol/l with 10 mg, 9.4 ± 2.9 mmol/l with 40 mg). Conclusions Glycaemic control deteriorated in patients with diabetes following high-dose statin therapy. Future controlled studies are needed to verify these findings and, if confirmed, determine whether such changes represent a true decline in glycaemic control. Presently, it appears that, based on the overwhelming prospective trial data available, the preventive effect of statin therapy supersedes that of the slight increase in HbA1c. [ABSTRACT FROM AUTHOR]

Aims Cardiovascular disease is the foremost cause of mortality in Malaysia but little is known about the prevalence of the metabolic syndrome and its associations with other known cardiovascular risk markers. We undertook a population-based study to examine these. Methods For the study, 4341 subjects were selected using a multistage stratified sampling method. Subjects were interviewed for personal and past medical history. Biomedical markers and anthropometric indices were measured. The metabolic syndrome was defined using the harmonized criteria. The associations between the metabolic syndrome and cardiovascular risk markers, including high-sensitivity C-reactive protein, microalbuminuria and HbA1c were examined. Results The prevalence of the metabolic syndrome was 42.5%. Subjects with the metabolic syndrome are significantly more likely to have higher BMI (> 25 kg/m2), HbA1c [≥ 42 mmol/mol (6.0%)], LDL (≥ 2.6 mmol/l), elevated albumin:creatinine ratio (> 2.5 μg/mmol creatinine for men, 3.5 μg/mmol creatinine for women) and high-sensitivity C-reactive protein (> 3 mg/l); odds ratio 5.48, 6.14, 1.44, 3.68 and 1.84, respectively, P < 0.001. The presence of an elevated albumin:creatinine ratio and high-sensitivity C-reactive protein are strong predictors for the presence of a higher number of positive criteria of the metabolic syndrome. HbA1c > 48 mmol/mol (6.5%) is associated with increased relative risk of elevated albumin:creatinine ratio, high-sensitivity C-reactive protein and LDL (relative risk 3.10, 2.46 and 1.65 respectively, P < 0.001). Conclusions We confirmed the high prevalence of the metabolic syndrome in Malaysia. Our study revealed a strong relationship between risk markers of elevated BMI, HbA1c, LDL, albumin:creatinine ratio and high-sensitivity C-reactive protein with the presence of the metabolic syndrome, putting them at a statistically high risk for cardiovascular mortality. [ABSTRACT FROM AUTHOR]

Diabet. Med. 29, 911-917 (2012) Abstract Aims To study whether HbA1c, and its relationship with fasting plasma glucose, was significantly different among Chinese, Malays and Indians in Singapore. Methods A sample of 3895 individuals without known diabetes underwent detailed interview and health examination, including anthropometric and biochemical evaluation, between 2004 and 2007. Pearson's correlation, analysis of variance and multiple linear regression analyses were used to examine the influence of ethnicity on HbA1c. Results As fasting plasma glucose increased, HbA1c increased more in Malays and Indians compared with Chinese after adjustment for age, gender, waist circumference, serum cholesterol, serum triglyceride and homeostasis model assessment of insulin resistance ( P-interaction < 0.001). This translates to an HbA1c difference of 1.1 mmol/mol (0.1%, Indians vs. Chinese), and 0.9 mmol/mol (0.08%, Malays vs. Chinese) at fasting plasma glucose 5.6 mmol/l (the American Diabetes Association criterion for impaired fasting glycaemia); and 2.1 mmol/mol (0.19%, Indians vs. Chinese) and 2.6 mmol/mol (0.24%, Malays vs. Chinese) at fasting plasma glucose 7.0 mmol/l, the diagnostic criterion for diabetes mellitus. Conclusions Using HbA1c in place of fasting plasma glucose will reclassify different proportions of the population in different ethnic groups. This may have implications in interpretation of HbA1c results across ethnic groups and the use of HbA1c for diagnosing diabetes mellitus. [ABSTRACT FROM AUTHOR]