Different protein sources in concentrate feed for dairy cows affect cheese-making properties and yield.

Soybean meal (SBM) is a commonly used protein source in feed. Yeast microbial protein could be used as a substitute for SBM, but its effect on cheese-making properties and yield is not known. Norwegian Red dairy cows (n = 48) in early or mid lactation were divided in 3 groups and fed a ration consisting of grass silage and concentrate, where the concentrates were barley based but with different additional protein sources. These were: completely barley based with no additional protein source (BAR), additional protein from SBM, or additional protein from yeast (Cyberlindnera jadinii; YEA). The SBM and YEA concentrates had a higher protein content than the barley concentrate. Four batches of cheese were made from pooled milk from each of the 3 groups of dairy cows. Milk samples were collected 5 times during the experiment. Milk from cows fed BAR concentrate showed inferior cheese-making properties (lower casein content, longer renneting time, lower content of phosphorus, and lower cheese yield) compared with SBM and YEA concentrates. Overall, SBM or YEA bulk milk had similar cheese-making properties, but when investigating individual milk samples, YEA milk showed better coagulation properties.

Feeding concentrates with different protein sources to high-yielding, mid-lactation Norwegian Red cows: Effect on cheese ripening.

Soybean meal is one of the most important protein sources in concentrate feeds for dairy cows. The objective of the present study was to provide knowledge on the effects of using a novel yeast microbial protein source (Candida utilis) in concentrate feed for dairy cows on the production and quality of a Gouda-type cheese. Forty-eight Norwegian Red dairy cows in early to mid lactation were fed a basal diet of grass silage, which was supplemented with 3 different concentrate feeds. The protein source of the concentrates was based on conventional soybean meal (SBM), novel yeast (C. utilis; YEA), or barley (BAR; used as negative control because barley has a lower protein content). The experiment was carried out for a period of 10 wk, with the first 2 wk as an adaptation period where all dairy cows were fed grass silage and the SBM concentrate. The cows were then randomly allocated to 1 of the 3 different compound feeds: SBM, yeast, or barley. Cheeses were made during wk 8 and 9 of the experiment, with 4 batches of cheese made from milk from each of the 3 groups. The cheeses made from milk from cows fed SBM concentrate (SBM cheese) had a higher content of dl-pyroglutamic acid and free amino acids than the other cheeses, indicating a faster ripening in the SBM cheeses. Despite these differences, the sensory properties, the microbiota, and the Lactococcus population at 15 wk of ripening were not significantly different between the cheeses. This experiment showed that although the raw materials used in the concentrate feed clearly influenced the ripening of the cheeses, this did not affect cheese quality. Yeast (C. utilis) as a protein source in concentrate feed for dairy cows can be used as a replacement for soybean meal without compromising the quality of Norwegian Gouda-type cheeses.

Factors associated with glycaemic control in adults with Type 1 diabetes: a registry-based analysis including 7601 individuals from 34 centres in Norway.

AIMS: To use data from the Norwegian Diabetes Registry for Adults and Statistics Norway to assess factors associated with glycaemic control in type 1 diabetes. METHODS: The analyses included all individuals aged ≥18 years who had a type 1 diabetes duration of >2 years and a recorded value in the registry between 2013 and 2015 (n=7601). Predicted mean HbA1c levels for subgroups of participants were assessed using linear regression analysis. RESULTS: Young age (18-25 years), low education levels, smoking, living alone, exercising infrequently, monitoring glucose infrequently, high insulin requirements, low frequency of symptomatic hypoglycaemia, history of ketoacidosis and a BMI <18.5 kg/m2 were associated with a 2-12-mmol/mol (0.2-1.1%) higher HbA1c level. Those with 10-15 years of diabetes duration had 5-mmol/mol (0.5%) higher HbA1c level than those who had a diabetes duration of 2-5 years. Sex, participation (ever) in a diabetes education course, or ever experiencing serious hypoglycaemia were not associated with glycaemic control. CONCLUSIONS: We present representative national data on factors that were associated with glycaemic control. A better understanding and awareness of these factors, together with technological advances in diabetes management, could lead to more personalized management strategies, better glycaemic control and a lower risk of diabetes complications.

Variation in the achievement of HbA1c , blood pressure and LDL cholesterol targets in type 2 diabetes in general practice and characteristics associated with risk factor control.

AIMS: To identify population, general practitioner, and practice characteristics associated with the achievement of HbA1c , blood pressure and LDL cholesterol targets, and to describe variation in the achievement of risk factor control. METHODS: We conducted a cross-sectional survey of 9342 people with type 2 diabetes, 281 general practitioners and 77 general practices in Norway. Missing values (7.4%) were imputed using multiple imputation by chained equations. We used three-level logistic regression with the achievement of HbA1c , blood pressure and LDL cholesterol targets as dependent variables, and factors related to population, general practitioners, and practices as independent variables. RESULTS: Treatment targets were achieved for HbA1c in 64%, blood pressure in 50%, and LDL cholesterol in 52% of people with type 2 diabetes, and 17% met all three targets. There was substantial heterogeneity in target achievement among general practitioners and among practices; the estimated proportion of a GPs diabetes population at target was 55-73% (10-90 percentiles) for HbA1c , 36-63% for blood pressure, and 47-57% for LDL cholesterol targets. The models explained 11%, 5% and 14%, respectively, of the total variation in the achievement of HbA1c , blood pressure and LDL cholesterol targets. Use among general practitioners of a structured diabetes form was associated with 23% higher odds of achieving the HbA1c target (odds ratio 1.23, 95% confidence interval (CI) 1.02-1.47) and 17% higher odds of achieving the LDL cholesterol target (odds ratio 1.17, 95% CI 1.01-1.35). CONCLUSIONS: Clinical diabetes management is difficult, and few people meet all three risk factor control targets. The proportion of people reaching target varied among general practitioners and practices. Several population, general practitioner and practice characteristics only explained a small part of the total variation. The use of a structured diabetes form is recommended.

Population, general practitioner and practice characteristics are associated with screening procedures for microvascular complications in Type 2 diabetes care in Norway.

AIMS: To assess population, general practitioner (GP) and practice characteristics associated with the performance of microvascular screening procedures and to propose strategies to improve Type 2 diabetes care. METHODS: A cross-sectional survey in Norway (281 GPs from 77 practices) identified 8246 people with a Type 2 diabetes duration of 1 year or more. We used multilevel regression models with either the recording of at least two of three recommended screening procedures (albuminuria, monofilament, eye examination) or each procedure separately as dependent variable (yes/no), and characteristics related to the person with diabetes, GP or practice as independent variables. RESULTS: The performance of recommended screening procedures was recorded in the following percentages: albuminuria 31.5%, monofilament 27.5% and eye examination 60.0%. There was substantial heterogeneity between practices, and between GPs within practices for all procedures. Compared with people aged 60-69 years, those aged < 50 years were less likely to have an albuminuria test performed [odds ratio (OR) 0.75, 95% CI 0.61 to 0.93] and eye examination (OR 0.79, 95% CI 0.66 to 0.95). People with macrovascular disease had fewer screening procedures recorded (OR 0.68, 95% CI 0.59 to 0.78). Use of an electronic diabetes form was associated with improved screening  (OR 2.65, 95% CI 1.86 to 3.78). GPs with high workload recorded fewer procedures (OR 0.59, 95% CI 0.39 to 0.90). CONCLUSIONS: Performance of screening procedures was suboptimal overall, and in people who should be prioritized. Performance varied substantially between GPs and practices. The use of a structured diabetes form should be mandatory.

Feeding a concentrate rich in rapeseed oil improves fatty acid composition and flavor in Norwegian goat milk.

Impaired quality due to a high content of free fatty acids (FFA) and off-flavors has caused challenges in the development of Norwegian goat milk products. The present study aimed to examine the effect of lipid-supplemented concentrates on milk fat content, fatty acid composition, FFA, lipoprotein lipase activity, sensory properties, and size of milk fat globules of goat milk. Thirty goats assigned to 3 experimental groups were fed different concentrates from 60 d in milk (DIM) until late lactation (230 DIM). The diets were (1) control concentrate (no added fat); (2) control concentrate with 8% (added on air-dry basis) hydrogenated palm oil enriched with palmitic acid (POFA); and (3) control concentrate with 8% (added on air-dry basis) rapeseed oil (RSO). The POFA group produced milk with the highest fat content, and fat content was positively correlated with the mean size of milk fat globules. Goats in the RSO group had a higher content of long-chain and unsaturated fatty acids, whereas milk from goats in the POFA group had a higher content of palmitic and palmitoleic acids (C16:0 and C16:1 cis). The control group produced milk with a higher content of short-, medium-, odd-, and branched-chain fatty acids compared with the 2 other groups. The content of FFA in milk was low in early and late lactation and peaked in mid lactation (90 DIM). A high content of FFA was correlated with poor sensory properties (tart/rancid flavor). The RSO group produced milk with lower content of FFA and off-flavors in mid lactation and a higher proportion of unsaturated fatty acids. Therefore, replacement of palm oil with rapeseed oil as a lipid source in dairy goat feed would be favorable.

Survival of lactic acid and propionibacteria in low- and full-fat Dutch-type cheese during human digestion ex vivo.

UNLABELLED: The survival of selected bacteria in semi-hard experimental cheeses was studied after exposure to human gastric and duodenal juices in an ex vivo model. Experimental cheeses (10 and 28% fat) were supplemented with different strains of Lactobacillus sp. and Propionibacterium sp. and ripened for 7 and 70 weeks. After digestion, greater numbers of the adjunct bacteria we rerecorded in the 7-week-old cheeses compared to the well-matured cheeses (70 weeks). The bacterial survival was strain dependent, and influenced by the fat content of the cheese. Lactobacilli showed better survival, especially when in low-fat cheeses. The strains of propionibacteria also survived well during the digestion of the low-fat cheeses. The results confirmed that cheese can potentially be a good carrier matrix for bacteria to the intestine. In addition, it has been shown that different strains present in cheese have different abilities to survive the conditions of the gastrointestinal tract. Younger cheese was indicated to be a better carrier, possibly because the bacteria present in those cheeses have had shorter exposure to the stress conditions occurring in cheese during prolonged maturation. SIGNIFICANCE AND IMPACT OF THE STUDY: Cheese can function as a suitable vehicle for the delivery of a variety of food-related micro-organisms to the intestine. Young cheese as well as low-fat cheeses are better carrier matrixes than full-fat and/or more well-ripened cheeses. Most of the lactobacilli and all the propionibacteria survived well during digestion of the low-fat cheeses. This study also showed the ability of cheese lactobacilli and PAB to survive the severe conditions of GIT.

Core Standards of the EUBIROD Project. Defining a European Diabetes Data Dictionary for Clinical Audit and Healthcare Delivery.

BACKGROUND: A set of core diabetes indicators were identified in a clinical review of current evidence for the EUBIROD project. In order to allow accurate comparisons of diabetes indicators, a standardised currency for data storage and aggregation was required. We aimed to define a robust European data dictionary with appropriate clinical definitions that can be used to analyse diabetes outcomes and provide the foundation for data collection from existing electronic health records for diabetes. METHODS: Existing clinical datasets used by 15 partner institutions across Europe were collated and common data items analysed for consistency in terms of recording, data definition and units of measurement. Where necessary, data mappings and algorithms were specified in order to allow partners to meet the standard definitions. A series of descriptive elements were created to document metadata for each data item, including recording, consistency, completeness and quality. RESULTS: While datasets varied in terms of consistency, it was possible to create a common standard that could be used by all. The minimum dataset defined 53 data items that were classified according to their feasibility and validity. Mappings and standardised definitions were used to create an electronic directory for diabetes care, providing the foundation for the EUBIROD data analysis repository, also used to implement the diabetes registry and model of care for Cyprus. CONCLUSIONS: The development of data dictionaries and standards can be used to improve the quality and comparability of health information. A data dictionary has been developed to be compatible with other existing data sources for diabetes, within and beyond Europe.

Preoperative octreotide therapy and surgery in acromegaly: associations between glucose homeostasis and treatment response.

In acromegaly, high GH/IGF-1 levels associate with abnormal glucose metabolism. Somatostatin analogs (SSAs) reduce GH and IGF-1 but inhibit insulin secretion. We studied glucose homeostasis in de novo patients with acromegaly and changes in glucose metabolism after treatment with SSA and surgery. In this post hoc analysis from a randomized controlled trial, 55 de novo patients with acromegaly, not using antidiabetic medication, were included. Before surgery, 26 patients received SSAs for 6 months. HbA1c, fasting glucose, and oral glucose tolerance test were performed at baseline, after SSA pretreatment and at 3 months postoperative. Area under curve of glucose (AUC-G) was calculated. Glucose homeostasis was compared to baseline levels of GH and IGF-1, change after SSA pretreatment, and remission both after SSA pretreatment and 3 months postoperative. In de novo patients, IGF-1/GH levels did not associate with baseline glucose parameters. After SSA pretreatment, changes in GH/IGF-1 correlated positively to change in HbA1c levels (both p < 0.03). HbA1c, fasting glucose, and AUC-G increased significantly during SSA pretreatment in patients not achieving hormonal control (all p < 0.05) but did not change significantly in patients with normalized hormone levels. At 3 months postoperative, HbA1c, fasting glucose, and AUC-G were significantly reduced in both cured and not cured patients (all p < 0.05). To conclude, in de novo patients with acromegaly, disease activity did not correlate with glucose homeostasis. Surgical treatment of acromegaly improved glucose metabolism in both cured and not cured patients, while SSA pretreatment led to deterioration in glucose homeostasis in patients not achieving biochemical control.

Potential of Lactobacillus curvatus LFC1 to produce slits in Cheddar cheese.

Defects in Cheddar cheese resulting from undesired gas production are a sporadic problem that results in significant financial losses in the cheese industry. In this study, we evaluate the potential of a facultatively heterofermentative lactobacilli, Lactobacillus curvatus LFC1, to produce slits, a gas related defect in Cheddar cheese. The addition of Lb. curvatus LFC1 to cheese milk at log 3 CFU/ml resulted in the development of small slits during the first month of ripening. Chemical analyses indicated that the LFC1 containing cheeses had less galactose and higher levels of lactate and acetate than the control cheeses. The composition the cheese microbiota was examined through a combination of two culture independent approaches, 16S rRNA marker gene sequencing and automated ribosomal intergenic spacer analysis; the results indicated that no known gas producers were present and that high levels of LFC1 was the only significant difference between the cheese microbiotas. A ripening cheese model system was utilized to examine the metabolism of LFC1 under conditions similar to those present in cheeses that exhibited the slit defect. The combined cheese and model system results indicate that when Lb. curvatus LFC1 was added to the cheese milk at log 3 CFU/ml it metabolized galactose to lactate, acetate, and CO2. For production of sufficient CO2 to result in the formation of slits there needs to be sufficient galactose and Lb. curvatus LFC1 present in the cheese matrix. To our knowledge, facultatively heterofermentative lactobacilli have not previously been demonstrated to result in gas-related cheese defects.

Grazing season and forage type influence goat milk composition and rennet coagulation properties.

Two different types of pasture (cultivated and rangeland) and 2 different hay qualities (high and low quality) were examined for their effects on goat milk composition and rennet coagulation properties. Furthermore, the effect of dietary treatments in both the early and late grazing season was studied. As lactation stage is known to influence milk composition, the goats in the early and late grazing season were in the same lactation stage at the start of the experiment. The milk composition was influenced both by dietary treatment and season. Milk from goats on pasture was superior to those on hay by containing a higher content of protein and casein, and the goats on cultivated pasture had the highest milk yield. Casein composition was significantly influenced by forage treatment. Goats grazing on cultivated pasture had higher contents of αs1-casein and also of κ-casein compared with the other treatments, whereas goats grazing on rangeland had the highest content of ß-casein. Factors such as milk yield, casein micelle size, αs2-casein, and calcium content were reduced in late compared with early season. More favorable rennet coagulation properties were achieved in milk from the early grazing season, with shorter firming time and higher curd firmness compared with milk from the late grazing season, but the firming time and curd firmness were not prominently influenced by forage treatment. The content of αs2-casein and calcium in the milk affected the firming time and the curd firmness positively. The influence of season and forage treatment on especially milk yield, casein content, and rennet coagulation properties is of economic importance for both the dairy industry and goat milk farmers.

Short communication: Is consumption of a cheese rich in angiotensin-converting enzyme-inhibiting peptides, such as the Norwegian cheese Gamalost, associated with reduced blood pressure?

Epidemiological and clinical studies have shown that angiotensin-converting enzyme (ACE)-inhibiting peptides derived from dairy products may decrease blood pressure. These peptides have been identified in many cheeses, and Gamalost, a traditional Norwegian cheese, is particularly rich in these peptides. The aim of this cross-sectional study was to examine whether frequency of Gamalost intake was associated with blood pressure in a Norwegian population sample. Blood pressure and other clinical measurements, including the factors of metabolic syndrome, were obtained from 168 participants (56% female, mean age = 51 yr) who completed a questionnaire about dietary habits and other health-related factors. Mean Gamalost intake was 2 servings per week. The prevalence of hypertension was 23.8% in the population, with mean systolic and diastolic blood pressures of 128 and 78 mmHg, respectively. Intake of Gamalost was inversely associated with systolic blood pressure. Each increase in frequency unit of Gamalost intake corresponded to a reduction in systolic blood pressure of 0.72 mmHg, after controlling for sex, age, education, waist circumference, physical activity, smoking status, and dairy food intake. Results from this study indicate that consumption of Gamalost (or other foods rich in ACE-inhibiting peptides) may reduce blood pressure.

Metabolism of milk fat globule membrane components by nonstarter lactic acid bacteria isolated from cheese.

The objective of this study was to investigate how components present in the milk fat globule membrane (MFGM) may be used for growth and survival by cheese-ripening lactobacilli. This was achieved by analyzing metabolites produced during incubation on appropriate media. The lactobacilli investigated were able to utilize components from the MFGM throughout a 24-d incubation period. We observed an apparent connection between the higher proteolytic activity of Lactobacillus paracasei INF448 and its ability to grow in the MFGM media after depletion of readily available sugars. All the studied strains produced large amounts of acetate when grown on an acylated aminosugar, presumably from deacetylation of the monosaccharides. Growth of Lb. plantarum INF15D on D-galactose resulted in a metabolic shift, expressed as different fates of the produced pyruvate, compared with growth on the other monosaccharides. For Lb. plantarum INF15D, the presence of D-galactose also seemed to initiate degradation of some amino acids known to take part in energy production, specifically Arg and Tyr.

Angiotensin I-converting enzyme-inhibitory activity of the Norwegian autochthonous cheeses Gamalost and Norvegia after in vitro human gastrointestinal digestion.

The angiotensin I-converting enzyme (ACE) inhibitory activity of Gamalost cheese, its pH 4.6-soluble fraction, and Norvegia cheese was monitored before and after digestion with human gastric and duodenal juices. Both Gamalost and Norvegia cheeses showed an increased ACE-inhibitory activity during gastrointestinal digestion. However, only Norvegia showed pronounced increased activity after duodenal digestion. More peptides were detected in digested Gamalost compared with digested Norvegia. Most of the peptides in Gamalost were derived from ß-casein (CN), some originated from α(s1)-CN, and only a very few originated from α(s2)-CN and κ-CN. In general, the number of peptides increased during gastrointestinal digestion, whereas some peptides were further degraded and disappeared; however, surprisingly, a few peptides remained stable. The aromatic amino acids, such as Tyr, Phe, and Trp; the positively charged amino acids (Arg and Lys); and Leu increased after simulated gastrointestinal digestion of Gamalost and Norvegia. After in vitro gastrointestinal digestion, both Gamalost and Norvegia showed high ACE-inhibitory activity, which may contribute in lowering of mild hypertension.

Strain-level characterization of nonstarter lactic acid bacteria in Norvegia cheese by high-resolution melt analysis.

The nonstarter lactic acid bacteria (NSLAB) constitute an important microbial group found during cheese ripening and they are thought to be fundamental to the quality of cheese. Rapid and accurate diagnostic tests for NSLAB are important for cheese quality control and in understanding the cheese ripening process. Here, we present a novel rapid approach for strain-level characterization through combined 16S rRNA gene and repetitive sequence-based high-resolution melt analysis (HRM). The approach was demonstrated through the characterization of 94 isolates from Norvegia, a Gouda-type cheese. The HRM profiles of the V1 and V3 variable regions of the 16S rRNA gene of the isolates were compared with the HRM profiles of 13 reference strains. The HRM profile comparison of the V1 and V3 regions of the 16S rRNA gene allowed discrimination of isolates and reference strains. Among the cheese isolates, Lactobacillus casei/paracasei (62 isolates) and Lactobacillus plantarum/Lactobacillus pentosus (27 isolates) were the dominant species, whereas Lactobacillus curvatus/Lactobacillus sakei were found occasionally (5 isolates). The HRM profiling of repetitive sequence-based PCR using the (GTG)(5) primer was developed for strain-level characterization. The clustering analysis of the HRM profiles showed high discriminatory power, similar to that of cluster analysis based on the gel method. In conclusion, the HRM approach in this study may be applied as a fast, accurate, and reproducible method for characterization of the NSLAB microflora in cheese and may be applicable to other microbial environments following selective plate culturing.

Survival of lactic acid bacteria from fermented milks in an in vitro digestion model exploiting sequential incubation in human gastric and duodenum juice.

In the present study, the survival of 9 lactic acid bacteria (5 Lactococcus strains, 3 Lactobacillus strains, and 1 strain of Enterococcus hirae), was investigated in vitro under conditions similar to human digestion using human gastric and duodenal juices. The tolerance of the bacteria was also tested with traditional methods using acidic conditions and bile salts. The strains were subjected to a model digestive system comprising sequential incubation in human gastric and duodenal juices, in a 2-step digestion assay at 37°C, simulating the human upper gastrointestinal tract with human gastric juices at pH 2.5 and human duodenal juices at pH 7. The bacterial strains were tested either as washed cells from culture media or in fermented milk. The initial in vitro testing in acid and bile salts showed that Lactobacillus strains and the E. hirae strain displayed a significantly higher acid tolerance than the lactococci. The lactobacilli and the Enterococcus numbers increased, whereas the lactococci decreased at least 1 log during the bile salt treatment. The Lactobacillus strains showed the highest survival rate in the model digestive system when washed bacterial cultures were used with a minor log reduction, whereas the lactococci numbers were reduced by at least log 4. However, when using fermented milks in the model digestion system it was demonstrated that the Enterococcus strain and 2 strains of Lactococcus lactis ssp. cremoris benefited significantly from the presence of the fermented milk as food matrix, with log numbers >log 7 and 5, respectively, after digestion of the fermented milk. The analyses reported comprise a comprehensive in vitro testing regimen suitable for evaluation of the survival of candidate probiotic bacteria in human digestion as an initial prescreen to clinical trials.

Rapid lactic acid bacteria identification in dairy products by high-resolution melt analysis of DGGE bands.

AIM: To investigate the application of high-resolution melt (HRM) analysis for rapid species-level identification of lactic acid bacteria (LAB) communities in dairy products, as well as for bacterial community profiling and monitoring. METHODS AND RESULTS: First, comparisons of HRM profiles of known reference strains of LAB and their denaturing gradient gel electrophoresis (DGGE) bands showed very good agreement, allowing species recognition and identification from DGGE bands by HRM. Second, samples of cheese, kefir grains and kefir were characterized by PCR-DGGE, and melting profiles of DGGE bands were compared with known reference strains. Of the 13 DGGE bands, ten were identified by HRM by comparison with the reference strains and only three required sequencing for identification. Use of HRM profiling for comparison and monitoring of total LAB communities from dairy products or starter cultures was also evaluated, and good agreement was found when comparing clustering of DGGE band profiles with clustering of HRM melting profiles. CONCLUSION: Identification of DGGE bands is possible by comparison of HRM melting profiles with known reference strains. SIGNIFICANCE AND IMPACT OF THE STUDY: HRM profiling is suggested as an additional approach for identification of DGGE bands.

Privacy impact assessment in the design of transnational public health information systems: the BIRO project.

OBJECTIVES: To foster the development of a privacy-protective, sustainable cross-border information system in the framework of a European public health project. MATERIALS AND METHODS: A targeted privacy impact assessment was implemented to identify the best architecture for a European information system for diabetes directly tapping into clinical registries. Four steps were used to provide input to software designers and developers: a structured literature search, analysis of data flow scenarios or options, creation of an ad hoc questionnaire and conduction of a Delphi procedure. RESULTS: The literature search identified a core set of relevant papers on privacy (n = 11). Technicians envisaged three candidate system architectures, with associated data flows, to source an information flow questionnaire that was submitted to the Delphi panel for the selection of the best architecture. A detailed scheme envisaging an "aggregation by group of patients" was finally chosen, based upon the exchange of finely tuned summary tables. CONCLUSIONS: Public health information systems should be carefully engineered only after a clear strategy for privacy protection has been planned, to avoid breaching current regulations and future concerns and to optimise the development of statistical routines. The BIRO (Best Information Through Regional Outcomes) project delivers a specific method of privacy impact assessment that can be conveniently used in similar situations across Europe.

Insulin detemir used in basal-bolus therapy in people with type 1 diabetes is associated with a lower risk of nocturnal hypoglycaemia and less weight gain over 12 months in comparison to NPH insulin.

AIM: The aim of this study was to compare the long-term safety and efficacy of twice-daily insulin detemir or NPH insulin as the basal component of basal-bolus therapy in people with type 1 diabetes. METHODS: A multicentre, open-label, parallel-group study was conducted over 12 months and completed by 308 people (from an original randomized cohort of 428). Patients were randomized in a 2:1 ratio to receive insulin detemir or NPH insulin before breakfast and dinner, with insulin aspart at mealtimes. RESULTS: Glycaemic control improved in both groups with HbA(1c) decreasing by 0.64 and 0.56% point in the insulin detemir and NPH insulin groups, reaching baseline-adjusted final values of 7.53 +/- 0.10% and 7.59 +/- 0.13%, respectively. No significant difference was apparent between treatments in terms of HbA(1c), fasting plasma glucose or 9-point blood glucose profiles. Fewer hypoglycaemic events (major and minor) occurred in association with insulin detemir compared with NPH insulin, but the overall hypoglycaemic risk did not differ statistically significantly (RR for detemir, 0.78 [0.56-1.08]). However, the risk of nocturnal hypoglycaemia during the maintenance phase (month 2-12) was 32% lower in the detemir group (p = 0.02) and lower in every month. This risk reduction remained statistically significant after correction for HbA(1c). After 12 months, baseline-adjusted mean body weight was significantly lower in the insulin detemir group than in the NPH insulin group (p < 0.001). CONCLUSIONS: In long-term basal-bolus therapy, insulin detemir with insulin aspart as mealtime insulin is well tolerated and reduces the risks of nocturnal hypoglycaemia and weight gain compared to NPH insulin.

Interpretation of hemoglobin A(1c) (HbA(1c)) values among diabetic patients: implications for quality specifications for HbA(1c).

BACKGROUND: Few studies have examined patients' views, knowledge, and understanding of glycohemoglobin A(1c) (HbA(1c)) testing. We explored such issues in patients with type 1 diabetes and used their statements to estimate analytical quality specifications for HbA(1c) testing. METHODS: We recruited 201 patients from a hospital outpatient clinic. A questionnaire was used to collect information on diabetes characteristics, perceived knowledge of HbA(1c), last HbA(1c) value, HbA(1c) target value, and thresholds for action. Patients were asked to indicate the magnitude of change in HbA(1c) from 9.4% that they would consider to be a true (real) change; from their responses, we calculated patient-derived quality specifications for HbA(1c). RESULTS: Fifty-eight percent of the patients felt they had "high" knowledge about HbA(1c), and >80% of responders knew their last HbA(1c) value, their target HbA(1c), and the threshold value of HbA(1c) for treatment intensification. The mean acceptable HbA(1c) value was 7.5%. Patients with lower values on their most recent tests reported lower target values for HbA(1c) and lower values for the upper HbA(1c) threshold for treatment intensification. An analytical CV (CV(a)) of 3.1% would be satisfactory for 75% of patients when HbA(1c) is increasing (80% confidence), and a CV(a) of 3.2% would be satisfactory for 75% when HbA(1c) is decreasing (95% confidence). CONCLUSIONS: Type 1 patients' perceived knowledge about HbA(1c) testing is high. They are well informed about their own personal results and about target values and the upper HbA(1c) threshold for action. The patient-derived analytical quality specification for imprecision (CV) is 3.1%.