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.

Switching from premixed insulin to basal-bolus insulin glargine plus rapid-acting insulin: the ATLANTIC study.

INTRODUCTION: Data on switching from premixed insulin to a basal-bolus regimen in routine clinical practice are sparse. The aim was to evaluate the efficacy and safety of switching from twice-daily premixed insulin to basal glargine plus rapid-acting insulin in a "real-world" clinical practice setting in Belgium and The Netherlands. METHODS: This prospective, 6-month, noninterventional, observational study was conducted in 37 centres in Belgium and 19 centres in The Netherlands. Adults (> or =18 years of age) with type 2 diabetes were eligible if they were not taking oral antihyperglycaemic drugs or only taking metformin. The primary objective was the proportion of patients attaining glycated haemoglobin (HbA1c) <7% at months 3 and 6. Secondary objectives included changes in HbA1c, weight, body mass index (BMI), insulin doses, hypoglycaemic events, and treatment satisfaction. RESULTS: There were 214 patients from Belgium and The Netherlands enrolled. Mean age was 64.6 years, weight was 89.5 kg, BMI was 31.4 kg/m2, and duration of diabetes was 12.1 years. At month 6, the percentage of patients with HbA1c <7% increased from 3.3% to 24.9% (p<0.001). Mean HbA1c at baseline was 8.9%; mean change from baseline was -1.5% (p<0.001). Glargine and prandial insulin doses increased (p<0.001, each), while body weight and BMI were unchanged. Hypoglycaemic events did not increase. Overall treatment satisfaction improved significantly (p<0.001). CONCLUSIONS: In a Belgian and Dutch clinical practice setting, patients with type 2 diabetes that is poorly controlled on premixed insulin experienced significant improvements in glycaemic control, without a concomitant increase in hypoglycaemic events or weight, when switched from premixed insulin to basal-bolus glargine plus rapid-acting insulin. As a result, treatment satisfaction significantly improved.

Prescribing quality indicators of type 2 diabetes mellitus ambulatory care.

BACKGROUND: Existing performance indicators for assessing quality of care in type 2 diabetes mellitus (T2DM) focus mostly on registration of measurements and clinical outcomes, and not on quality of prescribing. OBJECTIVE: To develop a set of valid prescribing quality indicators (PQI) for internal use in T2DM, and assess the operational validity of the PQI using electronic medical records. METHODS: Potential PQI for hypertension, hyperglycaemia, dyslipidaemia and antiplatelet treatment in T2DM were based on clinical guidelines, and assessed on face and content validity in an expert panel followed by a panel of GPs and diabetologists. Analysis of ratings was performed using the RAND/UCLA Appropriateness Method. The operational validity of selected indicators was assessed in a dataset of 3214 T2DM patients registered with 70 GPs. RESULTS: Out of 31 potential prescribing indicators, the expert panel considered 18 indicators as sufficiently valid, of which 14 indicators remained valid after assessment by the panel of GPs and diabetologists. Of these 14 indicators, one could not be calculated because of an absence of eligible patients. For the remaining indicators, outcomes varied from 10% for timely prescribing of insulin to 96% for prescribing of any antihyperglycemic medication in patients with elevated HbA1c levels. CONCLUSIONS: This study provides a set of face- and content-valid PQI for pharmacological management of patients with T2DM. While outcomes of some PQI were limited to patients with registration of clinical values, the selected PQI had good operational validity to be used in practice for assessment of prescribing quality.

Initiation of insulin glargine therapy in type 2 diabetes subjects suboptimally controlled on oral antidiabetic agents: results from the AT.LANTUS trial.

OBJECTIVE: For many patients with type 2 diabetes, oral antidiabetic agents (OADs) do not provide optimal glycaemic control, necessitating insulin therapy. Fear of hypoglycaemia is a major barrier to initiating insulin therapy. The AT.LANTUS study investigated optimal methods to initiate and maintain insulin glargine (LANTUS, glargine, Sanofi-aventis, Paris, France) therapy using two treatment algorithms. This subgroup analysis investigated the initiation of once-daily glargine therapy in patients suboptimally controlled on multiple OADs. RESEARCH DESIGN AND METHODS: This study was a 24-week, multinational (59 countries), multicenter (611), randomized study. Algorithm 1 was a clinic-driven titration and algorithm 2 was a patient-driven titration. Titration was based on target fasting blood glucose < or =100 mg/dl (< or =5.5 mmol/l). Algorithms were compared for incidence of severe hypoglycaemia [requiring assistance and blood glucose <50 mg/dl (<2.8 mmol/l)] and baseline to end-point change in haemoglobin A(1c) (HbA(1c)). RESULTS: Of the 4961 patients enrolled in the study, 865 were included in this subgroup analysis: 340 received glargine plus 1 OAD and 525 received glargine plus >1 OAD. Incidence of severe hypoglycaemia was <1%. HbA(1c) decreased significantly between baseline and end-point for patients receiving glargine plus 1 OAD (-1.4%, p < 0.001; algorithm 1 -1.3% vs. algorithm 2 -1.5%; p = 0.03) and glargine plus >1 OAD (-1.7%, p < 0.001; algorithm 1 -1.5% vs. algorithm 2 -1.8%; p = 0.001). CONCLUSIONS: This study shows that initiation of once-daily glargine with OADs results in significant reduction of HbA(1c) with a low risk of hypoglycaemia. The greater reduction in HbA(1c) was seen in patients randomized to the patient-driven algorithm (algorithm 2) on 1 or >1 OAD.

Initiation of insulin glargine in suboptimally controlled patients with type 2 diabetes: sub-analysis of the AT.LANTUS trial comparing treatment outcomes in subjects from primary and secondary care in the UK.

AIM: The AT.LANTUS study compared insulin glargine initiation and titration using one of two algorithms in suboptimally controlled subjects with type 2 diabetes mellitus (T2DM) based on a primary outcome of severe hypoglycaemia. Secondary outcomes included other categories of hypoglycaemia, glycaemic control, weight changes and insulin dose. Here, we report the results of a subanalysis of the trial, which investigated whether insulin glargine can be initiated and titrated as effectively in primary [general practitioner (GP)] as secondary (hospital) care in patients with T2DM in the UK. METHODS: The main study was a multicentre (n = 611), multinational (n = 59), open-label, 24-week randomized trial in 4,588 suboptimally controlled subjects with T2DM. Insulin glargine was titrated to target fasting blood glucose (FBG) levels of

European Union diabetes indicators: fact or fiction?

Diabetes mellitus is one of the major causes of morbidity and mortality in EU/EFTA countries. Monitoring risk factors for diabetes and its complications will offer the possibility to evaluate the development in time as well as the influence of possible interventions. In this investigation a list with core and secondary indicators is proposed. Availability of these indicators and their data sources is discussed. An important variability of data sources is used in EU/EFTA countries, interfering with the comparability of the outcome. Further harmonisation as well as continuous evaluation of data sources will be necessary to provide reliable tools to monitor diabetes mellitus and its outcome on a routine basis.

Comparison of efficacy of human and porcine insulin in treatment of diabetic ketoacidosis.

The efficacy of semisynthetic human insulin (HI) and monocomponent porcine insulin (PI) in treatment of diabetic ketoacidosis (DKA) was compared in 10 (PI) and 11 (HI) patients in a double-blind randomized study. Insulin (8 U/h i.v.), fluid replacement (0.65% NaCl and 5% glucose), and KCl supplements were administered according to a fixed protocol. Glucose, potassium, sodium, creatinine, calcium, phosphate, and free-insulin concentrations were never significantly different during the study. At the start, mean +/- SD of pH was 7.10 +/- 0.14 in the HI group and 7.10 +/- 0.12 in the PI group. The time to reach arbitrary values for pH, bicarbonate, base excess, and beta-hydroxybutyrate was shorter during HI treatment, but the differences were not statistically significant. During HI treatment, the arbitrary value of 1.0 mM of acetoacetate was reached faster than during PI treatment (5.2 +/- 2.6 and 8.4 +/- 0.9 h, respectively; P less than .05). The concentration of acetoacetate was significantly different between the two groups after 6 and 7 h of insulin treatment (6 h: HI 0.82 +/- 0.50 mM and PI 2.19 +/- 1.65 mM, P less than .05; 7 h: HI 0.51 +/- 0.40 mM and PI 1.74 +/- 1.54 mM, P = .05). We conclude that recovery from DKA during treatment with HI might be slightly faster than during treatment with PI. If this difference is real, it does not seem clinically important.

Non-specific binding of insulin in an equilibrium binding assay of insulin antibodies.

In liquid phase assays for insulin binding antibodies (IBA), total binding of insulin is composed of specific and non-specific binding (NSB). Sometimes NSB is determined in serum of healthy individuals and then subtracted from total binding of IBA positive serum to obtain specific binding. This method does not take into account that NSB might vary from plasma to plasma. This possibility was investigated by means of a computerised non-linear curve fitting routine for the evaluation of measurement results of an (equilibrium) binding assay for IBA, which yields estimates of NSB for each plasma individually. From each of 19 insulin treated diabetic patients, 4 blood samples, taken at different points in time, were available for IBA and NSB measurement. It was found that inter-patient variance of NSB exceeded within-patient variance (p less than 0.01) and, in a number of instances, within-patient variance was greater than experimental variance. Our results indicate that it is advisable to use methods of IBA evaluation that take these NSB variations into account.