Peter Beck

Meta-analysis of short-acting insulin analogues in adult patients with type 1 diabetes: continuous subcutaneous insulin infusion versus injection therapy

Aims/hypothesisThis study aimed to compare the effect of treatment with short-acting insulin (SAI) analogues versus structurally unchanged short-acting insulin (regular insulin) on glycaemic control and on the risk of hypoglycaemic episodes in type 1 diabetic patients using different insulin treatment strategies.MethodsWe performed a meta-analysis of 27 randomised controlled trials that compared the effect of SAI analogues with regular insulin in patients with type 1 diabetes mellitus. The treatments were administered either via continuous subcutaneous insulin infusion (CSII) or by conventional intensified insulin therapy (IIT) with short-acting insulin injections before meals and basal insulin administered once or twice daily in most cases.ResultsHbA1c levels were reported for 20 studies. For studies using CSII, the weighted mean difference between values obtained using SAI analogues and regular insulin was −0.19% (95% CI: −0.27 to −0.12), whereas the corresponding value for injection studies was −0.08% (95% CI: −0.15 to −0.02). For the analysis of overall hypoglycaemia, we used the results from nine studies that reported the mean frequency of hypoglycaemic episodes per patient per month. For studies using CSII, the standardised mean difference between SAI analogues and regular insulin was −0.07 (95% CI: −0.43 to 0.28), whereas for IIT studies the corresponding value was −0.04 (95% CI: −0.24 to 0.16).Conclusions/interpretationTaking into consideration the low quality of the trials included, we can conclude that use of a short-acting insulin analogue in CSII therapy provides a small, but statistically significant improvement in glycaemic control compared with regular insulin. An even smaller effect was obtained with the use of ITT. The rate of overall hypoglycaemic episodes was not significantly reduced with short-acting insulin analogues in either injection regimen.

Attitudes Towards Insulin Pump Therapy Among Adolescents and Young People

PURPOSE This study investigated reasons for the rejection and discontinuation of insulin pump therapy and explored general attitudes towards this mode of therapy among young patients with type 1 diabetes. METHODS A questionnaire was developed using a focus group of young people with diabetes. It was then used to survey a random sample of adolescents and young people identified by physicians specializing in diabetes care and participating in a voluntary quality improvement initiative in Germany. The physicians were also surveyed. RESULTS Eighty-eight patients participated in the survey (22 had never used the pump, 20 had formerly used the pump, and 46 were using the pump at that time, with an average age of between 20 and 22 years, depending on the group). Those who had never used the pump had had diabetes for a significantly shorter length of time and had undergone their first diabetes education more recently. Current pump users were significantly younger at the time of the first diabetes education. There were no significant differences between patients concerning where they obtained their information about the condition and treatment options. Although clinical factors were named, social and psychological factors were prominent as reasons both in reluctance to try the pump therapy and in discontinuing therapy. Technical problems as a disadvantage of the pump (aside from the catheter) were less likely to be named. Responses among physicians confirmed discipline and compliance were essential prerequisites for this therapy and supported findings that patients discontinuing pump therapy at their own request tend to do so for nonclinical reasons. CONCLUSIONS Although the technical reliability of the insulin pump was generally accepted by all patients regardless of current treatment, clinical disadvantages relating to the use of the pump but more commonly social/psychological factors were named, which resulted in patients being reluctant to try this therapy or discontinuing use of it.

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.

Effects of a multifaceted educational program on blood pressure and cardiovascular risk in hypertensive patients: the Austrian herz.leben project.

Objective Although hypertension is the most prevalent risk factor for cardiovascular and cerebrovascular morbidity and mortality, the level of blood pressure control remains poor. To amplify quality of care in hypertensive patients, a multifaceted program consisting of structured educational programs for both patients and staff, structured documentation and feedback reports with peer comparison, was implemented on a multicentre basis. Main targets were improvement of blood pressure control and reduction of cardiovascular risk. A provisional reimbursement was provided. Methods Patients were eligible for inclusion in the program if office blood pressure was uncontrolled (>160/95 or >140/90 mmHg) in addition to elevated cardiovascular risk [>15% according to the New Zealand Risk Score (NZRS)]. Blood pressure and lipid panels were measured at entry in the program and after 12 months. Patients attended four educational units held by hypertension nurses and physicians. All data were collected in structured documentation sheets and benchmarking reports were provided every 6 months. Results Two thousand and forty-one patients were enrolled in the program within 5 years and 3 months; 54% female, age 62.8 ± 11.1years, BMI 29.50 ± 7.88 kg/m2 (mean ± SD). To date, 744 patients have been seen at 1-year follow-up. Entry blood pressure was 156.1 ± 20.8/88.9 ± 11.1 mmHg. Total cholesterol showed mean levels of 207.0 ± 46.0 mg/dl, low-density lipoprotein 122.3 ± 41.6 mg/dl, high-density lipoprotein 57.2 ± 22.4 mg/dl and calculated cardiovascular risk level (NZRS) was 17.28 ± 8.29%. One year following the educational program, blood pressure was reduced to 139.2 ± 15.6 (P < 0.001)/82.1 ± 9.5 mmHg (P < 0.001). NZRS (14.1 ± 7.2%; P < 0.001) and BMI (29.26 ± 4.92 versus 29.06 ± 4.99) also improved significantly. Conclusion This structured educational program showed its ability to improve intermediate outcomes in hypertensive patients. Better blood pressure control and significant reduction of the individual cardiovascular risk profile were achieved. A broad implementation of the program in the management of hypertension seems justified.

Towards Personalization of Diabetes Therapy Using Computerized Decision Support and Machine Learning: Some Open Problems and Challenges

Diabetes mellitus (DM) is a growing global disease which highly affects the individual patient and represents a global health burden with financial impact on national health care systems. Type 1 DM can only be treated with insulin, whereas for patients with type 2 DM a wide range of therapeutic options are available. These options include lifestyle changes such as change of diet and an increase of physical activity, but also administration of oral or injectable antidiabetic drugs. The diabetes therapy, especially with insulin, is complex. Therapy decisions include various medical and life-style related information. Computerized decision support systems (CDSS) aim to improve the treatment process in patient’s self-management but also in institutional care. Therefore, the personalization of the patient’s diabetes treatment is possible at different levels. It can provide medication support and therapy control, which aid to correctly estimate the personal medication requirements and improves the adherence to therapy goals. It also supports long-term disease management, aiming to develop a personalization of care according to the patient’s risk stratification. Personalization of therapy is also facilitated by using new therapy aids like food and activity recognition systems, lifestyle support tools and pattern recognition for insulin therapy optimization. In this work we cover relevant parameters to personalize diabetes therapy, how CDSS can support the therapy process and the role of machine learning in this context. Moreover, we identify open problems and challenges for the personalization of diabetes therapy with focus on decision support systems and machine learning technology.

Standardized Glycemic Management with a Computerized Workflow and Decision Support System for Hospitalized Patients with Type 2 Diabetes on Different Wards.

Abstract Background: This study investigated the efficacy, safety, and usability of standardized glycemic management by a computerized decision support system for non-critically ill hospitalized patients with type 2 diabetes on four different wards. Materials and Methods: In this open, noncontrolled intervention study, glycemic management of 99 patients with type 2 diabetes (62% acute admissions; 41 females; age, 67±11 years; hemoglobin A1c, 65±21 mmol/mol; body mass index, 30.4±6.5 kg/m2) on clinical wards (Cardiology, Endocrinology, Nephrology, Plastic Surgery) of a tertiary-care hospital was guided by GlucoTab® (Joanneum Research GmbH [Graz, Austria] and Medical University of Graz [Graz, Austria]), a mobile decision support system providing automated workflow support and suggestions for insulin dosing to nurses and physicians. Results: Adherence to insulin dosing suggestions was high (96.5% bolus, 96.7% basal). The primary outcome measure, percentage of blood glucose (BG) measurements in the range of 70–140 mg/dL, occurred in 50.2±22.2% of all measurements. The overall mean BG level was 154±35 mg/dL. BG measurements in the ranges of 60–70 mg/dL, 40–60 mg/dL, and <40 mg/dL occurred in 1.4%, 0.5%, and 0.0% of all measurements, respectively. A regression analysis showed that acute admission to the Cardiology Ward (+30 mg/dL) and preexisting home insulin therapy (+26 mg/dL) had the strongest impact on mean BG. Acute admission to other wards had minor effects (+4 mg/dL). Ninety-one percent of the healthcare professionals felt confident with GlucoTab, and 89% believed in its practicality and 80% in its ability to prevent medication errors. Conclusions: An efficacious, safe, and user-accepted implementation of GlucoTab was demonstrated. However, for optimized personalized patient care, further algorithm modifications are required.

Efficacy, usability and sequence of operations of a workflow‐integrated algorithm for basal–bolus insulin therapy in hospitalized type 2 diabetes patients

To evaluate glycaemic control and usability of a workflow‐integrated algorithm for basal–bolus insulin therapy in a proof‐of‐concept study to develop a decision support system in hospitalized patients with type 2 diabetes.

Screening of depression in patients with diabetes mellitus

Objectives: The first aim of this study was to compare the effectiveness of four commonly used depression screening measures for medically ill populations in identifying depression within a diabetes sample. The second aim was to examine whether the inclusion of a measure for physical symptoms specific to diabetes is also necessary for a diagnosis of depression or alternatively whether any overlap would obscure the effect on the screening measure for depression. Research Design and Methods: One hundred fifty patients with Type 2 diabetes in two large public hospital outpatient clinics completed a questionnaire which included the Center for Epidemiological Studies—Depression Scale (CES-D), the Silverstone Concise Assessment for Depression (SCAD), the Hospital Anxiety and Depression Scale (HADS), and the Depression in the Medically Ill (DMI) Questionnaire. Patient scores on these questionnaires were then assessed against their responses on the Composite International Diagnostic Interview Short Form and the Diabetes Symptom Checklist to determine their effectiveness. Results and Conclusions: Logistic regression and receiver operating curves analysis, including areas under the curves, suggested selecting the CES-D, rather than the DMI-10, HADS or SCAD for screening for depression in a Type 2 diabetic patient. The CES-D performed well at predicting depression, had high sensitivity and specificity, and did not require the addition of diabetes symptoms to aid in diagnosis.

Gesundheitsstatus der Typ-2-Diabetiker in Österreich aus der Sicht einer Qualitätssicherungs-Initiative

SummaryOBJECTIVE: To determine the prevalence of late complications in a large clinical sample of type 2 diabetic patients in Austria. METHODS: Data of all patients with type 2 diabetes entered into the database of the Forum for Quality Systems in Diabetes Care Austria (FQSD-A) between 1 January 1997 and 1 September 2007 were used for the analyses. RESULTS: Data from 23,641 persons with Type 2 Diabetes Mellitus were collected. Patients were 66.3 ± 11.5 years old, with an average diabetes duration of 8.0 ± 8.5 years. Prevalence of blindness, amputation, myocardial infarction or bypass, stroke and end stage renal failure was 0.9%, 2.3%, 12.2%, 8.7% and 0.8%, respectively. CONCLUSIONS: Prevalence of late diabetic complications in Austria is high compared with other European countries. The management of persons with Type 2 Diabetes should be further optimized to reduce the incidence of late complications of diabetes.ZusammenfassungZIELSETZUNG: Ziel dieser Arbeit ist es, die Prävalenz von diabetischen Spätkomplikationen unter österreichischen Patienten mit Diabetes Mellitus Typ 2 anhand von im Rahmen einer Qualitätssicherungs-Initiative gewonnenen Daten zu bestimmen. METHODIK: Analyse der Daten aller Personen mit diagnostiziertem Diabetes Mellitus Typ 2, die in der Datenbank des Forums für Qualitätssicherung in der Diabetologie Österreich (FQSD-Ö) zwischen 1.1.1997 und 1.9.2007 dokumentiert wurden. ERGEBNISSE: Insgesamt wurden 23.641 Patienten mit Typ-2-Diabetes dokumentiert. Die Patienten waren im Schnitt 66,3 ± 11,5 Jahre alt, mit einer Diabetesdauer von 8,0 ± 8,5 Jahren. Von Blindheit waren 0,9 %, von einer Amputation 2,3 %, von Herzinfarkt oder Bypass 12,2 %, von Schlaganfall 8,7 % und von Nierenversagen 0,8 % der Patienten betroffen. SCHLUSSFOLGERUNGEN: Die Prävalenz der diabetischen Spätkomplikationen in der ausgewerteten österreichischen Population ist hoch, jedoch vergleichbar mit anderen europäischen Ländern. Die Behandlung von Patienten mit Diabetes in Österreich muss weiterhin optimiert werden, um das Auftreten von Spätschäden zu vermindern.OBJECTIVE To determine the prevalence of late complications in a large clinical sample of type 2 diabetic patients in Austria. METHODS Data of all patients with type 2 diabetes entered into the database of the Forum for Quality Systems in Diabetes Care Austria (FQSD-A) between 1 January 1997 and 1 September 2007 were used for the analyses. RESULTS Data from 23,641 persons with Type 2 Diabetes Mellitus were collected. Patients were 66.3 +/- 11.5 years old, with an average diabetes duration of 8.0 +/- 8.5 years. Prevalence of blindness, amputation, myocardial infarction or bypass, stroke and end stage renal failure was 0.9%, 2.3%, 12.2%, 8.7% and 0.8%, respectively. CONCLUSIONS Prevalence of late diabetic complications in Austria is high compared with other European countries. The management of persons with Type 2 Diabetes should be further optimized to reduce the incidence of late complications of diabetes.

Impact of errors in paper-based and computerized diabetes management with decision support for hospitalized patients with type 2 diabetes. A post-hoc analysis of a before and after study

OBJECTIVE Most preventable adverse drug events and medication errors occur during medication ordering. Medication order entry and clinical decision support are available on paper or as computerized systems. In this post-hoc analysis we investigated frequency and clinical impact of blood glucose (BG) documentation- and user-related calculation errors as well as workflow deviations in diabetes management. We aimed to compare a paper-based protocol to a computerized medication management system combined with clinical workflow and decision support. METHODS Seventy-nine hospitalized patients with type 2 diabetes mellitus were treated with an algorithm driven basal-bolus insulin regimen. BG measurements, which were the basis for insulin dose calculations, were manually entered either into the paper-based workflow protocol (PaperG: 37 patients) or into GlucoTab(®)-a mobile tablet PC based system (CompG: 42 patients). We used BG values from the laboratory information system as a reference. A workflow simulator was used to determine user calculation errors as well as workflow deviations and to estimate the effect of errors on insulin doses. The clinical impact of insulin dosing errors and workflow deviations on hypo- and hyperglycemia was investigated. RESULTS The BG documentation error rate was similar for PaperG (4.9%) and CompG group (4.0%). In PaperG group, 11.1% of manual insulin dose calculations were erroneous and the odds ratio (OR) of a hypoglycemic event following an insulin dosing error was 3.1 (95% CI: 1.4-6.8). The number of BG values influenced by insulin dosing errors was eightfold higher than in the CompG group. In the CompG group, workflow deviations occurred in 5.0% of the tasks which led to an increased likelihood of hyperglycemia, OR 2.2 (95% CI: 1.1-4.6). DISCUSSION Manual insulin dose calculations were the major source of error and had a particularly strong influence on hypoglycemia. By using GlucoTab(®), user calculation errors were entirely excluded. The immediate availability and automated handling of BG values from medical devices directly at the point of care has a high potential to reduce errors. Computerized systems facilitate the safe use of more complex insulin dosing algorithms without compromising usability. In CompG group, missed or delayed tasks had a significant effect on hyperglycemia, while in PaperG group insufficient precision of documentation times limited analysis. The use of old BG measurements was clinically less relevant. CONCLUSION Insulin dosing errors and workflow deviations led to measurable changes in clinical outcome. Diabetes management systems including decision support should address nurses as well as physicians in a computerized way. Our analysis shows that such systems reduce the frequency of errors and therefore decrease the probability of hypo- and hyperglycemia.