Gernot Brunner

Evaluation of a structured outpatient group education program for intensive insulin therapy.

OBJECTIVE To determine the efficacy and safety of a structured diabetes teaching and treatment program (DTTP) in patients with insulin-dependent diabetes mel-litus (IDDM) in an outpatient setting. RESEARCH DESIGN AND METHODS All patients with IDDM who completed a structured 5-day outpatient DTTP were reevaluated after a mean follow-up of 3 years. A standardized interview was used to assess frequency of severe hypoglycemia, type of insulin treatment, self-monitoring, and other diabetes-related parameters. HbA1c was measured by high-performance liquid chromatography. RESULTS Of 205 patients, 4 (2%) died during the observation period. HbA1c in the 201 surviving patients decreased significantly from 8.7 ± 2.0 to 7.5 ± 1.2% at follow-up (P < 0.001); frequency of severe hypoglycemia decreased from a mean of 0.46 to 0.13 per patient per year (P < 0.001). Hospital admission due to acute metabolic disturbances decreased from 4.5 ± 11.1 to 1.4 ± 6.7 days/patient-year (P < 0.001). At follow-up, intensive insulin therapy was carried out by 98% of the patients, and 80% of the patients reported three or more measurements of blood glucose per day. Diabetes-related knowledge had a positive (P < 0.01) and body mass index a negative (P < 0.02) influence on improving HbA1c assessed by multiple regression analysis. Severe hypoglycemia after DTTP was associated with a history of severe hypoglycemia before DTTP (P < 0.001) and the existence of overt diabetic nephrop-athy (P < 0.05). CONCLUSIONS A structured outpatient DTTP as used in this study is able to improve overall metabolic control and decrease the frequency of severe hypoglycemia in patients with IDDM.

Validation of home blood glucose meters with respect to clinical and analytical approaches

OBJECTIVE To evaluate the clinical and analytical accuracy of home blood glucose meters. RESEARCH DESIGN AND METHODS Six blood glucose meters—Reflolux S (Boehringer Mannheim, Mannheim, Germany), One Touch II (LifeScan, Milpitas, CA), Glucocard Memory (Menarini, Florence, Italy), Precision QID (Medisense, Cambridge, U.K.), HaemoCue (HaemoCue, Ängelholm, Sweden), and Accutrend a (Boehringer Mannheim, Mannheim, Germany)—were compared with a reference method (Beckman Glucose Analyzer II) under controlled conditions (glucose clamp technique). Validation of the blood glucose meters was accomplished by clinically oriented approaches (error grid analysis), statistical approaches (variance components analysis), and by the criteria of the American Diabetes Association (ADA), which recommend a target variability of <5%. RESULTS A total of 1,794 blood glucose monitor readings and 299 reference values ranging from 2.2 to 18.2 mmol/1 were analyzed (705 readings <3.89 mmol/1, 839 readings between 3.89 and 9.99 mmol/1, and 250 readings >9.99 mmol/1). According to error grid analysis, only Reflolux S and Glucocard M had 100% of estimations within the clinically acceptable zones A and B. Assessment of analytical accuracy revealed substantial differences between the glucose meters after separation of the data into defined glycemic ranges. None of the devices met the ADA criteria. CONCLUSIONS To evaluate accuracy of blood glucose meters, error grid analysis, as well as statistical models, are helpful means and should be performed together. Analytical performance of currently available home blood glucose meters differs substantially within defined glycemic ranges.

Dose-response relation of liquid aerosol inhaled insulin in type I diabetic patients.

Aims/hypothesis. The AERx insulin Diabetes Management System (AERx iDMS) is a liquid aerosol device that enables insulin to be administered to the peripheral parts of the lung. This study aimed to compare the pharmacokinetic and pharmacodynamic properties of insulin which is inhaled using AERx iDMS with insulin which is subcutaneously administered. Methods. In total, 18 C-peptide negative patients with Type I (insulin-dependent) diabetes mellitus participated in this randomised, open-label, 5-period cross-over trial. Human regular insulin was administered subcutaneously (0.12 U/kg body weight) or inhaled by means of the AERx iDMS (dosages 0.3, 0.6, 1.2, and 1.8 U/kg body weight). Thereafter plasma glucose was kept constant at 7.2 mmol/l for a 10-h period (glucose clamp technique). Results. Inhaled insulin provided a dose-response relation that was close to linear for both pharmacokinetic (AUC-Ins(0–10 h); Cmax-Ins) and pharmacodynamic (AUC-GIR(0–10 h); GIRmax) parameters. Time to maximum insulin concentration (Tmax-Ins) and time to maximum glucose infusion rate (TGIRmax) were shorter with inhaled insulin than with subcutaneous administration. The pharmacodynamic system efficiency of inhaled insulin (AUC-GIR(0–6 h)) was 12.7 % (95 % C. I.: 10.2–15.6). Conclusion/interpretation. The inhalation of soluble human insulin using the AERx iDMS is feasible and provides a clear dose response. Further long-term studies are required to investigate safety aspects, HbA1 c values, incidence of hypoglycaemic events and the quality of life. [Diabetologia (2001) 44: 305–308]

Evaluation of a Structured Teaching and Treatment Programme for Type 2 Diabetes in General Practice in a Rural Area of Austria

The efficacy of a treatment and teaching programme for non‐insulin‐treated Type 2 diabetic patients in general practice was evaluated in a prospective, controlled study. In a rural area in southern Austria, 53 patients from seven general practices participated in a structured programme (intervention group) and 55 patients from seven general practices without the programme served as the control group. After 6 months the weight reduction in the intervention group was 2.6 kg (1.6–3.7 kg, p < 0.001) and the difference in HbA1c between the groups was 0.92% (0.23–1.61%, p < 0.01) at follow‐up. Systolic (– 16.6 mmHg) and diastolic (–11.1 mmHg) blood pressure, serum triglycerides (– 0.63 mmol I−1), and serum cholesterol (– 0.40 mmol I−1) were reduced significantly in the intervention group (p < 0.006). The number of patients with callus formation and poor nail care decreased significantly after participating in the teaching programme (p < 0.001). In the control group no reduction in body weight, metabolic control or in risk factors for diabetic foot complications were observed. Calculated health care costs per patient and year decreased in the intervention group (£ − 33) and increased in the control group (£ +30) mainly due to changes in prescription of oral hypoglycaemic agents in both groups. This programme may be an efficient and helpful model to increase overall quality of diabetes care according to the St Vincent Declaration.

Post-prandial administration of the insulin analogue insulin aspart in patients with Type 1 diabetes mellitus.

Aims In intensified insulin therapy, the recent development of short‐acting insulin analogues with a very rapid onset of action forces a new discussion in terms of the optimal injection–meal interval. This study evaluated prandial glycaemia in patients with Type 1 diabetes following the subcutaneous injection of soluble human insulin (HI) and the insulin analogue insulin aspart (IAsp) at different injection–meal intervals and investigated whether administration of IAsp after the meal might provide satisfactory metabolic control.

Accuracy of home blood glucose meters during hypoglycemia

OBJECTIVE To evaluate the accuracy of home blood glucose meters during hypoglycemia. METHODS Six blood glucose meters—One Touch II (LifeScan, Milpitas, CA), Companion II (Medisense, Cambridge, U.K.), Reflolux (Boehringer Mannheim, Mannheim, Germany), Accutrend (Boehringer Mannheim), Elite (Bayer, Munich, Germany), and HemoCue (HemoCue, Ängelholm, Sweden)—were compared with a reference method (Beckman Glucose Analyzer 2). Glucose concentrations from arterialized venous blood samples were measured using all glucose meters (whole blood) and the reference method (plasma) during hypoglycemic-hyperinsulinemic clamps in 15 subjects. RESULTS In total, 663 blood glucose monitor readings and 119 reference values ranging from 2.28 to 3.89 mmol/l were analyzed. The correlation coefficients and the percentage of measurements within 20% and outside 40% of the reference values for each glucose meter were as follows: One Touch II: 0.91, 99.2% and 0%; Companion II: 0.81, 88.2% and 2.5%; Reflolux: 0.78, 85.0% and 0.9%; Accutrend: 0.88, 46.0% and 6.6%; Elite: 0.78, 75.6% and 4.2%; and HemoCue: 0.93, 96.6% and 0% (P < 0.001). CONCLUSIONS There were substantial differences between the blood glucose meters during hypoglycemia, and none of the devices met the latest criteria recommended by the American Diabetes Association.

Direct access to interstitial fluid in adipose tissue in humans by use of open-flow microperfusion.

To gain direct access to the interstitial fluid (ISF), a new technique called open-flow microperfusion has been evaluated. This method is based on a double-lumen catheter with macroscopic (0.3-0.5 mm diameter) perforations that is inserted into the subcutaneous adipose tissue and constantly perfused. Thus partial equilibration between the ISF and the perfusion fluid occurs. The glucose concentration of the ISF was determined by established (zero flow rate, no net flux, and recirculation procedures) and new (ionic reference and suction technique) calibration methods by use of open-flow microperfusion. The data show that 1) the glucose concentration in the ISF is significantly lower than the corresponding arterialized venous plasma values during basal steady-state conditions (adipose tissue 3.2 +/- 0.10 mM, plasma 5.27 +/- 0.12 mM) as well as during hyperglycemic clamp experiments (adipose tissue 7.3 +/- 0.13 mM, plasma 9.91 +/- 0.16 mM), and 2) it is possible to determine the recovery continuously by using the ion concentration of the ISF as an internal standard (ionic reference).To gain direct access to the interstitial fluid (ISF), a new technique called open-flow microperfusion has been evaluated. This method is based on a double-lumen catheter with macroscopic (0.3-0.5 mm diameter) perforations that is inserted into the subcutaneous adipose tissue and constantly perfused. Thus partial equilibration between the ISF and the perfusion fluid occurs. The glucose concentration of the ISF was determined by established (zero flow rate, no net flux, and recirculation procedures) and new (ionic reference and suction technique) calibration methods by use of open-flow microperfusion. The data show that 1) the glucose concentration in the ISF is significantly lower than the corresponding arterialized venous plasma values during basal steady-state conditions (adipose tissue 3.2 ± 0.10 mM, plasma 5.27 ± 0.12 mM) as well as during hyperglycemic clamp experiments (adipose tissue 7.3 ± 0.13 mM, plasma 9.91 ± 0.16 mM), and 2) it is possible to determine the recovery continuously by using the ion concentration of the ISF as an internal standard (ionic reference).

Q.E.D. Alcohol Test : A simple and quick method to detect ethanol in saliva of patients in emergency departments : Comparison with the conventional determination in blood

Objective: The aim of this pilot study was to assess whether ethanol concentrations in saliva are comparable to those in blood and to evaluate whether this new non-invasive saliva alcohol test is suitable for use in emergency departments. Design: Prospective, open, non-randomised study. Setting: University hospital emergency department. Patients and methods: 100 consecutive patients who were admitted to the emergency department whose smell and/or behaviour indicated alcohol abuse. Fifteen patients participated as a control group after they were asked to abstain from alcohol consumption for 24 h before the study. Interventions: Blood and saliva samples were obtained at the same time for ethanol measurement. The Q.E.D. Alcohol Test A 350 was used in order to measure the concentration of ethanol in saliva. Blood samples were analysed by the alcohol dehydrogenase method. Results: The mean difference between the ethanol levels in blood and saliva was − 0.1 mg/dl, whereas the values measured in saliva were on average 0.1 mg/dl higher than those measured in blood (p = 0.002). Conclusion: The Q.E.D. Alcohol Test A 350, which uses saliva, is well suited for quantitative determination of alcohol levels. The levels measured in saliva correlate well with those measured in blood at both the lower and the upper end of the scale. Because this test is quick and easy to perform by emergency room personnel and the results are accurate enough for clinical purposes, it should prove valuable to determine whether impaired consciousness is related to alcohol intoxication or to other likely causes.

Novel system for real-time ex vivo lactate monitoring in human whole blood

The objective of the study was to evaluate the performance of an amperometric enzyme based lactate sensor and to investigate the possibility of replacing a double lumen catheter based blood withdrawal system with a heparin coated single lumen system. The inner lumen of a double lumen catheter which was placed in a peripheral vein was perfused with heparin solution. The outer lumen was used to collect heparinized blood samples at a defined flow rate. The single lumen system was attached to a heparinized catheter which was also placed in a peripheral vein. The undiluted blood samples were collected at a specified flow rate. A sensor flow chamber incorporating an amperometric thin-film lactate microbiosensor was placed in the sampling line for real-time lactate monitoring. Plasma lactate concentrations were measured during frequently performed hyperlactatemia bicycle ergometer experiments in six healthy volunteers (age 25.8 +/- 2.8 years, BMI 22.7 +/- 1 kg/m2). Additionally, plasma lactate was measured in real-time using the lactate sensors. The first three experiments were performed with a double lumen based catheter system whereas the following three experiments were performed with a heparin coated catheter system. The correlation coefficients of sensor readings and laboratory analyzer results in all six experiments were between 0.93 and 0.99, respectively (P < 0.001). The miniaturized lactate sensors showed a linear range up to 25 mmol/l lactate concentration and 95% response times < 30 s in undiluted serum. During the experiments maximum lactate concentrations of 14 mmol/l were achieved. Improvements of system performance using heparin coated catheter systems could be shown. The overall SD of the sensor readings compared to laboratory results using three double lumen catheter based systems was 0.91 mmol/l whereas the SD using three heparin coated systems was 0.65 mmol/l. In summary, real-time monitoring of lactate in human whole blood is feasible with such a device and can be improved by using heparin coated catheter systems.

Implementation of a Surgical Safety Checklist: Interventions to Optimize the Process and Hints to Increase Compliance

Background A surgical safety checklist (SSC) was implemented and routinely evaluated within our hospital. The purpose of this study was to analyze compliance, knowledge of and satisfaction with the SSC to determine further improvements. Methods The implementation of the SSC was observed in a pilot unit. After roll-out into each operating theater, compliance with the SSC was routinely measured. To assess subjective and objective knowledge, as well as satisfaction with the SSC implementation, an online survey (N = 891) was performed. Results During two test runs in a piloting unit, 305 operations were observed, 175 in test run 1 and 130 in test run 2. The SSC was used in 77.1% of all operations in test run 1 and in 99.2% in test run 2. Within used SSCs, completion rates were 36.3% in test run 1 and 1.6% in test run 2. After roll-out, three unannounced audits took place and showed that the SSC was used in 95.3%, 91.9% and 89.9%. Within used SSCs, completion rates decreased from 81.7% to 60.6% and 53.2%. In 2014, 164 (18.4%) operating team members responded to the online survey, 160 of which were included in the analysis. 146 (91.3%) consultants and nursing staff reported to use the SSC regularly in daily routine. Conclusion These data show that the implementation of new tools such as the adapted WHO SSC needs constant supervision and instruction until it becomes self-evident and accepted. Further efforts, consisting mainly of hands-on leadership and training are necessary.