[Show abstract][Hide abstract] 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/m(2)) 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.
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.
An efficacious, safe, and user-accepted implementation of GlucoTab was demonstrated. However, for optimized personalized patient care, further algorithm modifications are required.
[Show abstract][Hide abstract] ABSTRACT: The soluble long-acting insulin analogue insulin detemir owes its protracted action profile to strong reversible albumin binding. To find an explanation for the lower potency of insulin detemir observed in humans compared to unmodified human insulin we investigated insulin detemir and human insulin concentrations directly at the level of peripheral insulin sensitive tissues in humans in vivo.
Euglycaemic-hyperinsulinemic clamp experiments were performed in healthy volunteers. Human insulin was administered intravenously at 6 pmol kg(-1) min(-1) and insulin detemir at 60 pmol kg(-1) min(-1) achieving a comparable steady-state pharmacodynamic action. In addition, insulin detemir was doubled to 120 pmol kg(-1) min(-1) . Minimally invasive open flow microperfusion (OFM) sampling methodology was combined with inulin calibration to quantify human insulin and insulin detemir in the interstitial fluid of subcutaneous adipose and skeletal muscle tissue.
The human insulin interstitial concentration was ~115 pmol L(-1) or ~30% of the serum concentration, whereas the insulin detemir concentration in the interstitial fluid was ~680 pmol L(-1) or ~2% of the serum concentration. The molar insulin detemir interstitial concentration was 5-6 times higher than the human insulin interstitial concentration and metabolic clearance of insulin detemir from serum was substantially reduced compared to human insulin.
OFM proved useful for target tissue measurements of human insulin and the analogue insulin detemir. Our tissue data confirm a highly effective retention of insulin detemir in the vascular compartment. The higher insulin detemir relative to human insulin tissue concentrations at comparable pharmacodynamics, however, indicate that the lower potency of insulin detemir in humans is due to a reduced effect in peripheral insulin sensitive tissues and is in line with the reduced in-vitro receptor affinity.
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Diabetes Obesity and Metabolism 08/2015; DOI:10.1111/dom.12551 · 6.36 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Inpatient glucose management is based on four daily capillary blood glucose (BG) measurements. The aim was to test the capability of continuous glucose monitoring (CGM) for assessing the clinical impact and safety of basal-bolus insulin therapy in non-critically ill hospitalized patients with type 2 diabetes mellitus (T2DM).
Eighty-four patients with T2DM (age, 68±10 years; glycosylated hemoglobin, 72±28 mmol/mol; body mass index, 31±7 kg/m(2)) were treated with basal-bolus insulin. CGM was performed with the iPro(®)2 system (Medtronic MiniMed, Northridge, CA) and calibrated retrospectively.
A remarkable consistency between CGM and BG measurements and therapy improvement was shown over the study period of 501 patient-days. The number of CGM and BG measurements (CGM/BG) in the range from 3.9-10 mmol/L increased from 67.7%/67.2% (on Day 1) to 77.5%/78.6% (on the last day) (P<0.04). The number of low glycemic episodes (3.3 to <3.9 mmol/L) during nighttime detected by CGM was 15-fold higher, and the number of episodes >13.9 mmol/L detected by CGM during night was 12.5-fold higher than the values from the BG measurements. Ninety-nine percent of data points were in the clinically accurate or acceptable Clarke Error Grid Zones A+B, and the relative numbers of correctly identified episodes of <3.9 and >13.9 mmol/L detected by CGM (sensitivity) were 47.3% and 81.5%, respectively.
Our data exhibit a good agreement between overall CGM and BG measurements, but there were a high number of missed hypo- and hyperglycemic episodes with BG measurements, particularly during nighttime. Overall assessment of glycemic control using CGM is feasible, whereas the use of CGM for individualized therapy decisions needs further improvement.
[Show abstract][Hide abstract] ABSTRACT: Background
The Space GlucoseControl system (SGC) is a nurse-driven, computer-assisted device for glycemic control combining infusion pumps with the enhanced Model Predictive Control algorithm (B. Braun, Melsungen, Germany). We aimed to investigate the performance of the SGC in medical critically ill patients.
Two open clinical investigations in tertiary centers in Graz, Austria and Zurich, Switzerland were performed. Efficacy was assessed by percentage of time within the target range (4.4-8.3 mmol/L; primary end point), mean blood glucose, and sampling interval. Safety was assessed by the number of hypoglycemic episodes (≤2.2 mmol/L) and the percentage of time spent below this cutoff level. Usability was analyzed with a standardized questionnaire given to involved nursing staff after the trial.
Forty medical critically ill patients (age, 62 ± 15 years; body mass index, 30.0 ± 8.9 kg/m2; APACHE II score, 24.8 ± 5.4; 27 males; 8 with diabetes) were included for a period of 6.5 ± 3.7 days (n = 20 in each center). The primary endpoint (time in target range 4.4 to 8.3 mmol/l) was reached in 88.3% ± 9.3 of the time and mean arterial blood glucose was 6.7 ± 0.4 mmol/l. The sampling interval was 2.2 ± 0.4 hours. The mean daily insulin dose was 87.2 ± 64.6 IU. The adherence to the given insulin dose advice was high (98.2%). While the percentage of time spent in a moderately hypoglycemic range (2.2 to 3.3 mmol/L) was low (0.07 ± 0.26% of the time), one severe hypoglycemic episode (<2.2 mmol/L) occurred (2.5% of patients or 0.03% of glucose readings).
SGC is a safe and efficient method to control blood glucose in critically ill patients as assessed in two European medical intensive care units.
[Show abstract][Hide abstract] ABSTRACT: Standardized insulin order sets for subcutaneous basal-bolus insulin therapy are recommended by clinical guidelines for the inpatient management of diabetes. The algorithm based GlucoTab system electronically assists health care personnel by supporting clinical workflow and providing insulin-dose suggestions. To develop a toolbox for improving clinical decision-support algorithms. The toolbox has three main components. 1) Data preparation: Data from several heterogeneous sources is extracted, cleaned and stored in a uniform data format. 2) Simulation: The effects of algorithm modifications are estimated by simulating treatment workflows based on real data from clinical trials. 3) Analysis: Algorithm performance is measured, analyzed and simulated by using data from three clinical trials with a total of 166 patients. Use of the toolbox led to algorithm improvements as well as the detection of potential individualized subgroup-specific algorithms. These results are a first step towards individualized algorithm modifications for specific patient subgroups.
Studies in health technology and informatics 07/2014; 198(2):248. DOI:10.4338/ACI-2014-04-RA-0033
[Show abstract][Hide abstract] ABSTRACT: Background: Glycaemic management in the hospital is based on glucose point-of-care testing (POCT) which lacks continuous information particularly in detecting hypoglycaemic events. The aim of this study was to analyse and compare the capability to detect hypoglycaemic events (<70 mg/dl) with either standard glucose POCT or continuous glucose monitoring (CGM) in hospitalized type 2 diabetes patients on basal-bolus insulin therapy. Methods: A total of 59 patients with type 2 diabetes (age: 68.9±9.5 yr, DM duration 14.3±10.3 yr, A1C: 8.5±3%, BMI: 29.9±6 kg·m-2, length of stay 8±4.5 days (mean±SD)) were treated with basal-bolus insulin therapy. Glucose POCT was performed at least 4 times per day (premeal, before bedtime), CGM was performed with the iPro2 system (MiniMed Medtronic) which was calibrated with the blood glucose measurements retrospectively. Results: 8,578 hours were recorded with 1,480 paired blood glucose-sensor readings. After adjusting the offset of sensor data 35 hypoglycaemic events (<70 mg/dl) were detected with glucose POCT compared to 134 detected by CGM. The majority of hypoglycaemic events that were detected with CGM occurred during the night (see Fig. 1). Sensitivity to detect hypoglycaemic events with the CGM was 42 %. Conclusion: Although the sensitivity of the CGM sensor signal system was low the data indicate a high number of hypoglycaemic events (<70 mg/dl) are not detected with standard glucose POCT in particular during the night. Better performing CGM sensors are needed for detecting hypoglycaemic events in clinical routine. Acknowledgement: The study is supported by the European Commission, Project REACTION (FP7-248590).
[Show abstract][Hide abstract] ABSTRACT: Purpose
To evaluate the effects of audit and feedback on service delivery and patient functioning in Austrian Geriatric Acute Care Units.
Quality initiative based on a standardised documentation form (core and optional data set) and a web-based performance feedback with peer comparison in 18 Geriatric Acute Care Units, representing 40% of all Austrian units. Main outcome measures were compliance with desired practice of geriatric care (comprehensive geriatric assessment [CGA], therapeutic consequences), discharge characteristics and mortality.
Overall 22,279 patient records were documented between 2008 and 2010. Active involvement in the web-based feedback system was indicated by a high frequency of data queries per year, 1401, 3148 and 2883 for 2008, 2009 and 2010, respectively. The mean completion rate for CGA tests increased from 73% in 2008 to 78% in 2010 (P < 0.05). For centres with completion of core and optional data (n = 8), the average number of documented therapeutic interventions increased from 4.4 to 5.0 (P < 0.05). Those aspects of CGA focusing on activities of daily living, mobility and cognition prompted the greatest degree of corresponding therapeutic interventions (> 90%). A lower intervention rate was induced by the nutritional assessment (< 20%). Mortality and discharge characteristics such as level of care and percentage of patients living at home after discharge did not change over the time.
Following implementation of a web-based performance feedback with peer comparison in Austrian Geriatric Acute Care Units, an improvement in health care professionals’ compliance with desired practice of geriatric care, but not in patients’ discharge characteristics, was observed.
European geriatric medicine 12/2013; 4(6). DOI:10.1016/j.eurger.2013.05.005 · 0.73 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To evaluate glycemic 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.
In this ward-controlled study, 74 type 2 diabetes patients (24 female, age 68 ± 11 years, HbA1c 8.7 ± 2.4%, BMI 30 ± 7) were assigned to either algorithm-based treatment with a basal-bolus insulin therapy or to standard glycemic management. Algorithm performance was assessed by continuous glucose monitoring and staff's adherence to algorithm-calculated insulin dose.
Average blood glucose levels (mmol/l) in the algorithm group were significantly reduced from 11.3 ± 3.6 (baseline) to 8.2 ± 1.8 (last 24h) over a period of 7.5 ± 4.6 days (p < 0.001). The algorithm group had a significantly higher percentage of glucose levels in the ranges from 5.6-7.8 mmol/l (target range) and 3.9-10.0 mmol/l compared to the standard group (33% vs. 23% and 73% vs. 53%, both p < 0.001). Physicians' adherence to the algorithm-calculated total daily insulin dose was 95% and nurses' adherence to inject the algorithm-calculated basal and bolus insulin doses was high (98% and 93%). In the algorithm group significantly more glucose values <3.9 mmol/l were detected in the afternoon relative to other times (p < 0.05), a finding mainly related to pronounced morning glucose excursions and requirements for corrective bolus insulin at lunch.
The workflow-integrated algorithm for basal-bolus therapy was effective in establishing glycemic control and was well accepted by medical staff. Our findings support the implementation of the algorithm in an electronic decision support system.
[Show abstract][Hide abstract] ABSTRACT: Background:
Successful control of hyperglycemia has been shown to improve outcomes for diabetes patients in a clinical setting. We assessed the quality of physician-based glycemic management in two general wards, considering the most recent recommendations for glycemic control for noncritically ill patients (<140 mg/dl for premeal glucose).
Quality of glycemic management of 50 patients in two wards (endocrinology, cardiology) was assessed retrospectively by analyzing blood glucose (BG) levels, the glycemic management effort, and the online questionnaire.
Glycemic control was clearly above the recommended target (mean BG levels: endocrinology: 175 ± 62 mg/dl; cardiology: 186 ± 68 mg/dl). When comparing the first half with the second half of the hospital stay, we found no difference in glycemic control (endocrinology: 168 ± 32 vs 164 ± 42 mg/dl, P = .67; cardiology: 174 ± 36 mg/dl vs 170 ± 42 mg/dl, P =.51) and in insulin dose (endocrinology: 15 ± 14 IU vs 15 ± 13 IU per day, P = .87; cardiology: 27 ± 17 IU vs 27 ± 18 IU per day, P = .92), despite frequent BG measurements (endocrinology: 2.7 per day; cardiology: 3.2 per day). A lack of clearly defined BG targets was indicated in the questionnaire.
The recommended BG target range was not achieved in both wards. Analysis of routine glycemic management demonstrated considerable glycemic management effort, but also a lack of translation into adequate insulin therapy. Implementation of corrective measures, such as structured treatment protocols, is essential.
Journal of diabetes science and technology 03/2013; 7(2):402-409. DOI:10.1177/193229681300700217
[Show abstract][Hide abstract] ABSTRACT: We aimed to investigate the performance of the Space GlucoseControl system (SGC) (B. Braun, Melsungen, Germany) in medical critically ill patients. The SGC is a nurse-driven, computer-assisted device for glycemic control combining infusion pumps with the enhanced Model Predictive Control algorithm.
The trial was designed as a single-center, open clinical investigation in a nine-bed medical intensive care unit in a tertiary center in Graz, Austria. Efficacy was assessed by percentage of time within the target range (4.4-8.3 mmol/L; primary end point), mean blood glucose, and sampling interval. Safety was assessed by the number of hypoglycemic episodes (≤2.2 mmol/L).
Twenty mechanically ventilated patients (age, 63±16 years; body mass index, 31.0±10.7 kg/m(2); Acute Physiology and Chronic Health Evaluation II score, 25.4±6.3; 14 males; six with diabetes) were included for a period of 7.0±3.6 days. Time within target range was 83.4±8.9% (mean±SD), and mean arterial blood glucose was 6.8±0.4 mmol/L. No severe hypoglycemic episodes (<2.2 mmol/L) occurred, and the percentage of time within 2.2 and 3.3 mmol/L was low (0.03±0.07%). The sampling interval was 2.0±0.4 h. The mean insulin dose was 93.5±80.1 IU/day, and the adherence to the given insulin dose advice was high (98.3%). A total of 11 unintended therapy interruptions (0.08 events/treatment day) caused by software problems occurred in four patients.
SGC is a safe and efficient method to control blood glucose in critically ill patients in the medical intensive care unit.