Göhl, M.

Heidbüchel, K.

Müller-Esch, G.

Peters, A.

Scriba, Peter Christian

English

Peters, Achim

Open Access LMU ( Ludwig-Maximilians-Univ. München)

Band 29 • Heft 4 April 1984 Biomed ica l Engineer ing Hoiiedizinis^ Icchnik Gemeinschaftsorgan der Deutschen*, der österreichischen und der Schweizerischen Gesellschaft für Biomedizinische Technik Publication of the German, Austrian and Swiss Association on Biomedical Engineering Herausgeber/Editors: Prof. Dr.-lng. U. Boenick, Fachgebiet Biomedizinische Technik, Technische Universität Berlin, Dovestraße 6, D-1000 Berlin 10 Prof. Dr. M. Schaldach, Zentralinstitut für Biomedizinische Technik der Universität Erlangen-Nürnberg, Turmstraße 5, D-8520 Erlangen Redaktion/Editorial Staff: Prof. Dr.-lng. U. Boenick, Fachgebiet Biomedizinische Technik, Technische Universität Berlin, Dovestraße 6, D-1000 Berlin 10, Tel. 030/3145112 (Deutschland) Prof. Dr. techn. S. Schuy, Institut für Elektro- und Biomedi-zinische Technik der Universität Graz, Inffeldgasse 18, A-8010 Graz, Tel. 0043316/77511/7390-92 (Österreich) Prof. Dr. sc. nat. M. Anliker, Institut für Biomedizinische Technik der Universität Zürich und ETHZ, Mousson-straße 18, CH-8044 Zürich, Tel. 00411/2564582 (Schweiz) Wissenschaftlicher Beirat/Editorial Board: Prof. Dr.-lng. O. Anna, Hannover Prof. Dr. med. K. Hammacher, Tübingen Prof. Dr. med. P. Heintzen, Kiel Prof. Dr. med. F. Heuck, Stuttgart Prof. Dr. med. D. Hohmann, Erlangen Prof. Dr.-lng. W. Irnich, Gießen Prof. Dr. med. H. Just, Freiburg Prof. Dr. med. H. Keller, St. Gallen Prof. Dr. rer. nat. H. Kresse, Erlangen Prof. Dr. med. H. Lutzeyer, Aachen Prof. Dr. med. J. D. Meyer-Erkelenz, Aachen Prof. Dr. rer. nat. H. Pfeift, Gießen Prof. Dr. med. G. Vossius, Karlsruhe Inhalt/Contents: Seite/Page G. Müler-Esch, A. Peters, M. Göhl, K. Heidbüchel, P. C. Scriba: Simplified Evaluation and Documentation of Data from Glucose Controlled Insulin Infusion Systems (GCIIS) 62 Computerunterstützte Datenauswertung und Doku-mentation beim Einsatz glukosekontrollierter Insulin-infusionssysteme H. Hutten: Überlegungen zur Einrichtung und Bewertung des medizintechnischen Dienstes im Krankenhaus . . 66 Considerations Concerning the Organization and Assessment of the Clinical Engineering Service N. Tiedt, R. Haidmayer, M. Moser, R. Kurz, T. Kenner: Time Optimal Binary Test Signal Sequences for the Analysis of the Respiration Control System in Babies 77 Die Anwendung zeitoptimaler Testsignal-Sequenzen für die Analyse der Atemregulation bei Säuglingen I. Adam-v. Sontagh: Ein Fortschritt in der apparativen Medikamenten-applikation: Das volständig implantierbare Pumpen-system - eine Übersicht 82 A Major Advance in Drug Administration: the Totally Implantable Pump System - an Overlook Kongresse/Veranstaltungen 87 Literaturschau 88 Buchbesprechungen 89 Neues aus Forschung und Industrie 90 Verlag/Publishing Company: Fachverlag Schiele & Schön GmbH Postfach 610280, Markgrafenstraße 11, D-1000 Berlin 61 Telefon-Sammel-Nr. 030/2516029 Telex 181470 sunds d Die Geschäftsstele der Deutschen Gesellschaft für Biomedizini-sche Technik e.V. befindet sich beim Fachverlag Schiele & Schön GmbH (Anschrift siehe oben) Hinweise für Autoren/Hints for Authors: Eine Kurzfassung der Hinweise für Autoren befindet sich auf der 3. Umschlagseite dieses Heftes. Die ausführliche Fassung kann beim geschäftsführenden Redak-teur oder beim Verlag angefordert werden. 62 Insulin Infusion System Biomedizinische Technik Band 29 Heft 4/1984 Biomed. Technik 29 (1984), 6 2 - 6 6 Simplified Evaluation and Documentation of Data from Glucose Controlled Insulin Infusion System (GCIIS) Computerunterstützte Datenauswertung und Dokumentation beim Einsatz glukosekontrollierter Insulininfusionssysteme Klinik für Innere Medizin, Medizinische Hochschule Lübeck, West Germany Key-words: Glucose controlled insulin infusion, artificial beta cell, data processing, metabolic control in diabetes mellitus A computer-assisted method for complete processing of data from a glucose-controlled insulin infusion system (GCIIS) is demonstrated. All data are transferred directly from the GCIIS to a microcomputer by means of an interface. A BASIC computer programme has been developed for rapid calculation of mean blood glucose (MBG), an index of blood glucose control (M-value) and a measure of diabetic instability (MAGE) in order to assess the state of glycemic control. All GCIIS-data as well as calculated parameters are stored on floppy disks and can be recorded by a printer-plotter immediately after the GCIIS control period. The device is particularly useful for optimizing conventional subcutaneous insulin therapy by means of a GCIIS. Schlüsselwörter: Glukosegesteuerte Insulin-Infusion, künstliche Beta-Zelle, Meßdatenverarbei-tung, Stoffwechselüberwachung beim Diabetes mellitus Eine computerunterstützte Methode zur vollständigen Datenverarbeitung beim Einsatz glukose-kontrollierter Insulininfusionssysteme (GCIIS) wird vorgestellt. Mit Hilfe eines Interface werden alle Daten direkt vom GCIIS auf einen Mikrocomputer übertragen. Ein BASIC-Computerpro-gramm wurde für die schnelle Berechnung von Kenngrößen des Glukosestoffwechsels (mittlerer Blutzucker, M-value als Index für die Blutzuckerkontrolle und MAGE als Maß für Blutzucker-schwankungen) entwickelt. Sämtliche GCIIS-Daten werden ebenso wie berechnete Parameter und Klartextkommentare auf Floppy-Disks gespeichert und können von einem Printer-Plotter ausgedruckt werden. Die Methode erlaubt eine vollständige Verarbeitung sämtlicher GCIIS-Daten am Krankenbett ; sie hat sich z. B. zur Überprüfung und Verbesserung der Stoffwechsel-kontrolle unter konventioneller subcutaner Insulin-Therapie bewährt. G. Müller-Esch A. Peters M. Göhl K. Heidbüchel P. C. Scriba Introduction Three parameters for assessment of metabolic control in diabetic patients commonly used are: 1) the diurnal mean blood glucose concentration (MBG), 2) the so-called M-value [11], the logarithmic transformation of the deviation of glycemia from an arbitrarily selected standard, and 3) MAGE [13] the mean amplitude of glycemic excursions. When applied to a few blood glucose values at selected time points during the course of the day, conventional mathematical evaluation of these parameters may be feasible. However, this is al-most impossible during the use of a glucose controlled insulin infusion system (GCIIS). Complete processing of GCIIS-data would require the time-consuming key-bord entry of a vast number of values into a calculator. For this reason, an interface between the GCIIS and a microcomputer has been employed to transfer all data directly at one minute intervals. Further, a BASIC com-puter programme has been developed for rapid calcu-lation of MBG, M-value and MAGE. Our bed-side method permits the complete processing and recording of GCIIS-data. Materials and methods A schematic diagram of the technical equipment is shown in figure 1. The patient is connected to the GCIIS (Biostator Controller, Life Science Instruments, Miles Laboratories, Elkhart, USA), the details of which have been described elsewhere [3, 4, 8]. By means of an inter-face all data for blood glucose concentration (BG), insulin infusion rate (IR) and dextrose infusion rate (DR) are transferred directly from the GCIIS to a microcomputer (PC 800, Magirus Datentechnik, Lein-felden-Echterdingen, West Germany) for further processing. The microcomputer provides the following functions (figure 1): 1) Monitoring: BG, IR and DR are plotted continuously. 2) Manual input: comments concerning e.g. the actual therapy can be entered via keybord. 3) Calculations: a BASIC computer programme has been developed for the calculation of - MBG (mg/dl) = — I BG n i Biomedizinische Technik Band 29 Heft 4/1984 Insulin Infusion System 63 OEXTROSE DILUTEO BLOOD INSULIN INFUSION PUMP PATIENT ANALYZER PUMP GLUCOSE ANALYZER COMPUTER MODULE}* GCIIS INTERFACE LUNCH 'EXERCISE PRINTER V PROCESSOR KEYBOARO MONITOR 1 FLOPPY-DRIVE COMPUTER MANUAL INPUT OF COMMENTS Figure 1. Schematic diagram of device used for processing of GCIIS-data. M-value: The M-value is a quantitative index of the deviation of several blood glucose (BG) determinations in a twenty-four-hour period from an arbitrarily selected stan-dard (120 mg/dl). The mathematical for-mula was designed to give proportionately greater emphasis to hypoglycemia than to hyperglycemia: M-value 1 n / n ! V 10 log BG„ BG 120mg/d x BGmjn MAGE: 20 mg/dl The calculation of MAGE is based on a logical algorithm (figure 2). It is defined as the arithmetic mean of those glycemic excursions which satisfy the following conditions: 1. The excursion (from blood glucose nadirs to peaks or vice versa) must exceed one standard deviation of the mean blood glucose of the same twenty-four-hour period. 2. The succeding excursion in opposite direction (peak to nadir or vice versa) must also exceed one standard devia-tion. 3. The excursion must have the same di-rection as the first excursion which exceeds one standard deviation and thus establishes the direction of calcu-lation. 4) Printer and Floppy Discs: All values for BG, IR, DR as well as comments which appear in their time-related positions, and calculated parameters are plotted and documented on 5 inch floppy discs. The BASIC-programme may be obtained by interested investigators from the authors upon writing. Results Figures 3 and 4 show as an example the data obtained from an insulin-dependent diabetic patient treated by a combination of. s.c. insulin injections and feedback control by the GCIIS. The first control period shows the assessment of additional insulin requirements for opti-mizing metabolic control. The patient received inter-mediate insulin, 28 U in the morning and 16 U in the evening. The total amount of insulin given in addition by the GCIIS for feedback control was 24.3 U regular insulin. Insulin requirements were highest after break-fast, lunch and evening snack. There was a tendency towards hypoglycemia during midnight, which was counterregulated by 7.7 g dextrose administered. According to these data the patient was placed on a new insulin regimen: 22 U intermediate plus 6 U regular insulin in the morning and 18 U intermediate insulin in the evening. A second control period six weeks later clearly showed improved metabolic control. The addi-tional amount of insulin given by the GCIIS was reduced to 4.7 U. There was only a slight tendency to-wards hypoglycemia during the night. Table 1 shows the parameters for metabolic control calculated for the two GCIIS runs using all data obtained from the system. Table 1. Parameters reflecting metabolic control calculated by complete evaluation of the two GCIIS runs. Run 1 Run 2 MBG±SD (mg/100 ml) 120±35 101±20 M-value 14 7 MAGE (mg/100 ml) 72 53 Number of excursions 5 4 Discussion Glucose controlled insulin infusion systems have been successfully used to determine insulin requirements for conventional subcutaneous insulin therapy [1, 6, 9, 10] and for continuous subcutaneous or intravenous insulin infusion with portable pumps [5,14]. In order to assess the state of glycemic control, three parameters are commonly used: MGB, the mean of all blood glucose values; the M-value, a parameter indicating the 64 Insulin Infusion System Biomedizinische Technik Band 29 Heft 4/1984 (START) E(1) = GM) 1=2.J=1 SLOPE FOR T=2 TO F-1 i (G(T)<G(T-J ) ANO G(TW3(T*1)1 OR (G (T) >G (T-J ) ANO G(T)>G(T*1)]^ l yes < G(T) = G ( U T ) ^ > ^ 4 ^ = ^ SLOPE NEXT T E(I)=G(T) 1 = 1*1 J = 1 E(I)= GIF) F U I 1=2 K1 = • K2=« L=0 Q N Ö ) Figure 2. Flow diagram for calculation of MAGE. Abbreviations: G (T) = blood glucose level at time T; E (I) = blood glucose level of the I-th relative extreme; F = number of measurements (T from 1 to F); FI = number of relative extrema (I from 1 to FI); J = duration of stationary relative extrema; L = indicates, whether all excursions are counted in peak-to-nadir (L = - 1 ) or in nadir- to-peak direction (L = +1); D = standard deviation; O, U = greatest relative maximum (O) and smallest relative minimum (U) during an interval. These values are tested according to the criteria for counted excursions; K, = total of excursions counted for MAGE; K> = number of excursions counted for MAGE. Biomedizinische Technik Band 29 Heft 4/1984 Insulin Infusion System 65 PATIENT J.L d* (30y) 10-28-82 £ 100-Figure 3. Blood glucose (BG), insulin infusion rates (IR) and dextrose infusion rates (DR) in a diabetic patient on conventional s.c. insulin therapy during a 24-hour feedback control by the GCIIS. Constants: VAR 100, BI 130, FI 325, RD 25, BD 65, FD 240. Assessment of additional insulin requirements for optimizing s.c. therapy. duration and the degree of pathological blood glucose values, and MAGE, the mean amplitude of glycemic excursions, a measure of diabetic instability. The results of this study offe the possibility to calculate on the basis of minute to minute blood glucose measurements these parameters more exactly than at selected time points, as suggested by others [7 ]. In part i-cular, the computer programme and the technical equipment employed have the following advantages: MGB, M-value and MAGE can be calculated immedia-tely after the end of a GCIIS control period. To our knowledge, rapid calculation of MAGE from GCIIS-data by means of a specific BASIC-computer pro-gramme using a micro-computer has not been reported up to now. In 1982, Brunetti et al. [2] for the first time presented a computerized system for evaluation and documentation of GCIIS-data. However, the concept of these authors required data transmission from a mini-computer to a computer center for mathematical and statistical analysis. Therefore, evaluation of metabolic parameters such as MAGE could not be performed as a bedside method. - Further, all data from each patient during a control period are stored on a floppy disc and can be printed at any time. This is of particular interest for evaluating and comparing treatment regimes during extended periods. Figures 3 and 4 illustrate the usefulness of our method for the improvement of therapy in a diabetic on conven-tional subcutaneous insulin regimen. Obviously, the procedure can be applied likewise in order to determine the insulin requirements and the state of metabolic PATIENT: J.L. <f (30y) 12-07-82 500-300-200-500 W0 - 100-Z X I/O OJ :£< _ t— O < _ en ^ ZD ZD J* CM NO e 100-Figure 4. GCIIS-data obtained from the same patient during a second 24-hour control period six weeks later. New insulin regimen calculated according to the data from the first GCIIS-run. Improved metabolic control. 66 Medizintechnischer Dienst im Krankenhaus Biomedizinische Technik Band 29 Heft 4/1984 control in preprogrammed insulin infusion therapy. Finally, the method is not confined to routine clinical management of diabetes mellitus. It can also be recom-mended in critical care medicine. Preliminary results [12] have proved its usefulness in evaluating the meta-bolic therapy with glucose-insulin-potassium infu-sions guided by a GCIIS in patients with acute myo-cardial infarction. References: [1] Beyer, J., G. Becker, G. Schulz, E. Gaberle, E. Wolf, W. Hassinger, U. Cordes: Blutzuckerkontrollierte Insulin-Infusionssysteme zur Schnelleinstellung insulinpflichti-ger Diabetiker. Dtsch. med. Wschr. 106 (1981), 1644-1649 [2] Brunetti , P., G. Calabrese, G. Cecconi, M. Massi-Bene-detti, A. Bueti, F. Santeusanio, F. Landi, G. Bellomo: Computerized system for the analysis of blood glucose regulation and beta cell function stimulation: applica-tion in a closed-loop system (Biostator, GCIIS). Horm. Metab. Res. Suppl. 12 (1982), 179-183 [3] Clemens, A. H., P. H. Chang, R. W. Myers: The develop-ment of Biostator, a glucose controlled insulin infusion system (GCIIS). Horm. Metab. Res. Suppl. 7 (1978), 2 3 - 3 3 [4] Fogt, E. J., L. M. Dodd, E. M. Jenning, A. H. Clemens: Development and evaluation of a glucose analyzer for a glucose-controlled insulin infusion system (Biostator). Clin. Chem. 24 (1978), 1366-1372 [5] Kolendorf, K., J. S. Christiansen, J. Bojsen, P. A. Svend-sen, L. L. S. Teglbjaerg: Determination of 24-hour insulin infusion pat tern by an artificial endocrine pancreas for intravenous insulin infusion with a miniature pump. Horm. Metab. Res. 13 (1980), 245-249 16] Lambert, A. E., M. Buysschaert, E. Marchand, M. Pierard, S. Wojcik, L. Lambotte: Determination of insulin re-quirements in britt le diabetic patients by the artificial pancreas. Diabetes 27 (1978), 825-833 [7] Molnar, G. D., W. F. Taylor, A. Langworthy: On mea-suring the adequacy of diabetes regulation: comparison of continuously monitored blood glucose pat terns with values at selected time points. Diabetologia 10 (1974), 139-143 [8] Pfeiffer, E. F., Ch. Thum, A. H. Clemens: The artificial beta-cell - a continuous control of blood sugar by exter-regulation of insulin infusion - (glucose controlled in-sulin infusion system). Horm. Metab. Res. 6 (1974), 339-342 [91 Ratzmann, K. P., W. Bruns, B. Schulz, E. Zander: Use of the artificial B-cell (Biostator) in improving insulin therapy in unstable insulin-dependent diabetes. Diabe-tes Care 5 (1982), 11 -17 [10] Rizza, R. A., J. E. Gerich, M. W. Haymond, R. E. Westland, L. D. Hall, A. H. Clemens, F. J. Service: Control of blood sugar in insulin-dependent diabetes: comparison of an artificial endocrine pancreas, continuous subcutaneous insulin infusion, and intensified conventional insulin therapy. N. Engl. J. Med. 303 (1980), 1313-1318 [11] Schlichtkrull, J., O. Munck, M. Jersild: The M-value, an index of blood sugar control in diabetics. Acta Med. Scand. 177 (1965), 95-102 [12] Scriba, P. C , H. Djonlagic, G. Müller-Esch: Endokrines System und Schock. Internist 23 (1982), 433-440 [13] Service, F. J., G. D. Molnar, J. W. Rosevear, E. Acker-mann, L. C. Gatewood, W. F. Taylor: Mean ampli tude of glycemic excursions, a measure of diabetic instability. Diabetes 19 (1970), 644-655 [14] Service, F. J., R. A. Rizza, R. E. Westland, L. D. Hall, R. L. Nelson, M. W. Haymond, A. H. Clemens, J. E. Gerich: Considerations for the programming of an open-loop insulin infusion device from the Biostator glucose con-troller. Diabetes Care 3 (1980), 278-284 175 Anschrift des Verfassers: Dr. med. Gert Müller-Esch Klinik für Innere Medizin Medizinische Hochschule Lübeck Ratzeburger Allee 160 D-2400 Lübeck 1 

Clemens: Development and evaluation of a glucose analyzer for a glucose-controlled insulin infusion system (Biostator).

Computerized system for the analysis of blood glucose regulation and beta cell function stimulation: application in a closed-loop system (Biostator,

Considerations for the programming of an open-loop insulin infusion device from the Biostator glucose controller.

Control of blood sugar in insulin-dependent diabetes: comparison of an artificial endocrine pancreas, continuous subcutaneous insulin infusion, and intensified conventional insulin therapy.

Mean amplitude of glycemic excursions, a measure of diabetic instability.

Müller-Esch: Endokrines System und Schock.

On measuring the adequacy of diabetes regulation: comparison of continuously monitored blood glucose patterns with values at selected time points.

Teglbjaerg: Determination of 24-hour insulin infusion pattern by an artificial endocrine pancreas for intravenous insulin infusion with a miniature pump.

The artificial beta-cell - a continuous control of blood sugar by exterregulation of insulin infusion - (glucose controlled insulin infusion system).

The development of Biostator, a glucose controlled insulin infusion system (GCIIS).

The M-value, an index of blood sugar control in diabetics.

Simplified Evaluation and Documentation of Data from Glucose Controlled Insulin Systems (GCIIS)

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Simplified Evaluation and Documentation of Data from Glucose Controlled Insulin Systems (GCIIS)

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