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Auf dem Weg zum „Closed-loop“-System

Bestandteile und Schritte

On course for a closed-loop system

Components and steps

  • Leitthema
  • Published:
Der Diabetologe Aims and scope

Zusammenfassung

Diabetestherapie bedeutet für einen Menschen mit Typ-1-Diabetes die Notwendigkeit, ein lebenslanges Management der Insulinsubstitution zu gewährleisten, beruhend auf profunden Kenntnissen zur Erkrankung, der Blutglucoseselbstmessung und der Insulindosisanpassung. Es ist deshalb ein sehnlicher Wunsch der Patienten, das Insulinmanagement zu automatisieren, was der technischen Lösung im Sinne eines artifiziellen Pankreas entspricht. Konkret gilt es, einen Kreislauf von Glucosemessung und Insulinabgabe so zu etablieren, dass sich ein geschlossenes System ergibt („Closed-loop“-System, CLS). Eine Nachahmung der physiologischen Situation ist nur eingegrenzt möglich, d. h., bei praktisch realisierbaren CLS erfolgt die Steuerung der s.c.-Insulin-Infusion über einen subkutan messenden Glucosesensor. Dies stellt eine Abweichung von der physiologischen Situation dar. Solche Abweichungen und die sich daraus ergebenden Schwierigkeiten gilt es durch geeignete Steuerungsalgorithmen zu kompensieren. Einige Voraussetzungen für CLS werden bereits heute im Alltag eingesetzt, so die Kalkulation von Insulindosen in den Pumpen sowie die Kopplung von Glucosesensor und Pumpe. Dadurch ist eine automatisierte Hypoglykämieabschaltung möglich; eine erste Stufe von CLS findet also bereits Verwendung in der täglichen Insulintherapie. Die Entwicklung bis zu vollautomatischen CLS, die als Produkte kommerziell verfügbar werden, wird über mehrere Entwicklungsstufen verlaufen. Aktuell wird eine Reihe von klinischen Studien durchgeführt, bei denen CLS die Kontrolle der Insulintherapie unter Alltagsbedingungen übernehmen; die bisherigen Ergebnisse dieser Studien sind ausgesprochen positiv.

Abstract

For a person with type 1 diabetes, the diabetes therapy means the necessity to ensure a lifelong management of insulin substitution entailing a profound knowledge of the disease, blood glucose self-monitoring and adjustment of insulin dosage. It is therefore a fervent desire of patients for insulin management to be automated and the technical solution corresponds to that of an artificial pancreas. In concrete terms this means establishment of a cycle of glucose measurement and insulin administration in a closed-loop system (CLS). Duplication of the physiological situation has only limited possibilities, i.e. a practically realizable CLS necessitates the control of subcutaneous insulin infusion via a subcutaneous glucose sensor measurement, which records deviations from the physiological situation. These deviations and the resulting difficulties must be compensated by suitable control algorithms. Some prerequisites for a CLS have already been implemented in the daily routine, such as calculation of the insulin dosage in the pumps and coupling of the glucose sensor and pump which allows and automatic shut-off in hypoglycemia. The first stage of a CLS is therefore already used in daily insulin therapy. The development to fully automated CLS and to a commercially available product will run over several developmental stages. A series of clinical studies are currently being carried out in which a CLS undertakes the control of insulin therapy under routine daily conditions and the results of these studies are so far extremely promising.

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Einhaltung ethischer Richtlinien

Interessenkonflikt. A. Thomas ist Scientific Manager der Fa. Medtronic, Geschäftsbereich Diabetes; Hersteller und Vertreiber von Insulinpumpen und CGM-Systemen. Er ist nichtstimmberechtigtes Mitglied im Beirat der Arbeitsgemeinschaft Diabetische Technologie der Deutschen Diabetes-Gesellschaft (DDG) und Chefredakteur der Zeitschrift Diabetes und Technologie. L. Heinemann ist Berater einer Reihe von Firmen, die neue diagnostische und therapeutische Optionen für die Diabetestherapie entwickeln. Er ist 1. Vorsitzender der Arbeitsgemeinschaft Diabetische Technologie der DDG und Redakteur der Zeitschrift Diabetes und Technologie. Weiterhin ist er Managing Editor der Zeitschrift Journal of Diabetes Science & Technology. G. Freckmann ist Ärztlicher Leiter und Geschäftsführer des „Instituts für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm“ (IDT). Das IDT führt eigene wissenschaftliche Projekte sowie Studien zur Untersuchung von Medizinprodukten und Systemen zur Blutzuckermessung im Auftrag verschiedener Unternehmen durch. Freckmann/IDT erhielt Vortrags-/Beratungshonorare von den Firmen Abbott, Bayer, Menarini Diagnostics, BD, Novo Nordisk, Roche Diagnostics, Ypsomed und Sanofi. Freckmann ist 2. Vorsitzender der Arbeitsgemeinschaft Diabetische Technologie der DDG und Redakteur der Zeitschrift Diabetes und Technologie. Dieser Beitrag beinhaltet keine Studien an Menschen oder Tieren.

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Authors and Affiliations

  1. Medtronic GmbH, Earl-Bakken-Platz 1, 40670, Meerbusch, Deutschland

    A. Thomas

  2. Science & Co. GmbH, Düsseldorf, Deutschland

    L. Heinemann

  3. Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH, Universität Ulm, Ulm, Deutschland

    G. Freckmann

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  1. A. Thomas
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  2. L. Heinemann
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  3. G. Freckmann
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Correspondence to A. Thomas.

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Thomas, A., Heinemann, L. & Freckmann, G. Auf dem Weg zum „Closed-loop“-System. Diabetologe 10, 48–55 (2014). https://doi.org/10.1007/s11428-013-1127-y

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