title: First application of a transcutaneous optical single-port glucose monitoring device in patients with type 1 diabetes mellitus.
abstract: The combination of continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion can be used to improve the treatment of patients with diabetes. The aim of this study was to advance an existing preclinical single-port system for clinical application by integrating the sensors of a phosphorescence based CGM system into a standard insulin infusion set. The extracorporeal optical phase fluorimeter was miniaturised and is now comparable with commercial CGM systems regarding size, weight and wear comfort. Sensor chemistry was adapted to improve the adhesion of the sensor elements on the insulin infusion set. In-vitro tests showed a linear correlation of R2=0.998 between sensor values and reference glucose values in the range of 0-300mg/dl. Electrical and cytotoxicity tests showed no negative impact on human health. Two single-port devices were tested in each of 12 patients with type 1 diabetes mellitus in a clinical set-up for 12h. Without additional data processing, the overall median absolute relative difference (median ARD) was 22.5%. For some of the used devices the median ARD was even well below 10%. The present results show that individual glucose sensors performance of the single-port system is comparable with commercial CGM systems but further improvements are needed. The new system offers a high extent of safety and usability by combining insulin infusion and continuous glucose measurement in a single-port system which could become a central element in an artificial pancreas for an improved treatment of patients with type 1 diabetes mellitus.
authors.affiliation: JOANNEUM RESEARCH Forschungsgesellschaft mbH, HEALTH - Institute of Biomedicine and Health Sciences, Graz, Austria.
authors.forename: M
authors.initials: M
authors.lastname: Rumpler
authors.affiliation: Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Diabetology, Graz, Austria.
authors.forename: J K
authors.initials: JK
authors.lastname: Mader
authors.affiliation: Pyro Science GmbH, Aachen, Germany.
authors.forename: J P
authors.initials: JP
authors.lastname: Fischer
authors.affiliation: Pyro Science GmbH, Aachen, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Thar
authors.affiliation: RESCOLL Société de Recherche, Pessac Cedex, France.
authors.forename: J M
authors.initials: JM
authors.lastname: Granger
authors.affiliation: RESCOLL Société de Recherche, Pessac Cedex, France.
authors.forename: F
authors.initials: F
authors.lastname: Deliane
authors.affiliation: Graz University of Technology, Institute of Analytical Chemistry and Food Chemistry, Graz, Austria.
authors.forename: I
authors.initials: I
authors.lastname: Klimant
authors.affiliation: Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Diabetology, Graz, Austria.
authors.forename: F
authors.initials: F
authors.lastname: Aberer
authors.affiliation: JOANNEUM RESEARCH Forschungsgesellschaft mbH, HEALTH - Institute of Biomedicine and Health Sciences, Graz, Austria; Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Diabetology, Graz, Austria.
authors.forename: F
authors.initials: F
authors.lastname: Sinner
authors.affiliation: JOANNEUM RESEARCH Forschungsgesellschaft mbH, HEALTH - Institute of Biomedicine and Health Sciences, Graz, Austria; Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Diabetology, Graz, Austria.
authors.forename: T R
authors.initials: TR
authors.lastname: Pieber
authors.affiliation: JOANNEUM RESEARCH Forschungsgesellschaft mbH, HEALTH - Institute of Biomedicine and Health Sciences, Graz, Austria. Electronic address: healthca@joanneum.at.
authors.forename: M
authors.initials: M
authors.lastname: Hajnsek
mesh_terms: D000293:Adolescent; D001234:Aspergillus niger / Q000201:enzymology; D015374:Biosensing Techniques / Q000295:instrumentation*; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood*; D004867:Equipment Design; D005260:Female; D005470:Fluorometry / Q000295:instrumentation; D005949:Glucose Oxidase / Q000737:chemistry; D006801:Humans; D007332:Insulin Infusion Systems; D008297:Male; D018670:Monitoring, Ambulatory / Q000295:instrumentation
chemical_list: D001786:Blood Glucose; D005949:Glucose Oxidase
keywords: Artificial pancreas; Continuous glucose monitoring; Optical glucose sensor; Phase fluorimeter; Single-port system; Type 1 diabetes mellitus