title: Evaluation of the performance of a novel system for continuous glucose monitoring.
abstract: BACKGROUND
  The performance of a continuous glucose monitoring (CGM) system in the early stage of development was assessed in an inpatient setting that simulates daily life conditions of people with diabetes. Performance was evaluated at low glycemic, euglycemic, and high glycemic ranges as well as during phases with rapid glucose excursions.
  
  
  METHODS
  Each of the 30 participants with type 1 diabetes (15 female, age 47 ± 12 years, hemoglobin A1c 7.7% ± 1.3%) wore two sensors of the prototype system in parallel for 7 days. Capillary blood samples were measured at least 16 times per day (at least 15 times per daytime and at least once per night). On two subsequent study days, glucose excursions were induced. For performance evaluation, the mean absolute relative difference (MARD) between CGM readings and paired capillary blood glucose readings and precision absolute relative difference (PARD), i.e., differences between paired CGM readings were calculated.
  
  
  RESULTS
  Overall aggregated MARD was 9.2% and overall aggregated PARD was 7.5%. During induced glucose excursions, MARD was 10.9% and PARD was 7.8%. Lowest MARD (8.5%) and lowest PARD (6.4%) were observed in the high glycemic range (euglycemic range, MARD 9.1% and PARD 7.4%; low glycemic range, MARD 12.3% and PARD 12.4%).
  
  
  CONCLUSIONS
  The performance of this prototype CGM system was, particularly in the hypoglycemic range and during phases with rapid glucose fluctuations, better than performance data reported for other commercially available systems. In addition, performance of this prototype sensor was noticeably constant over the whole study period. This prototype system is not yet approved, and performance of this CGM system needs to be further assessed in clinical studies.
authors.affiliation: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH, Ulm, Germany.
authors.forename: Eva
authors.initials: E
authors.lastname: Zschornack
authors.forename: Christina
authors.initials: C
authors.lastname: Schmid
authors.forename: Stefan
authors.initials: S
authors.lastname: Pleus
authors.forename: Manuela
authors.initials: M
authors.lastname: Link
authors.forename: Hans-Martin
authors.initials: HM
authors.lastname: Klötzer
authors.forename: Karin
authors.initials: K
authors.lastname: Obermaier
authors.forename: Michael
authors.initials: M
authors.lastname: Schoemaker
authors.forename: Monika
authors.initials: M
authors.lastname: Strasser
authors.forename: Gerhard
authors.initials: G
authors.lastname: Frisch
authors.forename: Günther
authors.initials: G
authors.lastname: Schmelzeisen-Redeker
authors.forename: Cornelia
authors.initials: C
authors.lastname: Haug
authors.forename: Guido
authors.initials: G
authors.lastname: Freckmann
mesh_terms: D000005:Abdomen; D000328:Adult; D015374:Biosensing Techniques / Q000295:instrumentation*; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation; D003922:Diabetes Mellitus, Type 1 / Q000097:blood*; D005260:Female; D006801:Humans; D020007:Implants, Experimental; D008297:Male; D008875:Middle Aged; D012680:Sensitivity and Specificity; D050151:Subcutaneous Fat; D055815:Young Adult
chemical_list: D001786:Blood Glucose
references.citation: Diabetes Care. 1987 Sep-Oct;10(5):622-8
references.pmid: 3677983
references.citation: J Diabetes Sci Technol. 2009 Sep 01;3(5):1207-14
references.pmid: 20144438
references.citation: Diabetes Technol Ther. 2007 Oct;9(5):399-409
references.pmid: 17931048
references.citation: Diabetes Care. 2011 May;34 Suppl 2:S197-201
references.pmid: 21525455
references.citation: Diabetes Care. 2002 May;25(5):889-93
references.pmid: 11978686
references.citation: Diabetes Care. 2011 Apr;34(4):795-800
references.pmid: 21335621
references.citation: J Diabetes Sci Technol. 2013 Jul 01;7(4):842-53
references.pmid: 23911165
references.citation: Diabetes Care. 2004 Mar;27(3):734-8
references.pmid: 14988294
references.citation: Diabetes Technol Ther. 2009 Feb;11(2):65-72
references.pmid: 19243265
references.citation: J Diabetes Sci Technol. 2011 Jul 01;5(4):860-70
references.pmid: 21880227
references.citation: Diabetes Obes Metab. 2013 Feb;15(2):130-5
references.pmid: 22974231
references.citation: Diabetes Care. 2013 Feb;36(2):251-9
references.pmid: 23275350
references.citation: J Diabetes Sci Technol. 2013 Jul 01;7(4):808-14
references.pmid: 23911161
references.citation: J Diabetes Sci Technol. 2013 Jul 01;7(4):833-41
references.pmid: 23911164
references.citation: J Diabetes Sci Technol. 2009 Sep 01;3(5):1146-54
references.pmid: 20144429
references.citation: J Diabetes Sci Technol. 2012 Sep 01;6(5):1103-6
references.pmid: 23063036
references.citation: Diabet Med. 2010 Jan;27(1):117-22
references.pmid: 20121899
references.citation: Diabetes Technol Ther. 2009 Dec;11(12):749-55
references.pmid: 20001675
references.citation: Diabetes Care. 2007 May;30(5):1125-30
references.pmid: 17337488
references.citation: J Diabetes Sci Technol. 2013 Jul 01;7(4):824-32
references.pmid: 23911163
references.citation: BMJ. 2011 Jul 07;343:d3805
references.pmid: 21737469