Delays in Minimally Invasive Continuous Glucose Monitoring Devices: A Review of Current Technology

Through the use of enzymatic sensors—inserted subcutaneously in the abdomen or ex vivo by means of microdialysis fluid extraction—real-time minimally invasive continuous glucose monitoring (CGM) devices estimate blood glucose by measuring a patient's interstitial fluid (ISF) glucose concentrati...

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Published inJournal of diabetes science and technology Vol. 3; no. 5; pp. 1207 - 1214
Main Authors Keenan, D. Barry, Mastrototaro, John J., Voskanyan, Gayane, Steil, Garry M.
Format Journal Article
LanguageEnglish
Published United States Diabetes Technology Society 01.09.2009
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Online AccessGet full text
ISSN1932-2968
1932-3107
1932-3107
DOI10.1177/193229680900300528

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Abstract Through the use of enzymatic sensors—inserted subcutaneously in the abdomen or ex vivo by means of microdialysis fluid extraction—real-time minimally invasive continuous glucose monitoring (CGM) devices estimate blood glucose by measuring a patient's interstitial fluid (ISF) glucose concentration. Signals acquired from the interstitial space are subsequently calibrated with capillary blood glucose samples, a method that has raised certain questions regarding the effects of physiological time lags and of the duration of processing delays built into these devices. The time delay between a blood glucose reading and the value displayed by a continuous glucose monitor consists of the sum of the time lag between ISF and plasma glucose, in addition to the inherent electrochemical sensor delay due to the reaction process and any front-end signal-processing delays required to produce smooth traces. Presented is a review of commercially available, minimally invasive continuous glucose monitors with manufacturer-reported device delays. The data acquisition process for the Medtronic MiniMed (Northridge, CA) continuous glucose monitoring system—CGMS® Gold—and the Guardian® RT monitor is described with associated delays incurred for each processing step. Filter responses for each algorithm are examined using in vitro hypoglycemic and hyperglycemic clamps, as well as with an analysis of fast glucose excursions from a typical meal response. Results demonstrate that the digital filters used by each algorithm do not cause adverse effects to fast physiologic glucose excursions, although nonphysiologic signal characteristics can produce greater delays.
AbstractList Through the use of enzymatic sensors—inserted subcutaneously in the abdomen or ex vivo by means of microdialysis fluid extraction—real-time minimally invasive continuous glucose monitoring (CGM) devices estimate blood glucose by measuring a patient's interstitial fluid (ISF) glucose concentration. Signals acquired from the interstitial space are subsequently calibrated with capillary blood glucose samples, a method that has raised certain questions regarding the effects of physiological time lags and of the duration of processing delays built into these devices. The time delay between a blood glucose reading and the value displayed by a continuous glucose monitor consists of the sum of the time lag between ISF and plasma glucose, in addition to the inherent electrochemical sensor delay due to the reaction process and any front-end signal-processing delays required to produce smooth traces. Presented is a review of commercially available, minimally invasive continuous glucose monitors with manufacturer-reported device delays. The data acquisition process for the Medtronic MiniMed (Northridge, CA) continuous glucose monitoring system—CGMS® Gold—and the Guardian® RT monitor is described with associated delays incurred for each processing step. Filter responses for each algorithm are examined using in vitro hypoglycemic and hyperglycemic clamps, as well as with an analysis of fast glucose excursions from a typical meal response. Results demonstrate that the digital filters used by each algorithm do not cause adverse effects to fast physiologic glucose excursions, although nonphysiologic signal characteristics can produce greater delays.
Through the use of enzymatic sensors-inserted subcutaneously in the abdomen or ex vivo by means of microdialysis fluid extraction-real-time minimally invasive continuous glucose monitoring (CGM) devices estimate blood glucose by measuring a patient's interstitial fluid (ISF) glucose concentration. Signals acquired from the interstitial space are subsequently calibrated with capillary blood glucose samples, a method that has raised certain questions regarding the effects of physiological time lags and of the duration of processing delays built into these devices. The time delay between a blood glucose reading and the value displayed by a continuous glucose monitor consists of the sum of the time lag between ISF and plasma glucose, in addition to the inherent electrochemical sensor delay due to the reaction process and any front-end signal processing delays required to produce smooth traces. Presented is a review of commercially available, minimally invasive continuous glucose monitors with manufacturer reported device delays. The data acquisition process for the Medtronic MiniMed (Northridge, CA) continuous glucose monitoring system-CGMS Gold-and the Guardian RT monitor is described with associated delays incurred for each processing step. Filter responses for each algorithm are examined using in vitro hypoglycemic and hyperglycemic clamps, as well as with an analysis of fast glucose excursions from a typical meal response. Results demonstrate that the digital filters used by each algorithm do not cause adverse effects to fast physiologic glucose excursions, although nonphysiologic signal characteristics can produce greater delays.Through the use of enzymatic sensors-inserted subcutaneously in the abdomen or ex vivo by means of microdialysis fluid extraction-real-time minimally invasive continuous glucose monitoring (CGM) devices estimate blood glucose by measuring a patient's interstitial fluid (ISF) glucose concentration. Signals acquired from the interstitial space are subsequently calibrated with capillary blood glucose samples, a method that has raised certain questions regarding the effects of physiological time lags and of the duration of processing delays built into these devices. The time delay between a blood glucose reading and the value displayed by a continuous glucose monitor consists of the sum of the time lag between ISF and plasma glucose, in addition to the inherent electrochemical sensor delay due to the reaction process and any front-end signal processing delays required to produce smooth traces. Presented is a review of commercially available, minimally invasive continuous glucose monitors with manufacturer reported device delays. The data acquisition process for the Medtronic MiniMed (Northridge, CA) continuous glucose monitoring system-CGMS Gold-and the Guardian RT monitor is described with associated delays incurred for each processing step. Filter responses for each algorithm are examined using in vitro hypoglycemic and hyperglycemic clamps, as well as with an analysis of fast glucose excursions from a typical meal response. Results demonstrate that the digital filters used by each algorithm do not cause adverse effects to fast physiologic glucose excursions, although nonphysiologic signal characteristics can produce greater delays.
Through the use of enzymatic sensors—inserted subcutaneously in the abdomen or ex vivo by means of microdialysis fluid extraction—real-time minimally invasive continuous glucose monitoring (CGM) devices estimate blood glucose by measuring a patient's interstitial fluid (ISF) glucose concentration. Signals ac-quired from the interstitial space are subsequently calibrated with capillary blood glucose samples, a method that has raised certain questions regarding the effects of physiological time lags and of the duration of processing delays built into these devices. The time delay between a blood glucose reading and the value displayed by a continuous glucose monitor consists of the sum of the time lag between ISF and plasma glucose, in addition to the inherent electro-chemical sensor delay due to the reaction process and any front-end signal-processing delays required to produce smooth traces. Presented is a review of commercially available, minimally invasive continuous glucose monitors with manufacturer-reported device delays. The data acquisition process for the Medtronic MiniMed (Northridge, CA) continuous glucose monitoring system—CGMS® Gold—and the Guardian® RT monitor is described with associated delays incurred for each processing step. Filter responses for each algorithm are examined using in vitro hypoglycemic and hyperglycemic clamps, as well as with an analysis of fast glucose excursions from a typical meal response. Results demonstrate that the digital filters used by each algorithm do not cause adverse effects to fast physiol-ogic glucose excursions, although nonphysiologic signal characteristics can produce greater delays.
Through the use of enzymatic sensors-inserted subcutaneously in the abdomen or ex vivo by means of microdialysis fluid extraction-real-time minimally invasive continuous glucose monitoring (CGM) devices estimate blood glucose by measuring a patient's interstitial fluid (ISF) glucose concentration. Signals acquired from the interstitial space are subsequently calibrated with capillary blood glucose samples, a method that has raised certain questions regarding the effects of physiological time lags and of the duration of processing delays built into these devices. The time delay between a blood glucose reading and the value displayed by a continuous glucose monitor consists of the sum of the time lag between ISF and plasma glucose, in addition to the inherent electrochemical sensor delay due to the reaction process and any front-end signal processing delays required to produce smooth traces. Presented is a review of commercially available, minimally invasive continuous glucose monitors with manufacturer reported device delays. The data acquisition process for the Medtronic MiniMed (Northridge, CA) continuous glucose monitoring system-CGMS Gold-and the Guardian RT monitor is described with associated delays incurred for each processing step. Filter responses for each algorithm are examined using in vitro hypoglycemic and hyperglycemic clamps, as well as with an analysis of fast glucose excursions from a typical meal response. Results demonstrate that the digital filters used by each algorithm do not cause adverse effects to fast physiologic glucose excursions, although nonphysiologic signal characteristics can produce greater delays.
Author Voskanyan, Gayane
Mastrototaro, John J.
Keenan, D. Barry
Steil, Garry M.
AuthorAffiliation 2 Children's Hospital Boston , Boston, Massachusetts
1 Medtronic MiniMed , Northridge, California
AuthorAffiliation_xml – name: 2 Children's Hospital Boston , Boston, Massachusetts
– name: 1 Medtronic MiniMed , Northridge, California
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  givenname: D. Barry
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  surname: Mastrototaro
  fullname: Mastrototaro, John J.
  organization: Medtronic MiniMed, Northridge, California
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  givenname: Gayane
  surname: Voskanyan
  fullname: Voskanyan, Gayane
  organization: Medtronic MiniMed, Northridge, California
– sequence: 4
  givenname: Garry M.
  surname: Steil
  fullname: Steil, Garry M.
  organization: Children's Hospital Boston, Boston, Massachusetts
BackLink https://www.ncbi.nlm.nih.gov/pubmed/20144438$$D View this record in MEDLINE/PubMed
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Disclosure: D. Barry Keenan, John J. Mastrototaro, and Gayane Voskanyan are employees of Medtronic MiniMed. Garry M. Steil is no longer employed by Medtronic MiniMed but was an employee at the time this article was written.
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Snippet Through the use of enzymatic sensors—inserted subcutaneously in the abdomen or ex vivo by means of microdialysis fluid extraction—real-time minimally invasive...
Through the use of enzymatic sensors-inserted subcutaneously in the abdomen or ex vivo by means of microdialysis fluid extraction-real-time minimally invasive...
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SubjectTerms Algorithms
Blood Glucose - metabolism
Blood Glucose Self-Monitoring - instrumentation
Diagnosis, Computer-Assisted
Diagnostic Equipment
Dietary Carbohydrates - administration & dosage
Dietary Carbohydrates - metabolism
Electrochemical Techniques - instrumentation
Equipment Design
Extracellular Fluid - metabolism
Humans
Predictive Value of Tests
Reproducibility of Results
Review
Signal Processing, Computer-Assisted
Time Factors
Title Delays in Minimally Invasive Continuous Glucose Monitoring Devices: A Review of Current Technology
URI https://www.ncbi.nlm.nih.gov/pubmed/20144438
https://www.proquest.com/docview/733120282
https://pubmed.ncbi.nlm.nih.gov/PMC2769894
https://journals.sagepub.com/doi/pdf/10.1177/193229680900300528
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