Accuracy of a Fourth-Generation Continuous Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes

Robert H. Slover, Jeanie B. Tryggestad, Linda DiMeglio, Larry A. Fox, Bruce W. Bode, Timothy S. Bailey, Ronald Brazg, Mark P. Christiansen, Jennifer L. Sherr, Eva Tsalikian, Kevin B. Kaiserman, Ashley Sullivan, Suiying Huang, John Shin, Scott W. Lee, Francine R. Kaufman

Research output: Contribution to journalArticle

Abstract

Background: This study evaluated the safety and performance of the Guardian™ continuous glucose monitoring (CGM) system in children and adolescents with type 1 diabetes (T1D). Materials and Methods: Subjects 2-18 years of age (mean ± standard deviation [SD] 13.1 ± 3.9 years) with T1D and duration of diagnosis ≥1 year were enrolled at 11 sites in the United States and wore two Guardian Sensor 3 sensors in the abdomen and/or buttock. Sensors were connected to a transmitter paired with either a Guardian Connect system (i.e., mobile device with software application allowing display of sensor glucose [SG] values) or a Guardian Link 3 transmitter used as a Glucose Sensor Recorder (GSR). There were 145 participants who underwent a 6-h in-clinic frequent sample testing (FST) on day 1 (n = 54), day 3 (n = 48), or day 7 (n = 43) postsensor insertion. During FST, SG values were compared with a Yellow Springs Instrument (YSI) plasma reference every 5-15 min (n = 124, 7-18 years of age; n = 2, 2-6 years of age), or to a self-monitoring of blood glucose (SMBG) reference every 5-30 min (n = 19, 2-6 years of age). Results: The overall mean absolute relative difference (ARD ± SD) between SG and reference values (YSI or SMBG) when calibrating approximately every 12 h, was 10.9% ± 10.7% (3102 paired points) for sensors communicating with the Guardian Connect system and 11.1% ± 10.6% (2624 paired points) for sensors connected to the GSR. The overall percentage of SG values within ±20% of reference values >80 mg/dL or within 20 mg/dL of reference values ≤80 mg/dL was 87.8% for the Guardian Connect system and 86.7% for the GSR, respectively. There was one device-related adverse event of contact dermatitis, but no serious device-related adverse events. Conclusions: The Guardian CGM system demonstrated good accuracy in children and adolescents. These findings support its use in sensor-integrated insulin pump platforms, as well as a standalone technology, for managing diabetes in pediatric populations.

LanguageEnglish (US)
Pages576-584
Number of pages9
JournalDiabetes Technology and Therapeutics
Volume20
Issue number9
DOIs
StatePublished - Sep 1 2018

Fingerprint

Type 1 Diabetes Mellitus
Glucose
Blood Glucose Self-Monitoring
Reference Values
Equipment and Supplies
Buttocks
Contact Dermatitis
Abdomen
Software
Insulin
Pediatrics
Technology
Safety
Population

Keywords

  • Continuous glucose monitoring
  • MARD
  • mobile device
  • Pediatrics
  • Sensor accuracy
  • Sensorintegrated pump

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Endocrinology
  • Medical Laboratory Technology

Cite this

Accuracy of a Fourth-Generation Continuous Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes. / Slover, Robert H.; Tryggestad, Jeanie B.; DiMeglio, Linda; Fox, Larry A.; Bode, Bruce W.; Bailey, Timothy S.; Brazg, Ronald; Christiansen, Mark P.; Sherr, Jennifer L.; Tsalikian, Eva; Kaiserman, Kevin B.; Sullivan, Ashley; Huang, Suiying; Shin, John; Lee, Scott W.; Kaufman, Francine R.

In: Diabetes Technology and Therapeutics, Vol. 20, No. 9, 01.09.2018, p. 576-584.

Research output: Contribution to journalArticle

Slover, RH, Tryggestad, JB, DiMeglio, L, Fox, LA, Bode, BW, Bailey, TS, Brazg, R, Christiansen, MP, Sherr, JL, Tsalikian, E, Kaiserman, KB, Sullivan, A, Huang, S, Shin, J, Lee, SW & Kaufman, FR 2018, 'Accuracy of a Fourth-Generation Continuous Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes' Diabetes Technology and Therapeutics, vol. 20, no. 9, pp. 576-584. https://doi.org/10.1089/dia.2018.0109
Slover, Robert H. ; Tryggestad, Jeanie B. ; DiMeglio, Linda ; Fox, Larry A. ; Bode, Bruce W. ; Bailey, Timothy S. ; Brazg, Ronald ; Christiansen, Mark P. ; Sherr, Jennifer L. ; Tsalikian, Eva ; Kaiserman, Kevin B. ; Sullivan, Ashley ; Huang, Suiying ; Shin, John ; Lee, Scott W. ; Kaufman, Francine R. / Accuracy of a Fourth-Generation Continuous Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes. In: Diabetes Technology and Therapeutics. 2018 ; Vol. 20, No. 9. pp. 576-584.
@article{92af3007a72246fbab58a553725c124d,
title = "Accuracy of a Fourth-Generation Continuous Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes",
abstract = "Background: This study evaluated the safety and performance of the Guardian™ continuous glucose monitoring (CGM) system in children and adolescents with type 1 diabetes (T1D). Materials and Methods: Subjects 2-18 years of age (mean ± standard deviation [SD] 13.1 ± 3.9 years) with T1D and duration of diagnosis ≥1 year were enrolled at 11 sites in the United States and wore two Guardian Sensor 3 sensors in the abdomen and/or buttock. Sensors were connected to a transmitter paired with either a Guardian Connect system (i.e., mobile device with software application allowing display of sensor glucose [SG] values) or a Guardian Link 3 transmitter used as a Glucose Sensor Recorder (GSR). There were 145 participants who underwent a 6-h in-clinic frequent sample testing (FST) on day 1 (n = 54), day 3 (n = 48), or day 7 (n = 43) postsensor insertion. During FST, SG values were compared with a Yellow Springs Instrument (YSI) plasma reference every 5-15 min (n = 124, 7-18 years of age; n = 2, 2-6 years of age), or to a self-monitoring of blood glucose (SMBG) reference every 5-30 min (n = 19, 2-6 years of age). Results: The overall mean absolute relative difference (ARD ± SD) between SG and reference values (YSI or SMBG) when calibrating approximately every 12 h, was 10.9{\%} ± 10.7{\%} (3102 paired points) for sensors communicating with the Guardian Connect system and 11.1{\%} ± 10.6{\%} (2624 paired points) for sensors connected to the GSR. The overall percentage of SG values within ±20{\%} of reference values >80 mg/dL or within 20 mg/dL of reference values ≤80 mg/dL was 87.8{\%} for the Guardian Connect system and 86.7{\%} for the GSR, respectively. There was one device-related adverse event of contact dermatitis, but no serious device-related adverse events. Conclusions: The Guardian CGM system demonstrated good accuracy in children and adolescents. These findings support its use in sensor-integrated insulin pump platforms, as well as a standalone technology, for managing diabetes in pediatric populations.",
keywords = "Continuous glucose monitoring, MARD, mobile device, Pediatrics, Sensor accuracy, Sensorintegrated pump",
author = "Slover, {Robert H.} and Tryggestad, {Jeanie B.} and Linda DiMeglio and Fox, {Larry A.} and Bode, {Bruce W.} and Bailey, {Timothy S.} and Ronald Brazg and Christiansen, {Mark P.} and Sherr, {Jennifer L.} and Eva Tsalikian and Kaiserman, {Kevin B.} and Ashley Sullivan and Suiying Huang and John Shin and Lee, {Scott W.} and Kaufman, {Francine R.}",
year = "2018",
month = "9",
day = "1",
doi = "10.1089/dia.2018.0109",
language = "English (US)",
volume = "20",
pages = "576--584",
journal = "Diabetes Technology and Therapeutics",
issn = "1520-9156",
publisher = "Mary Ann Liebert Inc.",
number = "9",

}

TY - JOUR

T1 - Accuracy of a Fourth-Generation Continuous Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes

AU - Slover, Robert H.

AU - Tryggestad, Jeanie B.

AU - DiMeglio, Linda

AU - Fox, Larry A.

AU - Bode, Bruce W.

AU - Bailey, Timothy S.

AU - Brazg, Ronald

AU - Christiansen, Mark P.

AU - Sherr, Jennifer L.

AU - Tsalikian, Eva

AU - Kaiserman, Kevin B.

AU - Sullivan, Ashley

AU - Huang, Suiying

AU - Shin, John

AU - Lee, Scott W.

AU - Kaufman, Francine R.

PY - 2018/9/1

Y1 - 2018/9/1

N2 - Background: This study evaluated the safety and performance of the Guardian™ continuous glucose monitoring (CGM) system in children and adolescents with type 1 diabetes (T1D). Materials and Methods: Subjects 2-18 years of age (mean ± standard deviation [SD] 13.1 ± 3.9 years) with T1D and duration of diagnosis ≥1 year were enrolled at 11 sites in the United States and wore two Guardian Sensor 3 sensors in the abdomen and/or buttock. Sensors were connected to a transmitter paired with either a Guardian Connect system (i.e., mobile device with software application allowing display of sensor glucose [SG] values) or a Guardian Link 3 transmitter used as a Glucose Sensor Recorder (GSR). There were 145 participants who underwent a 6-h in-clinic frequent sample testing (FST) on day 1 (n = 54), day 3 (n = 48), or day 7 (n = 43) postsensor insertion. During FST, SG values were compared with a Yellow Springs Instrument (YSI) plasma reference every 5-15 min (n = 124, 7-18 years of age; n = 2, 2-6 years of age), or to a self-monitoring of blood glucose (SMBG) reference every 5-30 min (n = 19, 2-6 years of age). Results: The overall mean absolute relative difference (ARD ± SD) between SG and reference values (YSI or SMBG) when calibrating approximately every 12 h, was 10.9% ± 10.7% (3102 paired points) for sensors communicating with the Guardian Connect system and 11.1% ± 10.6% (2624 paired points) for sensors connected to the GSR. The overall percentage of SG values within ±20% of reference values >80 mg/dL or within 20 mg/dL of reference values ≤80 mg/dL was 87.8% for the Guardian Connect system and 86.7% for the GSR, respectively. There was one device-related adverse event of contact dermatitis, but no serious device-related adverse events. Conclusions: The Guardian CGM system demonstrated good accuracy in children and adolescents. These findings support its use in sensor-integrated insulin pump platforms, as well as a standalone technology, for managing diabetes in pediatric populations.

AB - Background: This study evaluated the safety and performance of the Guardian™ continuous glucose monitoring (CGM) system in children and adolescents with type 1 diabetes (T1D). Materials and Methods: Subjects 2-18 years of age (mean ± standard deviation [SD] 13.1 ± 3.9 years) with T1D and duration of diagnosis ≥1 year were enrolled at 11 sites in the United States and wore two Guardian Sensor 3 sensors in the abdomen and/or buttock. Sensors were connected to a transmitter paired with either a Guardian Connect system (i.e., mobile device with software application allowing display of sensor glucose [SG] values) or a Guardian Link 3 transmitter used as a Glucose Sensor Recorder (GSR). There were 145 participants who underwent a 6-h in-clinic frequent sample testing (FST) on day 1 (n = 54), day 3 (n = 48), or day 7 (n = 43) postsensor insertion. During FST, SG values were compared with a Yellow Springs Instrument (YSI) plasma reference every 5-15 min (n = 124, 7-18 years of age; n = 2, 2-6 years of age), or to a self-monitoring of blood glucose (SMBG) reference every 5-30 min (n = 19, 2-6 years of age). Results: The overall mean absolute relative difference (ARD ± SD) between SG and reference values (YSI or SMBG) when calibrating approximately every 12 h, was 10.9% ± 10.7% (3102 paired points) for sensors communicating with the Guardian Connect system and 11.1% ± 10.6% (2624 paired points) for sensors connected to the GSR. The overall percentage of SG values within ±20% of reference values >80 mg/dL or within 20 mg/dL of reference values ≤80 mg/dL was 87.8% for the Guardian Connect system and 86.7% for the GSR, respectively. There was one device-related adverse event of contact dermatitis, but no serious device-related adverse events. Conclusions: The Guardian CGM system demonstrated good accuracy in children and adolescents. These findings support its use in sensor-integrated insulin pump platforms, as well as a standalone technology, for managing diabetes in pediatric populations.

KW - Continuous glucose monitoring

KW - MARD

KW - mobile device

KW - Pediatrics

KW - Sensor accuracy

KW - Sensorintegrated pump

UR - http://www.scopus.com/inward/record.url?scp=85052620154&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85052620154&partnerID=8YFLogxK

U2 - 10.1089/dia.2018.0109

DO - 10.1089/dia.2018.0109

M3 - Article

VL - 20

SP - 576

EP - 584

JO - Diabetes Technology and Therapeutics

T2 - Diabetes Technology and Therapeutics

JF - Diabetes Technology and Therapeutics

SN - 1520-9156

IS - 9

ER -