Accuracy of a Fourth-Generation Continuous Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes
This study evaluated the safety and performance of the Guardian™ continuous glucose monitoring (CGM) system in children and adolescents with type 1 diabetes (T1D). 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...
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| Veröffentlicht in: | Diabetes technology & therapeutics 2018-09, Vol.20 (9), p.576-584 |
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| creator | Slover, Robert H Tryggestad, Jeanie B DiMeglio, Linda A 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 |
| description | This study evaluated the safety and performance of the Guardian™ continuous glucose monitoring (CGM) system in children and adolescents with type 1 diabetes (T1D).
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).
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.
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. |
| doi_str_mv | 10.1089/dia.2018.0109 |
| format | Article |
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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).
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.
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.</description><identifier>ISSN: 1520-9156</identifier><identifier>EISSN: 1557-8593</identifier><identifier>DOI: 10.1089/dia.2018.0109</identifier><identifier>PMID: 30063162</identifier><language>eng</language><publisher>United States: Mary Ann Liebert, Inc</publisher><subject>Adolescent ; Age ; Blood Glucose - analysis ; Blood Glucose Self-Monitoring - instrumentation ; Child ; Child, Preschool ; Diabetes ; Diabetes Mellitus, Type 1 ; Female ; Glucose ; Glucose monitoring ; Humans ; Male ; Monitoring, Ambulatory - instrumentation ; Pediatrics ; Sensors ; Teenagers</subject><ispartof>Diabetes technology & therapeutics, 2018-09, Vol.20 (9), p.576-584</ispartof><rights>(©) Copyright 2018, Mary Ann Liebert, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c321t-c4fc67c36856c6084032ba290b8bb7561a9a31085292de23e2d0419fe069e9203</citedby><cites>FETCH-LOGICAL-c321t-c4fc67c36856c6084032ba290b8bb7561a9a31085292de23e2d0419fe069e9203</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30063162$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Slover, Robert H</creatorcontrib><creatorcontrib>Tryggestad, Jeanie B</creatorcontrib><creatorcontrib>DiMeglio, Linda A</creatorcontrib><creatorcontrib>Fox, Larry A</creatorcontrib><creatorcontrib>Bode, Bruce W</creatorcontrib><creatorcontrib>Bailey, Timothy S</creatorcontrib><creatorcontrib>Brazg, Ronald</creatorcontrib><creatorcontrib>Christiansen, Mark P</creatorcontrib><creatorcontrib>Sherr, Jennifer L</creatorcontrib><creatorcontrib>Tsalikian, Eva</creatorcontrib><creatorcontrib>Kaiserman, Kevin B</creatorcontrib><creatorcontrib>Sullivan, Ashley</creatorcontrib><creatorcontrib>Huang, Suiying</creatorcontrib><creatorcontrib>Shin, John</creatorcontrib><creatorcontrib>Lee, Scott W</creatorcontrib><creatorcontrib>Kaufman, Francine R</creatorcontrib><title>Accuracy of a Fourth-Generation Continuous Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes</title><title>Diabetes technology & therapeutics</title><addtitle>Diabetes Technol Ther</addtitle><description>This study evaluated the safety and performance of the Guardian™ continuous glucose monitoring (CGM) system in children and adolescents with type 1 diabetes (T1D).
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).
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.
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.</description><subject>Adolescent</subject><subject>Age</subject><subject>Blood Glucose - analysis</subject><subject>Blood Glucose Self-Monitoring - instrumentation</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Diabetes</subject><subject>Diabetes Mellitus, Type 1</subject><subject>Female</subject><subject>Glucose</subject><subject>Glucose monitoring</subject><subject>Humans</subject><subject>Male</subject><subject>Monitoring, Ambulatory - instrumentation</subject><subject>Pediatrics</subject><subject>Sensors</subject><subject>Teenagers</subject><issn>1520-9156</issn><issn>1557-8593</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkTFvFDEQRi1EREKgpEWWaGj2MrbPXrs8XcgRKREFoV55vbOcoz37sL2K7t_jVQJFqpni6dM38wj5xGDFQJurwdsVB6ZXwMC8IRdMyrbR0oi3y86hMUyqc_I-50cAaAVn78i5AFCCKX5B5o1zc7LuRONILb2Jcyr7ZocBky0-BrqNofgwxznT3TS7mJHex-BLTD78pj9PueCB-srt_TQkDNSGgW6GOGF2GEqmT77s6cPpiJTRa297LJg_kLPRThk_vsxL8uvm28P2e3P3Y3e73dw1rvYsjVuPTrVOKC2VU6DXIHhvuYFe930rFbPGivoFyQ0fkAvkA6yZGRGUQcNBXJKvz7nHFP_MmEt38LXWNNmA9aKOgwbNmW4X9Msr9LH-ItR2lTJcyTVIUanmmXIp5pxw7I7JH2w6dQy6xUdXfXSLj27xUfnPL6lzf8DhP_1PgPgLJKiE1w</recordid><startdate>201809</startdate><enddate>201809</enddate><creator>Slover, Robert H</creator><creator>Tryggestad, Jeanie B</creator><creator>DiMeglio, Linda A</creator><creator>Fox, Larry A</creator><creator>Bode, Bruce W</creator><creator>Bailey, Timothy S</creator><creator>Brazg, Ronald</creator><creator>Christiansen, Mark P</creator><creator>Sherr, Jennifer L</creator><creator>Tsalikian, Eva</creator><creator>Kaiserman, Kevin B</creator><creator>Sullivan, Ashley</creator><creator>Huang, Suiying</creator><creator>Shin, John</creator><creator>Lee, Scott W</creator><creator>Kaufman, Francine R</creator><general>Mary Ann Liebert, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>7X8</scope></search><sort><creationdate>201809</creationdate><title>Accuracy of a Fourth-Generation Continuous Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes</title><author>Slover, Robert H ; 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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).
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.
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.</abstract><cop>United States</cop><pub>Mary Ann Liebert, Inc</pub><pmid>30063162</pmid><doi>10.1089/dia.2018.0109</doi><tpages>9</tpages></addata></record> |
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| source | MEDLINE; Alma/SFX Local Collection |
| subjects | Adolescent Age Blood Glucose - analysis Blood Glucose Self-Monitoring - instrumentation Child Child, Preschool Diabetes Diabetes Mellitus, Type 1 Female Glucose Glucose monitoring Humans Male Monitoring, Ambulatory - instrumentation Pediatrics Sensors Teenagers |
| title | Accuracy of a Fourth-Generation Continuous Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes |
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