Accuracy of a portable glucose meter and of a Continuous Glucose Monitoring device used at home by patients with type 1 diabetes
Patients with diabetes are recommended to self-monitor their blood glucose levels also at home. Accuracy of a hand-held glucometer and a Continuous Glucose Monitoring (CGM) device were comparatively evaluated. Venous blood samples (for reference laboratory determinations; n=428) were collected from...
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| Veröffentlicht in: | Clinica chimica acta 2012-01, Vol.413 (1-2), p.312-318 |
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| creator | Francescato, M.P. Geat, M. Stel, G. Cauci, S. |
| description | Patients with diabetes are recommended to self-monitor their blood glucose levels also at home. Accuracy of a hand-held glucometer and a Continuous Glucose Monitoring (CGM) device were comparatively evaluated.
Venous blood samples (for reference laboratory determinations; n=428) were collected from 18 type 1 patients (35–65years old), immediately followed by capillary measurement (Bayer ContourLink meter) and CGM readings (Medtronic Paradigm).
Laboratory values did not differ statistically from ContourLink and CGM readings, mean difference (±SD) being −0.05±1.06mmol/L and 0.10±1.84mmol/L glucose, respectively. A bias ((value−reference)/reference×100) ≥15% was observed in 27.7% and 54.9% of cases, respectively. Notably, below 3.9mmol/L glucose (hypoglycemic threshold), an absolute error>0.8mmol/L was found in 78.9% and 94.1% of cases. The absolute errors of the CGM device were inversely related to the rate of glucose change (r=0.598, p0.8mM in 78.9% and 94.1% of cases. ► The errors of the CGM device were inversely related to the rate of glucose change. ► Future portable meters performance should be focused on the extreme glucose levels. |
| doi_str_mv | 10.1016/j.cca.2011.10.012 |
| format | Article |
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Venous blood samples (for reference laboratory determinations; n=428) were collected from 18 type 1 patients (35–65years old), immediately followed by capillary measurement (Bayer ContourLink meter) and CGM readings (Medtronic Paradigm).
Laboratory values did not differ statistically from ContourLink and CGM readings, mean difference (±SD) being −0.05±1.06mmol/L and 0.10±1.84mmol/L glucose, respectively. A bias ((value−reference)/reference×100) ≥15% was observed in 27.7% and 54.9% of cases, respectively. Notably, below 3.9mmol/L glucose (hypoglycemic threshold), an absolute error>0.8mmol/L was found in 78.9% and 94.1% of cases. The absolute errors of the CGM device were inversely related to the rate of glucose change (r=0.598, p<0.001).
A very large error was observed at the extreme glycemic values, which may lead to erroneous therapy. Consequently, performance of future portable glucometers should be focused in particular under hypo- and hyper-glycemia. Moreover, integrated CGM devices should not disregard the effect of the rate of blood glucose change on the sensor readings.
► Accuracy of a hand-held glucometer and a continuous monitoring device was evaluated. ► Overall, laboratory values did not differ from glucometer and CGM readings. ► Below the hypoglycemic threshold the error was >0.8mM in 78.9% and 94.1% of cases. ► The errors of the CGM device were inversely related to the rate of glucose change. ► Future portable meters performance should be focused on the extreme glucose levels.</description><identifier>ISSN: 0009-8981</identifier><identifier>EISSN: 1873-3492</identifier><identifier>DOI: 10.1016/j.cca.2011.10.012</identifier><identifier>PMID: 22032826</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Adult ; Aged ; Blood Glucose - analysis ; Continuous Glucose Monitoring system (CGMS) ; Diabetes ; Diabetes Mellitus, Type 1 - blood ; Error grid analysis ; Glycemia ; Humans ; Middle Aged ; Point-of-Care ; Self-monitoring blood glucose (SMBG)</subject><ispartof>Clinica chimica acta, 2012-01, Vol.413 (1-2), p.312-318</ispartof><rights>2011 Elsevier B.V.</rights><rights>Copyright © 2011 Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c352t-f086d0789240de35225a4fbcabedb2ff8e15d29be8980ce7f0162f06790767e33</citedby><cites>FETCH-LOGICAL-c352t-f086d0789240de35225a4fbcabedb2ff8e15d29be8980ce7f0162f06790767e33</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.cca.2011.10.012$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,777,781,3537,27905,27906,45976</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22032826$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Francescato, M.P.</creatorcontrib><creatorcontrib>Geat, M.</creatorcontrib><creatorcontrib>Stel, G.</creatorcontrib><creatorcontrib>Cauci, S.</creatorcontrib><title>Accuracy of a portable glucose meter and of a Continuous Glucose Monitoring device used at home by patients with type 1 diabetes</title><title>Clinica chimica acta</title><addtitle>Clin Chim Acta</addtitle><description>Patients with diabetes are recommended to self-monitor their blood glucose levels also at home. Accuracy of a hand-held glucometer and a Continuous Glucose Monitoring (CGM) device were comparatively evaluated.
Venous blood samples (for reference laboratory determinations; n=428) were collected from 18 type 1 patients (35–65years old), immediately followed by capillary measurement (Bayer ContourLink meter) and CGM readings (Medtronic Paradigm).
Laboratory values did not differ statistically from ContourLink and CGM readings, mean difference (±SD) being −0.05±1.06mmol/L and 0.10±1.84mmol/L glucose, respectively. A bias ((value−reference)/reference×100) ≥15% was observed in 27.7% and 54.9% of cases, respectively. Notably, below 3.9mmol/L glucose (hypoglycemic threshold), an absolute error>0.8mmol/L was found in 78.9% and 94.1% of cases. The absolute errors of the CGM device were inversely related to the rate of glucose change (r=0.598, p<0.001).
A very large error was observed at the extreme glycemic values, which may lead to erroneous therapy. Consequently, performance of future portable glucometers should be focused in particular under hypo- and hyper-glycemia. Moreover, integrated CGM devices should not disregard the effect of the rate of blood glucose change on the sensor readings.
► Accuracy of a hand-held glucometer and a continuous monitoring device was evaluated. ► Overall, laboratory values did not differ from glucometer and CGM readings. ► Below the hypoglycemic threshold the error was >0.8mM in 78.9% and 94.1% of cases. ► The errors of the CGM device were inversely related to the rate of glucose change. ► Future portable meters performance should be focused on the extreme glucose levels.</description><subject>Adult</subject><subject>Aged</subject><subject>Blood Glucose - analysis</subject><subject>Continuous Glucose Monitoring system (CGMS)</subject><subject>Diabetes</subject><subject>Diabetes Mellitus, Type 1 - blood</subject><subject>Error grid analysis</subject><subject>Glycemia</subject><subject>Humans</subject><subject>Middle Aged</subject><subject>Point-of-Care</subject><subject>Self-monitoring blood glucose (SMBG)</subject><issn>0009-8981</issn><issn>1873-3492</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kD1v2zAQhomiReOm_QFdits6yTlSsj6QKTDSNECKLu1MUOQxoSGJCkkl8NafXhp2MmYi7vjcC7wPY185rjny-mK31lqtBXKe5zVy8Y6teNuURVl14j1bIWJXtF3Lz9inGHd5rLDmH9mZEFiKVtQr9u9K6yUovQdvQcHsQ1L9QHA_LNpHgpESBVCTOf5v_ZTctPglws2J-OUnl3xw0z0YenKaYIlkQCV48CNBv4dZJUdTivDs0gOk_UzAwTjV5-z4mX2waoj05fSes78_rv9sfxZ3v29ut1d3hS43IhUW29pg03aiQkN5JTaqsr3OIaYX1rbEN0Z0PeW6qKmx2Y-wWDcdNnVDZXnOvh9z5-AfF4pJji5qGgY1Ua4jO2ybijflgeRHUgcfYyAr5-BGFfaSozx4lzuZvcuD98Mqe883307pSz-Seb14EZ2ByyNAueOToyCjzlI0GRdIJ2m8eyP-P0QAk9M</recordid><startdate>20120118</startdate><enddate>20120118</enddate><creator>Francescato, M.P.</creator><creator>Geat, M.</creator><creator>Stel, G.</creator><creator>Cauci, S.</creator><general>Elsevier B.V</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>7X8</scope></search><sort><creationdate>20120118</creationdate><title>Accuracy of a portable glucose meter and of a Continuous Glucose Monitoring device used at home by patients with type 1 diabetes</title><author>Francescato, M.P. ; Geat, M. ; Stel, G. ; Cauci, S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c352t-f086d0789240de35225a4fbcabedb2ff8e15d29be8980ce7f0162f06790767e33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Blood Glucose - analysis</topic><topic>Continuous Glucose Monitoring system (CGMS)</topic><topic>Diabetes</topic><topic>Diabetes Mellitus, Type 1 - blood</topic><topic>Error grid analysis</topic><topic>Glycemia</topic><topic>Humans</topic><topic>Middle Aged</topic><topic>Point-of-Care</topic><topic>Self-monitoring blood glucose (SMBG)</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Francescato, M.P.</creatorcontrib><creatorcontrib>Geat, M.</creatorcontrib><creatorcontrib>Stel, G.</creatorcontrib><creatorcontrib>Cauci, S.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Clinica chimica acta</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Francescato, M.P.</au><au>Geat, M.</au><au>Stel, G.</au><au>Cauci, S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Accuracy of a portable glucose meter and of a Continuous Glucose Monitoring device used at home by patients with type 1 diabetes</atitle><jtitle>Clinica chimica acta</jtitle><addtitle>Clin Chim Acta</addtitle><date>2012-01-18</date><risdate>2012</risdate><volume>413</volume><issue>1-2</issue><spage>312</spage><epage>318</epage><pages>312-318</pages><issn>0009-8981</issn><eissn>1873-3492</eissn><abstract>Patients with diabetes are recommended to self-monitor their blood glucose levels also at home. Accuracy of a hand-held glucometer and a Continuous Glucose Monitoring (CGM) device were comparatively evaluated.
Venous blood samples (for reference laboratory determinations; n=428) were collected from 18 type 1 patients (35–65years old), immediately followed by capillary measurement (Bayer ContourLink meter) and CGM readings (Medtronic Paradigm).
Laboratory values did not differ statistically from ContourLink and CGM readings, mean difference (±SD) being −0.05±1.06mmol/L and 0.10±1.84mmol/L glucose, respectively. A bias ((value−reference)/reference×100) ≥15% was observed in 27.7% and 54.9% of cases, respectively. Notably, below 3.9mmol/L glucose (hypoglycemic threshold), an absolute error>0.8mmol/L was found in 78.9% and 94.1% of cases. The absolute errors of the CGM device were inversely related to the rate of glucose change (r=0.598, p<0.001).
A very large error was observed at the extreme glycemic values, which may lead to erroneous therapy. Consequently, performance of future portable glucometers should be focused in particular under hypo- and hyper-glycemia. Moreover, integrated CGM devices should not disregard the effect of the rate of blood glucose change on the sensor readings.
► Accuracy of a hand-held glucometer and a continuous monitoring device was evaluated. ► Overall, laboratory values did not differ from glucometer and CGM readings. ► Below the hypoglycemic threshold the error was >0.8mM in 78.9% and 94.1% of cases. ► The errors of the CGM device were inversely related to the rate of glucose change. ► Future portable meters performance should be focused on the extreme glucose levels.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>22032826</pmid><doi>10.1016/j.cca.2011.10.012</doi><tpages>7</tpages></addata></record> |
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| subjects | Adult Aged Blood Glucose - analysis Continuous Glucose Monitoring system (CGMS) Diabetes Diabetes Mellitus, Type 1 - blood Error grid analysis Glycemia Humans Middle Aged Point-of-Care Self-monitoring blood glucose (SMBG) |
| title | Accuracy of a portable glucose meter and of a Continuous Glucose Monitoring device used at home by patients with type 1 diabetes |
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