Bolus Insulin Dose Error Distributions Based on Results From Two Clinical Trials Comparing Blood Glucose Monitoring Systems

Background: In 2 previous clinical trials, fingertip capillary blood samples were evaluated using prespecified blood glucose monitoring systems (BGMSs) and a reference YSI glucose analyzer. In post hoc analyses, hypothetical insulin doses were calculated using these blood glucose measurements; dosin...

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Veröffentlicht in:Journal of diabetes science and technology 2017-09, Vol.11 (5), p.970-974
Hauptverfasser: Pardo, Scott, Dunne, Nancy, Simmons, David A.
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Simmons, David A.
description Background: In 2 previous clinical trials, fingertip capillary blood samples were evaluated using prespecified blood glucose monitoring systems (BGMSs) and a reference YSI glucose analyzer. In post hoc analyses, hypothetical insulin doses were calculated using these blood glucose measurements; dosing errors were compared for each trial. Method: For each blood glucose measurement, premeal bolus insulin dosing was determined for a hypothetical person, assuming a 60-g carbohydrate meal and 100-mg/dL target blood glucose level (adjusting 1/25 insulin sensitivity and 1/15 insulin:carbohydrate ratio inputs to account for BGMS measurement error). Dosing error was the difference between doses calculated using the BGMS and YSI results. Results: In Clinical Trial 1, 95% dose error ranges (in units of insulin) were: CONTOUR®NEXT EZ BGMS (EZ), –0.9 to 0.5; Accu-Chek® Aviva BGMS (ACA), –0.5 to 1.8; FreeStyle Freedom Lite® BGMS (FFL), –3.2 to −0.3; OneTouch® Ultra®2 BGMS (OTU2), –4.1 to 0.3; and Truetrack® BGMS (TT), –3.9 to 2.2. In Clinical Trial 2, these ranges were: CONTOUR®NEXT BGMS (CN), –0.7 to 1.7; Accu-Chek® Aviva Nano BGMS (ACAN), –1.3 to 1.8; FreeStyle Lite® BGMS (FSL), –5.1 to 0.2; OTU2, –1.9 to 1.2; OneTouch® Verio® Pro BGMS (OTVP), –1.0 to 1.9; and TT, –5.1 to 1.7. Within each trial, EZ and CN had statistically significantly smaller insulin dose error ranges than other BGMSs (P
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In post hoc analyses, hypothetical insulin doses were calculated using these blood glucose measurements; dosing errors were compared for each trial. Method: For each blood glucose measurement, premeal bolus insulin dosing was determined for a hypothetical person, assuming a 60-g carbohydrate meal and 100-mg/dL target blood glucose level (adjusting 1/25 insulin sensitivity and 1/15 insulin:carbohydrate ratio inputs to account for BGMS measurement error). Dosing error was the difference between doses calculated using the BGMS and YSI results. Results: In Clinical Trial 1, 95% dose error ranges (in units of insulin) were: CONTOUR®NEXT EZ BGMS (EZ), –0.9 to 0.5; Accu-Chek® Aviva BGMS (ACA), –0.5 to 1.8; FreeStyle Freedom Lite® BGMS (FFL), –3.2 to −0.3; OneTouch® Ultra®2 BGMS (OTU2), –4.1 to 0.3; and Truetrack® BGMS (TT), –3.9 to 2.2. In Clinical Trial 2, these ranges were: CONTOUR®NEXT BGMS (CN), –0.7 to 1.7; Accu-Chek® Aviva Nano BGMS (ACAN), –1.3 to 1.8; FreeStyle Lite® BGMS (FSL), –5.1 to 0.2; OTU2, –1.9 to 1.2; OneTouch® Verio® Pro BGMS (OTVP), –1.0 to 1.9; and TT, –5.1 to 1.7. Within each trial, EZ and CN had statistically significantly smaller insulin dose error ranges than other BGMSs (P &lt;0.0001). Conclusions: The ranges of insulin dose errors were statistically significantly smaller with EZ and CN than with all other BGMSs in this post hoc analysis. Differences in BGMS accuracy could result in clinically important differences in insulin dosing.</description><identifier>ISSN: 1932-2968</identifier><identifier>EISSN: 1932-2968</identifier><identifier>EISSN: 1932-3107</identifier><identifier>DOI: 10.1177/1932296817713025</identifier><identifier>PMID: 28604064</identifier><language>eng</language><publisher>Los Angeles, CA: SAGE Publications</publisher><subject>Blood Glucose Self-Monitoring - adverse effects ; Blood Glucose Self-Monitoring - methods ; Clinical Trials as Topic ; Diabetes Mellitus, Type 1 - blood ; Diabetes Mellitus, Type 2 - blood ; Humans ; Hypoglycemic Agents - administration &amp; dosage ; Insulin - administration &amp; dosage ; Medication Errors - statistics &amp; numerical data ; Original</subject><ispartof>Journal of diabetes science and technology, 2017-09, Vol.11 (5), p.970-974</ispartof><rights>2017 Diabetes Technology Society</rights><rights>2017 Diabetes Technology Society 2017 Diabetes Technology Society</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3495-bb12416acc407ab25f7963eb440014baebb84e0621a19bd976ca58acb85942163</citedby><cites>FETCH-LOGICAL-c3495-bb12416acc407ab25f7963eb440014baebb84e0621a19bd976ca58acb85942163</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5950998/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5950998/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,727,780,784,885,21819,27924,27925,43621,43622,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28604064$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pardo, Scott</creatorcontrib><creatorcontrib>Dunne, Nancy</creatorcontrib><creatorcontrib>Simmons, David A.</creatorcontrib><title>Bolus Insulin Dose Error Distributions Based on Results From Two Clinical Trials Comparing Blood Glucose Monitoring Systems</title><title>Journal of diabetes science and technology</title><addtitle>J Diabetes Sci Technol</addtitle><description>Background: In 2 previous clinical trials, fingertip capillary blood samples were evaluated using prespecified blood glucose monitoring systems (BGMSs) and a reference YSI glucose analyzer. In post hoc analyses, hypothetical insulin doses were calculated using these blood glucose measurements; dosing errors were compared for each trial. Method: For each blood glucose measurement, premeal bolus insulin dosing was determined for a hypothetical person, assuming a 60-g carbohydrate meal and 100-mg/dL target blood glucose level (adjusting 1/25 insulin sensitivity and 1/15 insulin:carbohydrate ratio inputs to account for BGMS measurement error). Dosing error was the difference between doses calculated using the BGMS and YSI results. Results: In Clinical Trial 1, 95% dose error ranges (in units of insulin) were: CONTOUR®NEXT EZ BGMS (EZ), –0.9 to 0.5; Accu-Chek® Aviva BGMS (ACA), –0.5 to 1.8; FreeStyle Freedom Lite® BGMS (FFL), –3.2 to −0.3; OneTouch® Ultra®2 BGMS (OTU2), –4.1 to 0.3; and Truetrack® BGMS (TT), –3.9 to 2.2. In Clinical Trial 2, these ranges were: CONTOUR®NEXT BGMS (CN), –0.7 to 1.7; Accu-Chek® Aviva Nano BGMS (ACAN), –1.3 to 1.8; FreeStyle Lite® BGMS (FSL), –5.1 to 0.2; OTU2, –1.9 to 1.2; OneTouch® Verio® Pro BGMS (OTVP), –1.0 to 1.9; and TT, –5.1 to 1.7. Within each trial, EZ and CN had statistically significantly smaller insulin dose error ranges than other BGMSs (P &lt;0.0001). Conclusions: The ranges of insulin dose errors were statistically significantly smaller with EZ and CN than with all other BGMSs in this post hoc analysis. 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In post hoc analyses, hypothetical insulin doses were calculated using these blood glucose measurements; dosing errors were compared for each trial. Method: For each blood glucose measurement, premeal bolus insulin dosing was determined for a hypothetical person, assuming a 60-g carbohydrate meal and 100-mg/dL target blood glucose level (adjusting 1/25 insulin sensitivity and 1/15 insulin:carbohydrate ratio inputs to account for BGMS measurement error). Dosing error was the difference between doses calculated using the BGMS and YSI results. Results: In Clinical Trial 1, 95% dose error ranges (in units of insulin) were: CONTOUR®NEXT EZ BGMS (EZ), –0.9 to 0.5; Accu-Chek® Aviva BGMS (ACA), –0.5 to 1.8; FreeStyle Freedom Lite® BGMS (FFL), –3.2 to −0.3; OneTouch® Ultra®2 BGMS (OTU2), –4.1 to 0.3; and Truetrack® BGMS (TT), –3.9 to 2.2. In Clinical Trial 2, these ranges were: CONTOUR®NEXT BGMS (CN), –0.7 to 1.7; Accu-Chek® Aviva Nano BGMS (ACAN), –1.3 to 1.8; FreeStyle Lite® BGMS (FSL), –5.1 to 0.2; OTU2, –1.9 to 1.2; OneTouch® Verio® Pro BGMS (OTVP), –1.0 to 1.9; and TT, –5.1 to 1.7. Within each trial, EZ and CN had statistically significantly smaller insulin dose error ranges than other BGMSs (P &lt;0.0001). Conclusions: The ranges of insulin dose errors were statistically significantly smaller with EZ and CN than with all other BGMSs in this post hoc analysis. Differences in BGMS accuracy could result in clinically important differences in insulin dosing.</abstract><cop>Los Angeles, CA</cop><pub>SAGE Publications</pub><pmid>28604064</pmid><doi>10.1177/1932296817713025</doi><tpages>5</tpages><oa>free_for_read</oa></addata></record>
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subjects Blood Glucose Self-Monitoring - adverse effects
Blood Glucose Self-Monitoring - methods
Clinical Trials as Topic
Diabetes Mellitus, Type 1 - blood
Diabetes Mellitus, Type 2 - blood
Humans
Hypoglycemic Agents - administration & dosage
Insulin - administration & dosage
Medication Errors - statistics & numerical data
Original
title Bolus Insulin Dose Error Distributions Based on Results From Two Clinical Trials Comparing Blood Glucose Monitoring Systems
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