Use of Freestyle Libre 2.0 in children with type 1 diabetes mellitus and elevated HbA1c: Extension phase results after a 12-week randomized controlled trial
To investigate extension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with type 1 diabetes mellitus (T1DM) and elevated HbA1c (7.5-12.2% [58-110 mmol/mol]).AIMTo investigate extension phase outcomes with intermittently scanned continuous glucose mo...
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| creator | Zhou, Yongwen Wheeler, Benjamin J Boucsein, Alisa Styles, Sara E Chamberlain, Bronte Michaels, Venus R Crockett, Hamish R Lala, Anita Cunningham, Vicki Wiltshire, Esko J Serlachius, Anna S Jefferies, Craig |
| description | To investigate extension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with type 1 diabetes mellitus (T1DM) and elevated HbA1c (7.5-12.2% [58-110 mmol/mol]).AIMTo investigate extension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with type 1 diabetes mellitus (T1DM) and elevated HbA1c (7.5-12.2% [58-110 mmol/mol]).One hundred children with T1DM aged 4-13 years were initially in a 12-week randomised controlled trial (RCT) comparing glycaemic outcomes with isCGM 2.0 (intervention group, n = 49) with self-monitored blood glucose (Control group, n = 51). After the 12-week RCT both groups were offered an extension phase with isCGM 2.0 for another 12 weeks. HbA1c, CGM metrics, psychological outcomes and device utilization attitudes were measured.METHODSOne hundred children with T1DM aged 4-13 years were initially in a 12-week randomised controlled trial (RCT) comparing glycaemic outcomes with isCGM 2.0 (intervention group, n = 49) with self-monitored blood glucose (Control group, n = 51). After the 12-week RCT both groups were offered an extension phase with isCGM 2.0 for another 12 weeks. HbA1c, CGM metrics, psychological outcomes and device utilization attitudes were measured.After the initial 12-week RCT, 66 participants completed this 12-week extension: 36/49 (73%) and 30/51 (58.8%) from the isCGM/isCGM and Control/isCGM groups, respectively. In the isCGM/isCGM group, time below range 70 mg/dL (3.9 mmol/L) (TBR70) reduced from 10.7 ± 11.3% at baseline to 2.8 ± 2.8% and 2.1 ± 2.4% at 12 and 24 weeks, respectively (p |
| doi_str_mv | 10.1111/dme.15494 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest</sourceid><recordid>TN_cdi_proquest_miscellaneous_3146626810</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3146626810</sourcerecordid><originalsourceid>FETCH-LOGICAL-p153t-8fa10ffdb9b914e25ca916d72b130518f3f14970616599e71755832eff8194913</originalsourceid><addsrcrecordid>eNpNkD1PAzEMhiMEEqUw8A88slyJL_cVtqpqKVIlFjpXuTtHDeQ-SFJK-S38WCLBgBc_g19bfhi7RT7DWPdtRzPMM5mdsQlmRZZExvN_fMmuvH_lHFMp5IR9bz3BoGHliHw4WYKNqR1BOuNgemj2xraOejiasIdwGgkQWqNqCuShI2tNOHhQfQtk6UMFamFdz7F5gOVnoN6boYdxr-IRR_5gQ5zVgRwowDQ5Er2Bi-GhM18x2Qx9cIO1EYMzyl6zC62sp5u_PmXb1fJlsU42z49Pi_kmGTEXIam0Qq51W8taYkZp3iiJRVumNQqeY6WFxkyWvMAil5JKLPO8EilpXaGMSsSU3f3uHd3wfogedp3xTXxO9TQc_E5Ee0VaVMjFD5Kka2Y</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3146626810</pqid></control><display><type>article</type><title>Use of Freestyle Libre 2.0 in children with type 1 diabetes mellitus and elevated HbA1c: Extension phase results after a 12-week randomized controlled trial</title><source>Wiley Online Library Journals Frontfile Complete</source><creator>Zhou, Yongwen ; Wheeler, Benjamin J ; Boucsein, Alisa ; Styles, Sara E ; Chamberlain, Bronte ; Michaels, Venus R ; Crockett, Hamish R ; Lala, Anita ; Cunningham, Vicki ; Wiltshire, Esko J ; Serlachius, Anna S ; Jefferies, Craig</creator><creatorcontrib>Zhou, Yongwen ; Wheeler, Benjamin J ; Boucsein, Alisa ; Styles, Sara E ; Chamberlain, Bronte ; Michaels, Venus R ; Crockett, Hamish R ; Lala, Anita ; Cunningham, Vicki ; Wiltshire, Esko J ; Serlachius, Anna S ; Jefferies, Craig</creatorcontrib><description><![CDATA[To investigate extension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with type 1 diabetes mellitus (T1DM) and elevated HbA1c (7.5-12.2% [58-110 mmol/mol]).AIMTo investigate extension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with type 1 diabetes mellitus (T1DM) and elevated HbA1c (7.5-12.2% [58-110 mmol/mol]).One hundred children with T1DM aged 4-13 years were initially in a 12-week randomised controlled trial (RCT) comparing glycaemic outcomes with isCGM 2.0 (intervention group, n = 49) with self-monitored blood glucose (Control group, n = 51). After the 12-week RCT both groups were offered an extension phase with isCGM 2.0 for another 12 weeks. HbA1c, CGM metrics, psychological outcomes and device utilization attitudes were measured.METHODSOne hundred children with T1DM aged 4-13 years were initially in a 12-week randomised controlled trial (RCT) comparing glycaemic outcomes with isCGM 2.0 (intervention group, n = 49) with self-monitored blood glucose (Control group, n = 51). After the 12-week RCT both groups were offered an extension phase with isCGM 2.0 for another 12 weeks. HbA1c, CGM metrics, psychological outcomes and device utilization attitudes were measured.After the initial 12-week RCT, 66 participants completed this 12-week extension: 36/49 (73%) and 30/51 (58.8%) from the isCGM/isCGM and Control/isCGM groups, respectively. In the isCGM/isCGM group, time below range 70 mg/dL (3.9 mmol/L) (TBR70) reduced from 10.7 ± 11.3% at baseline to 2.8 ± 2.8% and 2.1 ± 2.4% at 12 and 24 weeks, respectively (p < 0.01 for both 12 and 24 weeks). Glucose test frequency increased from 4.7 (2.7) at baseline to 10.7 (4.6) and 9.2 (4.7) at 12 and 24 weeks, respectively (p < 0.01 for both 12 and 24 weeks). The Control/isCGM group decreased TBR70 from 10.7 ± 7.4% at 12 weeks to 2.9 ± 2.8% at 24 weeks and increased daily glucose test frequency from 3.2 (1.6) to 10.7 (5.4) from 12 to 24 weeks (both p < 0.01). However, HbA1c and time in range (TIR) were non-significant at 24 weeks in both groups.RESULTSAfter the initial 12-week RCT, 66 participants completed this 12-week extension: 36/49 (73%) and 30/51 (58.8%) from the isCGM/isCGM and Control/isCGM groups, respectively. In the isCGM/isCGM group, time below range 70 mg/dL (3.9 mmol/L) (TBR70) reduced from 10.7 ± 11.3% at baseline to 2.8 ± 2.8% and 2.1 ± 2.4% at 12 and 24 weeks, respectively (p < 0.01 for both 12 and 24 weeks). Glucose test frequency increased from 4.7 (2.7) at baseline to 10.7 (4.6) and 9.2 (4.7) at 12 and 24 weeks, respectively (p < 0.01 for both 12 and 24 weeks). The Control/isCGM group decreased TBR70 from 10.7 ± 7.4% at 12 weeks to 2.9 ± 2.8% at 24 weeks and increased daily glucose test frequency from 3.2 (1.6) to 10.7 (5.4) from 12 to 24 weeks (both p < 0.01). However, HbA1c and time in range (TIR) were non-significant at 24 weeks in both groups.Extension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with T1DM and elevated HbA1c showed a sustained reduction in hypoglycaemia and increased testing frequency at 24 weeks.CONCLUSIONSExtension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with T1DM and elevated HbA1c showed a sustained reduction in hypoglycaemia and increased testing frequency at 24 weeks.]]></description><identifier>ISSN: 1464-5491</identifier><identifier>EISSN: 1464-5491</identifier><identifier>DOI: 10.1111/dme.15494</identifier><language>eng</language><ispartof>Diabetic medicine, 2024-12, p.e15494</ispartof><rights>2024 The Author(s). Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids></links><search><creatorcontrib>Zhou, Yongwen</creatorcontrib><creatorcontrib>Wheeler, Benjamin J</creatorcontrib><creatorcontrib>Boucsein, Alisa</creatorcontrib><creatorcontrib>Styles, Sara E</creatorcontrib><creatorcontrib>Chamberlain, Bronte</creatorcontrib><creatorcontrib>Michaels, Venus R</creatorcontrib><creatorcontrib>Crockett, Hamish R</creatorcontrib><creatorcontrib>Lala, Anita</creatorcontrib><creatorcontrib>Cunningham, Vicki</creatorcontrib><creatorcontrib>Wiltshire, Esko J</creatorcontrib><creatorcontrib>Serlachius, Anna S</creatorcontrib><creatorcontrib>Jefferies, Craig</creatorcontrib><title>Use of Freestyle Libre 2.0 in children with type 1 diabetes mellitus and elevated HbA1c: Extension phase results after a 12-week randomized controlled trial</title><title>Diabetic medicine</title><description><![CDATA[To investigate extension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with type 1 diabetes mellitus (T1DM) and elevated HbA1c (7.5-12.2% [58-110 mmol/mol]).AIMTo investigate extension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with type 1 diabetes mellitus (T1DM) and elevated HbA1c (7.5-12.2% [58-110 mmol/mol]).One hundred children with T1DM aged 4-13 years were initially in a 12-week randomised controlled trial (RCT) comparing glycaemic outcomes with isCGM 2.0 (intervention group, n = 49) with self-monitored blood glucose (Control group, n = 51). After the 12-week RCT both groups were offered an extension phase with isCGM 2.0 for another 12 weeks. HbA1c, CGM metrics, psychological outcomes and device utilization attitudes were measured.METHODSOne hundred children with T1DM aged 4-13 years were initially in a 12-week randomised controlled trial (RCT) comparing glycaemic outcomes with isCGM 2.0 (intervention group, n = 49) with self-monitored blood glucose (Control group, n = 51). After the 12-week RCT both groups were offered an extension phase with isCGM 2.0 for another 12 weeks. HbA1c, CGM metrics, psychological outcomes and device utilization attitudes were measured.After the initial 12-week RCT, 66 participants completed this 12-week extension: 36/49 (73%) and 30/51 (58.8%) from the isCGM/isCGM and Control/isCGM groups, respectively. In the isCGM/isCGM group, time below range 70 mg/dL (3.9 mmol/L) (TBR70) reduced from 10.7 ± 11.3% at baseline to 2.8 ± 2.8% and 2.1 ± 2.4% at 12 and 24 weeks, respectively (p < 0.01 for both 12 and 24 weeks). Glucose test frequency increased from 4.7 (2.7) at baseline to 10.7 (4.6) and 9.2 (4.7) at 12 and 24 weeks, respectively (p < 0.01 for both 12 and 24 weeks). The Control/isCGM group decreased TBR70 from 10.7 ± 7.4% at 12 weeks to 2.9 ± 2.8% at 24 weeks and increased daily glucose test frequency from 3.2 (1.6) to 10.7 (5.4) from 12 to 24 weeks (both p < 0.01). However, HbA1c and time in range (TIR) were non-significant at 24 weeks in both groups.RESULTSAfter the initial 12-week RCT, 66 participants completed this 12-week extension: 36/49 (73%) and 30/51 (58.8%) from the isCGM/isCGM and Control/isCGM groups, respectively. In the isCGM/isCGM group, time below range 70 mg/dL (3.9 mmol/L) (TBR70) reduced from 10.7 ± 11.3% at baseline to 2.8 ± 2.8% and 2.1 ± 2.4% at 12 and 24 weeks, respectively (p < 0.01 for both 12 and 24 weeks). Glucose test frequency increased from 4.7 (2.7) at baseline to 10.7 (4.6) and 9.2 (4.7) at 12 and 24 weeks, respectively (p < 0.01 for both 12 and 24 weeks). The Control/isCGM group decreased TBR70 from 10.7 ± 7.4% at 12 weeks to 2.9 ± 2.8% at 24 weeks and increased daily glucose test frequency from 3.2 (1.6) to 10.7 (5.4) from 12 to 24 weeks (both p < 0.01). However, HbA1c and time in range (TIR) were non-significant at 24 weeks in both groups.Extension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with T1DM and elevated HbA1c showed a sustained reduction in hypoglycaemia and increased testing frequency at 24 weeks.CONCLUSIONSExtension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with T1DM and elevated HbA1c showed a sustained reduction in hypoglycaemia and increased testing frequency at 24 weeks.]]></description><issn>1464-5491</issn><issn>1464-5491</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNpNkD1PAzEMhiMEEqUw8A88slyJL_cVtqpqKVIlFjpXuTtHDeQ-SFJK-S38WCLBgBc_g19bfhi7RT7DWPdtRzPMM5mdsQlmRZZExvN_fMmuvH_lHFMp5IR9bz3BoGHliHw4WYKNqR1BOuNgemj2xraOejiasIdwGgkQWqNqCuShI2tNOHhQfQtk6UMFamFdz7F5gOVnoN6boYdxr-IRR_5gQ5zVgRwowDQ5Er2Bi-GhM18x2Qx9cIO1EYMzyl6zC62sp5u_PmXb1fJlsU42z49Pi_kmGTEXIam0Qq51W8taYkZp3iiJRVumNQqeY6WFxkyWvMAil5JKLPO8EilpXaGMSsSU3f3uHd3wfogedp3xTXxO9TQc_E5Ee0VaVMjFD5Kka2Y</recordid><startdate>20241210</startdate><enddate>20241210</enddate><creator>Zhou, Yongwen</creator><creator>Wheeler, Benjamin J</creator><creator>Boucsein, Alisa</creator><creator>Styles, Sara E</creator><creator>Chamberlain, Bronte</creator><creator>Michaels, Venus R</creator><creator>Crockett, Hamish R</creator><creator>Lala, Anita</creator><creator>Cunningham, Vicki</creator><creator>Wiltshire, Esko J</creator><creator>Serlachius, Anna S</creator><creator>Jefferies, Craig</creator><scope>7X8</scope></search><sort><creationdate>20241210</creationdate><title>Use of Freestyle Libre 2.0 in children with type 1 diabetes mellitus and elevated HbA1c: Extension phase results after a 12-week randomized controlled trial</title><author>Zhou, Yongwen ; Wheeler, Benjamin J ; Boucsein, Alisa ; Styles, Sara E ; Chamberlain, Bronte ; Michaels, Venus R ; Crockett, Hamish R ; Lala, Anita ; Cunningham, Vicki ; Wiltshire, Esko J ; Serlachius, Anna S ; Jefferies, Craig</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p153t-8fa10ffdb9b914e25ca916d72b130518f3f14970616599e71755832eff8194913</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zhou, Yongwen</creatorcontrib><creatorcontrib>Wheeler, Benjamin J</creatorcontrib><creatorcontrib>Boucsein, Alisa</creatorcontrib><creatorcontrib>Styles, Sara E</creatorcontrib><creatorcontrib>Chamberlain, Bronte</creatorcontrib><creatorcontrib>Michaels, Venus R</creatorcontrib><creatorcontrib>Crockett, Hamish R</creatorcontrib><creatorcontrib>Lala, Anita</creatorcontrib><creatorcontrib>Cunningham, Vicki</creatorcontrib><creatorcontrib>Wiltshire, Esko J</creatorcontrib><creatorcontrib>Serlachius, Anna S</creatorcontrib><creatorcontrib>Jefferies, Craig</creatorcontrib><collection>MEDLINE - Academic</collection><jtitle>Diabetic medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zhou, Yongwen</au><au>Wheeler, Benjamin J</au><au>Boucsein, Alisa</au><au>Styles, Sara E</au><au>Chamberlain, Bronte</au><au>Michaels, Venus R</au><au>Crockett, Hamish R</au><au>Lala, Anita</au><au>Cunningham, Vicki</au><au>Wiltshire, Esko J</au><au>Serlachius, Anna S</au><au>Jefferies, Craig</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Use of Freestyle Libre 2.0 in children with type 1 diabetes mellitus and elevated HbA1c: Extension phase results after a 12-week randomized controlled trial</atitle><jtitle>Diabetic medicine</jtitle><date>2024-12-10</date><risdate>2024</risdate><spage>e15494</spage><pages>e15494-</pages><issn>1464-5491</issn><eissn>1464-5491</eissn><abstract><![CDATA[To investigate extension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with type 1 diabetes mellitus (T1DM) and elevated HbA1c (7.5-12.2% [58-110 mmol/mol]).AIMTo investigate extension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with type 1 diabetes mellitus (T1DM) and elevated HbA1c (7.5-12.2% [58-110 mmol/mol]).One hundred children with T1DM aged 4-13 years were initially in a 12-week randomised controlled trial (RCT) comparing glycaemic outcomes with isCGM 2.0 (intervention group, n = 49) with self-monitored blood glucose (Control group, n = 51). After the 12-week RCT both groups were offered an extension phase with isCGM 2.0 for another 12 weeks. HbA1c, CGM metrics, psychological outcomes and device utilization attitudes were measured.METHODSOne hundred children with T1DM aged 4-13 years were initially in a 12-week randomised controlled trial (RCT) comparing glycaemic outcomes with isCGM 2.0 (intervention group, n = 49) with self-monitored blood glucose (Control group, n = 51). After the 12-week RCT both groups were offered an extension phase with isCGM 2.0 for another 12 weeks. HbA1c, CGM metrics, psychological outcomes and device utilization attitudes were measured.After the initial 12-week RCT, 66 participants completed this 12-week extension: 36/49 (73%) and 30/51 (58.8%) from the isCGM/isCGM and Control/isCGM groups, respectively. In the isCGM/isCGM group, time below range 70 mg/dL (3.9 mmol/L) (TBR70) reduced from 10.7 ± 11.3% at baseline to 2.8 ± 2.8% and 2.1 ± 2.4% at 12 and 24 weeks, respectively (p < 0.01 for both 12 and 24 weeks). Glucose test frequency increased from 4.7 (2.7) at baseline to 10.7 (4.6) and 9.2 (4.7) at 12 and 24 weeks, respectively (p < 0.01 for both 12 and 24 weeks). The Control/isCGM group decreased TBR70 from 10.7 ± 7.4% at 12 weeks to 2.9 ± 2.8% at 24 weeks and increased daily glucose test frequency from 3.2 (1.6) to 10.7 (5.4) from 12 to 24 weeks (both p < 0.01). However, HbA1c and time in range (TIR) were non-significant at 24 weeks in both groups.RESULTSAfter the initial 12-week RCT, 66 participants completed this 12-week extension: 36/49 (73%) and 30/51 (58.8%) from the isCGM/isCGM and Control/isCGM groups, respectively. In the isCGM/isCGM group, time below range 70 mg/dL (3.9 mmol/L) (TBR70) reduced from 10.7 ± 11.3% at baseline to 2.8 ± 2.8% and 2.1 ± 2.4% at 12 and 24 weeks, respectively (p < 0.01 for both 12 and 24 weeks). Glucose test frequency increased from 4.7 (2.7) at baseline to 10.7 (4.6) and 9.2 (4.7) at 12 and 24 weeks, respectively (p < 0.01 for both 12 and 24 weeks). The Control/isCGM group decreased TBR70 from 10.7 ± 7.4% at 12 weeks to 2.9 ± 2.8% at 24 weeks and increased daily glucose test frequency from 3.2 (1.6) to 10.7 (5.4) from 12 to 24 weeks (both p < 0.01). However, HbA1c and time in range (TIR) were non-significant at 24 weeks in both groups.Extension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with T1DM and elevated HbA1c showed a sustained reduction in hypoglycaemia and increased testing frequency at 24 weeks.CONCLUSIONSExtension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with T1DM and elevated HbA1c showed a sustained reduction in hypoglycaemia and increased testing frequency at 24 weeks.]]></abstract><doi>10.1111/dme.15494</doi><oa>free_for_read</oa></addata></record> |
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| title | Use of Freestyle Libre 2.0 in children with type 1 diabetes mellitus and elevated HbA1c: Extension phase results after a 12-week randomized controlled trial |
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