Yongwen Zhou, Benjamin J Wheeler, Alisa Boucsein, Sara E Styles, Bronte Chamberlain, Venus R Michaels, Hamish R Crockett, Anita Lala, Vicki Cunningham, Esko J Wiltshire, Anna S Serlachius, Craig Jefferies
{"title":"在1型糖尿病和HbA1c升高的儿童中使用Freestyle Libre 2.0: 12周随机对照试验后的延长期结果","authors":"Yongwen Zhou, Benjamin J Wheeler, Alisa Boucsein, Sara E Styles, Bronte Chamberlain, Venus R Michaels, Hamish R Crockett, Anita Lala, Vicki Cunningham, Esko J Wiltshire, Anna S Serlachius, Craig Jefferies","doi":"10.1111/dme.15494","DOIUrl":null,"url":null,"abstract":"<p><strong>Aim: </strong>To investigate extension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with type 1 diabetes mellitus (T1DM) and elevated HbA<sub>1c</sub> (7.5-12.2% [58-110 mmol/mol]).</p><p><strong>Methods: </strong>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. HbA<sub>1c</sub>, CGM metrics, psychological outcomes and device utilization attitudes were measured.</p><p><strong>Results: </strong>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, HbA<sub>1c</sub> and time in range (TIR) were non-significant at 24 weeks in both groups.</p><p><strong>Conclusions: </strong>Extension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with T1DM and elevated HbA<sub>1c</sub> showed a sustained reduction in hypoglycaemia and increased testing frequency at 24 weeks.</p>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":" ","pages":"e15494"},"PeriodicalIF":3.2000,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Use of Freestyle Libre 2.0 in children with type 1 diabetes mellitus and elevated HbA<sub>1c</sub>: Extension phase results after a 12-week randomized controlled trial.\",\"authors\":\"Yongwen Zhou, Benjamin J Wheeler, Alisa Boucsein, Sara E Styles, Bronte Chamberlain, Venus R Michaels, Hamish R Crockett, Anita Lala, Vicki Cunningham, Esko J Wiltshire, Anna S Serlachius, Craig Jefferies\",\"doi\":\"10.1111/dme.15494\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Aim: </strong>To investigate extension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with type 1 diabetes mellitus (T1DM) and elevated HbA<sub>1c</sub> (7.5-12.2% [58-110 mmol/mol]).</p><p><strong>Methods: </strong>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. HbA<sub>1c</sub>, CGM metrics, psychological outcomes and device utilization attitudes were measured.</p><p><strong>Results: </strong>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, HbA<sub>1c</sub> and time in range (TIR) were non-significant at 24 weeks in both groups.</p><p><strong>Conclusions: </strong>Extension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with T1DM and elevated HbA<sub>1c</sub> showed a sustained reduction in hypoglycaemia and increased testing frequency at 24 weeks.</p>\",\"PeriodicalId\":11251,\"journal\":{\"name\":\"Diabetic Medicine\",\"volume\":\" \",\"pages\":\"e15494\"},\"PeriodicalIF\":3.2000,\"publicationDate\":\"2024-12-10\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Diabetic Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/dme.15494\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diabetic Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/dme.15494","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
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.
Aim: 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]).
Methods: 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.
Results: 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.
Conclusions: 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.
期刊介绍：
Diabetic Medicine, the official journal of Diabetes UK, is published monthly simultaneously, in print and online editions.
The journal publishes a range of key information on all clinical aspects of diabetes mellitus, ranging from human genetic studies through clinical physiology and trials to diabetes epidemiology. We do not publish original animal or cell culture studies unless they are part of a study of clinical diabetes involving humans. Categories of publication include research articles, reviews, editorials, commentaries, and correspondence. All material is peer-reviewed.
We aim to disseminate knowledge about diabetes research with the goal of improving the management of people with diabetes. The journal therefore seeks to provide a forum for the exchange of ideas between clinicians and researchers worldwide. Topics covered are of importance to all healthcare professionals working with people with diabetes, whether in primary care or specialist services.
Surplus generated from the sale of Diabetic Medicine is used by Diabetes UK to know diabetes better and fight diabetes more effectively on behalf of all people affected by and at risk of diabetes as well as their families and carers.”
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