Julie C. Søholm, Sidse K. Nørgaard, Kirsten Nørgaard, Tine D. Clausen, Peter Damm, Elisabeth R. Mathiesen, Lene Ringholm
{"title":"随机使用速效胰岛素阿斯巴特或阿斯巴特胰岛素的 1 型糖尿病孕妇的传感器血糖指标--CopenFast 试验的二次分析。","authors":"Julie C. Søholm, Sidse K. Nørgaard, Kirsten Nørgaard, Tine D. Clausen, Peter Damm, Elisabeth R. Mathiesen, Lene Ringholm","doi":"10.1111/dme.15467","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Aims</h3>\n \n <p>We compared sensor-derived glycaemic metrics in pregnant women with type 1 diabetes (T1D) randomised to faster acting insulin aspart (faster aspart) or insulin aspart (IAsp).</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>A pre-planned secondary analysis of the CopenFast trial included women with T1D using intermittently scanned continuous glucose monitoring (isCGM) during pregnancy. Glycaemic metrics, including time in range (TIRp, 3.5–7.8 mmol/L) and time below range in pregnancy (TBRp, <3.5 mmol/L), were evaluated in the intervals: from randomisation (median 9.5 weeks, interquartile range 9.0–11.0) to 21 weeks, from 22 to 33 weeks and from 34 to 37 weeks.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>In total, 113 (91%) of 124 women using isCGM in the original trial were included. At randomisation, glycaemic metrics were comparable in both groups. Women randomised to faster aspart achieved higher TIRp from 22 to 33 weeks (estimated treatment difference 5.1% [95% confidence interval 0.3; 9.7], <i>p</i> = 0.04) and mean TIRp >70% from randomisation to 21 weeks onwards, while this was achieved after 34 weeks in women randomised to IAsp. TBRp remained stable around 4% throughout pregnancy in both groups. One (2%) versus 5 (9%) experienced ≥1 severe hypoglycaemic event (odds ratio 0.93 [−0.2; −0.01], <i>p</i> = 0.04). Infant birthweight standard deviation score was lower in the faster aspart group (estimated treatment difference −0.5 [−0.9; −0.03], <i>p</i> = 0.04); however, this attenuated when adjusting for parity (<i>p</i> = 0.10).</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>Women using faster aspart achieved more TIRp and experienced less severe hypoglycaemia compared to women using IAsp. Infant birthweight was lower and thereby more appropriate in the faster aspart group; however, this attenuated when adjusting for parity.</p>\n </section>\n </div>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":"42 1","pages":""},"PeriodicalIF":3.2000,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11635549/pdf/","citationCount":"0","resultStr":"{\"title\":\"Sensor-derived glycaemic metrics in pregnant women with type 1 diabetes randomised to faster acting insulin aspart or insulin aspart—A secondary analysis of the CopenFast trial\",\"authors\":\"Julie C. Søholm, Sidse K. Nørgaard, Kirsten Nørgaard, Tine D. Clausen, Peter Damm, Elisabeth R. Mathiesen, Lene Ringholm\",\"doi\":\"10.1111/dme.15467\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Aims</h3>\\n \\n <p>We compared sensor-derived glycaemic metrics in pregnant women with type 1 diabetes (T1D) randomised to faster acting insulin aspart (faster aspart) or insulin aspart (IAsp).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>A pre-planned secondary analysis of the CopenFast trial included women with T1D using intermittently scanned continuous glucose monitoring (isCGM) during pregnancy. Glycaemic metrics, including time in range (TIRp, 3.5–7.8 mmol/L) and time below range in pregnancy (TBRp, <3.5 mmol/L), were evaluated in the intervals: from randomisation (median 9.5 weeks, interquartile range 9.0–11.0) to 21 weeks, from 22 to 33 weeks and from 34 to 37 weeks.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>In total, 113 (91%) of 124 women using isCGM in the original trial were included. At randomisation, glycaemic metrics were comparable in both groups. Women randomised to faster aspart achieved higher TIRp from 22 to 33 weeks (estimated treatment difference 5.1% [95% confidence interval 0.3; 9.7], <i>p</i> = 0.04) and mean TIRp >70% from randomisation to 21 weeks onwards, while this was achieved after 34 weeks in women randomised to IAsp. TBRp remained stable around 4% throughout pregnancy in both groups. One (2%) versus 5 (9%) experienced ≥1 severe hypoglycaemic event (odds ratio 0.93 [−0.2; −0.01], <i>p</i> = 0.04). Infant birthweight standard deviation score was lower in the faster aspart group (estimated treatment difference −0.5 [−0.9; −0.03], <i>p</i> = 0.04); however, this attenuated when adjusting for parity (<i>p</i> = 0.10).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>Women using faster aspart achieved more TIRp and experienced less severe hypoglycaemia compared to women using IAsp. 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Sensor-derived glycaemic metrics in pregnant women with type 1 diabetes randomised to faster acting insulin aspart or insulin aspart—A secondary analysis of the CopenFast trial
Aims
We compared sensor-derived glycaemic metrics in pregnant women with type 1 diabetes (T1D) randomised to faster acting insulin aspart (faster aspart) or insulin aspart (IAsp).
Methods
A pre-planned secondary analysis of the CopenFast trial included women with T1D using intermittently scanned continuous glucose monitoring (isCGM) during pregnancy. Glycaemic metrics, including time in range (TIRp, 3.5–7.8 mmol/L) and time below range in pregnancy (TBRp, <3.5 mmol/L), were evaluated in the intervals: from randomisation (median 9.5 weeks, interquartile range 9.0–11.0) to 21 weeks, from 22 to 33 weeks and from 34 to 37 weeks.
Results
In total, 113 (91%) of 124 women using isCGM in the original trial were included. At randomisation, glycaemic metrics were comparable in both groups. Women randomised to faster aspart achieved higher TIRp from 22 to 33 weeks (estimated treatment difference 5.1% [95% confidence interval 0.3; 9.7], p = 0.04) and mean TIRp >70% from randomisation to 21 weeks onwards, while this was achieved after 34 weeks in women randomised to IAsp. TBRp remained stable around 4% throughout pregnancy in both groups. One (2%) versus 5 (9%) experienced ≥1 severe hypoglycaemic event (odds ratio 0.93 [−0.2; −0.01], p = 0.04). Infant birthweight standard deviation score was lower in the faster aspart group (estimated treatment difference −0.5 [−0.9; −0.03], p = 0.04); however, this attenuated when adjusting for parity (p = 0.10).
Conclusions
Women using faster aspart achieved more TIRp and experienced less severe hypoglycaemia compared to women using IAsp. Infant birthweight was lower and thereby more appropriate in the faster aspart group; however, this attenuated when adjusting for parity.
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.”