Salima Azahaf, Kaat Beunen, Nancy Van Wilder, Dominique Ballaux, Gerd Vanhaverbeke, Youri Taes, Xavier-Philippe Aers, Frank Nobels, Liesbeth Van Huffel, Joke Marlier, Dahae Lee, Joke Cuypers, Vanessa Preumont, Sarah E Siegelaar, Rebecca C Painter, Annouschka Laenen, Pieter Gillard, Chantal Mathieu, Jeroen Luyten, Katrien Benhalima
{"title":"与标准胰岛素治疗相比，晚期混合闭环治疗妊娠期1型糖尿病的成本效益：CRISTAL试验的经济评估","authors":"Salima Azahaf, Kaat Beunen, Nancy Van Wilder, Dominique Ballaux, Gerd Vanhaverbeke, Youri Taes, Xavier-Philippe Aers, Frank Nobels, Liesbeth Van Huffel, Joke Marlier, Dahae Lee, Joke Cuypers, Vanessa Preumont, Sarah E Siegelaar, Rebecca C Painter, Annouschka Laenen, Pieter Gillard, Chantal Mathieu, Jeroen Luyten, Katrien Benhalima","doi":"10.1016/j.eclinm.2025.103106","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>A multicentre, randomised controlled trial (the CRISTAL trial), demonstrated the safety and efficacy of MiniMed™ 780G advanced hybrid closed loop (AHCL) therapy during pregnancy, showing improved glycaemic control overnight, less hypoglycaemia, and improved treatment satisfaction compared to standard insulin therapy (SoC, mainly open-loop insulin pump therapy). This study aimed to assess the cost-effectiveness of AHCL, which has a higher initial cost, compared to SoC in pregnant women with type 1 diabetes (T1D).</p><p><strong>Methods: </strong>A decision tree model was developed to estimate the cost-effectiveness of AHCL compared to SoC in pregnant women with T1D, covering pregnancy to birth and postpartum hospital discharge (a time horizon of 28 weeks). Total costs per strategy (in 2024 euros, €) were calculated from a healthcare payer perspective. The base-case analysis derived prevalence of pregnancy complications and hospitalisations directly related to diabetes management from the CRISTAL trial. Uncertainty was analysed by exploring multiple scenarios and sensitivity analyses.</p><p><strong>Findings: </strong>In the base-case analysis, the cost of using AHCL during pregnancy was estimated at €13,988.75 (95% CI: €12,240 to €16,062) compared to €14,221.33 (95% CI: €12,380 to €16,420) for SoC, indicating cost-savings of €232.57 per individual, alongside the demonstrated clinical benefits of AHCL. The primary cost driver was the AHCL device cost. This cost was offset by savings from shorter and less frequent hospital admissions (mainly due to severe hypoglycaemia and dysregulated diabetes) in the AHCL group compared to SoC. In our probabilistic sensitivity analysis, AHCL was dominant in 73% of the simulated cost-effectiveness pairs.</p><p><strong>Interpretation: </strong>AHCL might be cost-saving compared to SoC for pregnant women with T1D. However, more robust data are needed to assess the potential impact of AHCL therapy on pregnancy and long-term health outcomes.</p><p><strong>Funding: </strong>Diabetes Liga Research Fund and Medtronic.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103106"},"PeriodicalIF":9.6000,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11874532/pdf/","citationCount":"0","resultStr":"{\"title\":\"Cost-effectiveness of advanced hybrid closed loop therapy compared to standard insulin therapy for type 1 diabetes in pregnancy: an economic evaluation of the CRISTAL trial.\",\"authors\":\"Salima Azahaf, Kaat Beunen, Nancy Van Wilder, Dominique Ballaux, Gerd Vanhaverbeke, Youri Taes, Xavier-Philippe Aers, Frank Nobels, Liesbeth Van Huffel, Joke Marlier, Dahae Lee, Joke Cuypers, Vanessa Preumont, Sarah E Siegelaar, Rebecca C Painter, Annouschka Laenen, Pieter Gillard, Chantal Mathieu, Jeroen Luyten, Katrien Benhalima\",\"doi\":\"10.1016/j.eclinm.2025.103106\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>A multicentre, randomised controlled trial (the CRISTAL trial), demonstrated the safety and efficacy of MiniMed™ 780G advanced hybrid closed loop (AHCL) therapy during pregnancy, showing improved glycaemic control overnight, less hypoglycaemia, and improved treatment satisfaction compared to standard insulin therapy (SoC, mainly open-loop insulin pump therapy). This study aimed to assess the cost-effectiveness of AHCL, which has a higher initial cost, compared to SoC in pregnant women with type 1 diabetes (T1D).</p><p><strong>Methods: </strong>A decision tree model was developed to estimate the cost-effectiveness of AHCL compared to SoC in pregnant women with T1D, covering pregnancy to birth and postpartum hospital discharge (a time horizon of 28 weeks). Total costs per strategy (in 2024 euros, €) were calculated from a healthcare payer perspective. The base-case analysis derived prevalence of pregnancy complications and hospitalisations directly related to diabetes management from the CRISTAL trial. Uncertainty was analysed by exploring multiple scenarios and sensitivity analyses.</p><p><strong>Findings: </strong>In the base-case analysis, the cost of using AHCL during pregnancy was estimated at €13,988.75 (95% CI: €12,240 to €16,062) compared to €14,221.33 (95% CI: €12,380 to €16,420) for SoC, indicating cost-savings of €232.57 per individual, alongside the demonstrated clinical benefits of AHCL. The primary cost driver was the AHCL device cost. This cost was offset by savings from shorter and less frequent hospital admissions (mainly due to severe hypoglycaemia and dysregulated diabetes) in the AHCL group compared to SoC. In our probabilistic sensitivity analysis, AHCL was dominant in 73% of the simulated cost-effectiveness pairs.</p><p><strong>Interpretation: </strong>AHCL might be cost-saving compared to SoC for pregnant women with T1D. However, more robust data are needed to assess the potential impact of AHCL therapy on pregnancy and long-term health outcomes.</p><p><strong>Funding: </strong>Diabetes Liga Research Fund and Medtronic.</p>\",\"PeriodicalId\":11393,\"journal\":{\"name\":\"EClinicalMedicine\",\"volume\":\"81 \",\"pages\":\"103106\"},\"PeriodicalIF\":9.6000,\"publicationDate\":\"2025-02-14\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11874532/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"EClinicalMedicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.eclinm.2025.103106\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/3/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"EClinicalMedicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.eclinm.2025.103106","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/3/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Cost-effectiveness of advanced hybrid closed loop therapy compared to standard insulin therapy for type 1 diabetes in pregnancy: an economic evaluation of the CRISTAL trial.
Background: A multicentre, randomised controlled trial (the CRISTAL trial), demonstrated the safety and efficacy of MiniMed™ 780G advanced hybrid closed loop (AHCL) therapy during pregnancy, showing improved glycaemic control overnight, less hypoglycaemia, and improved treatment satisfaction compared to standard insulin therapy (SoC, mainly open-loop insulin pump therapy). This study aimed to assess the cost-effectiveness of AHCL, which has a higher initial cost, compared to SoC in pregnant women with type 1 diabetes (T1D).
Methods: A decision tree model was developed to estimate the cost-effectiveness of AHCL compared to SoC in pregnant women with T1D, covering pregnancy to birth and postpartum hospital discharge (a time horizon of 28 weeks). Total costs per strategy (in 2024 euros, €) were calculated from a healthcare payer perspective. The base-case analysis derived prevalence of pregnancy complications and hospitalisations directly related to diabetes management from the CRISTAL trial. Uncertainty was analysed by exploring multiple scenarios and sensitivity analyses.
Findings: In the base-case analysis, the cost of using AHCL during pregnancy was estimated at €13,988.75 (95% CI: €12,240 to €16,062) compared to €14,221.33 (95% CI: €12,380 to €16,420) for SoC, indicating cost-savings of €232.57 per individual, alongside the demonstrated clinical benefits of AHCL. The primary cost driver was the AHCL device cost. This cost was offset by savings from shorter and less frequent hospital admissions (mainly due to severe hypoglycaemia and dysregulated diabetes) in the AHCL group compared to SoC. In our probabilistic sensitivity analysis, AHCL was dominant in 73% of the simulated cost-effectiveness pairs.
Interpretation: AHCL might be cost-saving compared to SoC for pregnant women with T1D. However, more robust data are needed to assess the potential impact of AHCL therapy on pregnancy and long-term health outcomes.
Funding: Diabetes Liga Research Fund and Medtronic.
期刊介绍：
eClinicalMedicine is a gold open-access clinical journal designed to support frontline health professionals in addressing the complex and rapid health transitions affecting societies globally. The journal aims to assist practitioners in overcoming healthcare challenges across diverse communities, spanning diagnosis, treatment, prevention, and health promotion. Integrating disciplines from various specialties and life stages, it seeks to enhance health systems as fundamental institutions within societies. With a forward-thinking approach, eClinicalMedicine aims to redefine the future of healthcare.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
