Sandrine Lablanche, Johanna Delagenière, Manon Jalbert, Emmanuel Sonnet, Muriel Benichou, Nathalie Arnold, Anne Spiteri, Jean-Philippe Le Berre, Eric Renard, Nicolas Chevalier, Sophie Borot, Elisabeth Bonnemaison, Christine Coffin, Marie-Pierre Teissier, Pierre Yves Benhamou, Jean-Christian Borel, Alfred Penfornis, Michael Joubert, Laurence Kessler
{"title":"Minimed 780G 高级闭环系统对 1 型糖尿病患者 12 个月的实际疗效:一项法国观察性、回顾性、多中心研究。","authors":"Sandrine Lablanche, Johanna Delagenière, Manon Jalbert, Emmanuel Sonnet, Muriel Benichou, Nathalie Arnold, Anne Spiteri, Jean-Philippe Le Berre, Eric Renard, Nicolas Chevalier, Sophie Borot, Elisabeth Bonnemaison, Christine Coffin, Marie-Pierre Teissier, Pierre Yves Benhamou, Jean-Christian Borel, Alfred Penfornis, Michael Joubert, Laurence Kessler","doi":"10.1089/dia.2023.0414","DOIUrl":null,"url":null,"abstract":"<p><p><b><i>Aim:</i></b> To evaluate the evolution of glycemic outcomes in patients living with type 1 diabetes (T1D) after 1 year of use of the MiniMed 780G advanced hybrid closed-loop (AHCL) system. <b><i>Methods:</i></b> We conducted an observational, retrospective, multicentric study in 20 centers in France. The primary objective was to evaluate the improvement in glycemic control after 1-year use of AHCL. The primary endpoint was the variation of time in range (TIR) between pre-AHCL and after 1-year use of AHCL. Secondary objectives were to analyze the glycemic outcomes after 3, 6, and 12 months of AHCL use, the safety, and the long-term observance of AHCL. <b><i>Results:</i></b> Two hundred twenty patients were included, and 200 were analyzed for the primary endpoint. 92.7% of patients continued to use AHCL. After 1 year of use of AHCL, TIR was 72.5% ± 10.6% (+9.1%; 95% confidence interval [CI] [7.6-10.5] compared to pre-AHCL initiation, <i>P</i> < 0.001), HbA1c 7.1% ± 0.7% (-0.5%; 95% CI [-0.6 to -0.4]; <i>P</i> < 0.001), time below range 2.0% [1.0; 3.0] (0.0% [-2.0; 0.0], <i>P</i> < 0.001), and time above range 24.8% ± 10.9% (-7.3%; 95% CI [-8.8 to -5.7]; <i>P</i> < 0.001). More patients achieved the glycemic treatment goals of HbA1c <7.0% (45.1% vs. 18.1%, <i>P</i> < 0.001) and TIR >70% (59.0% vs. 29.5% <i>P</i> < 0.001) when compared with pre-AHCL. Five patients experienced severe hypoglycemia events and two patients experienced ketoacidosis. <b><i>Conclusion:</i></b> After 1 year of use of AHCL, people living with T1D safely improved their glucose control and a higher proportion of them achieved optimal glycemic control.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"426-432"},"PeriodicalIF":5.7000,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"12-Month Real-Life Efficacy of the MiniMed 780G Advanced Closed-Loop System in Patients Living with Type 1 Diabetes: A French Observational, Retrospective, Multicentric Study.\",\"authors\":\"Sandrine Lablanche, Johanna Delagenière, Manon Jalbert, Emmanuel Sonnet, Muriel Benichou, Nathalie Arnold, Anne Spiteri, Jean-Philippe Le Berre, Eric Renard, Nicolas Chevalier, Sophie Borot, Elisabeth Bonnemaison, Christine Coffin, Marie-Pierre Teissier, Pierre Yves Benhamou, Jean-Christian Borel, Alfred Penfornis, Michael Joubert, Laurence Kessler\",\"doi\":\"10.1089/dia.2023.0414\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b><i>Aim:</i></b> To evaluate the evolution of glycemic outcomes in patients living with type 1 diabetes (T1D) after 1 year of use of the MiniMed 780G advanced hybrid closed-loop (AHCL) system. <b><i>Methods:</i></b> We conducted an observational, retrospective, multicentric study in 20 centers in France. The primary objective was to evaluate the improvement in glycemic control after 1-year use of AHCL. The primary endpoint was the variation of time in range (TIR) between pre-AHCL and after 1-year use of AHCL. Secondary objectives were to analyze the glycemic outcomes after 3, 6, and 12 months of AHCL use, the safety, and the long-term observance of AHCL. <b><i>Results:</i></b> Two hundred twenty patients were included, and 200 were analyzed for the primary endpoint. 92.7% of patients continued to use AHCL. After 1 year of use of AHCL, TIR was 72.5% ± 10.6% (+9.1%; 95% confidence interval [CI] [7.6-10.5] compared to pre-AHCL initiation, <i>P</i> < 0.001), HbA1c 7.1% ± 0.7% (-0.5%; 95% CI [-0.6 to -0.4]; <i>P</i> < 0.001), time below range 2.0% [1.0; 3.0] (0.0% [-2.0; 0.0], <i>P</i> < 0.001), and time above range 24.8% ± 10.9% (-7.3%; 95% CI [-8.8 to -5.7]; <i>P</i> < 0.001). More patients achieved the glycemic treatment goals of HbA1c <7.0% (45.1% vs. 18.1%, <i>P</i> < 0.001) and TIR >70% (59.0% vs. 29.5% <i>P</i> < 0.001) when compared with pre-AHCL. Five patients experienced severe hypoglycemia events and two patients experienced ketoacidosis. <b><i>Conclusion:</i></b> After 1 year of use of AHCL, people living with T1D safely improved their glucose control and a higher proportion of them achieved optimal glycemic control.</p>\",\"PeriodicalId\":11159,\"journal\":{\"name\":\"Diabetes technology & therapeutics\",\"volume\":\" \",\"pages\":\"426-432\"},\"PeriodicalIF\":5.7000,\"publicationDate\":\"2024-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Diabetes technology & therapeutics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1089/dia.2023.0414\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/2/7 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diabetes technology & therapeutics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1089/dia.2023.0414","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/2/7 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
12-Month Real-Life Efficacy of the MiniMed 780G Advanced Closed-Loop System in Patients Living with Type 1 Diabetes: A French Observational, Retrospective, Multicentric Study.
Aim: To evaluate the evolution of glycemic outcomes in patients living with type 1 diabetes (T1D) after 1 year of use of the MiniMed 780G advanced hybrid closed-loop (AHCL) system. Methods: We conducted an observational, retrospective, multicentric study in 20 centers in France. The primary objective was to evaluate the improvement in glycemic control after 1-year use of AHCL. The primary endpoint was the variation of time in range (TIR) between pre-AHCL and after 1-year use of AHCL. Secondary objectives were to analyze the glycemic outcomes after 3, 6, and 12 months of AHCL use, the safety, and the long-term observance of AHCL. Results: Two hundred twenty patients were included, and 200 were analyzed for the primary endpoint. 92.7% of patients continued to use AHCL. After 1 year of use of AHCL, TIR was 72.5% ± 10.6% (+9.1%; 95% confidence interval [CI] [7.6-10.5] compared to pre-AHCL initiation, P < 0.001), HbA1c 7.1% ± 0.7% (-0.5%; 95% CI [-0.6 to -0.4]; P < 0.001), time below range 2.0% [1.0; 3.0] (0.0% [-2.0; 0.0], P < 0.001), and time above range 24.8% ± 10.9% (-7.3%; 95% CI [-8.8 to -5.7]; P < 0.001). More patients achieved the glycemic treatment goals of HbA1c <7.0% (45.1% vs. 18.1%, P < 0.001) and TIR >70% (59.0% vs. 29.5% P < 0.001) when compared with pre-AHCL. Five patients experienced severe hypoglycemia events and two patients experienced ketoacidosis. Conclusion: After 1 year of use of AHCL, people living with T1D safely improved their glucose control and a higher proportion of them achieved optimal glycemic control.
期刊介绍:
Diabetes Technology & Therapeutics is the only peer-reviewed journal providing healthcare professionals with information on new devices, drugs, drug delivery systems, and software for managing patients with diabetes. This leading international journal delivers practical information and comprehensive coverage of cutting-edge technologies and therapeutics in the field, and each issue highlights new pharmacological and device developments to optimize patient care.