K Dovc, Ak Tuomaala, S Kuusela, A Shetty, I Rabbone, V Tiberi, F Campbell, C Peters, R Ahomäki, A Zanfardino, P Sundaram, R Schiaffini, R Re, B Jullian, F di Piazza, T van den Heuvel, J Castaneda, O Cohen
{"title":"2-6岁儿童自动胰岛素输送的一致性有效性和安全性：来自LENNY试验延续阶段的结果","authors":"K Dovc, Ak Tuomaala, S Kuusela, A Shetty, I Rabbone, V Tiberi, F Campbell, C Peters, R Ahomäki, A Zanfardino, P Sundaram, R Schiaffini, R Re, B Jullian, F di Piazza, T van den Heuvel, J Castaneda, O Cohen","doi":"10.1016/j.diabres.2025.112934","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>The LENNY randomized trial (NCT05574062) demonstrated that the MiniMed 780G system with Guardian™ 4 sensor (MM780G/G4S) is safe and effective for young children with type 1 diabetes (CwT1D). The continuation phase objective was to evaluate MM780G when used for extended time and when used with the Simplera Sync™ sensor (MM780G/SY).</p><p><strong>Methods: </strong>CwT1D who completed the initial study phase underwent a 12-24-week period using MM780G/G4S (in Auto Mode), after which they were randomly allocated to either continue using the same set-up or switch to MM780G/SY (in Auto Mode) for 12 weeks. The primary endpoint was the between-arm difference in mean HbA1c after the 12-week period (non-inferiority).</p><p><strong>Results: </strong>91 CwT1D were enrolled in the continuation phase. After the initial 12-24-week period, mean ± SD HbA1c was 7.16 ± 0.59 %. After the 12-week treatment period, mean ± SD HbA1c was 7.24 ± 0.64 % for MM780G/G4S and 7.30 ± 0.53 % for MM780G/SY (estimated treatment effect = 0.14 %, 95 % CI - 0.03 to 0.31 %). Over the 12 weeks, mean ± SD time-in-range (TIR) was 68.9 ± 8.6 % for MM780G/G4S and 69.7 ± 7.7 % for MM780G/SY. Non-inferiority was confirmed for HbA1c and TIR.</p><p><strong>Conclusion: </strong>In CwT1D aged 2-6 years and TDD ≥ 6, the safety and good glycemic control from MM780G were sustained for ≥ 1 year and MM780G/SY was non-inferior to MM780/G4S.</p>","PeriodicalId":11249,"journal":{"name":"Diabetes research and clinical practice","volume":" ","pages":"112934"},"PeriodicalIF":7.4000,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Consistent efficacy and safety of automated insulin delivery in children aged 2-6 Years: results from the LENNY trial continuation phase.\",\"authors\":\"K Dovc, Ak Tuomaala, S Kuusela, A Shetty, I Rabbone, V Tiberi, F Campbell, C Peters, R Ahomäki, A Zanfardino, P Sundaram, R Schiaffini, R Re, B Jullian, F di Piazza, T van den Heuvel, J Castaneda, O Cohen\",\"doi\":\"10.1016/j.diabres.2025.112934\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>The LENNY randomized trial (NCT05574062) demonstrated that the MiniMed 780G system with Guardian™ 4 sensor (MM780G/G4S) is safe and effective for young children with type 1 diabetes (CwT1D). The continuation phase objective was to evaluate MM780G when used for extended time and when used with the Simplera Sync™ sensor (MM780G/SY).</p><p><strong>Methods: </strong>CwT1D who completed the initial study phase underwent a 12-24-week period using MM780G/G4S (in Auto Mode), after which they were randomly allocated to either continue using the same set-up or switch to MM780G/SY (in Auto Mode) for 12 weeks. The primary endpoint was the between-arm difference in mean HbA1c after the 12-week period (non-inferiority).</p><p><strong>Results: </strong>91 CwT1D were enrolled in the continuation phase. After the initial 12-24-week period, mean ± SD HbA1c was 7.16 ± 0.59 %. After the 12-week treatment period, mean ± SD HbA1c was 7.24 ± 0.64 % for MM780G/G4S and 7.30 ± 0.53 % for MM780G/SY (estimated treatment effect = 0.14 %, 95 % CI - 0.03 to 0.31 %). Over the 12 weeks, mean ± SD time-in-range (TIR) was 68.9 ± 8.6 % for MM780G/G4S and 69.7 ± 7.7 % for MM780G/SY. Non-inferiority was confirmed for HbA1c and TIR.</p><p><strong>Conclusion: </strong>In CwT1D aged 2-6 years and TDD ≥ 6, the safety and good glycemic control from MM780G were sustained for ≥ 1 year and MM780G/SY was non-inferior to MM780/G4S.</p>\",\"PeriodicalId\":11249,\"journal\":{\"name\":\"Diabetes research and clinical practice\",\"volume\":\" \",\"pages\":\"112934\"},\"PeriodicalIF\":7.4000,\"publicationDate\":\"2025-10-09\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Diabetes research and clinical practice\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.diabres.2025.112934\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diabetes research and clinical practice","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.diabres.2025.112934","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
Consistent efficacy and safety of automated insulin delivery in children aged 2-6 Years: results from the LENNY trial continuation phase.
Objective: The LENNY randomized trial (NCT05574062) demonstrated that the MiniMed 780G system with Guardian™ 4 sensor (MM780G/G4S) is safe and effective for young children with type 1 diabetes (CwT1D). The continuation phase objective was to evaluate MM780G when used for extended time and when used with the Simplera Sync™ sensor (MM780G/SY).
Methods: CwT1D who completed the initial study phase underwent a 12-24-week period using MM780G/G4S (in Auto Mode), after which they were randomly allocated to either continue using the same set-up or switch to MM780G/SY (in Auto Mode) for 12 weeks. The primary endpoint was the between-arm difference in mean HbA1c after the 12-week period (non-inferiority).
Results: 91 CwT1D were enrolled in the continuation phase. After the initial 12-24-week period, mean ± SD HbA1c was 7.16 ± 0.59 %. After the 12-week treatment period, mean ± SD HbA1c was 7.24 ± 0.64 % for MM780G/G4S and 7.30 ± 0.53 % for MM780G/SY (estimated treatment effect = 0.14 %, 95 % CI - 0.03 to 0.31 %). Over the 12 weeks, mean ± SD time-in-range (TIR) was 68.9 ± 8.6 % for MM780G/G4S and 69.7 ± 7.7 % for MM780G/SY. Non-inferiority was confirmed for HbA1c and TIR.
Conclusion: In CwT1D aged 2-6 years and TDD ≥ 6, the safety and good glycemic control from MM780G were sustained for ≥ 1 year and MM780G/SY was non-inferior to MM780/G4S.
期刊介绍：
Diabetes Research and Clinical Practice is an international journal for health-care providers and clinically oriented researchers that publishes high-quality original research articles and expert reviews in diabetes and related areas. The role of the journal is to provide a venue for dissemination of knowledge and discussion of topics related to diabetes clinical research and patient care. Topics of focus include translational science, genetics, immunology, nutrition, psychosocial research, epidemiology, prevention, socio-economic research, complications, new treatments, technologies and therapy.
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