Consistent efficacy and safety of automated insulin delivery in children aged 2-6 Years: results from the LENNY trial continuation phase.

IF 7.4 3区医学 Q1 ENDOCRINOLOGY & METABOLISM

Diabetes research and clinical practice Pub Date : 2025-10-09 DOI:10.1016/j.diabres.2025.112934

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

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引用次数: 0

Abstract

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.

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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

目的：LENNY随机试验（NCT05574062）表明，配备Guardian™4传感器的MiniMed 780G系统（MM780G/G4S）对幼儿1型糖尿病（CwT1D）是安全有效的。继续阶段的目标是评估MM780G在延长使用时间和与Simplera Sync™传感器（MM780G/SY）一起使用时的情况。方法：完成初始研究阶段的CwT1D使用MM780G/G4S（自动模式）进行了12-24周的研究，之后他们被随机分配继续使用相同的设置或切换到MM780G/SY（自动模式）12 周。主要终点是12周后平均HbA1c的组间差异（非劣效性）。结果：91例CwT1D患者进入延续期。初始12-24周后，平均 ± SD HbA1c为7.16 ± 0.59 %。12周的治疗期后,意味着 ± SD糖化血红蛋白是7.24 ±0.64  % MM780G / G4S和7.30±0.53  % MM780G / SY(估计治疗效果 = 0.14  %,95 % CI  0.03到0.31 %)。 12周,意味着 ± SD time-in-range (行动)是68.9±8.6  % MM780G / G4S和69.7±7.7  % MM780G / SY。证实HbA1c和TIR无劣效性。结论：在2-6岁 岁、TDD ≥ 6的CwT1D患者中，MM780G的安全性和良好的血糖控制持续 ≥ 年，MM780G/SY不逊于MM780/G4S。

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来源期刊

Diabetes research and clinical practice 医学-内分泌学与代谢

CiteScore

10.30

自引率

3.90%

发文量

862

审稿时长

32 days

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.