| Title: | Consistent efficacy and safety of automated insulin delivery in children aged 2–6 years : results from the LENNY trial continuation phase |
|---|
| Authors: | ID Dovč, Klemen (Author)
ID Tuomaala, Anna-Kaisa (Author)
ID Kuusela, Salla (Author)
ID Shetty, Ambika (Author)
ID Rabbone, Ivana (Author)
ID Tiberi, V. (Author)
ID Campbell, Fiona (Author)
ID Peters, Catherine (Author), et al. |
|---|
| Files: |  PDF - Presentation file, download (785,96 KB)
MD5: E4C88D6188600E7037B8D004879452E2
 URL - Source URL, visit https://www.diabetesresearchclinicalpractice.com/article/S0168-8227(25)00948-9/fulltext
|
|---|
| Language: | English |
|---|
| Typology: | 1.01 - Original Scientific Article |
|---|
| Organization: |  UKC LJ - Ljubljana University Medical Centre
|
|---|
| 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. |
|---|
| Keywords: | type 1 diabetes, automated insulin delivery, young children, time-in-range, HbA1c |
|---|
| Publication status: | Published |
|---|
| Publication version: | Version of Record |
|---|
| Year of publishing: | 2025 |
|---|
| Number of pages: | str. 1-8 |
|---|
| Numbering: | Vol. 230, [article no.] 112934 |
|---|
| PID: | 20.500.12556/DiRROS-27780  |
|---|
| UDC: | 616.379 |
|---|
| ISSN on article: | 1872-8227 |
|---|
| DOI: | 10.1016/j.diabres.2025.112934 |
|---|
| COBISS.SI-ID: | 254607107 |
|---|
| Note: | Nasl. z nasl. zaslona;
Opis vira z dne 24. 10. 2025;
|
|---|
| Publication date in DiRROS: | 24.02.2026 |
|---|
| Views: | 38 |
|---|
| Downloads: | 19 |
|---|
| Metadata: |    |
|---|
|
:
|
Copy citation |
|---|
| | | | Share: |  |
|---|
Hover the mouse pointer over a document title to show the abstract or click
on the title to get all document metadata. |
