Automated insulin delivery in free-life shows better glucose control when used 24/7 vs evening and night in pre-pubertal children with type 1 diabetes: The Free-life Kid AP Study - Université de Montpellier
Communication Dans Un Congrès Année : 2020

Automated insulin delivery in free-life shows better glucose control when used 24/7 vs evening and night in pre-pubertal children with type 1 diabetes: The Free-life Kid AP Study

Résumé

Background and aims: Control of type 1 diabetes (T1D) is a daily challenge in children because of highly variable insulin needs. We assessed the safety and efficacy of automated insulin delivery (AID) in free-life in pre-pubertal T1D children while used 24/7 vs. evening & night (EN). Materials and methods: One hundred and twenty-two pre-pubertal T1D children treated by insulin pumps (CSII) were enrolled in a multicenter prospective open label randomized control trial comparing glucose control with 24/7 or EN use of the hybrid Tandem t:slim X2 with Control-IQ AID system for 18 weeks. After a 3-week run-in phase for Tandem X2 pump and Dexcom G6 CGM training, AID was activated 24/7 or EN according to randomization. Primary outcome is %time spent in 70-180 mg/dl target range (%TIR); secondary outcomes include average CGM, %time below and above target range (%TBR and %TAR, respectively), and the same metrics during day-time and overnight. Results: Patient characteristics at inclusion were: 49F/73M, age: 8.6±1.6, T1D duration: 5.2±2.3 years, CSII use: 4.6±2.5 years, HbA1c: 7.7±0.7% (61±5.3 mmol/mol). Except for 3 early drop-outs, 119 completed the trial. AID was effective for 93.6 and 50.9% of time on 24/7 and EN modes, respectively. The increase of %TIR was significantly larger on 24/7 vs. EN mode: 52.9±9.5 to 67.5±5.6 (+14.5%, CI: 12.4-16.7%) vs. 55.2±10.8 to 64.7±7.0 (+9.5%, CI: 7.4-11.6%), p<0.001. While mean %TBR was similarly reduced: 4.4 to 2.6 (24/7) and 4.6 to 2.7 (EN), mean %TAR decreased significantly more on 24/7 vs. EN mode: 42.9 to 29.8 (-12.2%, 95CI: 9.7-14.6%) vs. 39.7 to 32.3 (-7.4%, 95CI: 5.0-9.9%), p=0.008. Increased %TIR was superior on 24/7 vs. EN mode during daytime: 54.3±10.1 to 62.6±6.2 vs. 55.7±11 to 58.4±7.6, p=0.001, and reached 77.2% on average overnight on both modes. CGM levels (mg/dl) more significantly decreased on 24/7 vs. EN mode: 171.9±20.3 to 158.1±10.6 vs. 168.9±20.8 to 162.6±12.1, p=0.02, while % of patients with HbA1c level<7% (53 mmol/mol) moved from 14 to 36 (24/7) vs. 13 to 22 (EN), from baseline to week 18. SD of CGM levels (mg/dl) was also reduced significantly more on 24/7 vs. EN mode: 69.6±9.8 to 61.5±8.0 vs. 69.8±11.3 to 66.7±10.0, p=0.0001. %TIR was increased through the whole range of baseline HbA1c and %TIR levels and always more with 24/7 use. No ketoacidosis or severe hypoglycemia occurred during the study. Conclusion: Our study demonstrates the safety and efficacy on glucose control of Tandem Control-IQ AID system used in free-life in pre-pubertal T1D children for both 24/7 and EN use. 24/7 use shows better performance than EN use, with 14.5% more time in range, or more than 3.6h/day, with no safety issue. The post-study extension for 18 weeks will assess the sustainability of 24/7 use of AID in the full study cohort.
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Dates et versions

hal-04772727 , version 1 (08-11-2024)

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  • HAL Id : hal-04772727 , version 1

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Eric Renard, Nadia Tubiana-Rufi, Elisabeth Bonnemaison, Régis Coutant, Fabienne Dalla-Vale, et al.. Automated insulin delivery in free-life shows better glucose control when used 24/7 vs evening and night in pre-pubertal children with type 1 diabetes: The Free-life Kid AP Study. 56th Anual Meeting of the European Association for the Study of Diabetes (EASD Virtual meeting 2020), European Association for the Study of Diabetes, Sep 2020, Vienne, Austria. pp.171. ⟨hal-04772727⟩
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