التفاصيل البيبلوغرافية
| العنوان: |
Twelve‐month results of the ADAPT randomized controlled trial: Reproducibility and sustainability of advanced hybrid closed‐loop therapy outcomes versus conventional therapy in adults with type 1 diabetes. |
| المؤلفون: |
Edd, Shannon N., Castañeda, Javier, Choudhary, Pratik, Kolassa, Ralf, Keuthage, Winfried, Kroeger, Jens, Thivolet, Charles, Evans, Mark, Ré, Roseline, Cellot, Jessica, de Portu, Simona, Vorrink, Linda, Shin, John, van den Heuvel, Tim, Cohen, Ohad, Reznik, Yves, Catargi, Bogdan, Kessler, Laurence, Borot, Sophie, Schaepelynck‐Belicar, Pauline |
| المصدر: |
Diabetes, Obesity & Metabolism; Nov2023, Vol. 25 Issue 11, p3212-3222, 11p |
| مصطلحات موضوعية: |
TYPE 1 diabetes, INSULIN aspart, RANDOMIZED controlled trials, GLYCOSYLATED hemoglobin, HYPOGLYCEMIA, PATIENT reported outcome measures |
| مستخلص: |
Aims: To reassess the 6‐month efficacy and to assess the 12‐month sustained efficacy of the MiniMed™ 780G advanced hybrid closed‐loop automated insulin delivery (AID) system compared to multiple daily injections plus intermittently scanned glucose monitoring (MDI+isCGM) in people with type 1 diabetes not meeting glucose targets. Methods: The ADAPT study was a prospective, multicentre, open‐label, randomized control trial in people with type 1 diabetes, with a glycated haemoglobin (HbA1c) concentration of at least 8.0% (64 mmol/mol), on MDI+isCGM therapy. After a 6‐month study phase, participants randomized at baseline to MDI+isCGM switched to AID (SWITCH) while the others continued AID therapy (SUSTAIN) for an additional 6 months. The primary endpoint of this continuation phase was the within‐group change in mean HbA1c between 6 and 12 months, with superiority in the SWITCH group and noninferiority in the SUSTAIN group (ClinicalTrials.gov: NCT04235504). Results: A total of 39 SWITCH and 36 SUSTAIN participants entered the continuation phase. In the SWITCH group, HbA1c was significantly decreased by −1.4% (95% confidence interval [CI] −1.7% to −1.1%; P < 0.001) from a mean ± SD of 8.9% ± 0.8% (73.9 ± 8.6 mmol/mol) at 6 months to 7.5% ± 0.6% (58.5 ± 6.9 mmol/mol) at 12 months. Mean HbA1c increased by 0.1% (95% CI −0.05% to +0.25%), from 7.3% ± 0.6% (56.5 ± 6.7 mmol/mol) to 7.4% ± 0.8% (57.7 ± 9.1 mmol/mol) in the SUSTAIN group, meeting noninferiority criteria. Three severe hypoglycaemia events occurred in two SWITCH participants during the continuation phase. Conclusion: ADAPT study phase glycaemic improvements were reproduced and sustained in the continuation phase, supporting the early adoption of AID therapy in people with type 1 diabetes not meeting glucose targets on MDI therapy. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
