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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.

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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, ADAPT study Group
بيانات النشر: Wiley
//dx.doi.org/10.1111/dom.15217
Diabetes Obes Metab
سنة النشر: 2023
المجموعة: Apollo - University of Cambridge Repository
مصطلحات موضوعية: insulin pump therapy, patient reported outcomes, randomized trial, subcutaneous injection, type 1 diabetes, Humans, Adult, Diabetes Mellitus, Type 1, Hypoglycemic Agents, Insulin, Glycated Hemoglobin, Prospective Studies, Blood Glucose Self-Monitoring, Reproducibility of Results, Blood Glucose, Insulin Infusion Systems
الوصف: Funder: Medtronic International Trading Sàrl ; 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. ; The study was funded by Medtronic International Trading
نوع الوثيقة: article in journal/newspaper
وصف الملف: application/pdf; text/xml
اللغة: English
العلاقة: https://www.repository.cam.ac.uk/handle/1810/355466Test
الإتاحة: https://www.repository.cam.ac.uk/handle/1810/355466Test
حقوق: Attribution 4.0 International ; https://creativecommons.org/licenses/by/4.0Test/
رقم الانضمام: edsbas.9C376C44
قاعدة البيانات: BASE
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