214-OR: Cambridge Hybrid Closed-Loop in Children and Adolescents with T1D: A Multicentre Six-Month Randomised Trial
| العنوان: | 214-OR: Cambridge Hybrid Closed-Loop in Children and Adolescents with T1D: A Multicentre Six-Month Randomised Trial |
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| المؤلفون: | Roman Hovorka, Atrayee Ghatak, Craig Kollman, D. Steven Fox, Louise Denvir, Roy W. Beck, Charlotte K. Boughton, Lauren Kanapka, Rachel Besser, Bruce A. Buckingham, Nelly Mauras, Julia Fuchs, Nikki Davis, Martin Tauschmann, Malgorzata E. Wilinska, Ajay Thankamony, Korey K. Hood, Janet M. Allen, Stuart A. Weinzimer, R. Paul Wadwa, Judy Sibayan, Linda Dimeglio, Fiona Campbell |
| المصدر: | Diabetes. 70 |
| بيانات النشر: | American Diabetes Association, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Insulin pump, medicine.medical_specialty, business.operation, business.industry, Abbott Laboratories, Endocrinology, Diabetes and Metabolism, medicine.disease, Central laboratory, law.invention, Randomized controlled trial, law, Diabetes mellitus, Usual care, Internal Medicine, Clinical endpoint, Physical therapy, Medicine, business, Closed loop |
| الوصف: | Aims: We assessed safety and efficacy of Cambridge hybrid closed-loop (HCL) compared with usual care over 6 months in children and young people with T1D. Methods: In an open-label multicentre multinational parallel randomised controlled trial, we randomly assigned participants on insulin pump therapy aged 6 to 18 years to receive either HCL therapy (CL) or continue usual care (control) for 6 months. We used the same Cambridge model predictive control algorithm in two consecutive hardware iterations, FlorenceM then CamAPS FX. Primary endpoint was central laboratory HbA1c at 6 months. Results: We randomised 133 participants: 65 to CL and 68 to control (baseline HbA1c 8.2±0.7% vs. 8.3±0.8%). At 6 months mean HbA1c was 0.32% lower in CL compared to control (95% CI -0.59 to -0.04; p=0.02). Closed-loop usage was low (40% [26, 53]; median [IQR]) with FlorenceM due to hardware issues, and high (93% [88, 96]) with CamAPS FX. In the CamAPS FX CL group (n=21) HbA1c was 1.05% lower (95% CI -1.43 to -0.67; p Conclusion: Cambridge HCL is safe and significantly improves glycaemic control in children and young people with T1D. Efficacy relies on consistent usage of closed-loop, as demonstrated by CamAPS FX. Disclosure J. Fuchs: None. B. A. Buckingham: Advisory Panel; Self; Medtronic, Tolerion, Inc., Research Support; Self; Beta Bionics, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. N. Davis: None. L. Dimeglio: Advisory Panel; Self; MannKind Corporation. N. Mauras: Advisory Panel; Self; Novo Nordisk, Research Support; Self; LifeScan, Medtronic, Novo Nordisk. R. Besser: None. A. Ghatak: None. S. A. Weinzimer: Advisory Panel; Self; Dompe, Zealand Pharma A/S, Speaker’s Bureau; Self; Medtronic. K. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. D. Fox: None. L. Kanapka: None. C. K. Boughton: None. C. Kollman: Consultant; Self; Diasome Pharmaceuticals, Inc., Research Support; Self; Dexcom, Inc., Tandem Diabetes Care. J. Sibayan: None. R. Beck: Consultant; Self; Bigfoot Biomedical, Inc., Diasome Pharmaceuticals, Inc., Insulet Corporation, Lilly Diabetes, vTv Therapeutics, Research Support; Self; Beta Bionics, Inc., Dexcom, Inc., Medtronic, Novo Nordisk, Tandem Diabetes Care. R. Hovorka: Research Support; Self; Abbott Laboratories, Dexcom, Inc., Medtronic, Speaker’s Bureau; Self; Dexcom, Inc., Eli Lilly and Company, Stock/Shareholder; Self; CamDiab Ltd. Dan05 consortium: n/a. J. M. Allen: None. M. E. Wilinska: Consultant; Self; CamDiab Ltd. M. Tauschmann: None. L. Denvir: None. A. Thankamony: None. F. Campbell: n/a. R. Wadwa: Consultant; Self; Tandem Diabetes Care, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Tandem Diabetes Care. Funding National Institute of Diabetes and Digestive and Kidney Diseases (UC4DK108520) |
| تدمد: | 1939-327X 0012-1797 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_________::98495da42740e8c54c1fb91f755eb84dTest https://doi.org/10.2337/db21-214-orTest |
| حقوق: | CLOSED |
| رقم الانضمام: | edsair.doi...........98495da42740e8c54c1fb91f755eb84d |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 1939327X 00121797 |
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