Protocol for a prospective, multicenter, parallel-group, open-label randomized controlled trial comparing standard care with Closed lOoP In chiLdren and yOuth with Type 1 diabetes and high-risk glycemic control: the CO-PILOT trial.
| Autor: | Boucsein A; Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand., Zhou Y; Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.; Department of Endocrinology, Institute of Endocrine and Metabolic Diseases, Division of Life Sciences and Medicine, The First Affiliated Hospital of USTC, Clinical Research Hospital of Chinese Academy of Sciences (Hefei), University of Science and Technology of China (USTC), 230001 Hefei, Anhui China., Haszard JJ; Biostatistics Centre, University of Otago, Dunedin, New Zealand., Jefferies CA; Starship Child Health, Te Whatu Ora Te Toka Tumai Auckland, Auckland, New Zealand.; Liggins Institute, Department of Paediatrics, The University of Auckland, Auckland, New Zealand., Wiltshire EJ; Department of Paediatrics and Child Health, University of Otago Wellington, Wellington, New Zealand.; Te Whatu Ora Capital, Coast and Hutt Valley, Wellington, New Zealand., Styles SE; Department of Human Nutrition, University of Otago, Dunedin, New Zealand., Crocket HR; Te Huatakia Waiora School of Health, University of Waikato, Hamilton, New Zealand., Galland BC; Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand., Pasha M; Sidra Medicine, Doha, Qatar., Petrovski G; Sidra Medicine, Doha, Qatar., Paul RG; Te Huatakia Waiora School of Health, University of Waikato, Hamilton, New Zealand.; Waikato Regional Diabetes Service, Te Whatu Ora Waikato, Hamilton, New Zealand., de Bock MI; Department of Paediatrics, University of Otago, Christchurch, New Zealand.; Te Whatu Ora Waitaha Canterbury, Christchurch, New Zealand., Wheeler BJ; Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.; Te Whatu Ora Southern, Dunedin, New Zealand. |
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| Jazyk: | angličtina |
| Zdroj: | Journal of diabetes and metabolic disorders [J Diabetes Metab Disord] 2024 Mar 07; Vol. 23 (1), pp. 1397-1407. Date of Electronic Publication: 2024 Mar 07 (Print Publication: 2024). |
| DOI: | 10.1007/s40200-024-01397-4 |
| Abstrakt: | Purpose: Advanced hybrid closed loop (AHCL) systems have the potential to improve glycemia and reduce burden for people with type 1 diabetes (T1D). Children and youth, who are at particular risk for out-of-target glycemia, may have the most to gain from AHCL. However, no randomized controlled trial (RCT) specifically targeting this age group with very high HbA Methods: A prospective, multicenter, parallel-group, open-label RCT, comparing MiniMed™ 780G AHCL to standard care (multiple daily injections or continuous subcutaneous insulin infusion). Eighty participants aged 7-25 years with T1D, a current HbA Conclusion: This study will evaluate the efficacy and safety of AHCL in this population and has the potential to demonstrate that AHCL is the gold standard for children and youth with T1D experiencing out-of-target glucose control and considerable diabetes burden. Trial Registration: This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry on 14 November 2022 (ACTRN12622001454763) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1284-8452). Supplementary Information: The online version contains supplementary material available at 10.1007/s40200-024-01397-4. Competing Interests: Conflict of interestThe diabetes technology used in this study will be provided by Medtronic, in addition to partial financial support for some aspects of staffing related to study conduct. Authors BJW, MIdB, and RGP have received past speaker honoraria and compensation for travel costs from Medtronic. (© The Author(s) 2024.) |
| Databáze: | MEDLINE |
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