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.

Journal: Journal of diabetes and metabolic disorders
Published Date: Mar 7, 2024

Abstract

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 has previously been attempted. Therefore, the CO-PILOT trial (Closed lOoP In chiLdren and yOuth with Type 1 diabetes and high-risk glycemic control) aims to evaluate the efficacy and safety of AHCL in this group.

Authors

  • Alisa Boucsein
    Department of Paediatrics and Child Health, University of Otago, Dunedin, New Zealand.
  • Yongwen Zhou
    Department of Paediatrics and Child Health, University of Otago, Dunedin, New Zealand.
  • Jillian J Haszard
    Biostatistics Centre, University of Otago, Dunedin, New Zealand.
  • Craig A Jefferies
    Starship Child Health, Te Whatu Ora Te Toka Tumai Auckland, Auckland, New Zealand.
  • Esko J Wiltshire
    Department of Paediatrics and Child Health, University of Otago Wellington, Wellington, New Zealand.
  • Sara E Styles
    Department of Human Nutrition, University of Otago, Dunedin, New Zealand.
  • Hamish R Crocket
    Te Huatakia Waiora School of Health, University of Waikato, Hamilton, New Zealand.
  • Barbara C Galland
    Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.
  • Maheen Pasha
    Division of Endocrinology, Sidra Medicine, Doha, Qatar.
  • Goran Petrovski
    Division of Endocrinology, Sidra Medicine, Doha, Qatar.
  • Ryan G Paul
    Te Huatakia Waiora School of Health, University of Waikato, Hamilton, New Zealand.
  • Martin I de Bock
    Department of Paediatrics, University of Otago, Christchurch, New Zealand.
  • Benjamin J Wheeler
    Department of Paediatrics and Child Health, University of Otago, Dunedin, New Zealand.

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