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Good enough? Parental decisions to use DIY looping technology to manage type 1 diabetes in children

Abstract

People are using innovative internet of things technologies to gain individualised management of their type 1 diabetes. The #WeAreNotWaiting movement supports them to build their own hybrid closed loop systems and access their real time blood sugar data via any web connected device. A small number of parents in Australia use such DIY looping systems to manage their child’s type 1 diabetes, but these systems have not been approved by the Therapeutic Goods Administration in Australia, creating ethical dilemmas for clinicians about how to respond to the use of medical devices that are not registered on the Australian Register of Therapeutic Goods. This article considers whether the use of DIY looping is in the best interests of the child and, if not, whether intervention in parental decision making is justified to prevent harm to the child. It addresses the ongoing duty of healthcare professionals to provide care to children who are ‘looping.’ Reference is made to findings from a study, Personalised Closed Loop Systems for Childhood Diabetes, to illustrate stakeholders’ perceptions of benefits and harms of DIY looping systems. I conclude that the decision of parents to use DIY looping technology could be considered to be in a child’s best interests, broadly defined, and falls within the Zone of Parental Discretion, however healthcare practitioners who support parents may have professional concerns in doing so.

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Notes

  1. 1.

    https://openaps.org/ accessed 30.6.2021.

  2. 2.

    A survey in 2017 found twenty individuals in Australia were actively looping, of those two were teenagers and one was under 10 years of age. Hng and Burren (2018).

  3. 3.

    Data from Australian Institute of Health and Welfare, updated 3 Apr 2020, https://www.aihw.gov.au/reports/children-youth/australias-children/contents/health/children-diabetes, accessed 30 June 2021.

  4. 4.

    Section 41BD of the Therapeutic Goods Act 1989 Act defines a ‘medical device’ as an instrument, apparatus, appliance, including the software necessary for its proper application, used for monitoring, treatment or alleviation of a disease.

  5. 5.

    https://law.unimelb.edu.au/helex/research/research-projects/regulation-of-personalised-digital-hybrid-closed-loop-systems-to-manage-diabetes-in-children.

  6. 6.

    Family Law Act 1975 (Cth) and state and territory legislation, for example the Children, Youth and Families Act 2005 (Vic).

  7. 7.

    Director Clinical Services, Child &Adolescent Health Services and Kiszko & Anor [2016] FCWA 75 [53].

  8. 8.

    This is notable in court decisions in England & Wales, for example NHS Trust v MB [2006] EWHC 507 (Fam).

  9. 9.

    Evans & Anor v Alder Hey Children’s NHS Foundation Trust& Anor, Baroness Hale [14].

  10. 10.

    For example, NHS Trust v SR [2012] EWHC 3842, King's College Hospital NHS Foundation Trust v Hasstrup (Withdrawal of Treatment) [2018] EWHC 127 (Fam).

  11. 11.

    Wyatt v Portsmouth Hospital NHS Trust [2005] EWCA Civ 1181, Wall L.J. [87].

  12. 12.

    Director Clinical Services, Child &Adolescent Health Services and Kiszko & Anor [2016] FCWA 19 Thackray CJ. [30].

  13. 13.

    Director Clinical Services, Child &Adolescent Health Services and Kiszko & Anor [2016] FCWA 75 O’Brien J. [72]

  14. 14.

    In the Matter of Charlie Gard [2017] EWCA Civ 410 Lord Justice McFarlane [80].

  15. 15.

    Director Clinical Services, Child &Adolescent Health Services and Kiszko & Anor [2016] FCWA 75 O’Brien J.[78]

  16. 16.

    This could describe for example a second wave of parents who, on being aware of DIY looping from the diabetes community, set up and manage the system with insufficient knowledge, preparation or backup.

  17. 17.

    Yates & Anor v Great Ormond Street Hospital for Children NHS Foundation Trust & Anor (Rev 1) [2017] EWCA Civ 410 [54].

  18. 18.

    Portsmouth NHS Trust v. Wyatt [2005] EWHC 2293, [40].

References

  1. Auckland, C., and I. Goold. 2019. Parental Rights, Best Interests and Significant Harms: who should have the final say over a child’s medical care? Cambridge Law Review 78 (2): 287–323.

    Article  Google Scholar 

  2. Australian Human Rights Commission. 2019. Human Rights and Technology Discussion paper.

  3. Bester, J.C. 2019. The best interest standard and children: clarifying a concept and responding to its critics. Journal of Medical Ethics 45 (2): 117–124.

    Article  Google Scholar 

  4. Blustein, J. 1982. Parents and Children: The Ethics of the Family. New York: Oxford University Press.

    Google Scholar 

  5. Buchanan, A.E., and D.W. Brock. 1990. Deciding for Others: The Ethics of Surrogate Decision Making. New York: Cambridge University Press.

    Book  Google Scholar 

  6. Cherry, M. 2015. Re-thinking the role of the family in medical decision-making. Journal of Medicine and Philosophy 40: 451–472.

    Article  Google Scholar 

  7. Czapanskiy, K. 1999. Interdependencies, families, and children. Santa Clara l. Rev. 39 (4): 957.

    Google Scholar 

  8. Cooper, H., and R. Geyer. 2009. What can complexity do for diabetes management? Linking theory to practice. Journal of evaluation in clinical practice 15 (4): 761–765.

    Article  Google Scholar 

  9. De Ville, K., and G. Hassler. 2001. Healthcare Ethics Committees and the law: uneasy but inevitable bedfellows. HEC Forum 13: 13–31.

    Article  Google Scholar 

  10. Diabetes Australia. 2018. Diabetes Australia position statement—DIY technology for type 1 diabetes. Diabetes Australia 1–8.

  11. Diekema, D. 2004. Parental refusals of medical treatment: the harm principle as threshold for state intervention. Theoretical Medicine and Bioethics 25: 243–264.

    Article  Google Scholar 

  12. Editorial. 2018. Family matters in diabetes care. Lancet Diabetes & Endocrinology 6 (12): 911.

    Article  Google Scholar 

  13. Elbashy, M., et al. 2020. Exploring parental experiences of using a do-it-yourself solution for continuous glucose monitoring among children and adolescents with type 1 diabetes: a qualitative study. Journal of Diabetes Science and Technology 14 (5): 844–853.

    Article  Google Scholar 

  14. Freeman, R., Ginnivan, L. 2019. DIY looping technologies. Australian Diabetes Educator 22 (1)

  15. Gillam, L. 2016. The zone of parental discretion: An ethical tool for dealing with disagreement between parents and doctors about medical treatment for a child. Clinical Ethics 11 (1): 1–8.

    Article  Google Scholar 

  16. Herring, J. 1999. The Human Rights Act and the welfare principle in family law: conflicting or complementary? Child and Family Law Quarterly 11 (3): 223–235.

    Google Scholar 

  17. Hng, T.-M., and D. Burren. 2018. Appearance of Do-It-Yourself closed-loop systems to manage type 1 diabetes. Internal Medicine Journal 48 (11): 1400–1404.

    Article  Google Scholar 

  18. Jennings, P., and S. Hussain. 2020. Do-It-Yourself artificial pancreas systems: a review of the emerging evidence and insights for healthcare professionals. Journal of Diabetes, Science and Technology 14 (5): 868–887.

    Article  Google Scholar 

  19. Johnston, C., and L. Gillam. 2018. Legal and ethical issues arising from the use of emerging technologies in paediatric type 1 diabetes. QUT Law Review 18 (2): 93–110.

    Article  Google Scholar 

  20. Jonsen, A.R., M. Siegler, and W.J. Winslade. 1992. Clinical Ethics: A practical Approach to Ethical Decisions in Clinical Medicine, 3rd ed. New York): McGraw-Hill.

    Google Scholar 

  21. Kopleman, L.J. 1997. The best-interests standard as threshold, ideal, and standard of reasonableness. Philosophy of Medicine 22 (3): 271–289.

    Article  Google Scholar 

  22. Lum, J., R. Bailey, V. Barnes-Lomen, D. Naranjo, K. Hood, R.A. Lal, B. Arbiter, A. Brown, D.J. DeSalvo, J. Pettus, P. Calhoun, and R.W. Beck. 2021. A real-world prospective study of the safety and effectiveness of the loop open source automated insulin delivery system. Diabetes Technology & Therapeutics. https://doi.org/10.1089/dia.2020.0535.

    Article  Google Scholar 

  23. Mona, Elbalshy Sara, Boucher Hamish, Crocket Barbara, Galland Craig, MacKenzie Martin I., de Bock Craig, Jefferies Esko, Wiltshire Benjamin J., Wheeler. 2020. Exploring parental experiences of using a do-it-yourself solution for continuous glucose monitoring among children and adolescents with type 1 diabetes: a qualitative study. Journal of Diabetes Science and Technology 14 (5): 844–853. https://doi.org/10.1177/1932296819895290

  24. Markowitz, J. 2012. Re-examining a measure of diabetes-related burden in parents of young people with Type 1 diabetes: the Problem Areas in Diabetes Survey-Parent Revised version (PAID-PR). Diabetic Medicine 29 (4): 526–30.

    Article  Google Scholar 

  25. Rawls, J. 1971. A Theory of Justice. New York: Cambridge University Press.

    Google Scholar 

  26. Rhodes, R., and I. Holzman. 2014. Is the best interest standard good for pediatrics? Pediatrics 134 (Supplement 2): S121–S129.

    Article  Google Scholar 

  27. Roberts, J., V. Moore, and M. Quigley. 2021. Prescribing unapproved medical devices? The case of DIY artificial pancreas systems. Medical Law International 21 (1): 42–68.

    Article  Google Scholar 

  28. Ross, L.F. 2019. Better than best (interest standard) in pediatric decision making. The Journal of Clinical Ethics 30 (3): 183–195.

    Google Scholar 

  29. Royal College of Physicians. 2005. Ethics in Practice: Background and Recommendations for Enhanced Support. London: Royal College of Physicians.

    Google Scholar 

  30. Streuli, J.C., et al. 2021. Combining the best interest standard with shared decision-making in paediatrics-introducing the shared optimum approach based on a qualitative study. European Journal of Pediatrics 180 (3): 759–766.

    Article  Google Scholar 

  31. Wu, Z., S. Luo, X. Zheng, et al. 2020. Use of a do-it-yourself artificial pancreas system is associated with better glucose management and higher quality of life among adults with type 1 diabetes. Therapeutic Advances in Endocrinology and Metabolism 11: 1–11.

    Article  Google Scholar 

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Acknowledgements

Networked Society Institute, University of Melbourne for the seed funding for the Personalised Closed Loop Systems for Childhood Diabetes and to members of the project team.

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Correspondence to Carolyn Johnston.

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Johnston, C. Good enough? Parental decisions to use DIY looping technology to manage type 1 diabetes in children. Monash Bioeth. Rev. (2021). https://doi.org/10.1007/s40592-021-00133-5

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Keywords

  • Best interests
  • Zone of parental discretion
  • Harm principle
  • Children
  • Innovative treatment