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  • Does insulin pump therapy offer benefits for behaviour, mood, cognition and HbA1c in children and adolescents with type 1 diabetes? A randomised controlled trial with observational follow-up

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Original research
Does insulin pump therapy offer benefits for behaviour, mood, cognition and HbA1c in children and adolescents with type 1 diabetes? A randomised controlled trial with observational follow-up
  1. Michele A O'Connell1,2,3,
  2. Elisabeth A Northam2,
  3. Amy Brown2,
  4. Jennifer Papoutsis2,
  5. Tibor Schuster4,
  6. Timothy Skinner5,6,7,
  7. Alicia J Jenkins1,3,8,9,
  8. Geoffrey R Ambler9,10,
  9. Fergus J Cameron1,2,3
  1. 1 Endocrinology and Diabetes, The Royal Children's Hospital Melbourne, Parkville, Victoria, Australia
  2. 2 Murdoch Children's Research Institute, Parkville, Victoria, Australia
  3. 3 The University of Melbourne, Melbourne, Victoria, Australia
  4. 4 Department of Family Medicine, McGill University, Montreal, Quebec, Canada
  5. 5 La Trobe University, Melbourne, Victoria, Australia
  6. 6 Australian Centre for Behavioural Research in Diabetes, Deakin University, Geelong, Victoria, Australia
  7. 7 Institute of Psychology, Copenhagen University, Copenhagen, Denmark
  8. 8 Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia
  9. 9 The University of Sydney, Sydney, New South Wales, Australia
  10. 10 Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead, Westmead, New South Wales, Australia
  1. Correspondence to Dr Michele A O'Connell; michele.oconnell{at}rch.org.au

Abstract

Aims Improved behaviour, mood, cognition and HbA1c have been reported with short-term use of continuous subcutaneous insulin infusion (CSII) in youth with type 1 diabetes (T1D). We sought to re-examine these findings in a randomised controlled trial (RCT), with longitudinal follow-up.

Methods RCT of youth aged 7–15 years with T1D, at two tertiary paediatric centres. Participants were randomised to commence CSII or continue multiple daily injections (MDI). Behaviour, mood, cognition and HbA1c were assessed. Primary outcome was difference in parent-reported behaviour (BASC-2) at 4 months. After the 4-month RCT, MDI participants commenced CSII; outcomes were reassessed at +2 years.

Results Participating youth (n=101) were randomised to CSII (n=56) or MDI (n=45). Significant differences favouring CSII were found at 4 months in parent-reported behaviour problems (Cohen’s d 0.41 (95% CI 0.004 to 0.795); p=0.048) and HbA1c (mean (95% CI) difference: 7 (2.3 to 11.7) mmol/mol (0.6% (0.2 to 1.0%); p=0.001)). Improvements from baseline were documented in mood and cognitive outcomes in both study groups over the 4-month RCT; however, no between-group differences were evident at 4 months. Sixteen of 76 (21%) participants completing assessments at +2 years had discontinued CSII. In n=60 still using CSII, measurements of behaviour, mood and HbA1c were comparable to baseline.

Conclusions Parent-reported behaviour problems and HbA1c, but not mood or neurocognitive outcomes, were clinically significantly lower with CSII, relative to MDI, after 4 months. Observational follow-up indicated no impact of treatment modality at +2 years, relative to baseline levels. Taken together, these data indicate that use of CSII alone does not comprehensively benefit neuropsychological outcomes in childhood T1D.

  • diabetes
  • paediatrics

Data availability statement

Data are available upon reasonable request.

https://doi.org/10.1136/archdischild-2023-326007

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • Contributors MAO'C, EAN, AJJ, GRA and FJC conceived and designed the study. MAO'C, AB and JP conducted the research, collected the data and co-ordinated the study. AB, TS and TS analysed the data. MAO'C wrote the manuscript and is the guarantor of this work. All authors reviewed and edited the manuscript prior to submission.

    • Funding This investigator-initiated research was funded by grants received from the Australian National Health and Medical Research Council Centre of Clinical Research Excellence (NHMRC CCRE) in in Clinical Science in Diabetes and The Collier Charitable Fund.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; internally peer-reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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