Background Non-adherence to treatment in childhood chronic illness has serious consequences for health and healthcare costs. Accurate detailed objective data on adherence are minimal in this age group.
Objective To evaluate medication adherence using electronic monitoring systems in children with type 1 diabetes (T1D).
Design A cohort study of 90 T1D children (aged 13.6±2.5 years, 41 males) from two paediatric diabetes clinics, participated in a 12-month double-blind, randomised, placebo-controlled trial (1:1 allocation). This cohort provided 28 336 days of study observations; 7138 school holiday and 8875 weekend/public holiday days.
Method Adherence to intervention (metformin (n=45) or placebo (n=45)) was measured objectively by Medication Event Monitoring Systems (MEMS) including proportion of medication doses taken and daily adherence patterns and by tablet count at 3, 6 and 12 months. The trial was completed in June 2015.
Results There was an average (SD) of 363.3 (42) days of MEMS observations available for each study participant (94.1 (12.6) school holiday days and 117.1 (13.4) weekend/public holiday days). Adherence reduced during school holidays (adjusted OR (aOR) 0.81; 95% CI 0.72 to 0.91; p<0.001) and during weekends/public holidays (aOR 0.74; 95% CI 0.69 to 0.80; p<0.001). Adverse effects to the intervention did not affect overall adherence (aOR 0.77; 95% CI 0.3 to 2.01; p=0.6). Age, gender, body mass index, diabetes duration, insulin dose, HbA1c (Haemoglobin A1c) or socioeconomic status did not predict adherence.
Conclusion Medication adherence was reduced during school holidays and on weekends in children with T1D. Clinical characteristics including socioeconomic status and the presence of adverse effects did not predict adherence.
Trial registration number ACTRN12611000148976.
- adolescent health
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Contributors CL drafted the manuscript and had full access to the study data and acquired, analysed and interpreted the data and takes responsibility for the integrity of the contents of the article, the data and the accuracy of the data analysis. LG drafted the manuscript, provided statistical analysis and had full access to all of the data in the study and take responsibility for the integrity of the contents of the article, the data and the accuracy of the data analysis. JJAA obtained funding for this study and had full access to the study data and acquired, analysed and interpreted the data and takes responsibility for the integrity of the contents of the article, the data and the accuracy of the data analysis. MD drafted the manuscript and acquired, analysed and interpreted the data. ASP and JC obtained funding for this study, drafted the manuscript and had full access to the study data and acquired, analysed and interpreted the data and take responsibility for the integrity of the contents of the article, the data and the accuracy of the data analysis. All authors critically reviewed the manuscript for important intellectual content and approved the final version for publication.
Funding This study was funded by Diabetes Australia Research Trust, Women’s and Children’s Foundation research project grants and Australasian Paediatric Endocrine Care grants. JJAA held an MS McLeod Research Foundation fellowship.
Disclaimer The funders had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; and decision to submit the manuscript for publication.
Competing interests None declared.
Ethics approval The trial was approved by the Women’s and Children’s Hospital Research Ethics Committee (HREC 2327/12/13) and Flinders Medical Centre Research Ethics Committee (HREC 443.12).
Provenance and peer review Not commissioned; externally peer reviewed.
Patient consent for publication Not required.
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