Developing and evaluating a child-centred intervention for diabetes medicine management using mixed methods and a multicentre randomised controlled trial

Authors: Noyes J, Lowes L, Whitaker R, Allen D, Carter C, Tudor-Edwards R, Rycroft-Malone J, Sharp J, Edwards D, Spencer L, Sylvestre Y, Yeo S, Gregory J.

Journal: Health Services and Delivery Research Volume: 2 Issue: 8

Publication date: March 2014



Noyes J, Lowes L, Whitaker R, Allen D, Carter C, Tudor-Edwards R, et al.Developing and evaluating a child-centred intervention for diabetes medicine management using mixed methods and a multicentre randomised controlled trial. Health Serv Deliv Res 2014;2(8)

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To develop and evaluate an individually tailored age-appropriate diabetes diary and information pack for children and young people aged 6–18 years with type 1 diabetes to support decision-making and self-care with a specific focus on insulin management and blood glucose monitoring, compared with vailable resources in routine clinical practice.


Four-stage study following the Medical Research Council framework for designing and evaluating complex interventions. Stage 1: context – brief review of reviews and mixed-method systematic review; updating of database of children’s diabetes information; children’s diabetes information quality assessment and diabetes guideline analysis; and critical discourse analysis. Stage 2: intervention development – working with expert clinical advisory group; contextual qualitative interviews and focus groups with children and young people to ascertain their information preferences and self-care practices; ongoing consultation with children; development of intervention programme theory. Stage 3: randomised controlled trial (RCT) to evaluate the diabetes diaries and information packs in routine practice. Stage 4: process evaluation.


The RCT achieved 100% recruitment, was adequately powered and showed that the Evidence into Practice Information Counts (EPIC) packs and diabetes diaries were no more effective than receiving diabetes information in an ad hoc way. The cost per unit of producing the EPIC packs and diabetes diaries was low. Compared with treatment as usual information, the EPIC packs fulfilled all NHS policy imperatives that children and young people should receive high-quality, accurate and age-appropriate information about their condition, self-management and wider lifestyle and well-being issues. Diabetes guidelines recommend the use of a daily diabetes diary and EPIC diaries fill a gap in current provision. Irrespective of allocation, children and young people had a range of recorded glycated haemoglobin (HbA1c) levels, which showed that as a group their diabetes self-management would generally need to improve to achieve the HbA1c levels recommended in National Institute for Health and Care Excellence guidance. The process evaluation showed that promotion of the EPIC packs and diaries by diabetes professionals at randomisation did not happen as intended; the dominant ‘normalisation’ theory underpinning children’s diabetes information may be counterproductive; risk and long-term complications did not feature highly in children’s diabetes information; and children and young people engaged in risky behaviour and appeared not to care, and most did not use a diabetes diary or did not use the information to titrate their insulin as intended.


Recruitment of ‘hard to reach’ children and young people living away from their families was not successful. The findings are therefore more relevant to diabetes management within a family context.


The findings indicate a need to rethink context and the hierarchical relationships between children, young people, parents and diabetes professionals with regard to ‘partnership and participation’ in diabetes decision-making, self-care and self-management. Additional research, implementation strategies and service redesign are needed to translate available information into optimal self-management knowledge and subsequent optimal diabetes self-management action, including to better understand the disconnection between children’s diabetes texts and context; develop age-appropriate Apps/e-records for recording blood glucose measurements and insulin management; develop interventions to reduce risk-taking behaviour by children and young people in relation to their diabetes management; reconsider what could work to optimise children’s self-management of diabetes; understand how best to reorganise current diabetes services for children to optimise child-centred delivery of children’s diabetes information.

Study registration

Current Controlled Trials ISRCTN17551624.


The National Institute for Health Research Health Services and Delivery Research programme.

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