Trial reportBMJ open2020
Standardised self-management kits for children with type 1 diabetes: pragmatic randomised trial of effectiveness and cost-effectiveness.
Trial report in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed, 3 syntheses or guidelines pooled it, 8 citations in OpenAlex.
- Quality of life and physical activity in type 1 diabetes.BMC pediatrics · 2025Pooled it
- Effectiveness of Educational and Psychoeducational Self-Management Interventions in Children and Adolescents With Type 1 Diabetes: A Systematic Review and Meta-Analysis.Pediatric diabetes · 2024Pooled it
- The Effects of Diabetes Self-Management Education on Quality of Life for Persons With Type 1 Diabetes: A Systematic Review of Randomized Controlled Trials.The science of diabetes self-management and care · 2022Pooled it
- The Use of EQ-5D for Assessment of Health-Related Quality of Life and Its Determinants in Children with Complex Endocrine Conditions.Hormone research in paediatrics · 2026Article
- When technology improves patient care and provider experience.Research and practice in thrombosis and haemostasis · 2023Article
- Questionnaire-based service evaluation of the efficacy and usefulness of SEREN: a structured education programme for children and young people diagnosed with type 1 diabetes mellitus.BMJ open quality · 2021Article
- Clinical Utility of Psychoeducational Interventions for Youth with Type 1 Diabetes: A Scoping Review.Continuity in education · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 4 institutions in 1 country.
Funding
Abstract
objectiveTo estimate the effectiveness of standardised self-management kits for children with type 1 diabetes.
designPragmatic trial with randomisation ratio of two intervention: one control. Qualitative process evaluation.
setting11 diabetes clinics in England and Wales.
participantsBetween February 2010 and August 2011, we validly randomised 308 children aged 6-18 years; 201 received the intervention.
interventionWe designed kits to empower children to achieve glycaemic control, notably by recording blood glucose and titrating insulin. The comparator was usual treatment. OUTCOME MEASURES AT 3 AND 6 MONTHS: Primary: Diabetes Pediatric Quality of Life Inventory (PedsQL). Secondary: HbA1c; General PedsQL; EQ-5D; healthcare resource use.
resultsOf the five Diabetes PedsQL dimensions, Worry showed adjusted scores significantly favouring self-management kits at 3 months (mean child-reported difference =+5.87; Standard error[SE]=2.19; 95% confidence interval [CI]) from +1.57 to +10.18; p=0.008); but Treatment Adherence significantly favoured controls at 6 months (mean child-reported difference=-4.68; SE=1.74; 95%CI from -8.10 to -1.25; p=0.008). Intervention children reported significantly worse changes between 3 and 6 months on four of the five Diabetes PedsQL dimensions and on the total score (mean difference=-3.20; SE=1.33; 95% CI from -5.73 to -0.67; p=0.020). There was no evidence of change in HbA1c; only 18% of participants in each group achieved recommended levels at 6 months. No serious adverse reactions attributable to the intervention or its absence were reported.Use of kits was poor. Few children or parents associated blood glucose readings with better glycaemic control. The kits, costing £185, alienated many children and parents.
conclusionsStandardised kits showed no evidence of benefit, inhibited diabetes self-management and increased worry. Future research should study relationships between children and professionals, and seek new methods of helping children and parents to manage diabetes. TRIAL REGISTRATION NUMBER: ISRCTN17551624.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.