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Standardised self-management kits for children with type 1 diabetes: pragmatic randomised trial of effectiveness and
Jane Noyes1, Davina Allen2, Cynthia Carter3
1School of Health Sciences, Bangor University, Bangor, UK jane.noyes@bangor.ac.uk.
Insights
Standardised self-management kits for children with type 1 diabetes did not improve glycaemic control or quality of life. The kits were associated with increased worry and poor adherence, indicating a need for new management strategies.
Area of Science:
- Pediatric Endocrinology
- Diabetes Self-Management
- Clinical Trial Methodology
Background:
- Type 1 diabetes requires lifelong self-management, posing challenges for pediatric patients.
- Empowering children with diabetes through self-management tools is a key therapeutic goal.
Purpose of the Study:
- To evaluate the effectiveness of standardized self-management kits in improving glycaemic control and quality of life for children with type 1 diabetes.
- To assess the impact of these kits on patient-reported outcomes and adherence.
Main Methods:
- A pragmatic trial with a 2:1 intervention-to-control randomization ratio was conducted across 11 UK diabetes clinics.
- 308 children (aged 6-18 years) were randomized, with 201 receiving the intervention kits.
- Outcomes measured at 3 and 6 months included the Diabetes Pediatric Quality of Life Inventory (PedsQL) and HbA1c levels.
Main Results:
- Self-management kits did not demonstrate significant benefits in glycaemic control (HbA1c) or overall quality of life.
- While 'Worry' scores improved initially, 'Treatment Adherence' worsened at 6 months, and PedsQL scores declined.
- Kit utilization was low, with limited perceived association between glucose monitoring and improved control; kits were also found to be alienating.
Conclusions:
- Standardized self-management kits for pediatric type 1 diabetes showed no evidence of benefit and potentially hindered self-management, increasing patient worry.
- Future research should focus on the child-professional relationship and novel approaches to diabetes management support.
- The study highlights the need for more effective and less alienating tools for pediatric diabetes self-care.
Objective:
To estimate the effectiveness of standardised self-management kits for children with type 1 diabetes.
Design:
Pragmatic trial with randomisation ratio of two intervention: one control. Qualitative process evaluation.
Setting:
11 diabetes clinics in England and Wales.
Participants:
Between February 2010 and August 2011, we validly randomised 308 children aged 6-18 years; 201 received the intervention.
Intervention:
We 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.
Results:
Of 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.
Conclusions:
Standardised 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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