Dataset Information

Standardised self-management kits for children with type 1 diabetes: pragmatic randomised trial of effectiveness and cost-effectiveness.

ABSTRACT:

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.

SUBMITTER: Noyes J

PROVIDER: S-EPMC7069268 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Standardised self-management kits for children with type 1 diabetes: pragmatic randomised trial of effectiveness and cost-effectiveness.

Noyes Jane J Allen Davina D Carter Cynthia C Edwards Deborah D Edwards Rhiannon Tudor RT Russell Daphne D Russell Ian T IT Spencer Llinos Haf LH Sylvestre Yvonne Y Whitaker Rhiannon R Yeo Seow Tien ST Gregory John W JW

BMJ open 20200312 3

<h4>Objective</h4>To estimate the effectiveness of standardised self-management kits for children with type 1 diabetes.<h4>Design</h4>Pragmatic trial with randomisation ratio of two intervention: one control. Qualitative process evaluation.<h4>Setting</h4>11 diabetes clinics in England and Wales.<h4>Participants</h4>Between February 2010 and August 2011, we validly randomised 308 children aged 6-18 years; 201 received the intervention.<h4>Intervention</h4>We designed kits to empower children to ...[more]

PMID: 32169923

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Dataset Information

Standardised self-management kits for children with type 1 diabetes: pragmatic randomised trial of effectiveness and cost-effectiveness.

Objective

Design

Setting

Participants

Intervention

Results

Conclusions

Trial registration number

Publications

Standardised self-management kits for children with type 1 diabetes: pragmatic randomised trial of effectiveness and cost-effectiveness.

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