School of Health Sciences, Bangor University, Bangor, UK
School of Healthcare Sciences, Cardiff University, Cardiff, UK.
BMJ Open. 2020 Mar 12;10(3):e032163. doi: 10.1136/bmjopen-2019-032163.
To estimate the effectiveness of standardised self-management kits for children with type 1 diabetes.
Pragmatic trial with randomisation ratio of two intervention: one control. Qualitative process evaluation.
11 diabetes clinics in England and Wales.
Between February 2010 and August 2011, we validly randomised 308 children aged 6-18 years; 201 received the 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.
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.
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.
ISRCTN17551624.
评估标准化自我管理工具包对 1 型糖尿病患儿的有效性。
采用随机分组（两组干预：一组对照）的实用性试验。定性过程评估。
英格兰和威尔士的 11 家糖尿病诊所。
2010 年 2 月至 2011 年 8 月，我们对 308 名 6-18 岁的儿童进行了有效随机分组；201 名接受了干预。
我们设计了工具包，以使儿童能够实现血糖控制，特别是通过记录血糖和调整胰岛素剂量。对照组为常规治疗。
3 个月和 6 个月时：主要指标：儿童糖尿病生活质量量表（PedsQL）。次要指标：HbA1c；一般 PedsQL；EQ-5D；医疗资源使用情况。
在五个儿童糖尿病 PedsQL 维度中，担忧维度的调整后评分在 3 个月时明显有利于自我管理工具包（儿童报告的平均差异为+5.87；标准误差[SE]=2.19；95%置信区间[CI]为+1.57 至+10.18；p=0.008），但治疗依从性在 6 个月时明显有利于对照组（儿童报告的平均差异为-4.68；SE=1.74；95%CI 为-8.10 至-1.25；p=0.008）。干预组儿童在五个儿童糖尿病 PedsQL 维度中的四个维度以及总分上，报告的从 3 个月到 6 个月的变化明显更差（平均差异为-3.20；SE=1.33；95%CI 为-5.73 至-0.67；p=0.020）。HbA1c 没有变化的证据；只有 6 个月时每组 18%的参与者达到了推荐水平。未报告与干预或其缺失有关的任何严重不良反应。工具包的使用情况较差。很少有儿童或家长将血糖读数与更好的血糖控制联系起来。这些成本为 185 英镑的工具包使许多儿童和家长感到疏远。
标准化工具包没有证据表明有效，反而抑制了糖尿病的自我管理并增加了担忧。未来的研究应该研究儿童与专业人员之间的关系，并寻求帮助儿童和家长管理糖尿病的新方法。
ISRCTN84572054。
