Department of Women's and Children's Health, Karolinska Institute and Hospital, Stockholm, Sweden.
BMC Pediatr. 2013 Dec 20;13:212. doi: 10.1186/1471-2431-13-212.
Continuous subcutaneous insulin infusion (CSII) treatment among children with type 1 diabetes is increasing in Sweden. However, studies evaluating glycaemic control in children using CSII show inconsistent results. The distribution of responsibility for diabetes self-management between children and parents is often unclear and needs clarification. There is much published support for continued parental involvement and shared diabetes management during adolescence. Guided Self-Determination (GSD) is an empowerment-based, person-centred, reflection and problem solving method intended to guide the patient to become self-sufficient and develop life skills for managing difficulties in diabetes self-management. This method has been adapted for adolescents and parents as Guided Self-Determination-Young (GSD-Y). This study aims to evaluate the effect of an intervention with GSD-Y in groups of adolescents starting on insulin pumps and their parents on diabetes-related family conflicts, perceived health and quality of life (QoL), and metabolic control. Here, we describe the protocol and plans for study enrollment.
METHODS/DESIGN: This study is designed as a randomized, controlled, prospective, multicentre study. Eighty patients between 12-18 years of age who are planning to start CSII will be included. All adolescents and their parents will receive standard insulin pump training. The education intervention will be conducted when CSII is to be started and at four appointments in the first 4 months after starting CSII. The primary outcome is haemoglobin A1c levels. Secondary outcomes are perceived health and QoL, frequency of blood glucose self-monitoring and bolus doses, and usage of carbohydrate counting. The following instruments will be used: Disabkids, 'Check your health', the Diabetes Family Conflict Scale and the Swedish Diabetes Empowerment Scale. Outcomes will be evaluated within and between groups by comparing data at baseline, and at 6 and 12 months after starting treatment.
In this study, we will assess the effect of starting an CSII together with the model of GSD to determine whether this approach leads to retention of improved glycaemic control, QoL, responsibility distribution and reduced diabetes-related conflicts in the family.
瑞典接受 1 型糖尿病持续皮下胰岛素输注 (CSII) 治疗的儿童人数不断增加。然而，评估 CSII 治疗儿童血糖控制情况的研究结果不一致。儿童和父母之间的糖尿病自我管理责任分配通常不明确，需要加以澄清。有大量文献支持在青少年时期继续让父母参与并共同管理糖尿病。自主指导 (GSD) 是一种基于赋权、以患者为中心的、反思和解决问题的方法，旨在指导患者实现自给自足并发展管理糖尿病自我管理困难的生活技能。该方法已针对青少年及其父母进行了改编，形成了自主指导-青少年版（GSD-Y）。本研究旨在评估 GSD-Y 小组干预对开始使用胰岛素泵的青少年及其父母的糖尿病相关家庭冲突、感知健康和生活质量 (QoL) 以及代谢控制的影响。在这里，我们描述了研究入组的方案和计划。
方法/设计：这是一项设计为随机、对照、前瞻性、多中心研究。将纳入 80 名 12-18 岁计划开始 CSII 的患者。所有青少年及其父母都将接受标准胰岛素泵培训。教育干预将在开始 CSII 时以及开始 CSII 后的前 4 个月内的 4 次预约时进行。主要结局是血红蛋白 A1c 水平。次要结局是感知健康和 QoL、血糖自我监测和推注剂量的频率以及碳水化合物计数的使用。将使用以下工具：Disabkids、“Check your health”、糖尿病家庭冲突量表和瑞典糖尿病授权量表。通过比较基线时、开始治疗后 6 个月和 12 个月的数据，在组内和组间评估结果。
在本研究中，我们将评估开始 CSII 与 GSD 模型相结合的效果，以确定这种方法是否会导致改善的血糖控制、QoL、责任分配和减少家庭中与糖尿病相关的冲突得以维持。
