Steinbeck Katharine S, Shrewsbury Vanessa A, Harvey Vanessa, Mikler Kara, Donaghue Kim C, Craig Maria E, Woodhead Helen J
Academic Department of Adolescent Medicine, The Sydney Children's Hospital at Westmead, Westmead, New South Wales, Australia.
Discipline of Paediatrics and Child Health, University of Sydney, Sydney, NSW, Australia.
Pediatr Diabetes. 2015 Dec;16(8):634-9. doi: 10.1111/pedi.12229. Epub 2014 Nov 11.
There is a paucity of randomized controlled trials (RCT) examining transition from pediatric to adult care in type 1 diabetes mellitus (T1DM). This study aimed to determine if transition in T1DM is more effective with a comprehensive transition program (CTP) compared with standard clinical practice (SCP).
This RCT recruited as young people left pediatric diabetes services. The trial co-ordinator provided CTP participants with standardized telephone communication support at week 1, and 3, 6, and 12 months post-discharge from pediatric care. SCP participants were briefly contacted at 6 and 12 months post-discharge to confirm transfer status; they received no other post-discharge contact as per usual practice. At 12 months, the primary outcomes were engagement and retention in the adult service and secondary outcomes included hemoglobin A1c (HbA1c), diabetes-related hospitalizations, microvascular complication appearance, and global self-worth.
Most CTP participants (11/14) and all SCP (12/12) participants (P = 0.2) transferred to an adult diabetes service; the median time to transfer was 14-15 wk. Overall, participants' frequency of adult diabetes service visits was sub-optimal but their retention in adult care was high. The only group difference was a higher HbA1c at baseline and follow-up in the CTP group. However, a general linear model found that follow-up HbA1c increased by 1.2% for each percentage increase in baseline HbA1c [95% confidence interval (0.4, 1.9; P = 0.01)], independent of treatment group.
Despite the challenges in recruiting adequate numbers, these findings provide valuable insights for future T1DM transition RCTs that are needed to build a more solid evidence-base in this field.
目前缺乏关于1型糖尿病(T1DM)从儿科护理过渡到成人护理的随机对照试验(RCT)。本研究旨在确定与标准临床实践(SCP)相比,全面过渡计划(CTP)在T1DM过渡中是否更有效。
这项RCT招募了即将离开儿科糖尿病服务的年轻人。试验协调员在儿科护理出院后的第1周、3个月、6个月和12个月为CTP参与者提供标准化的电话沟通支持。SCP参与者在出院后6个月和12个月被简要联系以确认转诊状态;按照常规做法,他们在出院后没有接受其他联系。在12个月时,主要结局是参与并留在成人服务机构,次要结局包括糖化血红蛋白(HbA1c)、糖尿病相关住院、微血管并发症出现情况以及总体自我价值感。
大多数CTP参与者(11/14)和所有SCP参与者(12/12)(P = 0.2)转诊到了成人糖尿病服务机构;转诊的中位时间为14 - 15周。总体而言,参与者到成人糖尿病服务机构就诊的频率未达最佳,但他们留在成人护理中的比例较高。唯一的组间差异是CTP组在基线和随访时的HbA1c较高。然而,一个一般线性模型发现,随访时的HbA1c随着基线HbA1c每增加一个百分点而增加1.2% [95%置信区间(0.4,1.9;P = 0.01)],与治疗组无关。
尽管在招募足够数量的参与者方面存在挑战,但这些发现为未来T1DM过渡RCT提供了有价值的见解,而这对于在该领域建立更坚实的证据基础是必要的。