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每月视频咨询作为 1 型糖尿病患儿常规护理的附加手段的效果:一项为期 6 个月的准随机临床试验及后续扩展阶段。

Outcomes of monthly video consultations as an add-on to regular care for children with type 1 diabetes: A 6-month quasi-randomized clinical trial followed by an extension phase.

机构信息

Division of Pediatric Endocrinology and Diabetology, University Medical Center Schleswig-Holstein, Lübeck, Germany.

Institute for Social Medicine and Epidemiology, University of Lübeck, Lübeck, Germany.

出版信息

Pediatr Diabetes. 2020 Dec;21(8):1502-1515. doi: 10.1111/pedi.13133. Epub 2020 Oct 15.

Abstract

OBJECTIVE

To explore the outcomes of monthly video consultations for children with diabetes.

METHODS

The Virtual Outpatient Diabetes Clinic for Children and Youth (VIDIKI) was a 6-month multicenter controlled clinical trial followed by an extension phase. The 240 participants (1-16 years), all using a CGM, were quasi-randomized by residence location to the intervention group (IG) or the waitlist-control group (WG). The IG started immediately after enrollment with monthly video consultations as an add-on to regular care, while the WG received regular care for 6 months before starting the intervention. The extension phase lasted between 12 months and 2 years, depending on the enrollment date. Linear regression was applied to model the primary outcome of HbA1c after 6 months and other metabolic and psychosocial outcomes.

RESULTS

After covariate adjustments, the HbA1c at 6 months-corresponding to the controlled treatment phase-was 0.11% lower in the IG than that in the WG (95% CI -0.31 to 0.09, P = .277). For the total study sample, a significant HbA1c improvement was found after 12 months of video consultations, which increased further until month 15. The diabetes burden of the main caregivers was lower, and parental treatment satisfaction was significantly higher in the IG than that in the WG.

CONCLUSIONS

The VIDIKI study found no significant HbA1c difference between IG and WG after 6 months in the controlled phase, but there was a decreased diabetes burden and increased treatment satisfaction for the parents. In the longitudinal perspective, a significant HbA1c improvement was found after 12 and 15 months.

摘要

目的

探索每月为儿童糖尿病患者提供视频咨询的结果。

方法

儿童和青年虚拟门诊糖尿病诊所(VIDIKI)是一项为期 6 个月的多中心对照临床试验,随后是扩展阶段。240 名(1-16 岁)参与者均使用连续血糖监测仪,根据居住地点准随机分配到干预组(IG)或候补对照组(WG)。IG 在入组后立即开始每月进行视频咨询,作为常规护理的附加治疗,而 WG 在开始干预前先接受 6 个月的常规护理。扩展阶段的持续时间根据入组日期在 12 个月至 2 年之间。线性回归用于建立主要结局(HbA1c)在 6 个月后的模型以及其他代谢和心理社会结局。

结果

经过协变量调整后,IG 组在 6 个月时的 HbA1c 比 WG 组低 0.11%(95%CI-0.31 至 0.09,P =.277)。对于整个研究样本,在进行了 12 个月的视频咨询后,HbA1c 显著改善,并且在第 15 个月时进一步增加。IG 组的主要照顾者的糖尿病负担较低,并且父母对治疗的满意度明显高于 WG 组。

结论

VIDIKI 研究发现,在控制阶段的 6 个月内,IG 组和 WG 组的 HbA1c 没有显著差异,但父母的糖尿病负担减轻,治疗满意度增加。从纵向角度来看,在 12 个月和 15 个月后发现 HbA1c 显著改善。

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