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临床试验/NCT03505268
NCT03505268Unknown不适用

The Impact of Telehealthcare Intervention on Glycemic Control in Children and Adolescents With Type 1 Diabetes

Assuta Hospital Systems1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2018年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
75
试验地点
1
主要终点
The impact of telehealthcare intervention on the change of the glycemic control in children with type 1 diabetes

研究概览

简要总结

This study evaluates the effect of telemedicine intervention program upon glycemic control in type 1 diabetes mellitus children and their parents in Israel. Half of the participants will receive the telemedicine intervention for a period of six months while the other half will receive the regular treatment then vice versa. Each group will receive in the intervention period 6 telemedicine meeting with a dietician and six telemedicine meetings with a nurse.

The investigators hypothesized that the participants that are recieving the telemedicine intervention will have a better glycemic control after 6 months.

详细描述

The prevalence of type 1 diabetes has been steadily increasing for the past few decades and is a relatively common chronic disease of childhood (1). Managing type 1 diabetes in young children presents unique challenges to the patient, parents, and to the pediatric health care provider. The diabetes regimen includes intensive blood glucose monitoring, multiple daily injections of insulin ,and frequent insulin dose adjustments according to the amount of carbohydrate eaten, blood sugar, and physical activity. The Diabetes Control and Complications Trail (DCCT) showed a significant link between blood glucose control and a slower onset and progression of diabetes complications, with improved glycemic control decreasing the risk of micro- and macro- vascular complication (2,3,4).

Glycosylated hemoglobin A1c (HbA1c) measures the

In the past decade a significant progress took place in therapy and treatment of diabetes. However poor glycemic control is recorded in a significant proportion of adolescents.

Telehealthcare is the use of telecommunications to deliver healthcare services and involves the remote interaction between a primary care provider and specialist. Telemedicine represents a useful and cost-effective solution to the strict follow-up required in diabetes management ,

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
1 Year 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • diagnosed with typ1 1 diabetes for at least 6 months insulin dependent participants provided consent to participate in the study consent to use the Accu-Chek Connect diabetes management app -

排除标准

  • new onset of diabetes type 1 not specified as type 1 diabetes

研究组 & 干预措施

telemedicine intervention

Experimental

The intervention group, in addition to usual care, will get 10 telemedicine interventions by a certified nurse and dietitian who both specialize in treatment of type 1 diabetes.

干预措施: Telemedicine (Behavioral)

usual care

No Intervention

Usual care consisted of visits to the diabetes center every three months and communication with their doctor by phone when needed.

结局指标

主要结局

The impact of telehealthcare intervention on the change of the glycemic control in children with type 1 diabetes

时间窗: 6 months

The glycemic control will be measured by the change from baseline Glycosylated hemoglobin A1c (HbA1c) at 6 months.

次要结局

未报告次要终点

研究者

发起方
Assuta Hospital Systems
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zohar Landau

Principal Investigator

Assuta Hospital Systems

研究点 (1)

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