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临床试验/NCT01525784
NCT01525784Unknown不适用

Prospective Short and Long Term Follow up of Pediatric Diabetes Mellitus Patients Receiving RT-CGMS as Part of National Clinical Care

Assaf-Harofeh Medical Center4 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
4
主要终点
to examine prospectively frequency of hypoglycemia

研究概览

简要总结

The incidence of Type 1 Diabetes Mellitus is increasing annually, in all pediatric age groups, especially among infants and toddlers.However, only 30% of diabetic children manage to achieve and maintain glycated hemoglobin A1c (HbA1c) levels below 8%, although most are treated by intensive insulin therapy.Recently, devices for real-time continuous glucose monitoring (RT-CGMS) have been introduced to aid self management of glycemic control. These devices enable the patients to see the interstitial glucose levels continuously, the trends of decrement and increment, and to have alarms prior to a severe hypoglycemic episode .

The RT-CGMS was approved in Israel for routine usage in the pediatric population, 0-18 years in 2011, indicated for those with recurrent hypoglycemic episodes. So, the aim of the investigators study is to examine prospectively the short and long term effect of the RT-CGMS routine usage, in daily routine life of the diabetic child.

详细描述

The incidence of Type 1 Diabetes Mellitus is increasing annually, in all pediatric age groups, especially among infants and toddlers.

However, only 30% of diabetic children manage to achieve and maintain glycated hemoglobin A1c (HbA1c) levels below 8%, although most are treated by intensive insulin therapy by multiple daily injections (MDI) or by subcutaneous continuous insulin infusion (SCII). The presence of high HbA1c levels increase the probability for long term complications of diabetes, as retinopathy, nephropathy and neuropathy.

This failure is attributed to multiple reasons; irregular meals, unpredictable physical activity, behavioral difficulties, refusal to accept the diabetes and maintain the required lifestyle, resistance to insulin, but , most of all fear of hypoglycemia and hypoglycemia unawareness . Further more, recurrent hypoglycemic episodes under the age of 6 years old may cause neurocognitive permanent damage.

Recently, devices for real-time continuous glucose monitoring (RT-CGMS) have been introduced to aid self management of glycemic control. These devices enable the patients to see the interstitial glucose levels continuously, the trends of decrement and increment, and to have alarms prior to a severe hypoglycemic episode .

Only few studies were performed in the pediatric population. One showed a decrement of 0.27% in HbA1c after 1 month and the other a 1 % decrement in 50% of study population after 3 months, but in the adult population. A study performed in the minority group of well controlled diabetic patients (HA1c<7.5%) demonstrated an increment of 1.56 hours per day of normoglycemia, and less time spent an hypoglycemia among those using RT-CGMS for 26 weeks.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 1-18 years
  • Type 1 Diabetes Mellitus

排除标准

  • Refusal to participate

结局指标

主要结局

to examine prospectively frequency of hypoglycemia

时间窗: 3 years

次要结局

  • To examine prosectively the effect of rt-cgms on glycemic control(3 years)
  • to assess the effect of rt-cgms on quality of life of children and parents(3 years)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Assaf Harofeh MC

Dr. Marianna Rachmiel, Assaf Haroffeh Medical Center

Assaf-Harofeh Medical Center

研究点 (4)

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