NCT04936633已完成不适用
Efficacy of Remote Intervention by Medical Staff Based on a Cloud System of Continuous Glucose Monitoring Data in Patients With Insulin-dependent Diabetes Using a Flash Sensor-based Glucose Monitoring (FSGM)
Young Shin Song1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年6月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Changes in glycemic control measured by HbA1c
研究概览
简要总结
To investigate the efficacy of remote intervention by medical staff based on a cloud system of continuous glucose monitoring data in patients with insulin-dependent diabetes using flash sensor-based glucose monitoring (FSGM).
详细描述
- Previous studies have been reported on the efficacy of CGM or FSGM and education on glucose control in insulin-dependent diabetes patients.
- This study aims to investigate whether it is more effective to receive remote intervention by medical staff based on a cloud system, than only to use FSGM and receive general education on FSGM.
- Trial design : parallel group, allocation ratio 1:1, a superiority study design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 19 to 75 years old
- •Patients with type 1 diabetes
- •Patients on multiple daily insulin-injection or continuous subcutaneous insulin infusion therapy for more than 1 year
- •Patients with HbA1c ≥ 7.0% at screening
- •Patients willing to use a FSGM system
- •Patients with informed consent
排除标准
- •Gestational diabetes patients
- •Patients within 1 year of diabetic diagnosis
- •Patients taking drugs for severe cognitive impairment or psychiatric problems
- •Patients who received oral or parenteral corticosteroid therapy for more than 7 consecutive days within 1 month before screening test
- •Patients with severe infection, before and after surgery, and severe trauma
- •Patients on dialysis at the end of renal failure
- •Patients who have a history of substance abuse or alcoholism within 12 weeks through patient history taking, diagnosis records, and past treatment records
- •Pregnant or lactating women
- •Participating in other clinical trials under R&D other than this clinical trial, or if other clinical trial drugs are administered within 4 weeks before the trial
- •Patients who are using a CGMS/FSGM or who have been using it within 12 weeks
研究组 & 干预措施
No intervention by medical staff
No Intervention
The patients who start FSGM and receive general education on FSGM only.
Intervention by medical staff based on a cloud system
Experimental
The patients who start FSGM and receive general education on FSGM and remote intervention based on a cloud system.
干预措施: Intervention by medical staff based on a cloud system (Other)
结局指标
主要结局
Changes in glycemic control measured by HbA1c
时间窗: 3 months
Difference between baseline HbA1c and follow-up HbA1c
次要结局
- Changes in the mean glucose values(3 months)
- Changes in hypoglycemic episodes(3 months)
- Changes in the patient relative satisfaction with treatment assessed by questionnaires(3 months)
- Changes in depression assessed by questionnaires(3 months)
- Changes in the duration of hypoglycemic episodes(3 months)
- Changes in the duration of hyperglycemic episodes(3 months)
- Changes in blood pressure(3 months)
- Changes in body weight(3 months)
- Lifestyle changes in the duration of exercises(3 months)
- Changes in the time in range(3 months)
- Changes in the mean number of scans(3 months)
- Changes in the frequency of use of trend arrows(3 months)
- Changes in the insulin dose(3 months)
- Changes in the lipid parameter(3 months)
- Lifestyle changes in diet(3 months)
- Lifestyle changes in the number of exercises(3 months)
- Changes in the patient absolute satisfaction with treatment assessed by questionnaires(3 months)
- Changes in anxiety assessed by questionnaires(3 months)
研究者
Young Shin Song
A ssistant Professor
CHA University
研究点 (1)
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