Efficacy of FSGM Cloud-based Remote Intervention for Insulin-dEpendent Diabetic Patients (FRIEND)
2022年10月22日 更新者:Young Shin Song
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)
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).
研究概览
详细说明
- 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
研究类型
介入性
注册 (实际的)
36
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Gyeonggi-do
-
Seongnam、Gyeonggi-do、大韩民国、13496
- CHA Bundang Medical Center
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
19年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预:No intervention by medical staff
The patients who start FSGM and receive general education on FSGM only.
|
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实验性的:Intervention by medical staff based on a cloud system
The patients who start FSGM and receive general education on FSGM and remote intervention based on a cloud system.
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Remote intervention by medical staff (between Visit 1 and Visit 2; Week 2, 4, 6, 8, 10) : analyzing continuous glucose monitoring data for last two weeks in the cloud system - Intervention contents
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in glycemic control measured by HbA1c
大体时间:3 months
|
Difference between baseline HbA1c and follow-up HbA1c
|
3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in the time in range
大体时间:3 months
|
Difference in the duration of glucose values between 70 mg/dL and 180 mg/dL between baseline and the 3-month follow-up
|
3 months
|
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Changes in the duration of hyperglycemic episodes
大体时间:3 months
|
Difference in the duration of hyperglycemic glucose values (>180, 250 mg/dL) (baseline vs. follow-up)
|
3 months
|
|
Changes in the duration of hypoglycemic episodes
大体时间:3 months
|
Difference in the duration of hypoglycemic glucose values (<70, 54 mg/dL) (baseline vs. follow-up)
|
3 months
|
|
Changes in hypoglycemic episodes
大体时间:3 months
|
Difference between the frequency of hypoglycemic glucose values (<70, 54 mg/dL) (baseline vs. follow-up)
|
3 months
|
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Changes in the mean glucose values
大体时间:3 months
|
Difference in the mean glucose values (baseline vs. follow-up)
|
3 months
|
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Changes in the frequency of use of trend arrows
大体时间:3 months
|
Difference in the frequency of use of trend arrows (baseline vs. follow-up)
|
3 months
|
|
Changes in the mean number of scans
大体时间:3 months
|
Difference in the mean number of scans per day (baseline vs. follow-up)
|
3 months
|
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Changes in the insulin dose
大体时间:3 months
|
Difference in the insulin dose (baseline vs. follow-up)
|
3 months
|
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Changes in the lipid parameter
大体时间:3 months
|
Difference in the levels of total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol (baseline vs. follow-up)
|
3 months
|
|
Changes in blood pressure
大体时间:3 months
|
Difference in systolic blood pressure and diastolic blood pressure (baseline vs. follow-up)
|
3 months
|
|
Changes in body weight
大体时间:3 months
|
Difference in body weight (baseline vs. follow-up)
|
3 months
|
|
Lifestyle changes in diet
大体时间:3 months
|
Difference in the average number of meals and snacks per day (baseline vs. follow-up)
|
3 months
|
|
Lifestyle changes in the number of exercises
大体时间:3 months
|
Difference in the average number of exercises per week (baseline vs. follow-up)
|
3 months
|
|
Lifestyle changes in the duration of exercises
大体时间:3 months
|
Difference in the average duration of exercises per week (baseline vs. follow-up)
|
3 months
|
|
Changes in the patient absolute satisfaction with treatment assessed by questionnaires
大体时间:3 months
|
Difference in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) scores (baseline vs. follow-up)
|
3 months
|
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Changes in the patient relative satisfaction with treatment assessed by questionnaires
大体时间:3 months
|
Difference in Diabetes Treatment Satisfaction Questionnaire Change (DTSQc) scores (baseline vs. follow-up)
|
3 months
|
|
Changes in depression assessed by questionnaires
大体时间:3 months
|
Difference in Patient Health Questionnaire-9 (PHQ-9) scores (baseline vs. follow-up)
|
3 months
|
|
Changes in anxiety assessed by questionnaires
大体时间:3 months
|
Difference in General Anxiety Disorder-7 (GAD-7) scores (baseline vs. follow-up)
|
3 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Laffel LM, Kanapka LG, Beck RW, Bergamo K, Clements MA, Criego A, DeSalvo DJ, Goland R, Hood K, Liljenquist D, Messer LH, Monzavi R, Mouse TJ, Prahalad P, Sherr J, Simmons JH, Wadwa RP, Weinstock RS, Willi SM, Miller KM; CGM Intervention in Teens and Young Adults with T1D (CITY) Study Group; CDE10. Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2020 Jun 16;323(23):2388-2396. doi: 10.1001/jama.2020.6940.
- Pratley RE, Kanapka LG, Rickels MR, Ahmann A, Aleppo G, Beck R, Bhargava A, Bode BW, Carlson A, Chaytor NS, Fox DS, Goland R, Hirsch IB, Kruger D, Kudva YC, Levy C, McGill JB, Peters A, Philipson L, Philis-Tsimikas A, Pop-Busui R, Shah VN, Thompson M, Vendrame F, Verdejo A, Weinstock RS, Young L, Miller KM; Wireless Innovation for Seniors With Diabetes Mellitus (WISDM) Study Group. Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2020 Jun 16;323(23):2397-2406. doi: 10.1001/jama.2020.6928.
- Hermanns N, Ehrmann D, Schipfer M, Kroger J, Haak T, Kulzer B. The impact of a structured education and treatment programme (FLASH) for people with diabetes using a flash sensor-based glucose monitoring system: Results of a randomized controlled trial. Diabetes Res Clin Pract. 2019 Apr;150:111-121. doi: 10.1016/j.diabres.2019.03.003. Epub 2019 Mar 4.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年6月30日
初级完成 (实际的)
2022年4月30日
研究完成 (实际的)
2022年4月30日
研究注册日期
首次提交
2021年5月24日
首先提交符合 QC 标准的
2021年6月22日
首次发布 (实际的)
2021年6月23日
研究记录更新
最后更新发布 (实际的)
2022年10月25日
上次提交的符合 QC 标准的更新
2022年10月22日
最后验证
2022年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.