此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Information and Communication Technology Based Centralized Clinical Trial Monitoring System for Insulin Dose Adjustment (ICT)

2019年4月4日 更新者:Sang-Man Jin、Samsung Medical Center

An Information and Communication Technology-based Centralized Clinical Trial to Determine the Efficacy and Safety of Insulin Dose Adjustment Education Based on a Smartphone Personal Health Record Application

This is a 24-week, open-label, randomized, multi-center trial conducted in three tertiary hospitals. There are three follow-up measures; at baseline, post-intervention at Week 12, and Week 24. Subjects are diagnosed as type 1 DM, type 2 DM, and/or post-transplant DM, and initiate or currently use insulin therapy. After the given education on insulin dose titration and prevention for hypoglycemia and 1 week of run-in period, subjects are randomized in a 1:1 ratio to either the ICT-based intervention group or the conventional intervention group. Subjects in conventional intervention group will save and send their health information to the server via the PHR app, whereas those in ICT-based intervention group have additional algorithm-based feedback messages. The health information includes levels of blood glucose, insulin dose, details on hypoglycemia, food diary, and number of steps. The primary outcome will be the proportion of patients who reach an optimal insulin dose within 12 weeks of enrolling in the study without severe hypoglycemia or unscheduled clinic visits.

This study is based upon work supported by the Ministry of Trade, Industry & Energy (MOTIE, Korea) under Industrial Technology Innovation Program (No. 10059066, 'Establishment of ICT Clinical Trial System and Foundation for Industrialization.")

研究概览

详细说明

This is a 24-week, open, randomized, multi-center ICT-based clinical trial conducted in three different hospitals including Samsung Medical Center, Kangbuk Samsung Hospital, and Samsung Changwon Hospital. There are three follow-up measures; at baseline, post-intervention at Week 12, and Week 24. Subjects diagnosed as T1DM, T2DM, and/or post-transplant DM who initiate or currently use insulin therapy will be given education on insulin injection, dose adjustment, and prevention for hypoglycemia and provided at-home measurement device at Visit 1 for screening. Subjects will receive instructions to check daily glucose levels by home glucose meter, to record insulin regimen and dose, the hypoglycemia diary if blood glucose <70 mg/dL or a hypoglycemic event occurs in the apps, and to synchronize data for automatically transferring to system. Subjects who synchronized their information more than once during 1 week of run-in period will be selected into clinical trial and randomly assigned to either ICT-based intervention group or conventional intervention group at a ratio of 1:1. After the randomization, at Week 1, diabetes educators provide telephone counselling for re-instructing insulin dose adjustment and for re-confirming their use of at-home measurement device and PHR apps at Visit 2 (televisit). Subjects in ICT-based intervention group will have algorithm-based feedback messages when their glucose levels are out of ranges, in addition to recording, saving and sending their data to the server via the PHR app, and those in conventional intervention group will only record, save and send their data to the server via the PHR app. Investigators examine the saved health information such as levels of blood glucose, insulin dose, details on hypoglycemia recorded in hypoglycemia diary, food diary, and number of steps transferred through PHR apps. At each clinical visit, anthropometric parameters, current medication use including types of insulin, insulin dose, and other glucose-lowering agents, vital signs, body composition, and questionnaire for satisfaction investigation are examined face-to-face, and blood tests are performed. The unscheduled visit to clinic could be applied if a subject has one or more severe hypoglycemia (requiring other help for recovery) during the study period, or hypoglycemia (<70 mg/dL) twice or more times per week, or fasting blood glucose >200 mg/dL three or more times in the morning, and wants to see a doctor during Week 1-12. The unscheduled visit to clinic is also allowed to the subjects who have difficulty in insulin dose adjustment despite of two or more unscheduled tele-visit. However, even if this criterion does not apply, patients who initiate insulin or change their regimen (eg, from basal insulin once daily to premixed insulin or multiple dose insulin injections) will be allowed to have additional planned doctor visits prior to Visit 3, which is not included in the unscheduled visit, but will be evaluated as scheduled additional visit. The primary outcome will be the proportion of patients who reach an optimal insulin dose within 12 weeks of enrolling in the study without severe hypoglycemia or unscheduled clinic visits.

研究类型

介入性

注册 (实际的)

112

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

      • Seoul、大韩民国、135-710
        • Samsung Medical Center

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

18年 至 69年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria

  1. age between 18-69 years
  2. diagnosis of T1DM, T2DM, and/or post-transplant DM (Post-transplant DM includes both diagnosed T1DM or T2DM before organ transplantation and first diagnosed DM after organ transplantation)
  3. initiation or current use of insulin therapy including once-daily basal insulin (including basal insulin only or basal insulin plus rapid-acting insulin), premixed insulin, or NPH)
  4. most recent hemoglobin A1c (HbA1c) ≥7.0% based on the National Glycohemoglobin Standardization Program (NGSP) at least 3 months prior to participation (recent HbA1c values measured <3 months prior to screening are permitted.)
  5. available to use smartphone and wireless internet
  6. Voluntarily write consent to participate in the trial

Exclusion criteria

  1. on insulin pump
  2. history of alcohol or drug abuse 1 year prior to participation
  3. history of psychological disorder (e.g., schizophrenia, depression, or bipolar disorder)
  4. history of severe visual or hearing impairment
  5. pregnant
  6. any condition, in the investigator's opinion, not suitable for enrollment eligibility.

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
有源比较器:ICT-based intervention
Subjects in the ICT-based intervention group have algorithm-based feedback messages in addition to conventional intervention
ICT-based intervention group have algorithm-based feedback messages in addition to conventional intervention
Subjects will save and send their health information to the server via the personal health record app
安慰剂比较:Conventional intervention group
Subjects in the conventional intervention group will only save and send their health information to the server via the personal health record app
Subjects will save and send their health information to the server via the personal health record app

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
the proportion of patients who reach his/her optimal insulin dose within 12 weeks of enrolling in the study without severe hypoglycemia or unscheduled clinic visits.
大体时间:Week 12
Reaching optimal insulin dose: A.For a patient who uses basal insulin only or basal insulin with pre-meal rapid-acting insulin once per day,1)3 or more fasting blood glucose(FBG) values in the morning within the target range(80-130mg/dL or 100-140 mg/dL) during Week12,2)no nocturnal(11pm-7am) or pre-breakfast hypoglycemia(<70mg/dL) during Week12,3)variation of basal insulin dose (the difference between the highest and lowest basal insulin dose) of <10% of mean total basal insulin dose during Week12. B.For a patient who uses MDI at least twice per day, the criteria A plus 4)3 or more days in which correction dose premeal insulin is required less than 3times per day during the Week12,5) no daytime(7am-11pm) hypoglycemia during Week12. C.For a patient who uses premixed insulin or NPH,1)3 or more FBG values in the morning and evening within the target range during Week 12,2) no nocturnal or pre-breakfast hypoglycemia during Week12
Week 12

次要结果测量

结果测量
措施说明
大体时间
the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 24
大体时间:Week 24
the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 24
Week 24
the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 12
大体时间:Week 12
the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 12
Week 12
mean fasting blood glucose values for three consecutive days prior to Week 12 and Week 24
大体时间:Week 12 and 24
mean fasting blood glucose values for three consecutive days prior to Week 12 and Week 24
Week 12 and 24
levels of HbA1c at Week 12 and Week 24
大体时间:Week 12 and Week 24
levels of HbA1c at Week 12 and Week 24
Week 12 and Week 24
lipid profile at Week 12 and Week 24
大体时间:Week 12 and 24
lipid profile at Week 12 and Week 24
Week 12 and 24
the proportion of patients having hypoglycemia (total, asymptomatic, daytime, nighttime, severe hypoglycemia, and coma/convulsions) at Week 12 and Week 24
大体时间:Week 12 and Week 24
the proportion of patients having hypoglycemia (total, asymptomatic, daytime, nighttime, severe hypoglycemia, and coma/convulsions) at Week 12 and Week 24
Week 12 and Week 24
the number of steps during Week 1-12 and Week 13-24
大体时间:Week 12 and Week 24
the number of steps during Week 1-12 and Week 13-24
Week 12 and Week 24
recorded exchange unit by food group
大体时间:Week 12 and 24
recorded exchange unit by food group (grains, meats and protein, fruits, vegetables, dairy, and fats and oils) in each breakfast, lunch, and dinner on 3-day food diary at Week 12 and 24
Week 12 and 24
daily insulin dose
大体时间:Week 12 and Week 24
daily insulin dose at Week 12 and Week 24
Week 12 and Week 24
blood pressure
大体时间:Week 12 and Week 24
blood pressure at Week 12 and Week 24
Week 12 and Week 24
body weight
大体时间:Week 12 and Week 24
body weight at Week 12 and Week 24
Week 12 and Week 24
lean body mass
大体时间:Week 12 and 24
lean body mass at Week 12 and Week 24
Week 12 and 24
fat mass
大体时间:Week 12 and 24
fat mass at Week 12 and Week 24
Week 12 and 24
Satisfaction evaluation by questionnaire for ICT-based centralized clinical trial monitoring
大体时间:Week 12 and 24
Satisfaction evaluation by questionnaire for ICT-based centralized clinical trial monitoring at Week 12 and 24
Week 12 and 24
Satisfaction evaluation by DTSQ
大体时间:Week 12 and 24
Satisfaction evaluation by DTSQ at Week 12 and 24
Week 12 and 24
the number of telephone counselling by diabetes educators
大体时间:Week 12 and 24
the number of telephone counselling by diabetes educators
Week 12 and 24
the number of self-monitoring blood glucose measurements
大体时间:Week 12 and 24
the number of self-monitoring blood glucose measurements
Week 12 and 24

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。

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)

2017年9月26日

初级完成 (实际的)

2018年9月30日

研究完成 (实际的)

2018年12月30日

研究注册日期

首次提交

2017年4月4日

首先提交符合 QC 标准的

2017年4月9日

首次发布 (实际的)

2017年4月13日

研究记录更新

最后更新发布 (实际的)

2019年4月5日

上次提交的符合 QC 标准的更新

2019年4月4日

最后验证

2019年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

糖尿病的临床试验

3
订阅