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Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses

2020年4月18日 更新者：Marc Breton、University of Virginia

Pilot Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses

This will be a randomized, cross-over, unblinded study with subjects randomized upon entry into the study to either begin using the Klue software for 6 weeks or to continue with their usual care for 6 weeks. Subjects are eligible for enrollment if they are using a continuous glucose monitor (CGM) with an insulin pump or an insulin pen with memory, and are missing or late in giving at least 4 food boluses in the previous two weeks. Missing or late meal boluses will be assessed through their pump/pen and sensor downloads. This is a pilot study. There is no preliminary data to do a true power calculation. The primary outcome will be the change in the number of missed meal boluses in the two weeks prior to each visit. Secondary outcome measures will be the number of missed meal boluses in each month of the study, change in HbA1c levels (measured every 6 weeks), accuracy of the Klue software in detecting meals (true positive and false positive rates), and a user satisfaction survey.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

12

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

  • 美国
    • Virginia
      • Charlottesville、Virginia、美国、22908
        • University of Virginia

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 及以上 (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:

  • Age 18 and over
  • Using an insulin pump for at least 3 months and currently using CGM or using an insulin pen with memory and currently using a CGM
  • Willing to wear a CGM at least 70% of the time while in the study
  • Willing to wear an Apple watch on their dominant hand while awake
  • Missing or late in giving at least four food boluses in the previous 2 weeks
  • Understanding and willingness to follow the protocol and sign informed consent

Exclusion Criteria:

  • Pregnant or lactating women
  • A known medical condition that in the judgement of the investigator might interfere with the completion of the protocol Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
  • Current treatment for a seizure disorder
  • Inpatient psychiatric treatment in the past 6 months

Subject may participate in another trial if it is approved by the investigators of both trials.

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：支持治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Klue App Use then Usual Care
Subjects will use the Klue App during the first 6 weeks of the trial. At 6 weeks, subjects will discontinue Klue App use and will continue the final 6 weeks without the product.
其他：Klue App
The Klue App utilizes an Apple Watch to detect eating or drinking behavior. The App can initiate a sequence of questions when eating/drinking is detected to determine if a subject has administered a bolus for the meal or if they need to do so.
实验性的：Usual Care then Klue App Use
Subjects will begin the study without using the Klue App during the first 6 weeks of the trial. At 6 weeks, subjects will begin the use of the Klue App and will continue the final 6 weeks with the product.
其他：Klue App
The Klue App utilizes an Apple Watch to detect eating or drinking behavior. The App can initiate a sequence of questions when eating/drinking is detected to determine if a subject has administered a bolus for the meal or if they need to do so.

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
Number of missed meal boluses
大体时间：During the two weeks prior to each visit
The change in the number of missed meal boluses
During the two weeks prior to each visit

次要结果测量

结果测量
措施说明
大体时间
Number of missed meal boluses as a measure of attenuation to the alerts
大体时间：6 weeks
The change in the number of missed meal boluses as a measure of attenuation to the alerts
6 weeks
Number of missed meal boluses as a measure of attenuation to the alerts
大体时间：12 weeks
The change in the number of missed meal boluses as a measure of attenuation to the alerts
12 weeks
Change in Hemoglobin A1c Levels
大体时间：3 months
Change in Hemoglobin A1c Levels
3 months
Time in range 70-180 mg/dL
大体时间：6 weeks
Time in range 70-180 mg/dL as measured by CGM
6 weeks
Time in range 70-180 mg/dL
大体时间：12 weeks
Time in range 70-180 mg/dL as measured by CGM
12 weeks
Percent time <70 mg/dL mean glucose
大体时间：6 weeks
Percent time <70 mg/dL mean glucose as measured by CGM
6 weeks
Percent time <70 mg/dL mean glucose
大体时间：12 weeks
Percent time <70 mg/dL mean glucose as measured by CGM
12 weeks
Glucose Coefficient of Variation
大体时间：6 weeks
Glucose (as measured by CGM) Coefficient of Variation
6 weeks
Glucose Coefficient of Variation
大体时间：12 weeks
Glucose (as measured by CGM) Coefficient of Variation
12 weeks
Total daily insulin dose
大体时间：6 weeks
Total daily insulin dose
6 weeks
Total daily insulin dose
大体时间：12 weeks
Total daily insulin dose
12 weeks
Number of meal bolus injections each day
大体时间：6 weeks
Number of meal bolus injections each day
6 weeks
Number of meal bolus injections each day
大体时间：12 weeks
Number of meal bolus injections each day
12 weeks
Number of total bolus injections each day
大体时间：6 weeks
Number of total bolus injections each day
6 weeks
Number of total bolus injections each day
大体时间：12 weeks
Number of total bolus injections each day
12 weeks
Total daily basal insulin
大体时间：6 weeks
Total daily basal insulin
6 weeks
Total daily basal insulin
大体时间：12 weeks
Total daily basal insulin
12 weeks
Accuracy of Klue in detecting meals
大体时间：3 months
Accuracy of Klue in detecting meals (true positive and false positive rates)
3 months
User satisfaction of Klue
大体时间：3 months
User satisfaction of Klue
3 months
Diabetes-Specific Attitudes about Technology (DSAT) Scores
大体时间：3 months
DSAT Scores (Scaled from "Strongly Disagree" to "Strongly Agree" in relation to attitudes related to technology in diabetes treatment)
3 months
Diabetes Distress Scale (DDS) Scores
大体时间：3 months
DDS Scores (Scaled from "Not a Problem" to "A Very Serious Problem" in relation to feelings/mood related to diabetes)
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。

赞助

University of Virginia

合作者

Stanford University
Klue, Inc.

调查人员

  • 首席研究员：Marc Breton, PhD、University of Virginia

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

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)

2019年5月29日

初级完成 (实际的)

2019年11月18日

研究完成 (实际的)

2019年11月18日

研究注册日期

首次提交

2019年1月11日

首先提交符合 QC 标准的

2019年1月15日

首次发布 (实际的)

2019年1月18日

研究记录更新

最后更新发布 (实际的)

2020年4月21日

上次提交的符合 QC 标准的更新

2020年4月18日

最后验证

2020年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 180034

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

There is no current plan to share individual participant data

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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，1 型的临床试验

Klue App的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in United Kingdom

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

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