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Closed-loop Control of Overnight Glucose Levels in Adults and Adolescents With Type 1 Diabetes

2014年10月18日 更新者：Rémi Rabasa-Lhoret、Institut de Recherches Cliniques de Montreal

An Open-label, Randomized, Three-way, Multicenter Study to Compare the Efficacy of Single-hormone Closed-loop Strategy, Dual-hormone Closed-loop Strategy and Conventional Insulin Pump Therapy in Regulating Overnight Glucose Levels at Home in Adolescents and Adults With Type 1 Diabetes

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.

The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose levels in a out-patient study in adults and adolescents with type 1 diabetes.

The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating overnight glucose levels in adults and adolescents with type 1 diabetes compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.

We aim to conduct a multicenter study to compare the efficacy of conventional pump therapy, single-hormone closed-loop strategy and dual-hormone closed-loop strategy to regulate overnight glucose levels, at home, in adolescents and adults with type 1 diabetes. Each intervention will be tested on two nights: 1) After a carbohydrate-rich dinner meal (to exaggerate hyperglycemic risk and; 2) After an evening exercise (to exaggerate hypoglycemic risk).

研究类型

介入性

注册 (实际的)

28

阶段

  • 阶段2

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

  • 加拿大
    • Ontario
      • Toronto、Ontario、加拿大
        • Mount Sinai Hospital
    • Quebec
      • Montreal、Quebec、加拿大
        • Institut de recherches cliniques de Montréal
      • Montreal、Quebec、加拿大
        • Montreal Children Hospital

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

12年 及以上 (孩子、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:

  • Males and females aged ≥ 12 years of old.
  • Body mass index < 35
  • Clinical diagnosis of type 1 diabetes for at least one year.
  • The subject will have been on insulin pump therapy for at least 4 months.
  • HbA1c < 12%.
  • At least two visits with an endocrinology team in the past 1 year.

Exclusion Criteria:

  • Clinically significant nephropathy, neuropathy (peripheral or autonomic e.g. significant gastroparesis) or retinopathy as judged by the investigator.
  • Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  • A recent injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol.
  • Ongoing pregnancy.
  • Severe hypoglycemic episode within two weeks of screening.
  • Current use of glucocorticoid medication (except low stable dose and inhaled therapy).
  • Known or suspected allergy to the insulin aspart, glucagon, Medtronic sensors, or Medtronic infusion sets..
  • Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
  • Anticipating a significant change in treatment regimen between admissions (such as a major change in an exercise routine, significant change in dietary routine or in insulin therapy.
  • Failure to comply with team's recommendations.

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：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
有源比较器：Conventional insulin pump therapry
Subjects will use conventional pump therapy to regulate their glucose levels.
其他：Carbohydrate-rich meal
At 19:30, patients will eat a standardized large meal (110g carbohydrate for males; 90g carbohydrate for females). Conventional insulin pump therapy or closed-loop system will be use to control glucose levels from 21:00 until 7:00 next morning.
其他：Exercise
Study participants will go to a training facility around 18:00 to perform a 60min workout at 60% heart rate reserve. The workout will be on a treadmill and/or a stationary bicycle. Conventional insulin pump therapy or closed-loop system will be use to regulate glucose levels from 21:00 until 7:00 next morning.
有源比较器：Single-hormone closed-loop system
Variable subcutaneous insulin infusion rate will be used to regulate glucose levels. Insulin Aspart (Novorapid) will be infused using a subcutaneous infusion pump. The glucose level as measured by the real time sensor will be entered manually into the computer every 10 minutes. The pump's infusion rate will then be changed manually based on the computer-generated recommendations of infusion rates.
其他：Carbohydrate-rich meal
At 19:30, patients will eat a standardized large meal (110g carbohydrate for males; 90g carbohydrate for females). Conventional insulin pump therapy or closed-loop system will be use to control glucose levels from 21:00 until 7:00 next morning.
其他：Exercise
Study participants will go to a training facility around 18:00 to perform a 60min workout at 60% heart rate reserve. The workout will be on a treadmill and/or a stationary bicycle. Conventional insulin pump therapy or closed-loop system will be use to regulate glucose levels from 21:00 until 7:00 next morning.
有源比较器：Dual-hormone closed-loop system
Insulin Aspart (Novorapid) and glucagon (Paladin) will be infused using two separate subcutaneous infusion pumps. The glucose levels as measured by the real time sensor will be entered manually into the computer every 10 minutes. The pumps' infusion rate will then be changed manually based on the computer generated-recommendation delivery levels.
其他：Carbohydrate-rich meal
At 19:30, patients will eat a standardized large meal (110g carbohydrate for males; 90g carbohydrate for females). Conventional insulin pump therapy or closed-loop system will be use to control glucose levels from 21:00 until 7:00 next morning.
其他：Exercise
Study participants will go to a training facility around 18:00 to perform a 60min workout at 60% heart rate reserve. The workout will be on a treadmill and/or a stationary bicycle. Conventional insulin pump therapy or closed-loop system will be use to regulate glucose levels from 21:00 until 7:00 next morning.

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
Percentage of time in target range
大体时间：8 hours
Percentage of time for which glucose levels (as measured by the glucose sensor) are in target range. Target range is defined to be between 4.0 to 8.0 mmol/L
8 hours

次要结果测量

结果测量
措施说明
大体时间
Percentage of time in target range for each night separately
大体时间：8 hours
Percentage of time for which glucose levels are in target range for each night separately. Target range is defined to be between 4.0 and 8.0 mmol/L.
8 hours
Percentage of time in target range for the pooled data
大体时间：8 hours
Percentage of time for which glucose levels are in target range for the pooled data. Target range is defined to be between 4.0 to 8.0 mmol/L.
8 hours
Percentage of time spent below 4.0 mmol/L
大体时间：8 hours
Percentage of time for which glucose levels are below 4.0 mmol/L.
8 hours
Percentage of time spent below 3.3 mmol/L
大体时间：8 hours
Percentage of time for which glucose levels are spent below 3.3 mmol/L.
8 hours
Area under the curve for glucose levels below 4.0 mmol/L
大体时间：8 hours
8 hours
Area under the curve for glucose levels below 3.3 mmol/L
大体时间：8 hours
8 hours
Percentage of time spent above 8.0 mmol/L
大体时间：8 hours
Percentage of time for which glucose levels are above 8.0 mmol/L
8 hours
Percentage of time spent above 10.0 mmol/L
大体时间：8 hours
Percentage of time for which glucose levels are above 10.0 mmol/L.
8 hours
Area under the curve for glucose levels spent above 8.0 mmol/L
大体时间：8 hours
8 hours
Area under the curve for glucose levels spent above 10.0 mmol/L
大体时间：8 hours
8 hours
Mean glucose levels
大体时间：8 hours
8 hours
Standard deviation of glucose levels
大体时间：8 hours
Standard deviation of glucose levels as a measure of glucose variability.
8 hours
Total insulin delivery
大体时间：8 hours
8 hours
Number of subjects experiencing at least one hypoglycemic event requiring treatment
大体时间：8 hours
8 hours
Number of hypoglycemic events requiring treatment
大体时间：8 hours
8 hours

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

Institut de Recherches Cliniques de Montreal

合作者

McGill University
Mount Sinai Hospital, New York
Montreal Children's Hospital of the MUHC

调查人员

  • 首席研究员：Bruce Perkins、Mount Sinai Hospital

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

2013年7月1日

初级完成 (实际的)

2014年9月1日

研究完成 (实际的)

2014年9月1日

研究注册日期

首次提交

2013年7月12日

首先提交符合 QC 标准的

2013年7月17日

首次发布 (估计)

2013年7月22日

研究记录更新

最后更新发布 (估计)

2014年10月21日

上次提交的符合 QC 标准的更新

2014年10月18日

最后验证

2014年10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

  • CLASS-04

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.

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