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Closed-loop Control of Glucose Levels After Meal Intake in Adults With Type 1 Diabetes

2014年4月8日 更新者：Rémi Rabasa-Lhoret、Institut de Recherches Cliniques de Montreal

An Open-label, Randomized, Three-way, Cross-over Study to Compare the Efficacy of Closed-loop Operation Combined With Meal-and-carbohydrate-announcement Closed-loop Operation Combined With Meal-announcement, and Conventional Pump Therapy in Regulating Glucose Levels in 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 dosage based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon.

The objective of this project is to assess whether a dual-hormone closed-loop strategy would alleviate the burden of carbohydrate counting from patients with type 1 diabetes (T1D) without a significant degradation in post-meal glucose control.

Our primary hypothesis is that meal-announcement strategy (pre-meal CHO-independent bolus) is equivalent to meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) during closed-loop regulation of glucose levels in adults with T1D. Our secondary hypothesis is that closed-loop strategy with meal-announcement strategy (pre-meal CHO-independent bolus) or meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) is better than conventional pump treatment in regulation of glucose levels in adults with T1D.

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.

Each patient will be admitted three times to a clinical research facility. In the meal-and-carbohydrate-announcement visit, patients will eat 3 meals accompanied with a matching insulin bolus (depending on the carbohydrate content of the meal) and glucose levels will be subsequently regulated using dual-hormone closed-loop system. In the meal-announcement visit, patients will eat the 3 same meals but will inject only a partial insulin bolus (not depending on carbohydrate content of the meal) and the remaining needed insulin will be delivered based on glucose sensor excursions as part of closed-loop operation. In the control visit, patients will use conventional pump therapy to regulate glucose levels.

研究类型

介入性

注册 (实际的)

12

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
    • Quebec
      • Montreal、Quebec、加拿大、H2W1R7
        • Institut de recherches cliniques de Montréal

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:

  • Males and females ≥ 18 years of old.
  • Clinical diagnosis of type 1 diabetes for at least one year.
  • The subject will have been on insulin pump therapy for at least 3 months.
  • Last (less than 3 months) HbA1c ≤ 12%.

Exclusion Criteria:

  • Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
  • Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  • Ongoing pregnancy.
  • Severe hypoglycemic episode within two weeks of screening.
  • Medication likely to affect with the interpretation of the results because of their well known impact on gastric emptying: Motilium®, Prandase®, Victoza®, Byetta® and Symlin®.
  • Known or suspected allergy to the trial products, meal contents including nuts, peanuts, dairy products or eggs.
  • Unusual nutritional habits (e.g. vegetarians)
  • Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
  • Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).
  • Unreliable carbohydrate counting or lack of insulin to carbohydrate ratios
  • Problems with venous access

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：CHO-dependant bolus

An insulin bolus dependant of carbohydrate content will be given after each meal.

Each subject insulin-to-carbohydrate ratio (U per 10g CHO) will be used to calculate the insulin bolus to be given. The dual-hormone closed-loop strategy will give the remaining insulin needed based on the sensor readings.
其他：14 hours intervention
Subjects will be admitted at the IRCM at 6:30. Subjects will be asked to fast from midnight. At 8:00, a standardized (50g CHO for males; 30g CHO for females) meal will be served. At 12:00, a standardized (120g CHO for males; 90g CHO for females) meal will be served. At 17:00, a standardized (70g CHO for males; 50g CHO for females) meal will be served. Between meals, patients will be allowed to do sedentary activities (reading, watching television, and playing video games, etc).
有源比较器：CHO-independent bolus
An insulin bolus independent of carbohydrate content will be given after each meal. The dual-hormone closed-loop strategy will give the remaining insulin needed based on the sensor readings.
其他：14 hours intervention
Subjects will be admitted at the IRCM at 6:30. Subjects will be asked to fast from midnight. At 8:00, a standardized (50g CHO for males; 30g CHO for females) meal will be served. At 12:00, a standardized (120g CHO for males; 90g CHO for females) meal will be served. At 17:00, a standardized (70g CHO for males; 50g CHO for females) meal will be served. Between meals, patients will be allowed to do sedentary activities (reading, watching television, and playing video games, etc).
有源比较器：Conventional treatment
Patients will use conventional pump therapy to regulate glucose levels
其他：14 hours intervention
Subjects will be admitted at the IRCM at 6:30. Subjects will be asked to fast from midnight. At 8:00, a standardized (50g CHO for males; 30g CHO for females) meal will be served. At 12:00, a standardized (120g CHO for males; 90g CHO for females) meal will be served. At 17:00, a standardized (70g CHO for males; 50g CHO for females) meal will be served. Between meals, patients will be allowed to do sedentary activities (reading, watching television, and playing video games, etc).

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 positive incremental area under the curve of postprandial glucose excursions
大体时间：4 hours after meal intake
The positive incremental area under the curve (IAUC, as compared to pre-meal glucose value) of the 4-hr postprandial glucose excursions for the breakfast, lunch and dinner meals.
4 hours after meal intake

次要结果测量

结果测量
大体时间
Mean plasma glucose
大体时间：8h00 to 21h00
8h00 to 21h00
Incremental two hours postprandial glucose
大体时间：2 hours after meal intake
2 hours after meal intake
Incremental postprandial peak-glucose values
大体时间：8h00 to 21h00
8h00 to 21h00
Percentage of time of plasma glucose levels between 4.0 and 10.0 mmol/L
大体时间：8h00 to 21h00
8h00 to 21h00
Percentage of time of plasma glucose levels spent above 10.0 mmol/L
大体时间：8h00 to 21h00
8h00 to 21h00
Percentage of time of plasma glucose levels spent below 4.0 mmol/L
大体时间：8h00 to 21h00
8h00 to 21h00
Total insulin delivery
大体时间：8h00 to 21h00
8h00 to 21h00
Total glucagon delivery
大体时间：8h00 to 21h00
8h00 to 21h00
Standard deviation of glucose levels
大体时间：8h00 to 21h00
8h00 to 21h00
Percentage of time of plasma glucose concentrations below 3.5 mmol/L
大体时间：8h00 to 21h00
8h00 to 21h00
Percentage of time of plasma glucose concentrations above 14 mmol/L
大体时间：8h00 to 21h00
8h00 to 21h00
Mean plasma insulin concentration
大体时间：8h00 to 21h00
8h00 to 21h00
Mean plasma glucagon concentration
大体时间：8h00 to 21h00
8h00 to 21h00
Number of patients experiencing hypoglycemia requiring oral treatment
大体时间：8h00 to 21h00
8h00 to 21h00
Incremental area under the curve of the 4-hr postprandial glucose excursions but the reference glucose is set to 5.0 mmol/L if premeal glucose is less than 5.0 mmol/L.
大体时间：4 hours after meal intake
4 hours after meal intake

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

Juvenile Diabetes Research Foundation

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8月1日

初级完成 (实际的)

2014年2月1日

研究完成 (实际的)

2014年2月1日

研究注册日期

首次提交

2013年8月23日

首先提交符合 QC 标准的

2013年8月23日

首次发布 (估计)

2013年8月28日

研究记录更新

最后更新发布 (估计)

2014年4月9日

上次提交的符合 QC 标准的更新

2014年4月8日

最后验证

2014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

  • CLASS-05

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