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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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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).

研究の種類

介入

入学 (実際)

28

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • カナダ
    • Ontario
      • Toronto、Ontario、カナダ
        • Mount Sinai Hospital
    • Quebec
      • Montreal、Quebec、カナダ
        • Institut de recherches cliniques de Montréal
      • Montreal、Quebec、カナダ
        • Montreal Children Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

12年歳以上 (子、大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：Conventional insulin pump therapry
Subjects will use conventional pump therapy to regulate their glucose levels.
他の：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.
他の：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.
アクティブコンパレータ：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.
他の：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.
他の：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.
アクティブコンパレータ：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.
他の：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.
他の：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Percentage of time in target range
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of time in target range for each night separately
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：8 hours
8 hours
Area under the curve for glucose levels below 3.3 mmol/L
時間枠：8 hours
8 hours
Percentage of time spent above 8.0 mmol/L
時間枠：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
時間枠：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
時間枠：8 hours
8 hours
Area under the curve for glucose levels spent above 10.0 mmol/L
時間枠：8 hours
8 hours
Mean glucose levels
時間枠：8 hours
8 hours
Standard deviation of glucose levels
時間枠：8 hours
Standard deviation of glucose levels as a measure of glucose variability.
8 hours
Total insulin delivery
時間枠：8 hours
8 hours
Number of subjects experiencing at least one hypoglycemic event requiring treatment
時間枠：8 hours
8 hours
Number of hypoglycemic events requiring treatment
時間枠：8 hours
8 hours

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Institut de Recherches Cliniques de Montreal

協力者

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

捜査官

  • 主任研究者：Bruce Perkins、Mount Sinai Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2013年7月1日

一次修了 (実際)

2014年9月1日

研究の完了 (実際)

2014年9月1日

試験登録日

最初に提出

2013年7月12日

QC基準を満たした最初の提出物

2013年7月17日

最初の投稿 (見積もり)

2013年7月22日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年10月21日

QC基準を満たした最後の更新が送信されました

2014年10月18日

最終確認日

2014年10月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CLASS-04

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