Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes
A Single-blind, Randomized, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy at Preventing Hypoglycemia During Unannounced and Announced Exercise in Adults With Type 1 Diabetes
Regular physical activity is associated with many health benefits for individuals with type 1 diabetes including improved cardiovascular fitness and vascular health, decreased insulin requirements, improved body composition and quality of life. However, exercise-induced hypoglycemia is very frequent and thus is the main limiting factor for physical activity practice in this population.
The artificial pancreas 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. The artificial pancreas has the potential to reduce the risk of exercise-induced hypoglycemia but the importance of announcing exercise to the artificial pancreas is yet to be explored.
The objective of this study is to investigate 1) if announcing postprandial exercise to the artificial pancreas is beneficial in reducing the risk of hypoglycemia and 2) if an insulin bolus reduction is necessary when announcing the exercise to the artificial pancreas.
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Quebec
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Montreal、Quebec、カナダ、H2W 1R7
- Institut de Recherches Cliniques de Montreal
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
- Use of medication with an effect on heart rate (e.g. beta-blockers).
- Abnormal blood panel and/or anemia.
- Ongoing or planned pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
- Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).
- Problems with venous access.
研究計画
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:独身
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:Unannounced exercise
The target blood glucose of the algorithm will be as usual.
A pre-meal full insulin bolus will be given.
|
患者の通常の速効型インスリンアナログが使用されます。
Dexcom G4 Platinum グルコース センサーは、グルコース レベルの測定に使用されます。
Patients will be admitted at the research clinical facility at 6:30.
The artificial pancreas intervention will start at 7:00.
A standardized breakfast will be served at 8:00.
At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max.
At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served.
Patients will be discharged after lunch consumption.
Patient's insulin pump will be used to infuse insulin.
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels.
Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump.
The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) 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 recommendation infusion rates.
|
アクティブコンパレータ:Announced exercise with pre-meal full bolus
The target blood glucose of the algorithm will be increased and a pre-meal full bolus will be given
|
患者の通常の速効型インスリンアナログが使用されます。
Dexcom G4 Platinum グルコース センサーは、グルコース レベルの測定に使用されます。
Patients will be admitted at the research clinical facility at 6:30.
The artificial pancreas intervention will start at 7:00.
A standardized breakfast will be served at 8:00.
At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max.
At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served.
Patients will be discharged after lunch consumption.
Patient's insulin pump will be used to infuse insulin.
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels.
Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump.
The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) 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 recommendation infusion rates.
|
アクティブコンパレータ:Announced exercise with reduced insulin bolus
The target blood glucose of the algorithm will be increased and the pre-meal insulin bolus will be reduced by 33%.
|
患者の通常の速効型インスリンアナログが使用されます。
Dexcom G4 Platinum グルコース センサーは、グルコース レベルの測定に使用されます。
Patients will be admitted at the research clinical facility at 6:30.
The artificial pancreas intervention will start at 7:00.
A standardized breakfast will be served at 8:00.
At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max.
At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served.
Patients will be discharged after lunch consumption.
Patient's insulin pump will be used to infuse insulin.
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels.
Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump.
The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) 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 recommendation infusion rates.
|
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 |
時間枠 |
---|---|
Percentage of time of plasma glucose levels spent below 3.9 mmol/L
時間枠:From 9:30 to 11:30 (120 minutes)
|
From 9:30 to 11:30 (120 minutes)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Relative decrease in glucose levels during exercise compared to pre-breakfast levels
時間枠:From 8:00 to 10:50 (170 minutes)
|
Difference between pre-breakfast levels and the lowest glucose level from the start of the exercise until 20 minutes after exercise
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From 8:00 to 10:50 (170 minutes)
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Number of patients experiencing exercise-induced hypoglycemia requiring treatment
時間枠:From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
|
Decremental area under the curve from the start of the exercise
時間枠:From 9:30 to 11:00 (90 minutes)
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From 9:30 to 11:00 (90 minutes)
|
|
Percentage of time of plasma glucose levels spent below 3.9 mmol/L
時間枠:From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
|
Percentage of time of plasma glucose levels spent below 3.3 mmol/L
時間枠:From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
|
Percentage of time of plasma glucose levels spent below 2.8 mmol/L
時間枠:From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
|
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Percentage of time of plasma glucose levels spent between 3.9 and 7.8 mmol/L
時間枠:From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
|
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Percentage of time of plasma glucose levels spent above 10 mmol/L
時間枠:From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
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Percentage of time of plasma glucose levels spent above 13.9 mmol/L
時間枠:From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
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Percentage of time of plasma glucose levels spent above 16.7 mmol/L
時間枠:From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
|
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Mean plasma glucose levels
時間枠:From 8:00 to 11:30 (210 minutes)
|
From 8:00 to 11:30 (210 minutes)
|
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Standard deviation of glucose levels
時間枠:From 8:00 to 11:30 (210 minutes)
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From 8:00 to 11:30 (210 minutes)
|
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Coefficient of variation of glucose levels
時間枠:From 8:00 to 11:30 (210 minutes)
|
From 8:00 to 11:30 (210 minutes)
|
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Mean time (minutes) to the first hypoglycemic event
時間枠:From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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