Closed-loop Control of Glucose Levels (Artificial Pancreas) During Exercise in Adults With Type 1 Diabetes
An Open-label, Randomized, Cross-over Study to Compare the Efficacy of Single-hormone Closed-loop Strategy and Dual-hormone Closed-loop Strategy at Regulating Glucose Levels During Continuous Exercise and Interval Exercise 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 dosages 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 is to compare the efficacy of single-hormone closed-loop strategy and dual-hormone closed-loop strategy at regulating glucose levels during continuous exercise and interval exercise.
The investigator hypothesized that dual-hormone closed-loop strategy is superior to single-hormone closed-loop strategy in regulating glucose levels during exercise periods.
調査の概要
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 hormones: insulin and glucagon.
We aim to conduct a randomized two-way cross-over trial comparing single-hormone closed-loop strategy and dual-hormone closed-loop strategy to compare the two interventions during exercise periods in adults with type 1 diabetes. A moderate intensity exercise will be performed for 60 minutes at 60% of the maximum oxygen consumption (VO2max). A high intensity exercise will be 40 minutes of interval training. The interval training will be preceded by a 10 minutes warm-up and followed by a 10 minutes cool down.
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
-
-
Quebec
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Montreal、Quebec、カナダ、H2W 1R7
- Institut de Recherches Cliniques de Montreal
-
-
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.
- Ongoing 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：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：Single-hormone closed-loop system
In single-hormone closed-loop system, variable subcutaneous insulin infusion rate will be used to regulate glucose levels
|
Patients will be admitted at the research clinical facility at 14:30.
Closed-loop strategy will start at 15:30.
At 18:00, patients will performed a 60-minute exercise at 60% of VO2 max.
Patients will be discharged at 20:00.
Patients will be admitted at the research clinical facility at 14:30.
Closed-loop strategy will start at 15:30.
At 18:00, patients will performed a 40-minute interval exercise.
Patients will be discharged at 20:00.
|
|
アクティブコンパレータ：Dual-hormone closed-loop system
In dual-hormone closed-loop system, variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels
|
Patients will be admitted at the research clinical facility at 14:30.
Closed-loop strategy will start at 15:30.
At 18:00, patients will performed a 60-minute exercise at 60% of VO2 max.
Patients will be discharged at 20:00.
Patients will be admitted at the research clinical facility at 14:30.
Closed-loop strategy will start at 15:30.
At 18:00, patients will performed a 40-minute interval exercise.
Patients will be discharged at 20:00.
|
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 |
|---|---|
|
The number of patients experiencing exercise-induced hypoglycemia requiring dextrose infusion (< 3.3 mmol/L symptomatic or < 3.0 mmol/L regardless of symptoms).
時間枠：18:00 hours to 19:30 hours
|
18:00 hours to 19:30 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Decrease in glucose levels during each exercise
時間枠：18:00 to 19:30 hours or 18:00 to 19:10 depending on the exercise performed
|
Difference between glucose levels at the beginning of the exercise and the lowest glucose level from the start of the exercise until 30 minutes after exercise).
|
18:00 to 19:30 hours or 18:00 to 19:10 depending on the exercise performed
|
|
Area under the curve of plasma glucose levels < 4 mmol/L
時間枠：15:30 hours to 19:30 hours
|
15:30 hours to 19:30 hours
|
|
|
Percentage of time of plasma glucose levels < 4 mmol/L
時間枠：15:30 hours to 19:30 hours
|
15:30 hours to 19:30 hours
|
|
|
Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L
時間枠：15:30 hours to 19:30 hours
|
15:30 hours to 19:30 hours
|
|
|
Decremental area under the curve from the start of the exercise for 90 minutes.
時間枠：18:00 to 19:30
|
18:00 to 19:30
|
|
|
Percentage of time-in-target defined as between 4 and 10 mmol/L
時間枠：15:30 hours to 19:30 hours
|
15:30 hours to 19:30 hours
|
|
|
Mean time (minutes) to the first hypoglycemic event during the exercise period
時間枠：18:00 to 19:00
|
18:00 to 19:00
|
|
|
The amount of dextrose infused
時間枠：15:30 to 19:30
|
15:30 to 19:30
|
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 (見積もり)
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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