Comparison of the Efficacy of Rapid-acting Aspart and Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels
An Open-label, Double-blind, Randomized, Two-way, Cross-over Pilot Study to Provide Preliminary Evidence of the Efficacy of Rapid-acting Aspart Compared to Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial 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 dosages based on the sensor's readings.
The objective of this pilot study is to inform both the decision whether to conduct a confirmatory study and the design of the larger confirmatory trial. In addition, we want to estimate postprandial glucose levels parameters and confidence interval in an 11-hour in-patient study with standardized conditions in adults with type 1 diabetes, estimate the size and direction of the treatment effect.
Faster insulin Aspart (FiAsp) will provide preliminary evidence of efficacy to regulate postprandial glucose levels compared to rapid-acting Aspart in adults with type 1 diabetes using insulin pump therapy.
調査の概要
状態
条件
研究の種類
段階
- フェーズ2
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 6 months.
- HbA1c ≤ 12%.
Exclusion Criteria:
- Using a patch-pump (e.g. Omnipod)
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
- Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Ongoing or planned pregnancy.
- Breastfeeding.
- Severe hypoglycemic episode within two weeks of screening.
- Current use of glucocorticoid medication (except low stable dose and inhaled stable treatment).
- Known or suspected allergy to the trial products or meal contents.
- 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 meals/snacks, 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：ダブル
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：Rapid-acting Aspart
Rapid-acting Aspart will be used to regulate glucose levels
|
The participant's insulin pump will be used to infuse insulin
The Dexcom G4 Platinum will be used to measure glucose levels
Subjects will be admitted at IRCM at 9:30. An intravenous catheter will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing rapid-acting Aspart or faster acting Aspart will be placed in the insulin pump. Closed-loop strategy will start at 10:00 until 21:00. A glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pumps' parameters will then be changed manually to implement the computer generated recommendations. At 12:00, a lunch meal will be served. An insulin bolus will be given 15 minutes before the meal. At 17:00, a dinner meal will be served. As recommended, an insulin bolus will be given at the time of the meal. Each subject will ingest the same meals during both visits. Venous blood samples will be obtained for the measurement of plasma glucose and insulin concentrations. Blood samples will be taken every 20 minutes. |
|
アクティブコンパレータ：Faster insulin Aspart
Faster insulin Aspart will be used to regulate glucose levels
|
The participant's insulin pump will be used to infuse insulin
The Dexcom G4 Platinum will be used to measure glucose levels
Subjects will be admitted at IRCM at 9:30. An intravenous catheter will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing rapid-acting Aspart or faster acting Aspart will be placed in the insulin pump. Closed-loop strategy will start at 10:00 until 21:00. A glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pumps' parameters will then be changed manually to implement the computer generated recommendations. At 12:00, a lunch meal will be served. An insulin bolus will be given 15 minutes before the meal. At 17:00, a dinner meal will be served. As recommended, an insulin bolus will be given at the time of the meal. Each subject will ingest the same meals during both visits. Venous blood samples will be obtained for the measurement of plasma glucose and insulin concentrations. Blood samples will be taken every 20 minutes. |
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 |
|---|---|
|
Change in plasma glucose levels 1 hour after the meal
時間枠：1 hour
|
1 hour
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Area under the curve of plasma glucose levels for the 1-hour period following the meal.
時間枠：1 hour
|
1 hour
|
|
Area under the curve of plasma glucose levels for the 2-hour period following the meal.
時間枠：2 hours
|
2 hours
|
|
Plasma glucose level 1 hour after the meal.
時間枠：1 hour
|
1 hour
|
|
Plasma glucose level 2 hours after the meal.
時間枠：2 hours
|
2 hours
|
|
Glycemic peak in the 3 hours following the meal.
時間枠：3 hours
|
3 hours
|
|
Change in plasma glucose levels 2 hours after the meal.
時間枠：2 hours
|
2 hours
|
|
Peak time of glucose levels over the 4 hours following the meal.
時間枠：4 hours
|
4 hours
|
|
Number of hypoglycemic events less than 4.0 mmol/L over the 4 hours following the meal.
時間枠：4 hours
|
4 hours
|
|
Percentage of time of plasma glucose levels between 3.9 and 7.8 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels between 3.9 and 7.8 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels between 3.9 and 10 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels between 3.9 and 10 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels below 3.9 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels below 3.9 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels below 3.3 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels below 3.3 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels below 2.8 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels below 2.8 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels above 10 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels above 10 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels above 13.9 mmol/L
時間枠：11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels above 13.9 mmol/L
時間枠：11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels above 16.7 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels above 16.7 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels below 3.9 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels below 3.9 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels below 3.3 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels below 3.3 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels below 2.8 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels below 2.8 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels above 10.0 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels above 10.0 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels above 13.9 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels above 13.9 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels above 16.7 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels above 16.7 mmol/L.
時間枠：11 hours
|
11 hours
|
|
Standard deviation of plasma glucose levels.
時間枠：11 hours
|
11 hours
|
|
Standard deviation of sensor glucose levels.
時間枠：11 hours
|
11 hours
|
|
Coefficient of variance of plasma glucose levels.
時間枠：11 hours
|
11 hours
|
|
Coefficient of variance of sensor glucose levels.
時間枠：11 hours
|
11 hours
|
|
Total insulin delivery.
時間枠：11 hours
|
11 hours
|
|
Mean plasma glucose level.
時間枠：11 hours
|
11 hours
|
|
Mean sensor glucose level.
時間枠：11 hours
|
11 hours
|
|
Mean plasma insulin concentration.
時間枠：11 hours
|
11 hours
|
|
Number of hypoglycemic events less than 3.3 mmol/L (>20 minutes).
時間枠：11 hours
|
11 hours
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
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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