Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation - Part 2
In previous studies, investigators have studied if a pre-meal insulin bolus based on estimated carbohydrate meal size would alleviate the burden of carbohydrate counting without a significant degradation in postprandial glucose control. With this strategy, the patient would only have to evaluate the size of the meal in terms of carbohydrate (snack, regular, large or very large). It is however important to establish the safety of this simplified meal bolus approach. The safety of overestimating a meal insulin bolus in the context of closed-loop strategy needs to be assessed. For ethical reasons, only dual-hormone closed-loop will be tested.
Investigators hypothesize that dual-hormone closed-loop with overestimated meal size bolus will not increase time below 4.0 mmol/L compared to dual-hormone closed-loop with an adequately estimated meal size bolus.
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 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 and currently using a fast acting insulin analog (Lispro, Aspart or Glulisine).
- Last (less than 3 months) HbA1c ≤ 10%.
- Currently using carbohydrate counting as the meal insulin dose strategy.
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.
- Pregnancy.
- Severe hypoglycemic episode within 1 month of screening.
- Agents affecting gastric emptying (Motilium®, Prandase®, Victoza®, Byetta® and Symlin®) as well as oral anti-diabetic agents (Metformin, SGLT-2 inhibitors and DPP-4 inhibitors) if not at a stable dose for 3 months. Otherwise, these medications are acceptable and will be kept stable during the entire protocol.
- Oral steroids unless patients present a low stable dose (e.g. 10 mg or less of prednisone per day or physiological doses, less than 35 mg/day, of hydrocortisone Cortef®). Inhale steroids at stable dose in the last month are acceptable.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator (e.g. unstable psychiatric condition).
- Failure to comply with team's recommendations (e.g. not willing to change pump parameters, follow algorithm's suggestions, etc).
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:Dual-hormone CL with overestimation of meal size category
A regular size standardized meal of 45g of carbohydrates will be provided to the patient and the meal size will be overestimated by one category, which will result in a meal insulin bolus for a meal of 65g of carbohydrates.
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グルカゴン (Eli Lilly) は、デュアル ホルモン クローズド ループ戦略で使用されます。
Interventions will be undertaken 1 to 5 days after sensor insertion.
Subjects will be admitted at the research center at 7:00.
Subject's pump will be substituted with the study pump and an additional pump containing glucagon will be installed.
At 7:00, closed-loop will be initiated.
At 9:00, a standardized breakfast (45g CHO) will be served.
Study subjects will consume the same meal on the two intervention days.
During the intervention, patients will be allowed to do sedentary activities.
Patients will be allowed to consume caffeine during the intervention, but will have to replicate their caffeine consumption on both interventions.
The intervention day will end at 13:00.
Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra).
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アクティブコンパレータ:Dual-hormone CL with adequate estimation of meal size category
A regular size standardized meal of 45g of carbohydrates will be provided to the patient and the meal size will be adequately estimated, which will result in a meal insulin bolus for a meal of 35g of carbohydrates.
|
グルカゴン (Eli Lilly) は、デュアル ホルモン クローズド ループ戦略で使用されます。
Interventions will be undertaken 1 to 5 days after sensor insertion.
Subjects will be admitted at the research center at 7:00.
Subject's pump will be substituted with the study pump and an additional pump containing glucagon will be installed.
At 7:00, closed-loop will be initiated.
At 9:00, a standardized breakfast (45g CHO) will be served.
Study subjects will consume the same meal on the two intervention days.
During the intervention, patients will be allowed to do sedentary activities.
Patients will be allowed to consume caffeine during the intervention, but will have to replicate their caffeine consumption on both interventions.
The intervention day will end at 13:00.
Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra).
|
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 below 4.0 mmol/L
時間枠:The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
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The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Mean glucose
時間枠:The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
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The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
|
Percentage of time of glucose concentrations between 4.0 and 8.0 mmol/L
時間枠:The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
|
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
|
Percentage of time of glucose concentrations between 4.0 and 10.0 mmol/L
時間枠:The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
|
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
|
Percentage of time of glucose concentrations below 3.1 mmol/L
時間枠:The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
|
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
|
Area under the curve of glucose values below 4.0 mmol/L
時間枠:The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
|
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
|
Area under the curve of glucose values below 3.1 mmol/L
時間枠:The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
|
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
|
Number of patients with at least one hypoglycemic event with or without symptoms
時間枠:The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
|
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
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Total number of hypoglycemic event below 3.1 mmol/L
時間枠:The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
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The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
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Total carbohydrate intake for hypoglycemia correction
時間枠:The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
|
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
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Total insulin delivery
時間枠:The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
|
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
|
Total glucagon delivery
時間枠:The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
|
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
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協力者と研究者
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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