Closing the Loop in Adults With Type 1 Diabetes - Alcohol Consumption (ANGELA02)
Randomised, Two-Period Crossover Study to Assess the Efficacy of Overnight Computer-based Glucose Control Compared With Conventional Pump Therapy Following the Consumption of Alcohol in Adults With Type 1 Diabetes
調査の概要
詳細な説明
People with type 1 diabetes need regular insulin injections or continuous delivery of insulin using an insulin pump. Keeping blood sugars in the normal range is known to reduce the risk of long term complications involving the eyes, kidneys and heart. However, achieving treatment goals can be very difficult as the tighter we try to control blood glucose levels, the greater the risk of the person developing episodes of low glucose levels (hypoglycaemia). One solution is using a system where the amount of insulin injected closely matches the blood sugar levels on a continuous basis. This can be achieved by what is known as a "closed loop system" where a small glucose sensor placed under the skin communicates with a computer containing an algorithm that drives a subcutaneous insulin pump. This system is being developed in Cambridge and is undergoing trials in children and adults with type 1 diabetes. Results thus far show that the system is very effective at preventing hypoglycaemia and maintaining blood glucose levels in target range.
We plan to test the closed loop in various challenging conditions faced by patients in daily life. One of these is the consumption of alcohol, which can give rise to delayed hypoglycaemia in patients with diabetes. The studies will be done in a clinical research facility under supervised conditions. Subjects will attend for two study nights where they will receive a specific volume of alcohol with an evening meal. On one night this will be followed by closed loop algorithm control of their insulin overnight. On the other (control) night subjects will remain on their usual pump therapy regime overnight.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Cambridge、イギリス、CB2 0QQ
- Addenbrooke's Hospital
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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:
- Type 1 diabetes, as defined by WHO for at least 6 months or confirmed C-peptide negative
- On insulin pump therapy for at least 3 months
Exclusion Criteria:
- Non-type 1 diabetes mellitus
- Any physical/psychological disease likely to interfere with the study
- Taking medication likely to interfere with interpretation of results
- Known/suspected allergy against insulin
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
- Unstable blood glucose control, including recurrent severe hypoglycaemia as judged by the investigator
- Current pregnancy/breastfeeding
- Total daily insulin dose > 1.4 IU/kg
- HbA1C > 10% within the last 3 months
- Unable/unwilling to consume the necessary quantity of alcohol stated in the study protocol
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 |
|---|---|
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実験的:Closed loop (algorithm)
Subcutaneous delivery of Novorapid insulin, dose calculated by computer-driven control algorithm, based on continuous glucose sensor readings
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ノボラピッド インスリンの皮下送達、連続的なグルコース センサーの読み取り値に基づいて、制御アルゴリズムによって用量が計算されます。
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プラセボコンパレーター:Open loop
Subcutaneous delivery of Novorapid insulin according to usual pump regime
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通常のポンプ方式によるノボラピッド インスリンの皮下送達
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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 |
|---|---|
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Percentage of plasma glucose values in target (3.9-8.0 mmol/L)
時間枠:2200-1200hr
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2200-1200hr
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Percentage of CGM (continuous glucose monitoring) values in target (3.9-8.0 mmol/L)
時間枠:2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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Percentage of plasma glucose and CGM values in target (3.9-8.0 mmol/L)
時間枠:0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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Percentage of plasma glucose and CGM values below 3.9 mmol/L
時間枠:2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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Percentage of plasma glucose and CGM values above 8.0 mmol/L
時間枠:2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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Average plasma and CGM glucose
時間枠:2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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Average plasma insulin concentration
時間枠:2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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Total dose of insulin administered
時間枠:2200-1200hrs
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2200-1200hrs
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Low blood glucose index (LBGI) score
時間枠:2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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High blood glucose index (HBGI) score
時間枠:2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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Percentage of plasma glucose and CGM values below 3.0 mmol/L
時間枠:2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Mark L Evans, MD FRCP、University of Cambridge, UK
- スタディディレクター:Roman Hovorka, PhD、University of Cambridge, UK
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
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