Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Type 1 Diabètes Adults With Hypoglycemia Unawareness and Documented Nocturnal Hypoglycemia
An Open-label, Randomized, Cross-over Study to Assess the Efficacy of Single-hormone and Dual-hormone Closed-loop Strategy in Regulating Overnight Glucose Levels in Type 1 diabètes Adults With Hypoglycemia Unawareness and Documented Nocturnal Hypoglycemia
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 strategy would regulate glucose levels through the infusion of two hormones: insulin and glucagon.
The main objective of this project is to compare the efficacy of single-hormone and dual-hormone closed-loop strategy to regulate overnight glucose levels in a in-patient study in type 1 diabetes adults with hypoglycemia unawareness and documented nocturnal hypoglycemia.
The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating overnight glucose levels compared to single-hormone closed-loop strategy.
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 strategy would regulate glucose levels through the infusion of two hormones: insulin and glucagon.
The investigators aim to conduct the 1st randomized cross-over trial comparing single- hormone and dual-hormone closed-loop strategy to regulate overnight glucose levels. The investigators aim to compare the two interventions for 10 hours in two subgroups of adults with type 1 diabètes. Patients from both subgroups will present documented nocturnal hypoglycemia. One subgroup will consist of patients with hypoglycemia unawareness while the other subgroup will consist of patients with hypoglycemia unawareness. This study will allow to determine if there is a greater benefit of a closed-loop strategy in a higher-risk hypoglycemia unaware group.
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.
- HbA1c ≤ 12%.
- Hypoglycemia awareness or unawareness assessed by a questionnaire.
- Documented NH during the run-in period.
Exclusion Criteria:
- 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.
- Pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- Current use of glucocorticoid medication (except low stable dose).
- Known or suspected allergy to the trial products or snack 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.
- Anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport).
- Failure to comply with team's recommendations (e.g. not willing to eat snacks, not willing to change pump parameters, 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：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 strategy
|
Subjects will be admitted at the research facility at 19:00.
A cannula will be inserted into an arm or a hand vein for blood sampling purposes.
On dual-hormone closed-loop visits, glucagon will be reconstituted according to the manufacturer's instructions and a MiniMed® Paradigm® Veo™ pump containing the glucagon solution will be installed.
At 20:30, a snack containing 20g of carbohydrate will be given.
Closed-loop strategy will start at 20:00 until 7:00 next morning.
A glucose sensor reading will be entered manually in a tablet every 10 minutes.
The tablet will generate a recommendation for the basal rates of insulin delivery and glucagon mini-boluses (glucagon recommendations will only be generated during the dual hormone closed-loop visits).
Pumps' parameters will then be changed manually to implement the tablet generated recommendations.
|
|
アクティブコンパレータ：Dual-hormone closed-loop strategy
|
Subjects will be admitted at the research facility at 19:00.
A cannula will be inserted into an arm or a hand vein for blood sampling purposes.
On dual-hormone closed-loop visits, glucagon will be reconstituted according to the manufacturer's instructions and a MiniMed® Paradigm® Veo™ pump containing the glucagon solution will be installed.
At 20:30, a snack containing 20g of carbohydrate will be given.
Closed-loop strategy will start at 20:00 until 7:00 next morning.
A glucose sensor reading will be entered manually in a tablet every 10 minutes.
The tablet will generate a recommendation for the basal rates of insulin delivery and glucagon mini-boluses (glucagon recommendations will only be generated during the dual hormone closed-loop visits).
Pumps' parameters will then be changed manually to implement the tablet generated recommendations.
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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 |
|---|---|
|
Percentage of time of plasma glucose levels spent below 4 mmol/L
時間枠：Up to 8 hours
|
Up to 8 hours
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
総インスリン投与量
時間枠：最大8時間
|
最大8時間
|
|
Percentage of time of plasma glucose levels spent between 4 and 8 mmol/L
時間枠：Up to 8 hours
|
Up to 8 hours
|
|
Percentage of time of plasma glucose levels spent between 4 and 10 mmol/L
時間枠：Up to 8 hours
|
Up to 8 hours
|
|
Percentage of time of plasma glucose levels spent below 3.5 mmol/L
時間枠：Up to 8 hours
|
Up to 8 hours
|
|
Percentage of time of plasma glucose levels spent below 3.3. mmol/L
時間枠：Up to 8 hours
|
Up to 8 hours
|
|
Percentage of time of plasma glucose levels spent above 8 mmol/L
時間枠：Up to 8 hours
|
Up to 8 hours
|
|
Percentage of time of plasma glucose levels spent above 10 mmol/L
時間枠：Up to 8 hours
|
Up to 8 hours
|
|
Area under the curve of plasma glucose levels spent below 4 mmol/L
時間枠：Up to 8 hours
|
Up to 8 hours
|
|
Area under the curve of plasma glucose levels spent below 3.5 mmol/L
時間枠：Up to 8 hours
|
Up to 8 hours
|
|
Area under the curve of plasma glucose levels spent below 3.3 mmol/L
時間枠：Up to 8 hours
|
Up to 8 hours
|
|
Area under the curve of plasma glucose levels spent above 8 mmol/L
時間枠：Up to 8 hours
|
Up to 8 hours
|
|
Area under the curve of plasma glucose levels spent above 10 mmol/L
時間枠：Up to 8 hours
|
Up to 8 hours
|
|
Mean plasma glucose levels
時間枠：Up to 8 hours
|
Up to 8 hours
|
|
Standard deviation of plasma glucose levels
時間枠：Up to 8 hours
|
Up to 8 hours
|
|
Total glucagon delivery
時間枠：Up to 8 hours
|
Up to 8 hours
|
|
Number of subjects experiencing at least one hypoglycemic event requiring oral treatment
時間枠：Up to 8 hours
|
Up to 8 hours
|
|
Total number of hypoglycemic events requiring treatment
時間枠：Up to 8 hours
|
Up to 8 hours
|
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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