- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02798250
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.
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 2
Контакты и местонахождение
Места учебы
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Quebec
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Montreal, Quebec, Канада, H2W 1R7
- Institut de Recherches Cliniques de Montreal
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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).
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Активный компаратор: 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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Глюкагон (Eli Lilly) будет использоваться во время двухгормональной стратегии замкнутого цикла.
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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Активный компаратор: 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.
|
Глюкагон (Eli Lilly) будет использоваться во время двухгормональной стратегии замкнутого цикла.
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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
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Percentage of time below 4.0 mmol/L
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Временное ограничение |
---|---|
Mean glucose
Временное ограничение: 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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Percentage of time of glucose concentrations between 4.0 and 8.0 mmol/L
Временное ограничение: 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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Percentage of time of glucose concentrations between 4.0 and 10.0 mmol/L
Временное ограничение: 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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Percentage of time of glucose concentrations below 3.1 mmol/L
Временное ограничение: 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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Area under the curve of glucose values below 4.0 mmol/L
Временное ограничение: 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
Временное ограничение: 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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Number of patients with at least one hypoglycemic event with or without symptoms
Временное ограничение: 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 number of hypoglycemic event below 3.1 mmol/L
Временное ограничение: 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
Временное ограничение: 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 insulin delivery
Временное ограничение: 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 glucagon delivery
Временное ограничение: 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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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Нарушения метаболизма глюкозы
- Метаболические заболевания
- Заболевания иммунной системы
- Аутоиммунные заболевания
- Заболевания эндокринной системы
- Сахарный диабет
- Сахарный диабет, тип 1
- Гипогликемические агенты
- Физиологические эффекты лекарств
- Желудочно-кишечные агенты
- Гормоны, заменители гормонов и антагонисты гормонов
- Инсулин
- Инсулин, Глобин Цинк
- Глюкагон
- Гормоны
Другие идентификационные номера исследования
- CLASS-Safety study - Part 2
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Диабет 1 типа
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Ain Shams Maternity HospitalРекрутингПлохой ответ на индукцию овуляции Poseidon Type IVЕгипет
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P. Herzen Moscow Oncology Research InstituteNational Medical Research Radiological Centre of the Ministry of Health of RussiaЕще не набираютРак желудка | Рак желудка | Siewert Type III Аденокарцинома пищеводно-желудочного переходаРоссийская Федерация
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P. Herzen Moscow Oncology Research InstituteNational Medical Research Radiological Centre of the Ministry of Health of RussiaЕще не набираютРак пищевода | Рак пищевода | Аденокарцинома пищеводно-желудочного перехода Siewert I типа | Siewert Type III Аденокарцинома пищеводно-желудочного переходаРоссийская Федерация
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Novartis PharmaceuticalsПрекращеноСиндром семейной хиломикронемии (FCS) (HLP Type I)Южная Африка, Германия, Соединенное Королевство, Франция, Соединенные Штаты, Канада, Нидерланды
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Oxford Brookes UniversityUniversity of OxfordЗавершенныйФизическая активность | Психическое здоровье Wellness 1 | Когнитивная функция 1, социальная | Academic Attainment | Fitness TestingСоединенное Королевство
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Merck Sharp & Dohme LLCРекрутингНемелкоклеточный рак легкого | Солидные опухоли | Запрограммированная смерть клеток-1 (PD1, PD-1) | Запрограммированная гибель клеток 1, лиганд 1 (PDL1, PD-L1) | Запрограммированная гибель клеток 1, лиганд 2 (PDL2, PD-L2)Япония
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Rambam Health Care CampusIsrael Science FoundationЗавершенный
-
Alvotech Swiss AGЗавершенный
-
PfizerЗавершенный
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St. James's Hospital, IrelandНеизвестныйПищевод Барретта | Аденокарцинома пищеводно-желудочного перехода Siewert II типа | Рак пищевода | Аденокарцинома пищеводно-желудочного перехода Siewert I типа | Siewert Type III Аденокарцинома пищеводно-желудочного переходаИрландия
Клинические исследования Глюкагон
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Xeris PharmaceuticalsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)ЗавершенныйВрожденный гиперинсулинизмСоединенные Штаты