- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT05221359
Pilot Study Evaluating Safety of ExOlin® in Patients With Poorly Controlled Type 1 Diabetes (Pilot'Ex)
An Open Label, Monocentric, Pilot Study Evaluating Safety of ExOlin® in Patients With Poorly Controlled Type 1 Diabetes With High Glucose Fluctuations, Prone to Severe Hypoglycemia
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
-
Strasbourg, Франция, 67000
- Рекрутинг
- Hopitaux Universitaires de Strasbourg
-
Контакт:
- Nathalie Jeandidier, MD
- Номер телефона: +33 3 88 11 66 03
- Электронная почта: Nathalie.jeandidier@chru-strasbourg.fr
-
Главный следователь:
- Nathalie Jeandidier, MD
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Adult men or women (age ≥ 18 years);
- Diagnosis of Type 1 Diabetes (T1D) for more than 2 years at the start of screening;
- Body mass index (BMI) > 16 kg/m2 and < 35 kg/m2;
Well managed intensive SubCutaneous (SC) insulin therapy, i.e. patient using for at least 3 months:
- CSII, whatever the insulin pump used, and
- Continuous Glucose Monitoring (CGM), by using Dexcom G6;
- 7.0% < Serum HbA1c < 12.0%;
Patient characterized by one of the following conditions:
Unstable diabetes/poor glycemic control, meaning patient presenting:
- at least one episode of severe hypoglycemia during the 12 months prior to study screening. Severe hypoglycemia is defined by American Diabetes Association (ADA) standards as "severe cognitive impairment requiring assistance from another person for recovery" (as per ADA's definition in "standards of care in diabetes");
- or glycemic excursions (post-prandial hyperglycemic or nocturnal hypoglycemic episodes) considered as too frequent and of high amplitude by the investigator, during the previous month;
Presence of adverse side effects of SC insulin-therapy:
- SC insulin resistance;
- or severe acquired lipodystrophy resistant to pump treatment;
- or genetic skin atrophy or lipodystrophy.
Exclusion Criteria:
- Renal glomerular filtration rate <30 mL/min/1.73m2 as per Chronic Kidney Disease - Epidemiology Collaboration (CDK-EPI) calculation;
- Immunocompromised patient;
- Local or systemic acute or chronic inflammation (rheumatoid arthritis, sclerodermia);
- Active infection or inflammation;
- Known history of skin affliction that could impact ExOlin® tolerance;
- Ongoing active anticoagulant therapy;
- Severe wound healing issues;
- Parietal reinforcement prostheses;
- Known allergy to one of the devices' components, including known allergy to fixation systems (e.g. patch, plaster) for SC administration devices such as external pumps and CGM, or chronic allergy related to prolonged wearing of such systems;
- Known allergy to insulin NovoRapid®;
- Known allergy to anesthetics, or products containing iodine and its derivates, or antibiotics used during surgery (cefazolin, and combination of clindamycin and gentamycin);
- Activity contraindicated as per external pump and CGM use recommendations;
- Patient willing to practice activities with risks of trauma or major change in the environment pressure such as combat sport or scuba diving;
- Cardiac condition incompatible with surgery requirements as per anesthesiologist's opinion;
- Unstable diabetic retinopathy (as per ophthalmologist's review within 6 months before screening);
- Current or history of unresolved malignancy within 5 years before screening (with exceptions for squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast carcinoma without lymph node metastases, well-differentiated thyroid carcinoma or other non-invasive lesion that, in the opinion of the investigator, is considered as cured with minimal risk of recurrence within 5 years);
- Other surgical or medical condition that, in the judgment of the investigator, might warrant exclusion or be contraindicated, like for instance visual or hand-use symptoms;
- Mental handicap or psychiatric condition incompatible with appropriate handling of devices or compliance to treatment or investigation-related tasks;
- Known active alcohol or drug abuse;
- Having received corticoid treatment within 4 weeks prior to enrollment;
- Having received an investigational product within 12 weeks prior to enrollment, or currently participating in another clinical trial, with the exception of observational / non-interventional; registries, for which written prior approval of Defymed is needed;
- Women planning for pregnancy, being pregnant or breastfeeding or unwilling to use adequate contraceptive methods for the duration of the study (oral hormonal contraceptives, implants, injectables, hormonal or copper intrauterine device, or vasectomized partner);
- Person under guardianship, trusteeship or deprived of liberty;
- Person not affiliated to one of the French social security systems;
- Unwilling to give written informed consent to participation in the study, or unable to do so for psychiatric, cognitive or linguistic reasons.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: test arm
All patients will be enrolled in same arm which contains the two interventions (device + drug) and follow mandatory phases of trial: screening, implantation, treatment with ExOlin, explantation.
|
Implantation of ExOlin® device, safety follow-up followed by a treatment period in which device is used to administer insulin. Device explanted with a safety follow-up.
Use of NovoRapid insulin during all periods of the clinical investigations
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Safety: Percentage of patients who will experience at least one relevant adverse event (AE) judged by the investigator as probably or highly probably related to ExOlin® for the duration of mandatory phases of the study
Временное ограничение: From implantation of the device (4 weeks after screening visit) till end of post-explantation safety follow-up (week 36), meaning a duration of 32 weeks.
|
Percentage of patients who will experience at least one relevant adverse event (AE) judged by the investigator as probably or highly probably related to ExOlin® for the duration of the study :
The primary endpoint will be achieved when the device has been retrieved from all enrolled patients and post-explantation observation time (3 months post explantation) has been completed. |
From implantation of the device (4 weeks after screening visit) till end of post-explantation safety follow-up (week 36), meaning a duration of 32 weeks.
|
Safety: Percentage of patients who will experience at least one relevant adverse event (AE) judged by the investigator as probably or highly probably related to ExOlin® for the whole duration of the study (extension phase included)
Временное ограничение: From implantation of the device (4 weeks after screening visit) till end of post-explantation safety follow-up, meaning a duration up to of 168 weeks maximum for patients completing extension phase.
|
Percentage of patients who will experience at least one relevant adverse event (AE) judged by the investigator as probably or highly probably related to ExOlin® for the duration of the study :
The primary endpoint will be achieved when the device has been retrieved from all enrolled patients and post-explantation observation time (3 months post explantation) has been completed. |
From implantation of the device (4 weeks after screening visit) till end of post-explantation safety follow-up, meaning a duration up to of 168 weeks maximum for patients completing extension phase.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Safety : Percentage of patients who will experience at least one AE, according to its severity, seriousness, relation with the device or the surgery or the treatment, outcome, by system-organ-class and preferred term.
Временное ограничение: From implantation of the device through study completion, meaning from 1 month after screening, duration of 8 months for mandatory phases and up to 3 years and 3 months for patients reaching end of extension phase
|
Percentage of patients who will experience at least one AE, according to its severity, seriousness, relation with the device or the surgery or the treatment, outcome, by system-organ-class and preferred term.
|
From implantation of the device through study completion, meaning from 1 month after screening, duration of 8 months for mandatory phases and up to 3 years and 3 months for patients reaching end of extension phase
|
Safety: Percentage of participants with abnormal vital signs or physical findings.
Временное ограничение: From implantation of the device through study completion, meaning from 1 month after screening, duration of 8 months for mandatory phases and up to 3 years and 3 months for patients reaching end of extension phase
|
Percentage of participants with abnormal vital signs (blood pressures, heart rate, body temperature) or physical findings (i.e.
significant abnormal lab results s.a.
WBC or observation of abnormal scar)
|
From implantation of the device through study completion, meaning from 1 month after screening, duration of 8 months for mandatory phases and up to 3 years and 3 months for patients reaching end of extension phase
|
Early Performance: Glycemic control
Временное ограничение: 2nd month of treatment (meaning week 20) vs end of screening (week 4)
|
Glycemic control as measured by use of a Continuous Glucose Monitor (Dexcom G6): comparison of data collected when ExOlin® is used versus data collected during Continuous Subcutaneous Insulin Infusion (CSII)
|
2nd month of treatment (meaning week 20) vs end of screening (week 4)
|
Early Performance: Glycemic control
Временное ограничение: 3rd month of treatment (meaning week 24) vs end of screening (week 4)
|
Glycemic control as measured by use of a Continuous Glucose Monitor (Dexcom G6): comparison of data collected when ExOlin® is used versus data collected during Continuous Subcutaneous Insulin Infusion (CSII)
|
3rd month of treatment (meaning week 24) vs end of screening (week 4)
|
Early Performance: Glycemic control
Временное ограничение: Every 4 weeks starting from 2nd month of treatment (meaning week 20) and till end of use of ExOlin (up to week 160) vs end of screening (week 4)
|
Glycemic control during the global Follow-Up (FU) of the patient across all study (monthly values, by use of Continuous Glucose Monitor Dexcom G6) by comparison of data collected when ExOlin® is used versus data collected during CSII
|
Every 4 weeks starting from 2nd month of treatment (meaning week 20) and till end of use of ExOlin (up to week 160) vs end of screening (week 4)
|
Early Performance
Временное ограничение: Baseline, then every 12 weeks up to end of use of ExOlin (up to week 160)
|
Glycemic control as per HbA1c
|
Baseline, then every 12 weeks up to end of use of ExOlin (up to week 160)
|
Quality of Life: Overall score and subscores of the Diabetes Quality of Life (DQOL) questionnaire
Временное ограничение: at the end of the Treatment phase (3rd month of treatment) versus data at the end of the Screening phase (1 month duration)
|
Overall score and subscores of the Diabetes Quality of Life (DQOL) questionnaire: scale from 0 to 100.
The higher patient rates, the better the outcome is.
|
at the end of the Treatment phase (3rd month of treatment) versus data at the end of the Screening phase (1 month duration)
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
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
Другие идентификационные номера исследования
- DEXN-T1D-2017-01
- 2020-A01763-36 (Идентификатор реестра: ID-RCB France)
- 2020-003020-17 (Номер EudraCT)
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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
-
Ain Shams Maternity HospitalРекрутингПлохой ответ на индукцию овуляции Poseidon Type IVЕгипет
-
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
-
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
-
Novartis PharmaceuticalsПрекращеноСиндром семейной хиломикронемии (FCS) (HLP Type I)Южная Африка, Германия, Соединенное Королевство, Франция, Соединенные Штаты, Канада, Нидерланды
-
Oxford Brookes UniversityUniversity of OxfordЗавершенныйФизическая активность | Психическое здоровье Wellness 1 | Когнитивная функция 1, социальная | Academic Attainment | Fitness TestingСоединенное Королевство
-
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
-
Rambam Health Care CampusIsrael Science FoundationЗавершенный
-
Alvotech Swiss AGЗавершенный
-
PfizerЗавершенный
-
SanionaЗавершенный
Клинические исследования ExOlin®
-
Dong-A ST Co., Ltd.ЗавершенныйФункциональная диспепсияКорея, Республика
-
Chung-Ang University Hosptial, Chung-Ang University...НеизвестныйФункциональная диспепсияКорея, Республика
-
Sanofi Pasteur, a Sanofi CompanyЗавершенныйКоклюш | Дифтерия | ПолиомиелитСоединенные Штаты
-
Amir AzarpazhoohInstitut Straumann AGЗавершенный
-
Novartis PharmaceuticalsЗавершенныйЛегочные заболевания, хроническая обструктивная болезнь (ХОБЛ)Аргентина
-
GuerbetЗавершенныйПервичная опухоль головного мозгаКолумбия, Корея, Республика, Соединенные Штаты, Мексика
-
Chong Kun Dang PharmaceuticalЗавершенный
-
University of MiamiBSN Medical IncРекрутинг
-
Galderma R&DЗавершенныйАтопический дерматитФилиппины, Китай
-
University Hospital, CaenЗавершенный