Evaluating Glucose Control Using a Next-Generation AID Algorithm in Individuals With T1D

Официальное название

Evaluation Glucose Control Using a Next-Generation Automated Insulin Delivery Algorithm in Individuals With Type 1 Diabetes: EVOLUTION T1D

Обзор

Feasibility study to evaluate the safety and feasibility of Omnipod automated insulin delivery algorithms in individuals with type 1 diabetes. This study will enroll up to 80 participants to have a minimum of 48 participants to initiate the use of Omnipod. The study will include hotel and outpatient evaluation periods.

Вмешательства

• Устройство Omnipod M System
  Participants will use the Omnipod M System
• Устройство Omnipod S
  Participants will use the Omnipod S System

Первичные конечные точки

• Percentage of time <54 mg/dL [Срок оценки: 72-hour Omnipod M Hotel Period]
• Percentage of time <70 mg/dL [Срок оценки: 72-hour Omnipod M Hotel Period]
• Percentage of time >180 mg/dL [Срок оценки: 72-hour Omnipod M Hotel Period]
• Percentage of time <54 mg/dL [Срок оценки: 4-week Omnipod M outpatient]
• Percentage of time <54 mg/dL [Срок оценки: Final 3 weeks of Omnipod S outpatient]
• Percentage of time <70 mg/dL [Срок оценки: 4-week Omnipod M outpatient]
• Percentage of time <70 mg/dL [Срок оценки: Final 3-weeks Omnipod S outpatient]
• Percentage of time >180 mg/dL [Срок оценки: 4-week Omnipod M outpatient]
• Percentage of time >180 mg/dL [Срок оценки: Final 3-weeks Omnipod S outpatient]

Вторичные конечные точки (12)

• Mean glucose [Срок оценки: 4-weeks Omnipod M outpatient]
• Mean glucose [Срок оценки: Final 3-weeks Omnipod S outpatient]
• Percentage of time >250 mg/dL [Срок оценки: 4-weeks Omnipod M outpatient]
• Percentage of time >250 mg/dL [Срок оценки: Final 3-weeks Omnipod S outpatient]
• Percentage of time >300 mg/dL [Срок оценки: 4-weeks Omnipod M outpatient]
• Percentage of time >300 mg/dL [Срок оценки: Final 3-weeks Omnipod S outpatient]
• Percentage of time 70-180 mg/dL [Срок оценки: 4-weeks Omnipod M outpatient]
• Percentage of time 70-180 mg/dL [Срок оценки: Final 3-weeks Omnipod S outpatient]
• Standard Deviation [Срок оценки: 4-weeks Omnipod M outpatient]
• Standard Deviation [Срок оценки: Final 3-weeks Omnipod S outpatient]
• Coefficient of variation [Срок оценки: 4-weeks Omnipod M outpatient]
• Coefficient of variation [Срок оценки: Final 3-weeks Omnipod S outpatient]

Критерии участия

Критерии включения

• Age at time of consent 2-70 years (inclusive)
• Type 1 diabetes diagnosis for at least 6 months, for those aged 8-70 years, or 3 months for those aged 2-7 years, based on Investigator assessment
• Basal/Bolus insulin delivery via multiple daily injections or insulin pump with or without automation
• Willing to use the following types of U-100 insulin during the study: Humalog U-100, Novorapid or their generic equivalents
• Deemed appropriate for pump therapy per Investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
• If using noninsulin glucose-lowering medications or weight reduction medications, dose has been stable for 6-weeks prior to screening; and participant is willing to not change the dose unless required for safety purposes.
• Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol
• Willing to wear the system continuously throughout the study
• Willing and able to sign the Informed Consent Form (ICF) or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from participants per local regulatory requirements
• Able to read and understand English
• If of childbearing potential, willing and able to have pregnancy testing

Критерии исключения

• Any medical condition, which in the opinion of the Investigator, would put the participant at an unacceptable safety risk. This may include untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, unstable proliferative retinopathy, unstable psychiatric conditions such as eating disorders, drug or alcohol abuse.
• Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or a history of myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, or arrhythmias requiring intervention within the 12 months prior to screening
• Any planned surgery during the study which could be considered major in the opinion of the Investigator
• History of more than 1 severe hypoglycaemia in the past 6 months. Severe hypoglycaemia is defined as an event that requires the assistance of another person due to altered consciousness, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions
• History of more than 1 diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness; kinked, dislodged, or occluded cannula; or initial diabetes diagnosis Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement
• Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c
• Use of hydroxyurea
• Plans to receive blood transfusion over the course of the study
• Has taken systemic corticosteroids (oral or injectable) within 4 weeks or has had a local steroid injection (intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during the study
• Use of non-insulin glucose-lowering medication or weight loss medications other than metformin and/or GLP1, in the 4 weeks prior to screening. Participants taking metformin and/or GLP1 should remain on a steady dose without dose increases during study participation
• Pregnant or lactating, or is of childbearing potential and not using an acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilisation such as tubal ligation or hysterectomy, or vasectomised partner); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal).
• In the past 30-days, has participated in a clinical study using any investigational drug or any investigational device that in the opinion of the investigator may have therapeutic impact on their diabetes management. Additionally, may not intend to participate in any other interventional clinical study during this study period
• Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the Investigator's clinical judgment
• Participant is an employee of Insulet, an Investigator or a member of Investigator's study team, or immediate family member of any of the aforementioned

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Новая Зеландия · 1 центр

• University of Otago — Christchurch

Идентификаторы

NCT: NCT07593625 · EVOLUTION T1D

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗