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Идёт набор NCT06668935

Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring

— Наблюдательное Diabetes Mellitus

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: To utilize the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) to help prolong the length of time people with diabetes maintain adherence to GLP-1 and dual GIP/GLP-1 agonists.
Кому может быть актуально
Состояния в реестре: Diabetes Mellitus. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

This study is to see if the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) will help prolong the length of time people with diabetes maintain adherence to glucagon-like peptide 1 (GLP-1/GIP) agonists.

Подробное описание

Subjects with type 2 diabetes who are newly beginning GLP-1 or GLP-1/GIP drug therapy will be randomized to use either FSL3 or their existing Standard of Care to manage their diabetes. Up to 800 subjects will be enrolled across the United States with 200 evaluable subjects in each group (intervention and control) for a total of 400 evaluable subjects. Subjects will be on the study approximately 210 days. Subjects will wear one sensor applied to the back of the upper arm and will have a paired smartphone that will be used to start the sensor and collect glucose readings.

Вмешательства

  • Устройство To utilize the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) to help prolong the length of time people with diabetes maintain adherence to GLP-1 and dual GIP/GLP-1 agonists
    All subjects will then begin use of their prescribed GLP-1 or combination GIP/GLP-1 medication in accordance with the HCP's instructions. Subjects will be titrated to their maximum tolerable dose per the medication's approved titration schedule and according to their HCP's standard of care between Visits 2 and 3.

Первичные конечные точки

  • To assess the length of time subjects in each group remain on a GLP-1 or GLP-1/GIP combination drug [Срок оценки: 210 days]

Критерии участия

Критерии включения

  • Subject must be at least 18 years of age.
  • Subject must be able to read and understand English.
  • Subject must have a type 2 diabetes diagnosis.
  • In the investigator's opinion, subject must meet the criteria for beginning use of GLP-1 or GIP/GLP-1 medications for management of their diabetes.
  • Subject is beginning use of GLP-1 / GIP/GLP-1 medication for management of their diabetes.
  • Subject must be willing to allow venous samples to be obtained to test HbA1c.
  • Subject must be willing to either continue using their existing standard of care device or must be willing to use the FreeStyle Libre 3 Continuous Glucose Monitoring System to manage their diabetes throughout the duration of the study.
  • In the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
  • Subject must be available to participate in all study visits.
  • Subject must be willing and able to provide written signed and dated informed consent.

Критерии исключения

  • Subject is a member of the Study Staff.
  • Subject has a diagnosis of type 1 or gestational diabetes.
  • Subject is currently using or has previously used GLP-1 or GIP/GLP-1 drugs for any reason.
  • Subject is currently using a Continuous Glucose Monitor (CGM) as their standard of care device to manage their diabetes.
  • Subject has known allergy to medical grade adhesive, isopropyl alcohol and/or ethyl alcohol used to disinfect skin.
  • Subject is taking any type of rapid-acting insulin, including Neutral Protamine Hagedorn (NPH) and premix insulin.
  • Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff.
  • Subject currently is participating in another clinical trial.
  • Subject is unsuitable for participation due to any other cause as determined by the Investigator

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 2 центра
  • East Coast Institute for Research, LLC — Jacksonville
  • Excellence Medical and Research — Miami Gardens

Идентификаторы

NCT: NCT06668935 · ADC-US-RES-24254

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗