Periodic Continuous Glucose Monitoring in Patients With Type 2 Diabetes
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: Periodic CGM group with data analysis report- Intervention group.
- Кому может быть актуально
- Состояния в реестре: Type 2 Diabetes. Базовые параметры: 18 лет — 80 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
- Швеция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Periodic Continuous Glucose Monitoring to Support a Person-centered Approach During Diabetes Consultations in Patients With Type 2 Diabetes- A Randomised Controlled Study
Обзор
The aim of this randomised controlled trial is to investigate the effectiveness of periodic CGM (continuous glucose monitoring) to support a person-centered approach versus self-monitoring of blood glucose (SMBG) in adults with type 2 diabetes on glucose control and patient reported outcomes.
Подробное описание
This is a 16-week prospective, multicenter, randomised, open-labelled, two-armed study in adults with type 2 diabetes conducted at primary care practices in Sweden.
Periodic CGM group- Intervention group:
The participants in the intervention group will be provided with FreeStyle Libre (Abbott Diabetes Care). Participants wear the sensor and check their glucose level for a period of 28 days (14 days X 2) during week 0-4 and week 10-13.Patient's measurement data from the FreeStyle Libre system 2 will be transferred to the OneTwo Analytics (DDA) analysis tool for an automated analysis and this Insight report will be presented to the participants at visit week 4 (digital) and at visit week 16 (clinical). The diabetes nurse and the patient reviews and discuss trends, patterns, and challenges to support the person's self-care management of their type 2 diabetes. This approach is intended to facilitate communication and patient participation and create the conditions for shared informed decisions and health planning.
Self-monitoring of blood glucose, SMBG and usual care - Control Group The participants in the control group perform SMBG testing as usual including fasting, pre- or post-prandial measurements. They also receive usual care which comprises consultation with physician diabetes specialist or diabetes nurse depending on individual health care needs.
Вмешательства
- Поведенческое Periodic CGM group with data analysis report- Intervention group
The patients are also instructed to continue to perform SMBG by finger prick if they experience symptoms of hypo- or hyperglycemia. During visit 0 (baseline) the patients is also instructed about how they can log in to the National Diabetes Register (NDR) to access their own NDR's recorded data and use the diabetes questionnaire.
Первичные конечные точки
- HbA1c [Срок оценки: change at week 16]
Вторичные конечные точки (12)
- Percentage of time spent in range (Glucose) [Срок оценки: change first 28 days in the study compared with the last 28 days]
- Percentage time spent in hyperglycaemia [Срок оценки: change first 28 days in the study compared with the last 28 days]
- Percentage time spent in hypoglycaemia [Срок оценки: change first 28 days in the study compared with the last 28 days]
- Average glucose value [Срок оценки: change first 28 days in the study compared with the last 28 days]
- Standard deviation for glucose value [Срок оценки: change first 28 days in the study compared with the last 28 days]
- Percentage time in euglycemia, time in target [Срок оценки: change first 28 days in the study compared with the last 28 days]
- Number of hyperglycemic episodes per day [Срок оценки: change first 28 days in the study compared with the last 28 days]
- Number of hypoglycemic episodes per day [Срок оценки: change first 28 days in the study compared with the last 28 days]
- Data availability in % of all time [Срок оценки: change first 28 days in the study compared with the last 28 days]
- Prandial delta within 2 hours, post - pre-prandial values for breakfast, lunch and dinner. [Срок оценки: change first 28 days in the study compared with the last 28 days]
- Postprandial peak during 2 hours for breakfast, lunch and dinner. [Срок оценки: change first 28 days in the study compared with the last 28 days]
- Night-time insulin effect [Срок оценки: change first 28 days in the study compared with the last 28 days]
Критерии участия
Критерии включения
- Adults aged 18-80 years
- Type 2 diabetes with a duration of > 6 months
- HbA1c 45-70 mmol/mol
- Have a smartphone
- Experience of self-monitoring of blood glucose prior to the study start
Критерии исключения
- Prandial insulin
- Pregnancy or planning pregnancy during the study
- Breastfeeding
- Renal disease with estimated glomerular filtration rate (eGFR) <45 mL/ min/1.73 m2
- Active malignancy or under investigation for malignancy
- Severe visual impairment
- Severe skin allergy that inhibits the use of a continuous glucose monitoring device
- Glucocorticoids (systemic)
- Planned or currently using weight reduction medications, programs, or surgery
- Cognitively or psychologically unable to participate and read instructions
- Enrolled in other clinical trials
- Eating disorders
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
Швеция · 1 центр
- Sophiahemmet University — Stockholm
Идентификаторы
NCT: NCT05633628 · Periodic Glucose Insights