Diabetes Self-management With Continuous Glucose Monitoring
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Type 1 Diabetes. Базовые параметры: 18 лет — 85 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
- Дания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
The Impact of Continuous Glucose Monitoring Based Self-management on Patient-Reported Outcomes and Glycaemia in Type 1 Diabetes
Обзор
The overall goal of this observational study is to investigate the interaction between people with type 1 diabetes and continuous glucose monitoring (CGM) and the impact of this interaction on quality of life, particularly the level of diabetes distress, and glycaemic metrics. Participants will: * Visit the clinic twice with a 14-day interval * Fill out a survey before the first and at the last visit * Use CGM as usual and use smart insulin pens and an activity tracker * Register food intake * Answer two-three questions twice a day in REDCap
Подробное описание
A two-centre observational study conducted in Denmark, including adults with type 1 diabetes (n=500) on multiple daily injections already using FreeStyle Libre 2.
Upon recruitment, participants will complete a survey of 11 validated questionnaires, including T1-DDS-28. For 14 days, participants will continue regular CGM use, smart insulin pens will record real-time insulin dosage, and an activity sensor will monitor physical activity and sleep. Participants will register food intake in the LibreLink app and respond to queries on quality of life twice daily through REDCap. At the end of the study, participants will complete the T1-DDS-28 and Health Literacy Questionnaire.
Our primary objectives is to investigate the association between diabetes distress (assessed by Type 1 Diabetes Distress Scale (T1-DDS-28)) and:
1. frequency of reading CGM data, 2. frequency of low glucose alarms, 3. frequency of high glucose alarms, 4. frequency of daily between-meal insulin corrections, 5. frequency of hypoglycaemic events preceded by correction of hyperglycaemia with insulin, 6. frequency of hyperglycaemic events preceded by correction of hypoglycaemia with carbohydrates, and 7. sociodemographic and psychosocial characteristics of CGM users.
Our secondary objective is to investigate the association between glycaemic metrics and the variables described above. Glycaemic metrics will be reported as CGM-metrics, including time in range defined as the percentage of time the sensor glucose is 3.9-10.0 mmol/L (70-180 mg/dL), per international consensus (ATTD, 2022)
Первичные конечные точки
- Diabetes Distress [Срок оценки: At baseline and after 14 days.]
Вторичные конечные точки (12)
- Time in range (TIR) [Срок оценки: 14 days]
- Time in tight range (TIR) [Срок оценки: 14 days]
- Time below range level 1 (TBR1) [Срок оценки: 14 days]
- Time below range level 2 (TBR2) [Срок оценки: 14 days]
- TBR1 night [Срок оценки: 14 days]
- TBR1 day [Срок оценки: 14 days]
- TBR2 night [Срок оценки: 14 days]
- TBR2 day [Срок оценки: 14 days]
- Time above range level 1 (TAR1) [Срок оценки: 14 days]
- Time above range level 2 (TAR2) [Срок оценки: 14 days]
- TAR1 night [Срок оценки: 14 days]
- TAR1 day [Срок оценки: 14 days]
Критерии участия
Критерии включения
- Age between 18 and 85 years.
- Diagnosed with T1D over one year ago.
- Actively using FreeStyle Libre 2 (>80% sensor activity).
- Used FreeStyle Libre 2 for over three months.
- Uses multiple daily insulin injections.
- Capable of providing written informed consent.
- Willing and able to complete study procedures, including using smart caps or pens and completing questionnaires at the investigator's discretion.
Критерии исключения
- History of allergic reactions to materials or adhesives used in CGM devices.
- Presence of severe cognitive or psychiatric conditions that could hinder the effective use of CGM or smart caps or pens - at the investigator's discretion.
- Current use of steroids unless part of a chronic therapy plan.
- Daily consumption of vitamin C ≥ 500 mg.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Дания · 2 центра
- Steno Diabetes Center Copenhagen — Herlev
- Copenhagen University Hospital, North Zealand - Hilleroed — Hillerød
Публикации
- Nitschke MJ, Demir C, Brosen JMB, Tapager IW, Norgaard K, Kristensen PL, Pedersen-Bjergaard U. Diabetes self-management observational study investigating how CGM use impacts diabetes distress, glycaemia and functions as a technological substitute for hypoglycaemia awareness: a study protocol. BMJ Open. 2025 Sep 2;15(9):e103469. doi: 10.1136/bmjopen-2025-103469. PMID 40897486
Идентификаторы
NCT: NCT06453434 · U1111-1306-6133