Идёт набор NCT05756829

Type 1 Diabetes Virtual Self-management Education and Support

Без фазы С лечением type1diabetes

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: High frequency, low touch virtual health care.
Кому может быть актуально: Состояния в реестре: type1diabetes. 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: Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

OVERVIEW: People living with type 1 diabetes (T1D) are expected to fit self-management and regular clinical consultations into busy lives. T1D self-management programs that offer frequent contact with care teams are most effective in helping patients achieve optimal glycemic control. However, this is difficult to deliver in the context of current T1D care which involves time-consuming in-person visits during working hours. The proposed study will test a virtual health care intervention to deliver "high frequency, low touch" care aimed at improving metabolic control, while reducing the burden on individuals and their healthcare teams. STUDY DESIGN: A pragmatic multicenter, open-label, randomized trial to evaluate the short-term effectiveness of a multifaceted virtual health care intervention in improving glycemic control in individuals with T1D. Planned recruitment is 580 participants from 10 specialized T1D centres in Ontario. INTERVENTION: Our intervention will include 1) frequent, brief virtual visits between patients with T1D and certified diabetes educators (conducted in real time using a secure telemedicine video interface accessible from any PC, tablet or smart phone) combined with automatic appointment reminders, and 2) a centralized web-based platform to provide educational classes, tools, and resources for diabetes self-management. Virtual visits will be an adjunct to routine in-clinic visits for blood pressure monitoring, foot checks, and surveillance for other complications of diabetes. This approach aims to enable patients to receive more education and support than is feasible in traditional health care models, and in a way that is more seamless (i.e. results in fewer disruptions to their daily life) and tailored to their individual needs based on their stage in life.

Вмешательства

Другое High frequency, low touch virtual health care
Virtual visits between certified diabetes educators and patients occurring every 2 +/- 1 weeks for a total of 6 months

Первичные конечные точки

Change from Baseline HbA1c at 6 months [Срок оценки: Baseline, pre-intervention AND Up to 4 weeks after the intervention]

Критерии участия

Критерии включения

Outpatients ≥18 years of age
Physician diagnosis of type 1 diabetes
Currently on an insulin pump or using multiple daily insulin injections.
HbA1c ≥ 7.5% on most recent laboratory report or estimated from CGM/FGM\* report, within the last 4 months

\*14 day look back window, with a wear rate of 70%, based on Estimated A1c or Glucose management Indicator (GMI)

Has access to a mobile device or computer/tablet with a video camera
Seen for at least one visit in the previous 6 months by participating certified diabetes educator at the selected diabetes clinic OR If a transitioning patient: Currently enrolled in a diabetes program below AND had at least one visit or touch-point prior in the previous 6 months by participating certified diabetes educator at on of our participating diabetes clinics
OHIP coverage
Currently using an active email address or be willing to obtain an email address
Has consistent and reliable access to internet
Willing and able to comply with scheduled in-person and virtual visits for 6 month intervention period