Идёт набор NCT07154251

Utilizing Community Health Workers as Diabetes Technology Coaches for Children With Type 1 Diabetes Using Automated Insulin Delivery

Без фазы С лечением Type 1 Diabetes (T1D)

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: Community Health Worker.
Кому может быть актуально: Состояния в реестре: Type 1 Diabetes (T1D). Базовые параметры: 5 лет — 17 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: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Utilizing a Community Health Worker in the Role of a Diabetes Technology Coach for Black Children Using Automated Insulin Delivery and Not Meeting Glycemic Targets (CHWs AID Youth)

Обзор

This study uses community health workers (CHW) as diabetes technology coaches for African American children using automated insulin delivery systems but have an HbA1c of 8% or higher. Families will meet with the CHW monthly x 6 months with additional visits as needed. All participants and parents/guardians will fill out questionnaires at the beginning and end of the 6 month intervention in addition to an interview at 6 months. This will be followed by 6 months with no extra help from the CHW, but we will continue to follow CGM and pump download data.

Вмешательства

Другое Community Health Worker
Community Health Worker will meet with families monthly (and more often as needed) in the role of a diabetes technology coach

Первичные конечные точки

Change in capillary HbA1c [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months]
Change in number of participants who use an automated insulin delivery system with at least 80% time in automated mode over the past 30 days, as measured by download of data from the automated insulin delivery system [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months]

Вторичные конечные точки (12)

Change in time in range (70-180 mg/dL) as measured by continuous glucose monitoring [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months]
Change in time under 70 mg/dL as measured by continuous glucose monitoring [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months]
Change in time over 250 mg/dL as measured by continuous glucose monitoring [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months]
Change in continuous glucose monitor wear time as measured by continuous glucose monitoring [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months]
Change in time in automated mode as measured by automated insulin delivery system [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months]
Change in psychosocial functioning of children/adolescents, as measured by the strengths and difficulties questionnaire given to parents/guardians [Срок оценки: Baseline, 6 months]
Change in diabetes family conflict, as measured by the Diabetes Family Conflict Scale [Срок оценки: Baseline, 6 months]
Change in child/adolescent quality of life, as measured by PedsQL Type 1 diabetes module by parent-proxy [Срок оценки: Baseline, 6 months]
Change in parental burden related to diabetes, as measured by Problem Areas in Pediatric Diabetes - Parent Revised Version [Срок оценки: Baseline, 6 months]
Change in medical distrust, as measured by the Group Based Medical Distrust Scale [Срок оценки: Baseline, 6 months]
Change personal frequency of discrimination in healthcare, as measured by the Racism in Healthcare Index [Срок оценки: Baseline, 6 months]
Change in perceptions of racism in healthcare, as measured by the Racism in Healthcare Index [Срок оценки: Baseline, 6 months]

Критерии участия

Критерии включения

Self-reported as non-Hispanic Black
Clinical diagnosis of type 1 diabetes, requiring treatment with insulin at the time of consent
Currently using, or have used within the past 3 months, an automated insulin delivery system (consisting of a continuous glucose monitor and an insulin pump as well as an automated insulin delivery algorithm)
Clinical care provided at UH Cleveland Medical Center
Has not previously worked with a community health worker for help with diabetes technology