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Идёт набор NCT07742306

Continuous Glucose Monitoring in High-Risk Children and Youth With Type 1 Diabetes in the Dominican Republic

— Наблюдательное 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: Intermittent CGM.
Кому может быть актуально
Состояния в реестре: Type 1 Diabetes (T1D). Базовые параметры: 10 лет — 19 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
Dominican Republic
Следующий шаг
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Официальное название

The Effects of Continuous Glucose Monitoring Interventions in High-Risk Children and Youth With Type 1 Diabetes in the Dominican Republic

Обзор

The goal of this pilot longitudinal study is to investigate whether intermittent use of the Dexcom G7 continuous glucose monitor, together with pediatric endocrinology follow-up, diabetes education, and psychological support, can improve glucose control in children and adolescents with high-risk type 1 diabetes in the Dominican Republic. The study will include 40 participants, 10 to 19 years of age, from two pediatric diabetes care centers. Participants will use the Dexcom G7 during two short monitoring periods in the early part of the study. Each participant will use six sensors in total. Between and after these monitoring periods, participants will return to their usual finger-stick glucose monitoring with a glucometer. Participants and their families will also attend scheduled medical visits, diabetes education sessions, and psychological support sessions. Study information will be collected from medical records, laboratory results, Dexcom Clarity reports, participant glucose logs, study forms, and questionnaires. The study will assess changes in HbA1c, time in range, average glucose, glucose variability, low and high blood glucose episodes, adverse events, diabetes-related distress, fear of hypoglycemia, and satisfaction with glucose monitoring.

Вмешательства

  • Устройство Intermittent CGM
    Intermittent CGM + pediatric endocrinology follow-up, diabetes education and psychological support

Первичные конечные точки

  • Change in HbA1c [Срок оценки: Baseline, 3 months, 6 months, 9 months and 12 months]
  • Change in % CGM Time in Range [Срок оценки: Baseline, Month 1 and Month 4]
Вторичные конечные точки (10)
  • Mean sensor glucose [Срок оценки: Month 1 and Month 4]
  • % CGM Time in tight range [Срок оценки: Month 1 and Month 4]
  • % CGM time spent above range [Срок оценки: Month 1 and Month 4]
  • % CGM time below range [Срок оценки: Month 1 and Month 4]
  • CGM glycemic variability [Срок оценки: Month 1 and Month 4]
  • Episodes of diabetic ketoacidosis [Срок оценки: Throughout study follow-up duration of 12 months]
  • Episodes of severe hypoglycemia [Срок оценки: Throughout study follow-up duration of 12 months]
  • Change in Fear of Hypoglycemia [Срок оценки: Baseline and Month 3]
  • Change in Diabetes-Related Distress [Срок оценки: Baseline and Month 3]
  • Satisfaction With Glucose Monitoring [Срок оценки: Month 6]

Критерии участия

Критерии включения

  • HbA1c >9.0%
  • Age range: 10-19 years
  • Disposition and availability for patients and families to attend scheduled provider meetings, as well as general diabetic educational and psychological support meetings throughout the whole study. Namely, meeting every 2 weeks for the first 3 months and then every 4 weeks until completion of study for next 12 months.
  • Willingness and ability to provide signed voluntary consent form. Date and signature is requested however based on literacy levels a patient can provide consent verbally as long as there is a witness who is 18 years or older and demonstration of acknowledgement of information provided.

Критерии исключения

  • Diagnosis of T1D within the past 12 months
  • Previous or current use of CGM like FreeStyle Libre 2, Dexcom (G6, G7), or similar devices from other companies not mentioned
  • Current use of continuous insulin pump in combination with CGM use at present or prior to study
  • Residence location with greater than 3 hours of travel time distance from each health center in setting of cost and feasibility for families to travel on frequent necessary basis
  • Current steroid therapy orally or intravenously.
  • Medical comorbidities including chronic renal disease, hemoglobinopathies, leukemia, hematologic or oncologic conditions that can affect glycemia
  • Pregnancy

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Dominican Republic · 3 центра
  • Hospital Infantil Regional Universitario Dr. Arturo Grullón — Santiago de los Caballeros
  • Fundación Aprendiendo a Vivir — Santo Domingo
  • Hospital Infantil Robert Reid Cabral — Santo Domingo

Идентификаторы

NCT: NCT07742306 · 0114112023

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗