Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics

Официальное название

AID-BEYOND: Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics

Обзор

The goal of this clinical trial is to determine if transitioning to automated insulin delivery (AID) systems, can improve objectively measured sleep quality and quantity and alleviate cardiovascular risk factors in both children and adults diagnosed with type 1 diabetes. The main questions it aims to answer are: * Does the intervention improve sleep efficiency as measured by the HomeSleepTest, EEG based device, 4 months after initiation? * Can the use of AID treatment alleviate cardiovascular risk measured by heart rate variability (HRV), blood pressure and inflammatory markers? * Researchers will compare AID systems to usual treatment, including both multiple daily injections and sensor augmented pumps to see if the above benefits can be achieved with AID in comparison. Participants will be randomized 1:1 to either start AID treatment or to continue their usual care. The study will be open label. Participants will, at baseline and after 4 months: * Have taken blood and urine samples to measure metabolic and inflammatory parameters * Perform digital cognitive testing using the CANTAB software * Fill out questionnaires related to quality of life, fear of hypoglycemia, hypoglycemia awareness, eating habits and sleep quality * Wear a blinded CGM for 10 days * Monitor sleep at home using the HomeSleepTest for 3 consecutive nights * Wear a Holter monitor for 24 hours to determine HRV parameters * Measure blood pressure for 24 hours at 30 min intervals * Wear an ActiGraph for 7 days to assess sleep and activity, supported by daily electronic sleep diaries Participants randomized to AID treatment will receive education in the use of the systems. Virtual follow-up visits are scheduled at week 1, 5 and 9 for both control and intervention groups during the study, following baseline examinations.

Вмешательства

• Устройство Automated insuling delivery system
  Closed-loop insulin pumps including MiniMed 780G, Tandom T2-slim x2 and YpsoCamAPS

Первичные конечные точки

• Difference in change from baseline to study end in sleep efficiency between the two groups. [Срок оценки: Baseline and week 18]

Вторичные конечные точки (12)

• Total sleep duration [Срок оценки: Baseline and week 18]
• Time in sleep stages [Срок оценки: Baseline and week 18]
• Time in sleep stages [Срок оценки: Baseline and week 18]
• Sleep latency [Срок оценки: Baseline and week 18]
• Waking after sleep onset [Срок оценки: Baseline and week 18]
• 24-hour blood pressure [Срок оценки: Baseline and week 18]
• Heart rate variability [Срок оценки: Baseline and week 18]
• Heart rate variability [Срок оценки: Baseline and week 18]
• Heart rate variability [Срок оценки: Baseline and week 18]
• Heart rate variability [Срок оценки: Baseline and week 18]
• Cognitive function [Срок оценки: Baseline and week 18]
• Cognitive function [Срок оценки: Baseline and week 18]

Критерии участия

Inclusion Criteria (Adults):

• Age ≥18 years
• Type 1 diabetes ≥3 years
• CGM or intermittently scanned CGM (isCGM) use ≥6 months
• Approval from the responsible health care provider (HCP) to start AID
• Specific AID system chosen ahead of screening after participant has been thoroughly informed

Inclusion Criteria (Children):

• Age 7-17 years
• Type 1 diabetes ≥6 months
• CGM or isCGM use ≥6 months
• Approval from the responsible HCP to start AID
• Specific AID system chosen ahead of screening after participant has been thoroughly informed

Критерии исключения

• Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
• Use of commercial or open-source AID systems prior to study participation
• Daily use of paracetamol (acetaminophen)
• Breast-feeding, pregnancy or planning to become pregnant within 4 months
• Alcohol or drug abuse
• Severe cardiac disease
• Retinopathy contraindicating HbA1c <53 mmol/mol
• Other concomitant medical or psychological condition that, according to the investigator's assessment, makes the person unsuitable for study participation
• Lack of compliance with key study procedures at the discretion of the investigator

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

Лечение

Центры проведения

Дания · 3 центра

• Steno Diabetes Center Copenhagen — Herlev
• Steno Diabetes Center Aarhus — Aarhus
• Diagnostisk Center, Regionshospitalet Silkeborg — Silkeborg

Идентификаторы

NCT: NCT06469593 · H-23074743

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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