The Impact of Early Automated Insulin Delivery (AID) Therapy on Diabetes Control and Comorbidities, and Cost-effectiveness of AID Treatment

Официальное название

The Impact of Early Automated Insulin Delivery (AID) Therapy on Diabetes Control and Comorbidities, and Cost-effectiveness of AID Treatment - a Prospective, Randomized, Controlled Study on Pediatric Patients With Type 1 Diabetes

Обзор

The purpose of this study is to investigate the effect of early initiated automated insulin de-livery (AID) treatment in type diabetes in children aged 7-16 years to glycemic control, diabe-tes distress of patients and caregivers, long-term micro- and macrovascular complications and cost-effectiveness compared to multiple daily injections (MDI) and continuous glucose monitoring (CGM). The immediate costs of AID therapy are higher than costs of multiple daily injection therapy, and there has been debate whether the more expensive AID therapy is justified. No research on the cost-effectiveness of AID use in children has been conducted so far in Finland, and there is generally very little research data on the long-term treatment of type 1 diabetes with AID systems. AID therapy has been studied from the point of diagno-sis of type 1 diabetes in two centers (USA and the UK) but from the perspective of maintain-ing subject's own insulin secretion. A long-term randomized and controlled study on the out-comes and cost-effectiveness of AID therapy, started from diagnosis of diabetes, is essential to create evidence-based data for optimizing current treatment recommendations. Our hypothesis is that AID treatment keeps the glycemic outcomes in targets in the long term and decreases diabetes distress. During longer time, AID system decreases the amount of micro- and macrovascular complications and is cost-effective treatment for children with type 1 diabetes (CwT1D).

Вмешательства

• Устройство Omnipod 5
  Omnipod5 uses a SmartAdjust™ closed-loop algorithm to automate insulin delivery. Algorithm continuously predicts glucose trends and self-adjusts insulin delivery within safety boundaries
• Препарат Multiple daily injections of insulin
  Multiple daily infections of insulin to treat type 1 diabetes

Первичные конечные точки

• Time in Range [Срок оценки: During the first 2 years]

Вторичные конечные точки (8)

• TINR [Срок оценки: During the first 2 years]
• Complications [Срок оценки: 15 years]
• HbA1c [Срок оценки: 2 years]
• Mean sensor glucose value [Срок оценки: 2 years]
• Glycemic variability [Срок оценки: 2 years]
• Continuous Ketone monitoring (CKM) [Срок оценки: During the first 2 years]
• Cost-effectiveness [Срок оценки: 15 years]
• Custom food list [Срок оценки: During the first 2 years]

Критерии участия

Критерии включения

• Children and adolescents aged 7-15 years who are re-cently (within a month) diagnosed with type 1 diabetes at the Children's and Adolescents' Unit of HUH at the New Children's Hospital and Jorvi Hospital

Критерии исключения

• Addison's disease
• Renal failure
• Untreated coeliac disease
• Untreated thyroid disorder
• Poorly controlled asthma, per investigator judgment.
• Unresolved adverse skin conditions in the area of sensor placement (e.g. pso-riasis, rash, Staphylococcus infection).
• Participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before enrollment into this study, as per investigator judgment.

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

Финляндия · 2 центра

• Jorvi Hospital — Espoo
• New Children's Hospital — Helsinki

Идентификаторы

NCT: NCT07423637 · HelDiabKids_AID

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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