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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Time in Range
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Early AID-treatment
Automated insulin delivery system (Omnipod 5) is initiated after T1D diagnosis. Omnipod5 uses a SmartAdjust™ closed-loop algorithm to automate insulin delivery. Algorithm continuously predicts glucose trends and self-adjusts insulin delivery within safety boundaries. Continious glucose monitoring (CGM) is used.
干预措施: Omnipod 5 (Device)
Control group
Multiple daily insulin injections (MDI) is initiated after T1D with a standard treatment protocol. Continious glucose monitoring (CGM) is used.
干预措施: Multiple daily injections of insulin (Drug)
结局指标
主要结局
Time in Range
时间窗: During the first 2 years
Percentage (%) of the time patients' glucose levels are within the target range based on continuous glucose monitoring (time in range =TIR, 3.9-10 mmol/l).
次要结局
- TINR(During the first 2 years)
- Complications(15 years)
- HbA1c(2 years)
- Mean sensor glucose value(2 years)
- Glycemic variability(2 years)
- Cost-effectiveness(15 years)
- Custom food list(During the first 2 years)
- Continuous Ketone monitoring (CKM)(During the first 2 years)
研究者
Tero Varimo, MD, PhD
MD, PhD, pediatric endocrinologist
Helsinki University Central Hospital