Advanced Hybrid Closed-Loop Treatment in Adults With Type 1 Diabetes Not Meeting Glycaemic Targets: A Randomised Controlled Trial - The Steno 780G Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Difference between treatment groups in change in TIR (3.9-10.0 mmol/l) from baseline to Week 14
研究概览
简要总结
Treatment with insulin pumps and sensor-based glucose monitoring has proven superior to other treatment methods in type 1 diabetes. Still, the majority of people treated with insulin pumps and glucose sensors still does not meet the recommended sensor-based glycaemic targets. Automated insulin delivery systems, also known as closed-loop systems, have shown to improve TIR, TAR, and TBR compared with insulin pump and CGM systems that cannot automatically dose insulin.
The primary objective of the Steno 780G study is to test the effects of the MiniMed 780G system in persons with T1D treated with insulin pump and CGM/isCGM who are not meeting glycaemic targets.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Type 1 diabetes ≥2 years.
- •HbA1c >=58 mmol/mol
- •Insulin pump treatment ≥12 months
- •CGM or isCGM use ≥6 months
- •Novorapid use ≥1 week
- •Carbohydrate counting and use of the insulin pump bolus calculator for most snacks and meals.
- •Carbohydrate intake >80 grams per day (assessed by review of intake recorded in the insulin pump during the 2 weeks prior to the screening visit)
排除标准
- •Breast-feeding, pregnancy or planning to become pregnant.
- •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 hybrid closed-loop systems
- •Daily use of paracetamol (acetaminophen)
- •Alcohol or drug abuse.
- •Severe cardiac disease or 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.
- •Unacceptable adverse events at the discretion of the investigator.
结局指标
主要结局
Difference between treatment groups in change in TIR (3.9-10.0 mmol/l) from baseline to Week 14
时间窗: From baseline to week 14
Difference between treatment groups in change in TIR (3.9-10.0 mmol/l) from baseline to Week 14 assessed by 2 weeks of CGM data (12 AM-12 AM (wake + sleep)).
次要结局
- Difference in standard deviation(From baseline to week 14)
- Difference between treatment groups in change in TIR (3.9-10.0 mmol/l) from baseline to Week 14 assessed by 2-week CGM data (6 AM - 12 AM (wake), and 12 AM - 6 AM (sleep))(From baseline to week 14)
- Body weight(From baseline to week 14)
- Total daily carbohydrate intake(From baseline to week 14)
- Difference in coefficient of variation(From baseline to week 14)
- Percentage of time with glucose values > 13.9 mmol/l (TAR level 2).(From baseline to week 14)
- Difference in mean glucose(From baseline to week 14)
- Percentage of time with glucose values > 10.0 mmol/l (TAR level 1).(From baseline to week 14)
- HbA1c(From baseline to week 14)
- Total daily insulin dose(From baseline to week 14)
- Percentage of time with glucose values < 3.9 mmol/l (TBR level 1).(From baseline to week 14)
- Percentage of time with glucose values < 3.0 mmol/l (TBR level 2).(From baseline to week 14)
- Glucose management indicator (an estimate of the laboratory HbA1c value).(From baseline to week 14)
研究者
Merete Bechmann Christensen
Principal Investigator, MD, PhD
Steno Diabetes Center Copenhagen