Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Percentage time spent in glucose target (3.9-10mmol/L)
研究概览
简要总结
This is a staggered randomised controlled trial that aims to assess the impact of an automated insulin delivery (AID) system on glucose, gastrointestinal and patient-reported outcomes.
详细描述
Following a run-in period of 2 weeks, participants will be randomised to control or hybrid automated insulin delivery (AID) using the 780G system and will remain in the intervention phase of the study for 12 weeks (4-week control, then 4-week AID or Control and finally 4-week AID). The total duration for each participant will be 14 weeks. There are 5 study visits (combination of face to face or/and remote) and two telephone visits in total.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years of age or older
- •Type 1 diabetes confirmed on the basis of clinical features
- •Type 1 diabetes for greater than 1 year
- •On an intensified insulin regimen with multiple dose injection or insulin pump for > 3 months
- •HbA1c >7.5% (58mmol/mol) (or %TIR 3.9-10mmol/L <52% for participants already using a continuous glucose sensor)
- •Gastroparesis Cardinal Symptom Index (GCSI) ≥ 18 or evidence of delayed gastric emptying on nuclear medicine gastric emptying study
排除标准
- •Enrolled in other clinical trials
- •Estimated glomerular filtration rate of ≤30ml/min
- •Pregnant or planning pregnancy
- •Have active malignancy or under investigation for malignancy
- •Severe visual impairment
- •Reduced manual dexterity
- •Use of any automated insulin delivery system
- •Unable to participate due to other factors, as assessed by the Chief Investigator
结局指标
主要结局
Percentage time spent in glucose target (3.9-10mmol/L)
时间窗: 4 - 8 weeks
The change in percentage time in glucose target between baseline and intervention/control
次要结局
- Percentage time spent in hyperglycaemia (>10mmol/L)(4 - 8 weeks)
- Percentage time spent in hypoglycaemia (<3.9mmol/L)(4 - 8 weeks)
- Percentage time spent in hypoglycaemia (<3.0mmol/L)(4 - 8 weeks)