Sensor-Augmented Continuous Correction in Insulin Pump-Treated Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Percentage of time CGM values are in the target range 3.9-8.0 mmol/l in the time period 8:00-17:00.
研究概览
简要总结
The potential of currently available diabetes technologies could be further exploited. The investigators propose that sensor-augmented insulin pump therapy may be improved by continuous correction, i.e. continuous evaluation of the need for correction boluses. In practice, this is carried out by running the bolus calculator every 10 minutes. The glucose sensor will provide the bolus calculator with glucose input. Many times, the bolus calculator will come to the result that no insulin is needed. However, when the blood glucose is above the pre-set target value and a correction bolus is needed, an appropriate bolus is automatically delivered by the insulin pump.
The investigators hypothesize that sensor-augmented continuous correction insulin pump therapy can reduce hyperglycemia without increasing the risk of hypoglycemia in patients with type 1 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Age ≥ 18 years
- •T1D ≥ 3 years
- •CSII ≥ 1 year
- •HbA1c ≤ 8.0% (64 mmol/mol)
排除标准
- •Pregnancy or nursing
- •Hypoglycemia unawareness
- •Gastroparesis
- •Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to the study
- •Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
研究组 & 干预措施
Continuous correction
The insulin pump is set to automatically deliver the patient's usual insulin basal rate. The insulin pump bolus calculator is run every 10 minutes by the attending physician. Bolus calculations are based on glucose sensor values.
干预措施: Continuous Correction (Procedure)
Control
Regular sensor-augmented pump therapy.
结局指标
主要结局
Percentage of time CGM values are in the target range 3.9-8.0 mmol/l in the time period 8:00-17:00.
时间窗: Every 5 min for 9 hours on each study day.
The primary outcome is difference in the percentage of time CGM values are in the target range 3.9-8.0 mmol/l in the time period 8:00-17:00 on CC-days and Control-days.
次要结局
- Percentage of time when CGM values are > 8.0 mmol/l.(Every 5 min for 9 hours on each study day.)
- CGM standard deviation.(Every 5 min for 9 hours on each study day.)
- Number of hypoglycemic episodes.(Every 5 min for 9 hours on each study day.)
- Percentage of time when CGM values are < 3.9 mmol/l.(Every 5 min for 9 hours on each study day.)
- Amount of insulin delivered.(Every 30 min for 9 hours on each study day.)
- Positive Incremental Area Under the Curve(Every 5 min for 9 hours on each study day.)
- Mean CGM glucose value.(Every 5 min for 9 hours on each study day.)
研究者
Signe Schmidt
MD
Hvidovre University Hospital