NCT03939065终止不适用
Sensor Augmented Pump (SAP) Therapy for Inpatient Cystic Fibrosis Related Diabetes (CFRD) Management
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Differences in CGM percent time over 140 mg/dl
研究概览
简要总结
This research proposes a pilot study using the combination of continuous glucose monitor (CGM) and insulin pump therapy, also known as sensor augmented pump (SAP) therapy, for cystic fibrosis related diabetes (CFRD) management in the inpatient setting, with the aim of improving glycemic control.
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
- 8 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥8 years
- •Confirmed diagnosis of CF by consensus guidelines [50]
- •Diagnosis of CFRD based on American Diabetes Association and CFF criteria [51]
- •Admission for pulmonary exacerbation
排除标准
- •Known type 1 or type 2 diabetes, monogenic diabetes (MODY)
- •Critical illness requiring admission to the intensive care unit
- •Admission for indications other than pulmonary exacerbation (ex. Distal intestinal obstructive syndrome, surgery)
结局指标
主要结局
Differences in CGM percent time over 140 mg/dl
时间窗: through study completion, up to 3 weeks
Differences in percent time \>140 mg/dl on CGM between groups
次要结局
- Change in Pulmonary Function(baseline and 1 week)
- Weight change(baseline and 1 week)
- Statstrip glucose(through study completion, up to 3 weeks)
- Circulatory markers of inflammation(baseline and 1 week)
研究者
研究点 (2)
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