Hybrid Closed Loop Insulin Pump and Bariatric Surgery in Patients With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 3
- 主要终点
- time spent within glycemic target 70-180 mg/dL
研究概览
简要总结
Bariatric surgery is increasingly performed on patients with type 1 diabetes. It exposes these patients to an increased risk of hypoglycemia, including severe hypoglycemia, and of severe episodes of hyperglycemia, beyond the perioperative period. The long-term efficacy and safety of hybrid closed-loop insulin pump in these patients has not yet been published.
详细描述
Patients with type 1 diabetes and obesity are at risk of "double diabetes". Bariatric surgery may be indicated for these patients, to combat insulin resistance. Nevertheless, post-operative patients are at risk of hypoglycemia.
At the same time, patients with type 1 diabetes can benefit from a hybrid closed loop insulin pump to improve diabetes control and reduce the occurrence of hypoglycemia.
In type 1 diabetic patients who have undergone bariatric surgery and are treated with a hybrid closed loop insulin pump, continuous glucose measurement can be studied. In the medium and long term, the efficacy and safety of this system in this context will be described.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Major patient
- •With type 1 diabetes for > 1 year
- •Obese (BMI≥30)
- •Having undergone bariatric surgery
- •On a hybrid closed-loop insulin pump
- •Not pregnant
- •No hybrid closed-loop insulin pump discontinuation for more than 45 days after surgery
排除标准
- •Patient informed and opposed to data use
结局指标
主要结局
time spent within glycemic target 70-180 mg/dL
时间窗: at 3 months
time spent within glycemic target 70-180 mg/dL in type 1 diabetes patients who underwent bariatric surgery,
次要结局
- Time spent in level 2 hyperglycemia (>250 mg/dL)(at 3 months)
- Coefficient of variation(at 3 months)
- Time spent in level 1 hyperglycemia (181-250 mg/dL)(at 3 months)
- HbA1c(at 3 months)
- Time spent in level 1 hypoglycemia (51-70 mg/dl)(at 3 months)
- Time spent in level 2 hypoglycemia (< 50 mg/gdl)(at 3 months)