Closed-loop Insulin Delivery Systems ("Artificial Pancreas") in Patients With Pancreatitis or Pancreatectomy-induced Diabetes: an Observational Case Series
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Percentage of time spent in the target
研究概览
简要总结
The purpose of this study is to evaluate the metabolic and the safety outcomes in people living with pancreatic diabetes (pancreatitis or pancreatectomy-induced diabetes) and using a closed-loop insulin delivery systems ("artificial pancreas").
详细描述
Secondary pancreatic diabetes is an unstable diabetes, due to deficiency in B cells which produce insulin, alpha cells which produce glucagon, and exorcrine insufficiency. Patients with secondary pancreatic diabetes are exposed to high glycemic variability and severe hypoglycemic episodes. Hybrid closed loop treatment has shown efficacy and safety for patients with type 1 diabetes and has the potential to improve the control of secondary pancreatic diabetes but has rarely been studied in this particular indication.
A retrospective observational cohort study in patients will be contucted suffering from secondary pancreatic diabetes in whom this device was implemented in order to observe metabolic and safety outcomes compared to the period before they were treated with hybrid closed-loop system.
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
- •Adult patient
- •Presenting secondary pancreatic diabetes
- •Treatment with insulin closed-loop delivery
排除标准
- •Patient who objected to the use of data
结局指标
主要结局
Percentage of time spent in the target
时间窗: at day 90
Percentage of time spent in the target, between 70 and 180 mg/dl the last 90 days available (T1) after starting hybrid closed loop
次要结局
- Percentage of time spent(at day 90)
- Hyperglycemia events(at day 90)
- Hypoglycemia events (serveral hypoglycemia )(at day 90)
- Pourcentage of closed-loop mode use(at day 90)
- Glucose Management Indicator (GMI)(at day 90)
- Coeffecient of variabilty of Glucose Management Indicator(at day 90)
- Microangiopathic events(at day 90)