NL-OMON20928招募中不适用
Algorithm to control Postprandial, Post exercise and night glucose Excursions in a portable Closed Loop format in patients after Total Pancreatectomy
Amsterdam UMC (Academic Medical Center)0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients who underwent total pancreatectomy;
- •Diabetes treatment with continuous subcutaneous insulin infusion, sensor augmented pump therapy or subcutaneous insulin injections;
- •Age =18 years.
排除标准
- •Total pancreatectomy was performed within less than 3 months before start of the trial;
- •Impaired awareness of hypoglycemia (score = 4) according to Gold and/or Clarke questionnaire;11,12
- •BMI > 35 kg/m2;
- •HbA1c > 90 mmol/mol;
- •Use of oral corticosteroids;
- •Use of acetaminophen during the open loop or closed loop period, as this may influence the sensor glucose measurements;
- •Limited ability to see, and to hear or feel alarm signals of the closed loop system;
- •Refusal of disconnecting own glucose sensors during the closed loop system study period;
- •Pregnancy and/or breastfeeding;
- •Living alone during the night during the closed loop period (the patient may ask someone to stay over temporarily);
- •Any condition that the local investigator feels would interfere with study participation or the evaluation of the results.
- •Patients who are not motivated or not willing to comply with the artificial pancreas therapy;
- •Patients undergoing treatment with Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, X-ray or high frequency electrical heat (diathermy) treatment while wearing the AP system (must be removed);
- •Patients using the artificial pancreas system during sauna or swimming;
- •Known or suspected allergies or problems related to subcutaneous administration of insulin or glucagon;
- •Artificial pancreas therapy is not recommended for people who are unwilling or unable to maintain contact with their medical professional;
- •Alcohol and drug abusing patients;
- •Patients with insufficient general mental and physical abilities;
- •Known or suspected problems related to enzyme based glucose sensor usage;
- •Patients receiving dialysis.
研究者
相似试验
已完成
不适用
Algorithm to control Postprandial, Post exercise and night glucose Excursions in a portable Closed Loop format in patients after Total Pancreatectomy, APPEL 5+DiabetesNL-OMON49195Academisch Medisch Centrum12
已完成
不适用
Algorithm to control Postprandial, Post exercise and night glucose Excursions in a portable closed Loop format, APPEL 4Diabetes Mellitus type 1 / diabetes10018424NL-OMON40156Academisch Medisch Centrum12
已完成
不适用
Algorithm to control Postprandial, Post exercise and night glucose Excursions in a portable closed Loop format, APPEL 5Diabetes Mellitus type 1 / Diabetes10018424NL-OMON46864Academisch Medisch Centrum34
已完成
不适用
Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop FormatDiabetes Mellitus, Type 1NCT02160275J.H. DeVries16
已完成
不适用
Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format,Diabetes Mellitus, Type 1NCT03858062J.H. DeVries36