DRKS00032140已完成Unknown
A prospective, monocenter, single-arm, open-label study to collect data for algorithm optimization of the Continuous Glucose Monitoring System CareSens Neon in adult patients with type 1 diabetes - IfDT-2230-IE
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- i-SENS, Inc.
- 入组人数
- 23
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Patients with type 1 diabetes who have been using intensive insulin therapy for at least 3 months
- •- Patients who voluntarily decided to participate in the study and provide written informed consent
排除标准
- •1. Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment
- •2. Hypoglycemia unawareness
- •3. Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of menopause, sterilization or hysterectomy)
- •4. Known severe tape reactions or allergies
- •5. Skin alteration at the insertion sites (i.e. Psoriasis vulgaris, scars, lipodystrophia)
- •6. MRT, CT, radiofrequency ablation, high-frequency electrical heat or high intensity focused ultrasound needed during the course of the study.
- •7. Patients unwilling to abstain from use of nutritional supplements containing xylose
- •8. Serious acute or chronic disease besides diabetes mellitus or an anamnesis which might, in the opinion of the investigator, pose a risk to the subject, e.g. seizure disorder, adrenal disorder, dialysis for renal failure, cystic fibrosis, active infection
- •9. Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g. mental or visual incapacity, language barriers, alcohol or drug misuse
- •10. Dependency from the sponsor or the clinical investigator
- •11. HbA1c > 10%
研究者
相似试验
已完成
不适用
Algorithm optimization of a new continuous glucose monitoring system in children, adolescents and adult patients with type 1 diabetes – A pilot study.Type 1 diabetesACTRN12621000836831i-SENS, Inc.30
尚未招募
Unknown
A prospective, monocenter, single-arm, open-label, interventional, post-market follow-up evaluation of the CareSens Air continuous glucose monitoring system in adult patients with type 1 and type 2 diabetesE14Unspecified diabetes mellitusDRKS00034614i-SENS, Inc.30
已完成
4 期
A prospective, multicenter, single-arm, open-label, phase 4 study to evaluate the effects of macitentan on Right vEntricular remodeling in Pulmonary ArterIal hypeRtension assessed by cardiac magnetic resonance imagingPulmonary Arterial HypertensionElevated blood pressure in blood vessels in the lungs.10037454NL-OMON45109Actelion Pharmaceuticals15
进行中（未招募）
1 期
A study of the effects of macitentan on the heart in patients with elevated blood pressure in blood vessels of the lungs.MedDRA version: 20.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersPulmonary Arterial HypertensionEUCTR2014-004066-20-DEActelion Pharmaceuticals Ltd.87
进行中（未招募）
1 期
A study of the effects of macitentan on the heart in patients with elevated blood pressure in blood vessels of the lungs.Pulmonary Arterial HypertensionMedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2014-004066-20-GBActelion Pharmaceuticals Ltd.100