KCT0009215已完成Unknown
A prospective, multicenter, single arm, open-label, pivotal study to evaluate the efficacy and safety of the Continuous Glucose Monitoring System ‘CareSens Air’ in adult patients with type I and type II diabetes
i-sens0 个研究点目标入组 85 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 85
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
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1.Aged = 19 years
- •2.With Type I or Type II diabetes using intensive insulin treatment, or insulin treatment.
- •- Intensive insulin treatment: a treatment that uses multiple daily insulin injections or an insulin pump.
- •- Definition of intensive insulin treatment: 2 times or more daily injections with a combination of basal and bolus insulin
- •- Definition of insulin treatment: At least one injection per day, regardless of insulin type
- •3.Stop to consume Xylose 24 hours prior to enrollment in this trial and agree to stop consuming Xylose for the duration of the trial (limitations of CareSens Dual).
- •4.Voluntarily decide to participate in this trial and provide written consent
排除标准
- •1.With any of the following skin abnormalities/diseases at the CGMS sensor attachment site
- •- Severe psoriasis, recent burns or severe sunburn, severe eczema, severe scarring, extensive tattoos, dermatitis herpesiformis, severe rashes, staphylococcus aureus infection, etc.
- •2.Allergic to medical adhesives
- •3.Had a severe hypoglycemia event within 6 months prior to screening
- •- Severe hypoglycemia: A seizure caused by hypoglycemia that results in loss of consciousness or requires emergency care.
- •4.Hematocrit (Hct) level of <15% or >65% (limitation of CareSens Dual)
- •5.Currently with anemic, hemoglobin (Hb) level of <13 g/dL (male) or <12 g/dL (female) (Limitations of venous blood collection for YSI 2300 STAT PLUS measurement).
- •6.Had diabetic ketoacidosis (DKA) within 6 months prior to screening.
- •7.Medical history of cerebrovascular disease and cardiovascular disease (ischemic heart disease, peripheral vascular disease, cardiomyopathy, congenital heart disease, serious arrhythmias, etc.) within 6 months prior to screening
- •8.Had epilepsy, syncope, or adrenal disease within 6 months prior to screening.
- •9.Currentlytake antibiotics for a chronic infectious disease (e.g., osteomyelitis, endocarditis) or medications that may affect glucose metabolism (e.g., steroids). However, may be enrolled if maintained on a stable dose for 3 months prior to screening and throughout the duration of this trial
- •10.Take or apply medications (e.g. Methimazole, Isoniazid) and substances (e.g. Resorcinol, P-Phenylenediamine) that may damage the YSI sensor system or cause false readings (See Appendix 7).
- •11.Dialysis for kidney disease
- •12.Donated blood within 2 months prior to screening
- •13.Scheduled X-ray, MRI, CT scan, radiofrequency heat treatment, diathermy, or focused ultrasound treatment that cannot be rescheduled during this trial.
- •14.Women who are pregnant, nursing, or planning to become pregnant within the duration of this trial or who do not agree to use adequate contraception
- •15.Participation in another clinical trial within 2 weeks prior to screening or currently participating in another clinical trial or planning to participate in another clinical trial during the duration of this trial
- •16.Have a level of education, knowledge, and language comprehension (at least secondary school education, able to recognize blood glucose and hygiene, able to understand Arabic numerals and basic words dealing with the device) that, in the opinion of the investigator, makes them unsuitable for this trial or inexperienced in using a portable device with a graphical user interface. Have any other condition that, in the opinion of the investigator, makes them unsuitable for this trial or may increase the risks associated with participation in the trial.
研究者
相似试验
未知
3 期
Bosentan DDigital ulcers associated with systemic sclerosisJPRN-jRCT2080222130Actelion Pharmaceuticals Japan Ltd.20
进行中（未招募）
1 期
Triumeq As an Integrase Single Tablet Regimen in People with HIV who Inject DrugsHuman Immunodeficiency Virus (HIV) infectionEUCTR2016-000087-42-IEniversity College Dublin50
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