DRKS00034614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 diabetes - IfDT-2412-IE
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- i-SENS, Inc.
- 入组人数
- 30
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
- •Clinical diagnosis of type 1 or type 2 diabetes mellitus
- •Intensive insulin therapy established for at least six months
- •An understanding of and willingness to follow the protocol
- •Signed informed consent
排除标准
- •Hypoglycemia unawareness
- •Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment
- •HbA1c > 10%
- •Known severe skin reactions (including allergic contact dermatitis) or allergies to medical adhesives
- •Skin alteration at the insertion sites (e.g., severe psoriasis vulgaris, severe scaring, severe lipodystrophy, severe rash, large tattoos hindering insertion at unchanged skin regions)
- •Severe diabetes-relevant complications (i.e., severe macro- and/or microangiopathy, severe neuro-, retino- or nephropathy)
- •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
- •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
- •Unwilling to abstain from use of nutritional supplements containing xylose
- •Intake of anticoagulants, except of platelet aggregation inhibitors
- •Unwilling to avoid thermal bathing, sauna, excessive exercises and contact sports for the duration of the core study period
- •Planned medical procedures during the core study period that could affect the performance of the CGM systems, including magnetic resonance imaging, computer tomography scan, radiofrequency ablation, high-frequency electrical heat or high intensity focused ultrasound
- •Wearing a cardiac pace maker or other comparable medical devices
- •Dependency from the sponsor or the clinical investigator
- •Infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immuno-deficiency virus (HIV) or other chronic infectious disease
- •Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of reported menopause, sterilization or hysterectomy)
研究者
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