DRKS00033697已完成Unknown
Clinical performance evaluation of three continuous glucose monitoring systems in adults with diabetes mellitus using a newly proposed testing procedure - IfDT-2332-I
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT)0 个研究点目标入组 24 人开始时间: 2024年3月26日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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
- •1. Clinical diagnosis of type 1 or type 2 diabetes mellitus
- •2. Age = 18 years
- •3. Intensive insulin therapy established for at least six months
- •4. An understanding of and willingness to follow the protocol
- •5. Signed informed consent
排除标准
- •1. HbA1c > 10%
- •2. Hypoglycemia unawareness
- •3. Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment
- •4. Severe acute or severe chronic illness (at the physician’s discretion)
- •5. Known severe skin reactions (including allergic contact dermatitis) or allergies to medical adhesives
- •6. Skin alteration at the insertion sites (e.g., severe psoriasis vulgaris, severe scaring, severe lipodystrophia, severe rash)
- •7. Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of reported menopause, sterilization or hysterectomy)
- •8. 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
- •9. Dependency from the sponsor or the clinical investigator
- •10. Intake of substances known to affect the performance of the investigational CGM systems, i.e., hydroxyurea, acetaminophen, and nutritional supplementation of ascorbic acid (vitamin C)
- •11. Planned medical procedures during the core study period that could affect the performance of the investigational CGM systems, including magnetic resonance imaging, computer tomography scan, radiofrequency ablation, high-frequency electrical heat or high intensity focused ultrasound
- •12. Infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immuno-deficiency virus (HIV) or other chronic infectious disease
- •13. Body mass index (BMI) <20 kg/m²
- •14. Intake of anticoagulants, except for acetylsalicylic acid in doses up to 100 mg
研究者
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