A prospective, monocenter, single arm, open-label study to collect data for algorithm optimization of a novel continuous glucose monitoring system in children, adolescents and adult patients with type 1 diabetes

i-SENS, Inc.0 个研究点目标入组 30 人开始时间: 2021年6月30日最近更新: 2022年1月31日

适应症

试验速览

暂无简介。

•1.Aged 2 years and over
•2.Patient with Type 1 Diabetes
•3.Patient and/or their parent(s)/guardian(s) (if applicable) are able to speak, read, and write English
•4.Participant agrees to participate in the study by giving informed consent/assent (as applicable)
•5.Parent(s)/guardian(s) agree to participate in the study by giving signed informed consent (if applicable)

•1. Presence of abnormal skin/skin diseases at the sensor attachment site e.g. Extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, severe rash, Staphylococcus aureus infection, etc.
•2. Known moderate to severe allergy to medical adhesives
•3. Diagnosed with any chronic medical, psychiatric, developmental/behavioral condition that at the discretion of the investigator would affect their performance in the study.
•4. Patient scheduled for X-ray, MRI, CT scan, radiofrequency ablation, high-frequency electrical heat, or MR-guided focused ultrasound during the study period that cannot be rescheduled
•5. Pregnancy (females aged greater than or equal to 14 years will have urine pregnancy test).
•6. Participation in an investigational study (drug or device) within 2 weeks prior to screening or is planning to participate in another study during the study period that at the discretion of the investigator would impair the results of this investigational study.

发起方