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临床试验/NCT07139808
NCT07139808招募中不适用

Safety and Effectiveness of A Novel Continuous Glucose and Ketone Monitoring System

Henan University of Science and Technology2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年8月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
12
试验地点
2
主要终点
System performance on glucose measurement

研究概览

简要总结

The study is to evaluate the accuracy and safety of a novel real-time continuous glucose and ketone monitoring system among adult patients with type 1 diabetes mellitus (T1DM) with respect to Yellow Spring Instrument (YSI) and Randox reference venous plasma sample measurements.

详细描述

The study is to evaluate the accuracy and safety of a novel real-time continuous glucose and ketone monitoring (CGKM) system among adult patients with type 1 diabetes mellitus with respect to YSI and Randox reference venous plasma sample measurements. Up to 14 patients will be enrolled. Interstitial glucose and ketone readings from the sensors will be obtained immediatedly following each venous blood sample test. Each participant will make 3 visits to the clinical study site, including the screening visit.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Diagonsed with T1DM on Continuous subcutaneous insulin infusion (CSII)
  • Venous blood sampling access can be established in the forearm
  • Capable of independently reading instructions and complying with the clinical trial requirements
  • Willing to sign the Informed Consent Form (ICF)

排除标准

  • Severe hypoglycemia within the past 6 months
  • A diagnosed history of Diabetic ketoacidosis (DKA) in the past 3 months
  • Heart failure or hemiplegic sequelae due to prior cerebrovascular disease
  • Severe skin conditions at the sensor wear site
  • Extensive systemic skin disorders
  • Having difficulty with wound healing, bleeding disorders, and/or taking anticoagulant medications
  • Anemia or abnormal hematocrit
  • Blood donation within the past 6 months
  • Pregnancy (defined as positive urine test in women ≤55 years), lactation, or plans for pregnancy within ≤30 days
  • Current or recent (≤1 month) participation in other clinical trials
  • Planned MRI/CT scans during sensor wear
  • Allergy to medical adhesives or alcohol
  • Conditions impairing comprehension of informed consent or study procedures
  • Other exclusionary conditions per investigator's discretion

研究组 & 干预措施

Adult patients with T1DM

Experimental

Adult patients with T1DM

干预措施: GK5 CGKM (Device)

结局指标

主要结局

System performance on glucose measurement

时间窗: 15 days

The CGK system performance for glucose measurement will be assessed by comparing to the Yellow Springs Instrument comparator venous plasma measurements

System performance on ketone measurement

时间窗: 15 days

The CGK system performance for ketone measurement will be assessed by comparing to the Randox comparator venous plasma measurements

次要结局

  • System-related Safety(15 days)

研究者

发起方
Henan University of Science and Technology
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peng Liu

Investigator

Henan University of Science and Technology

研究点 (2)

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