Effects of Novel Flash Glucose Monitoring System on Glycemic Control in Adult Patients With Type 1 Diabetes Mellitus
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 76
Summary
- Conditions
- Diabetes Mellitus - Type 1
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Subjects with Type 1 diabetes who meet criteria will be enrolled at up to eight clinical research sites in China. Subjects will be randomized to either flash glucose monitoring system(Freestyle Libre®;Abbott Diabetes Care,Witney, Oxon,UK) or conventional Self Measurement of Blood Glucose (Bayer®)alo...
Subjects with Type 1 diabetes who meet criteria will be enrolled at up to eight clinical research sites in China. Subjects will be randomized to either flash glucose monitoring system(Freestyle Libre®;Abbott Diabetes Care,Witney, Oxon,UK) or conventional Self Measurement of Blood Glucose (Bayer®)alone at least three times per day. Primary outcome variable is the difference in HbA1c which will be analyzed in a central laboratory between baseline and the 26weeks follow-up. Secondary outcome variables such as time-in-range, frequency and duration of and hyperglycemic episodes etc. will be assessed at baseline (Week 0 to 2), Week 12-14 and Week 24-26 via professional continuous glucose system (Ipro2®; Medtronic). At the same time, demographic factors, clinical data, patient reported outcome (PROs) will be collected. Assessment of Adverse Events will occur via self-reporting at each visit and/or phone call. All patients will receive same ordinary diabetes education.
Tracking Information
- NCT #
- NCT03522870
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Fang Liu, PHD Shanghai Jiao Tong University Affiliated Sixth People's Hospital Principal Investigator: Xiuzhen Li, PHD Guangzhou Women and Children's Medical Center Principal Investigator: Zhe Su, PHD Shenzhen Children's Hospital Principal Investigator: Puneng Wang, MD Foshan Hospital of TCM Principal Investigator: Liling Qiu, PHD Zhongshan People's Hospital, Guangdong, China Principal Investigator: Hongting Zheng, PHD Xinqiao Hospital of AMU Principal Investigator: Xueying Zheng, MD The First Affiliated Hospital of USTC
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