The Effectiveness of Flash Glucose Monitoring System on Glycemic Control in Patients With New-onset Type 2 Diabetes
NCT ID: NCT04535830
Last Updated: 2020-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2019-04-01
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
The primary outcome is the between-group difference in mean HbA1c at 3 months. Meanwhile,researchers want to know whether differences in glucose variability and diabetes-specific distress between two groups.
TREATMENT
NONE
Study Groups
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Flash glucose monitor system(FSL)
Except at baseline and at the end of the experiment,participants at the FSL group will be asked to wear a flash glucose monitoring sensor for a period of 2 weeks and have a care visit every month.
Flash Glucose Monitoring System
During the three months experimental period,participants at the FSL group will be asked to wear a flash glucose monitoring sensor for a period of 2 weeks and have a care visit every month while people at SMBG group will receive a care visit every month.
Self-monitoring blood glucose(SMBG)
People at SMBG group will wear the sensor at baseline and at the end of the experiment for data analysis only,and will have a care visit every month.
No interventions assigned to this group
Interventions
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Flash Glucose Monitoring System
During the three months experimental period,participants at the FSL group will be asked to wear a flash glucose monitoring sensor for a period of 2 weeks and have a care visit every month while people at SMBG group will receive a care visit every month.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* type 2 diabetes duration of \<6months
* with certain read-write ability
* willing to use FSL or follow study protocol
Exclusion Criteria
* pregnancy,lactating or planning pregnancy
* allergy to adhesive tape
* skin with large area of rubefaction and wounds
18 Years
70 Years
ALL
No
Sponsors
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Yufan Wang
Director of endocrinology
Locations
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Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0304N18020
Identifier Type: -
Identifier Source: org_study_id
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