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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04797416
Other study ID # 2020477
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 1, 2019
Est. completion date December 30, 2021

Study information

Verified date March 2021
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective randomized controlled study to evaluate consistency by finger stick blood glucose or venous blood glucose in different infiltration time (including the time between activation of the sensor and storage of the first blood glucose value) of Flash glucose monitoring(FGM). In this study, the relationship between the dynamic blood glucose and finger stick blood glucose or venous blood glucose in type 2 diabetes mellitus patients(T2DM), was explored. And the investigators also analyzed the deviation and accuracy of FGM in practical application,so as to provide a good reference for clinical application.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 480
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with type 2 diabetes fit the 1999 who diagnostic criteria for diabetes - Aged 18 or above - Without serious complications, such as diabetic ketoacidosis, severe infection,severe cardiac insufficiency, severe liver and kidney diseases - Voluntary and signed informed consent to participate - Be able to read and understand Chinese, perform all research visits and tasks, and follow research instructions Exclusion Criteria: - Patients with known allergy to medical grade adhesive or isopropanol used for skin disinfection, edema, skin damage, scar, redness, infection, etc. during pregnancy or preparation of pregnancy or at the sensor application site (dorsal side of upper arm). - The examinee took drugs such as ascorbic acid (vitamin C) and salicylic acid (an ingredient in aspirin and many painkillers) that affected the accuracy of the sensor. - MRI is required during the study. - The examinee had poor compliance and could not continue to complete the study.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
FGM infiltration 1 hour group
The sensor is activated immediately after wearing (including the time between the sensor activation and the first blood glucose value stored,about 1 hour).
FGM infiltration 6-hour group
Reactivate the sensor 5 hours after wearing (including the time between the sensor activation and the first blood glucose value stored,about 1 hour).
FGM infiltration 12-hour group
Reactivate the sensor 11 hours after wearing (including the time between the sensor activation and the first blood glucose value stored,about 1 hour).

Locations

Country Name City State
China endocrinology department of the first affiliated hospital of Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference value The difference between finger stick blood glucose or venous blood glucose and FGM value. Up to 21 days
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