The Evaluation of Consistency by Finger Stick Blood Glucose or Venous Blood Glucose of Flash Glucose Monitoring in Different Infiltration Time

Type 2 Diabetes Clinical Trial

Official title:

The Evaluation of Consistency by Finger Stick Blood Glucose or Venous Blood Glucose of Flash Glucose Monitoring in Different Infiltration Time

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04797416
• Other study ID #: 2020477
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Conscience
• Flash Glucose Monitoring
• Type 2 Diabetes

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