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

Sun Yat-sen University

Status: Unknown

Conditions: Flash Glucose Monitoring; Conscience; Type 2 Diabetes

Treatments: Device: FGM infiltration 6-hour group; Device: FGM infiltration 12-hour group; Device: FGM infiltration 1 hour group

Study type: Interventional

Funder types: Other

Identifiers

NCT04797416

2020477

Details and patient eligibility

About

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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 3 patient groups

1-hour group

Active Comparator group

Description:

The time between the activation of the sensor and the storage of the first blood glucose value is 1 hour.

Treatment:

Device: FGM infiltration 1 hour group

6-hour group

Experimental group

Description:

The time between the activation of the sensor and the storage of the first blood glucose value is 6 hours.

Treatment:

Device: FGM infiltration 6-hour group

12-hour group

Experimental group

Description:

The time between the activation of the sensor and the storage of the first blood glucose value is 12 hours.

Treatment:

Device: FGM infiltration 12-hour group