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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes, Flash Glucose Monitoring, Conscience

Intervention / Treatment
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* Device: FGM infiltration 1 hour group
* Device: FGM infiltration 6-hour group
* Device: FGM infiltration 12-hour group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1-hour group<br>The time between the activation of the sensor and the storage of the first blood glucose value is 1 hour. | Device: FGM infiltration 1 hour group<br>* The sensor is activated immediately after wearing (including the time between the sensor activation and the first blood glucose value stored，about 1 hour).<br>|
| Experimental: 6-hour group<br>The time between the activation of the sensor and the storage of the first blood glucose value is 6 hours. | Device: FGM infiltration 6-hour group<br>* Reactivate the sensor 5 hours after wearing (including the time between the sensor activation and the first blood glucose value stored，about 1 hour).<br>|
| Experimental: 12-hour group<br>The time between the activation of the sensor and the storage of the first blood glucose value is 12 hours. | Device: FGM infiltration 12-hour group<br>* Reactivate the sensor 11 hours after wearing (including the time between the sensor activation and the first blood glucose value stored，about 1 hour).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference value | The difference between finger stick blood glucose or venous blood glucose and FGM value. | Up to 21 days |