Comparing the Accuracy of Different Blood Glucose Monitoring Systems (CGM and FGM)

Study Overview
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Brief Summary
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To compare the accuracy of different blood glucose monitoring systems (CGM and FGM) in diabetic patients with insufficient islet function.

Detailed Description
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To compare the accuracy of different blood glucose monitoring systems (CGM and FGM) in diabetic patients with insufficient islet function with Venous Blood Glucose (including FGM early, middle and late, pre-and post-meal, high and low blood glucose).

Official Title
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Comparing the Accuracy of Different Blood Glucose Monitoring Systems (CGM and FGM) With Venous Blood Glucose

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Device: CGM
* Device: FGM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: volunteer to participate and be able to sign informed consent prior to the trial. patients with type 2 diabetes or type 1 diabetes, aged 18-80 years old. No acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc. Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise. Exclusion Criteria: Patients with insulin allergy. Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value; Serum creatinine was 1.3 times higher than the upper limit of normal. Drug abuse and alcohol dependence in the past 5 years. Systemic hormone therapy was used in the last three months. Patients with poor compliance and irregular diet and exercise. Patients with pregnancy, lactation or pregnancy intention. Any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGM（continuous glucose monitoring）<br>Each diabetic patient received three CGM tests within 14 days of FGM monitoring, on days 1-3, 6-9 and 12-14, respectively. | Device: CGM<br>* Continuous Glucose Monitoring System<br>|
| Experimental: FGM（Flash glucose monitoring）<br>Each diabetic patient received one FGM test for 14 days. | Device: FGM<br>* Flash glucose monitoring System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of different blood glucose monitoring systems (CGM and FGM) with intravenous blood glucose level as the gold standard | To compare the accuracy of different blood glucose monitoring systems (CGM and FGM) with intravenous blood glucose level as the gold standard in diabetic patients with insufficient islet function. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| three-day blood glucose fluctuation of CGM |  | 3 DAYS | 
| forty-day blood glucose fluctuation of FGM |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FGM, CGM