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

Not Applicable

• Conditions: Type 2 Diabetes
• Interventions: Device: FGM; Device: CGM

• Registration Number: NCT04099745
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief Summary

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

Detailed Description

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).

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-16
• Study First Submitted QC: 2019-09-19
• Last Update Submitted: 2019-09-19
• Study First Posted: 2019-09-23
• Last Update Posted: 2019-09-23
• Study Start: 2019-10-01
• Primary Completion: 2019-12-30
• Study Completion: 2020-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FGM（Flash glucose monitoring）	FGM	Each diabetic patient received one FGM test for 14 days.
CGM（continuous glucose monitoring）	CGM	Each diabetic patient received three CGM tests within 14 days of FGM monitoring, on days 1-3, 6-9 and 12-14, respectively.

Primary Outcome Measures

Name	Time	Method
Accuracy of different blood glucose monitoring systems (CGM and FGM) with intravenous blood glucose level as the gold standard	2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
three-day blood glucose fluctuation of CGM	3 DAYS
forty-day blood glucose fluctuation of FGM	14 days