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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04099745
• Other study ID #: KY20190823-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: September 2019
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 1, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Device:
• CGM
Continuous Glucose Monitoring System
• FGM
Flash glucose monitoring System

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	three-day blood glucose fluctuation of CGM		3 DAYS
Secondary	forty-day blood glucose fluctuation of FGM		14 days