The Effectiveness of Flash Glucose Monitoring System on Glycemic Control in Patients With New-onset Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

The Effectiveness of Flash Glucose Monitoring System on Glycemic Control in Patients With New-onset Type 2 Diabetes#A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04535830
• Other study ID #: 0304N18020
• Status: Recruiting
• Phase: Phase 4
• Start date: April 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: August 2020
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Yufan Wang, Doctor
• Phone: 13761675784
• Email: yyffwangdr[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if Flash glucose monitoring system improves glycemic control in adults with new-onset type 2 diabetes

Description:

People with new-onset type 2 diabetes who achieve and sustain glycemic targets is important for reducing the risk of complications and all-cause mortality.Glucose monitoring is the key point of diabetes management.Continuous glucose monitoring(CGM)can identify day-to-day glucose profiles to guide management decisions.Flash glucose monitoring is a variant of CGM and is factory calibrated,requiring no finger pricks.The purpose of this study is to determine if Flash glucose monitoring improves glycemic control in adults with new-onset type 2 diabetes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 30, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• peolpe with type 2 diabetes in accordance with the dignosed criteria of CDS2017

• type 2 diabetes duration of <6months

• with certain read-write ability

• willing to use FSL or follow study protocol

Exclusion Criteria:

• acute complication of diabetes condition(DKA,HHH)

• pregnancy,lactating or planning pregnancy

• allergy to adhesive tape

• skin with large area of rubefaction and wounds

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Flash Glucose Monitoring

Intervention

Device:
• Flash Glucose Monitoring System
During the three months experimental period,participants at the FSL group will be asked to wear a flash glucose monitoring sensor for a period of 2 weeks and have a care visit every month while people at SMBG group will receive a care visit every month.

Locations

Country	Name	City	State
China	Shanghai First People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the between-group difference in mean HbA1c	difference in mean HbA1c between FSL group and SMBG group	3months
Secondary	the between-group difference in mean time in target glucose range	difference in mean time in target glucose range between FSL group and SMBG group	3months
Secondary	the between-group difference in mean time in hypoglycemia	difference in mean time in hypoglycemia between FSL group and SMBG group	3months
Secondary	the between-group difference in mean time in other biochemical indexes,such as LDL-C,TC,TG and so on	difference in some biochemical indexes between FSL group and SMBG group	3months