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

Phase 4

• Conditions: Diabetes Mellitus, Type 2; Flash Glucose Monitoring
• Interventions: Device: Flash Glucose Monitoring System

• Registration Number: NCT04535830
• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2019-04-01
• Status Verified: 2020-08
• Study First Submitted: 2020-08-28
• Study First Submitted QC: 2020-08-28
• Last Update Submitted: 2020-08-28
• Study First Posted: 2020-09-02
• Last Update Posted: 2020-09-02
• Primary Completion: 2021-08-01
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flash glucose monitor system(FSL)	Flash Glucose Monitoring System	Except at baseline and at the end of the experiment,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.

Primary Outcome Measures

Name	Time	Method
the between-group difference in mean HbA1c	3months	difference in mean HbA1c between FSL group and SMBG group

Secondary Outcome Measures

Name	Time	Method
the between-group difference in mean time in hypoglycemia	3months	difference in mean time in hypoglycemia between FSL group and SMBG group
the between-group difference in mean time in other biochemical indexes,such as LDL-C,TC,TG and so on	3months	difference in some biochemical indexes between FSL group and SMBG group
the between-group difference in mean time in target glucose range	3months	difference in mean time in target glucose range between FSL group and SMBG group

Trial Locations

Locations (1)

Shanghai First People's Hospital; 🇨🇳 Shanghai, Shanghai, China