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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: Flash Glucose Monitoring; Diabetes Mellitus, Type 2

Treatments: Device: Flash Glucose Monitoring System

Study type: Interventional

Funder types: Other

Identifiers

NCT04535830

0304N18020

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Flash glucose monitor system(FSL)

Experimental group

Description:

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.

Treatment:

Device: Flash Glucose Monitoring System

Self-monitoring blood glucose(SMBG)

No Intervention group

Description:

People at SMBG group will wear the sensor at baseline and at the end of the experiment for data analysis only,and will have a care visit every month.