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

Shanghai Jiao Tong University logo

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)

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.

Trial contacts and locations

1

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Central trial contact

Yufan Wang, Doctor

Data sourced from clinicaltrials.gov

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