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

NCT ID: NCT04535830

Last Updated: 2020-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-09-30

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2 Flash Glucose Monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is an open-label, randomized controlled trial. The investigators plan to recruit 200 persons with type 2 diabetes diagnosed within six months. Participants will be randomly assigned (1:1) to either use of a flash glucose monitoring system(FSL) or self-monitoring blood glucose(SMBG) . All participants need to wear the flash glucose monitoring sensor at baseline and at the end of the experiment for data analysis.During the three months of experiment,participants at the FSL group will wear a flash glucose monitoring sensor for 14 days and have a care visit every month,while people at SMBG group will monitor their glucose by pricking a finger at home and receive a care visit every month as well.

The primary outcome is the between-group difference in mean HbA1c at 3 months. Meanwhile,researchers want to know whether differences in glucose variability and diabetes-specific distress between two groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Flash glucose monitor system(FSL)

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.

Group Type EXPERIMENTAL

Flash Glucose Monitoring System

Intervention Type DEVICE

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.

Self-monitoring blood glucose(SMBG)

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Freestyle Libre

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Yufan Wang

Director of endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai First People's Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yufan Wang, Doctor

Role: CONTACT

13761675784

Facility Contacts

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Yufan Wang, Doctor

Role: primary

18918236256

Ying Huang, Doctor

Role: backup

17321027916

Other Identifiers

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0304N18020

Identifier Type: -

Identifier Source: org_study_id

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