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

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

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

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2; Flash Glucose Monitoring
• Intervention / Treatment: Device: Flash Glucose Monitoring System

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200080
      • Recruiting
      • Shanghai First People's Hospital
      • Contact: Yufan Wang, Doctor; Phone Number: 18918236256; Email: yyffwangdr@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Freestyle Libre
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the between-group difference in mean HbA1c	difference in mean HbA1c between FSL group and SMBG group	3months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
the between-group difference in mean time in hypoglycemia	difference in mean time in hypoglycemia between FSL group and SMBG group	3months
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

Collaborators and Investigators

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: August 28, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (Actual): September 2, 2020

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 28, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: type 2 diabetes; Flash glucose monitoring system; Glucose management
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 0304N18020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No