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

Study Overview
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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.

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

Conditions
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Diabetes Mellitus, Type 2, Flash Glucose Monitoring

Intervention / Treatment
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* Device: Flash Glucose Monitoring System


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flash glucose monitor system(FSL)<br>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<br>* 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.<br>* Other names: Freestyle Libre;|
| No Intervention: Self-monitoring blood glucose(SMBG)<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes, Glucose management, Flash glucose monitoring system