Clinical trial NCT04535830: The Effectiveness of Flash Glucose Monitoring System on Glycemic Control in Patients With New-onset Type 2 Diabetes
Official title: The Effectiveness of Flash Glucose Monitoring System on Glycemic Control in Patients With New-onset Type 2 Diabetes#A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Flash Glucose Monitoring
Keywords: type 2 diabetes
Glucose management
Flash glucose monitoring system
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: the between-group difference in mean HbA1c
timeFrame: 3months
Secondary outcomes:
measure: the between-group difference in mean time in target glucose range
timeFrame: 3months
measure: the between-group difference in mean time in hypoglycemia
timeFrame: 3months
measure: the between-group difference in mean time in other biochemical indexes,such as LDL-C,TC,TG and so on
timeFrame: 3months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
Study officials:
References: