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

NCT04535830 | Unknown Phase 4 DMC

• 1 other identifier: 0304N18020
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 2; Flash Glucose Monitoring

Keywords

type 2 diabetes; Glucose management; Flash glucose monitoring system

Outcome Measures

Primary Outcomes (1)

• the between-group difference in mean HbA1c

  difference in mean HbA1c between FSL group and SMBG group

  3months

Secondary Outcomes (3)

• the between-group difference in mean time in target glucose range

  3months

• the between-group difference in mean time in hypoglycemia

  3months

• the between-group difference in mean time in other biochemical indexes,such as LDL-C,TC,TG and so on

  3months

Study Arms (2)

Flash glucose monitor system(FSL)

EXPERIMENTAL

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

Self-monitoring blood glucose(SMBG)

NO INTERVENTION

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.

Interventions

Flash Glucose Monitoring System 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.

Also known as: Freestyle Libre

Flash glucose monitor system(FSL)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• acute complication of diabetes condition(DKA,HHH)
• pregnancy,lactating or planning pregnancy
• allergy to adhesive tape
• skin with large area of rubefaction and wounds

Sponsors & Collaborators

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

Study Sites (1)

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Yufan Wang, Doctor

CONTACT

13761675784; yyffwangdr@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of endocrinology

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 2, 2020
• Study Start: April 1, 2019
• Primary Completion: August 1, 2021
• Study Completion: September 30, 2021
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

CN (1)