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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04535830
Recruitment Status : Recruiting
First Posted : September 2, 2020
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Yufan Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Flash Glucose Monitoring Device: Flash Glucose Monitoring System Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness of Flash Glucose Monitoring System on Glycemic Control in Patients With New-onset Type 2 Diabetes#A Randomized Controlled Trial
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

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 Name: 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.



Primary Outcome Measures :
  1. the between-group difference in mean HbA1c [ Time Frame: 3months ]
    difference in mean HbA1c between FSL group and SMBG group


Secondary Outcome Measures :
  1. the between-group difference in mean time in target glucose range [ Time Frame: 3months ]
    difference in mean time in target glucose range between FSL group and SMBG group

  2. the between-group difference in mean time in hypoglycemia [ Time Frame: 3months ]
    difference in mean time in hypoglycemia between FSL group and SMBG group

  3. the between-group difference in mean time in other biochemical indexes,such as LDL-C,TC,TG and so on [ Time Frame: 3months ]
    difference in some biochemical indexes between FSL group and SMBG group



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04535830


Contacts
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Contact: Yufan Wang, Doctor 13761675784 yyffwangdr@yahoo.com

Locations
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China, Shanghai
Shanghai First People's Hospital Recruiting
Shanghai, Shanghai, China, 200080
Contact: Yufan Wang, Doctor    18918236256    yyffwangdr@yahoo.com   
Contact: Ying Huang, Doctor    17321027916    hy952@163.com   
Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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Responsible Party: Yufan Wang, Director of endocrinology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT04535830    
Other Study ID Numbers: 0304N18020
First Posted: September 2, 2020    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yufan Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine:
type 2 diabetes
Glucose management
Flash glucose monitoring system
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases