Diabetes Mellitus, Type 2, Flash Glucose Monitoring
Conditions
Keywords
type 2 diabetes, Glucose management, Flash glucose monitoring system
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.
Interventions
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.
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the between-group difference in mean HbA1c | 3months | difference in mean HbA1c between FSL group and SMBG group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the between-group difference in mean time in target glucose range | 3months | difference in mean time in target glucose range between FSL group and SMBG group |
| the between-group difference in mean time in hypoglycemia | 3months | difference in mean time in hypoglycemia between FSL group and SMBG group |
| the between-group difference in mean time in other biochemical indexes,such as LDL-C,TC,TG and so on | 3months | difference in some biochemical indexes between FSL group and SMBG group |
Countries
China
Contacts
Primary ContactYufan Wang, Doctor
Outcome results
None listed