The Management of Glucose Control and Hypoglycemic Prevention Using Continuous Glucose Monitoring System in Patients With Type 1 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Yonsei University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The change of glycated hemoglobin (HbA1c) level
Study Overview
Brief Summary
This study was designed to evaluate the glucose control and hypoglycemic prevention effect of using continuous glucose monitoring system(CGMS) in patients with type 1 diabetes. This is a prospective randomized controlled, single-center clinical study. Patients will randomized 1:1 to either CGMS or conventional self-monitoring of blood glucose (SMBG) group. After 12 weeks of applying the CGMS sensors, the improvement of parameters collected from the CGMS will be estimated in comparison with data collected from the SMBG.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female patients ages >= 20 years
- •Patients diagnosed with type 1 diabetes.
- •Patients with glycated hemoglobin (HbA1c) > 8.0% within 6 months before screening
- •Patients who agree to perform self blood glucose monitoring responsibly during the study period
- •Patients diagnosed with type 1 diabetes minimum 3 months prior to recruitment
Exclusion Criteria
- •Patients diagnosed with type 2 diabetes.
- •Patients with chronic disease (Excluding thyroid disorders in which thyroid function is controlled in the normal range), or psychiatric disease
- •Patients who cannot use the device properly such as an illiterate person or foreigners
- •Patients incapable of making decisions based on their own judgement and will
- •A person who may not participate in the study according to investigator's judgement
Arms & Interventions
CGMS group
Using continuous glucose monitoring system(CGMS) group
Intervention: Continuous glucose monitoring system(CGMS) (Device)
SMBG group
Self-monitoring of blood glucose group (conventional fingerpricking method)
Intervention: Self-monitoring of blood glucose (conventional fingerpricking method) (Device)
Outcomes
Primary Outcomes
The change of glycated hemoglobin (HbA1c) level
Time Frame: 12 weeks after applying continuous glucose monitoring system
The HbA1c levels in this study will analyzed twice during the study, once at the baseline and after the CGMS testing was initiated. The improvement of HbA1c level in CGMS group will be estimated and compare it with the change in HbA1c level in the SMBG group.
Secondary Outcomes
- The number of participants with improved clinical glycometabolic parameters(12 weeks after applying continuous glucose monitoring system)