The Management of Glucose Control and Hypoglycemic Prevention Using Continuous Glucose Monitoring System in Patients With Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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The Management of Glucose Control and Hypoglycemic Prevention Using Continuous Glucose Monitoring System in Patients With Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Continuous glucose monitoring system(CGMS)
* Device: Self-monitoring of blood glucose (conventional fingerpricking method)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGMS group<br>Using continuous glucose monitoring system(CGMS) group | Device: Continuous glucose monitoring system(CGMS)<br>* Patients will randomized 1:1 to either continuous glucose monitoring system(CGMS) or conventional self-monitoring of blood glucose (SMBG) group. After the randomization, patients in CGMS group will given education on how to use the device and check the result using the smart phone. The data collected from the sensors were computed to generate the respective ambulatory glucose profiles so as to determine the total numbers of scans conducted during the study period.<br>|
| Active Comparator: SMBG group<br>Self-monitoring of blood glucose group (conventional fingerpricking method) | Device: Self-monitoring of blood glucose (conventional fingerpricking method)<br>* Patients will randomized 1:1 to either continuous glucose monitoring system(CGMS) or conventional self-monitoring of blood glucose (SMBG) group. After the randomization, patients in SMBG group will check their blood glucose by finger pricking method and record the data in a notebook to share the data in their outpatient clinic visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of glycated hemoglobin (HbA1c) level | 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. | 12 weeks after applying continuous glucose monitoring system | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants with improved clinical glycometabolic parameters | Clinical glycometabolic parameters (HbA1c, glycated albumin, glycemic variability, hypoglycemia, calculated insulin dose, patient's self confidence in diabetes self-care, Quality of life) and anthropometric parameters (Blood pressure, Body weight, BMI etc) | 12 weeks after applying continuous glucose monitoring system |