Type 1 Diabetes
Conditions
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.
Interventions
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.
DEVICESelf-monitoring of blood glucose (conventional fingerpricking method)
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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients ages \>= 20 years 2. Patients diagnosed with type 1 diabetes. 3. Patients with glycated hemoglobin (HbA1c) \> 8.0% within 6 months before screening 4. Patients who agree to perform self blood glucose monitoring responsibly during the study period 5. Patients diagnosed with type 1 diabetes minimum 3 months prior to recruitment
Exclusion criteria
1. Patients diagnosed with type 2 diabetes. 2. Patients with chronic disease (Excluding thyroid disorders in which thyroid function is controlled in the normal range), or psychiatric disease 3. Patients who cannot use the device properly such as an illiterate person or foreigners 4. Patients incapable of making decisions based on their own judgement and will 5. A person who may not participate in the study according to investigator's judgement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of glycated hemoglobin (HbA1c) level | 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
| Measure | Time frame | Description |
|---|---|---|
| The number of participants with improved clinical glycometabolic parameters | 12 weeks after applying continuous glucose monitoring system | 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) |
Countries
South Korea
Contacts
Primary ContactEunSeok Kang, Ph.D
Outcome results
None listed