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

Yonsei University

Status: Unknown

Conditions: Type 1 Diabetes

Treatments: Device: Continuous glucose monitoring system(CGMS); Device: Self-monitoring of blood glucose (conventional fingerpricking method)

Study type: Interventional

Funder types: Other

Identifiers

NCT04684030

4-2020-0831

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

CGMS group

Experimental group

Description:

Using continuous glucose monitoring system(CGMS) group

Treatment:

Device: Continuous glucose monitoring system(CGMS)

SMBG group

Active Comparator group

Description:

Self-monitoring of blood glucose group (conventional fingerpricking method)

Treatment:

Device: Self-monitoring of blood glucose (conventional fingerpricking method)