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

Not Applicable

• Conditions: Type 1 Diabetes
• Interventions: Device: Self-monitoring of blood glucose (conventional fingerpricking method); Device: Continuous glucose monitoring system(CGMS)

• Registration Number: NCT04684030
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-28
• Study First Submitted: 2020-12-20
• Study First Submitted QC: 2020-12-20
• Study First Posted: 2020-12-24
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-06
• Primary Completion: 2022-06
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SMBG group	Self-monitoring of blood glucose (conventional fingerpricking method)	Self-monitoring of blood glucose group (conventional fingerpricking method)
CGMS group	Continuous glucose monitoring system(CGMS)	Using continuous glucose monitoring system(CGMS) group

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Severance Hospital Diabetes Center, Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of