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

Primary Purpose

Type 1 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Continuous glucose monitoring system(CGMS)
Self-monitoring of blood glucose (conventional fingerpricking method)
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Severance Hospital Diabetes Center, Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CGMS group

SMBG group

Arm Description

Using continuous glucose monitoring system(CGMS) group

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

First Posted
December 20, 2020
Last Updated
May 3, 2021
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT04684030
Brief Title
The Management of Glucose Control and Hypoglycemic Prevention Using Continuous Glucose Monitoring System in Patients With Type 1 Diabetes
Official Title
The Management of Glucose Control and Hypoglycemic Prevention Using Continuous Glucose Monitoring System in Patients With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 28, 2020 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CGMS group
Arm Type
Experimental
Arm Description
Using continuous glucose monitoring system(CGMS) group
Arm Title
SMBG group
Arm Type
Active Comparator
Arm Description
Self-monitoring of blood glucose group (conventional fingerpricking method)
Intervention Type
Device
Intervention Name(s)
Continuous glucose monitoring system(CGMS)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Self-monitoring of blood glucose (conventional fingerpricking method)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change of glycated hemoglobin (HbA1c) level
Description
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.
Time Frame
12 weeks after applying continuous glucose monitoring system
Secondary Outcome Measure Information:
Title
The number of participants with improved clinical glycometabolic parameters
Description
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)
Time Frame
12 weeks after applying continuous glucose monitoring system

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
EunSeok Kang, Ph.D
Phone
+82-2-2228-1968
Email
EDGO@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EunSeok Kang, Ph.D
Organizational Affiliation
Severance Hospital Diabetes Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital Diabetes Center, Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
EunSeok Kang, Ph.D
Phone
+82-2-2228-1968
Email
EDGO@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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