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

NCT04684030 | Unknown DMC

• 1 other identifier: 4-2020-0831
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The number of participants with improved clinical glycometabolic parameters

  12 weeks after applying continuous glucose monitoring system

Study Arms (2)

CGMS group

EXPERIMENTAL

Using continuous glucose monitoring system(CGMS) group

Device: Continuous glucose monitoring system(CGMS)

SMBG group

ACTIVE COMPARATOR

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

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

Interventions

Continuous glucose monitoring system(CGMS) DEVICE

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.

CGMS group

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

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.

SMBG group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Continuous Glucose Monitoring; Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Self-Testing; Self Care; Therapeutics

Study Officials

• EunSeok Kang, Ph.D

  Severance Hospital Diabetes Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

EunSeok Kang, Ph.D

CONTACT

+82-2-2228-1968; EDGO@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2020
• First Posted: December 24, 2020
• Study Start: August 28, 2020
• Primary Completion: June 1, 2022
• Study Completion: August 1, 2022
• Last Updated: May 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)