The Management of Glucose Control and Hypoglycemic Prevention Using Continuous Glucose Monitoring System in Patients With Type 1 Diabetes
NCT ID: NCT04684030
Last Updated: 2021-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2020-08-28
2022-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CGMS group
Using continuous glucose monitoring system(CGMS) group
Continuous glucose monitoring system(CGMS)
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.
SMBG group
Self-monitoring of blood glucose group (conventional fingerpricking method)
Self-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.
Interventions
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Continuous glucose monitoring system(CGMS)
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.
Self-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.
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Principal Investigators
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EunSeok Kang, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital Diabetes Center
Locations
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Severance Hospital Diabetes Center, Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4-2020-0831
Identifier Type: -
Identifier Source: org_study_id
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