Comparison of CSII and MDI in Pediatric Patients With Type 1 Diabetes
NCT ID: NCT05201846
Last Updated: 2022-03-03
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
66 participants
INTERVENTIONAL
2022-01-18
2023-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Continuous subcutaneous insulin infusion
Continuous subcutaneous insulin infusion using insulin pump (DIA:CONN G8) with continuous glucose monitoring
DIA:CONN G8 insulin pump
Subjects on continuous subcutaneous insulin infusion system with CGM
Multiple daily insulin injection
Multiple daily insulin injection with continuous glucose monitoring
Multiple daily insulin injection
Subjects on multiple daily insulin injection with CGM
Interventions
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DIA:CONN G8 insulin pump
Subjects on continuous subcutaneous insulin infusion system with CGM
Multiple daily insulin injection
Subjects on multiple daily insulin injection with CGM
Eligibility Criteria
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Inclusion Criteria
2. The subject with one or more of the below at diagnosis
* serum c-peptide \< 0.6 ng/mL
* positive glutamic acid decarboxylase (GAD) antibody
* positive Islet cell antibody
* positive anti-Insulin antibody
* positive anti-Islet Antigen-2 (IA-2) antibody
3. The subject was diagnosed with type 1 diabetes ≥ 1 year
4. The subject is treated with multiple daily insulin injection
5. The subject must have available continuous glucose monitoring (CGM) data with a percentage of active CGM time ≥ 70% in the past 4 weeks.
Exclusion Criteria
2. Any systemic treatment with drugs known to interfere with glucose metabolism within 12 weeks prior to trial
3. Subjects with underlying hematologic disorders that can affect the HbA1c levels
4. Subjects with underlying medical disorders that can affect glucose metabolism
5. Subjects with a neuropsychiatric disorder such as depression or eating disorder
6. Subjects with underlying thyroid disorders and abnormal thyroid function
2 Years
17 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Choong Ho Shin
Professor
Principal Investigators
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Choong Ho Shin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Hospital
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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21111431275
Identifier Type: -
Identifier Source: org_study_id
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