Effects of AHCL Insulin Pump on Glycemic Control and Psychosocial Outcomes in Pediatric Patients With Type 1 Diabetes
NCT ID: NCT06414564
Last Updated: 2024-05-16
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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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-02-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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AHCL system application
insulin infusion using AHCL system insulin pump (Medtronic 780G) with continous glucose monitoring (guardian G4)
Medtronic 780G insulin pump
Subjects on insulin infusion by 780G AHCL system
Interventions
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Medtronic 780G insulin pump
Subjects on insulin infusion by 780G AHCL system
Eligibility Criteria
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Inclusion Criteria
2. The subject with one or more of the below
* serum c-peptide ≤ 0.6 ng/mL at diagnosis
* 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 has been continuously treated at least for 8 weeks at the start of the study, by one of the existing insulin treatment methods \[insulin multi-injection (MDII), general insulin pump (CSII), sensor-linked insulin pump (SAP), or 770G insulin pump (HCL system)\]
5. The subject has been applied with real-time continuous glucose monitoring at least for 8 weeks at the start of the study
Exclusion Criteria
2. Subjects with underlying hematologic disorders that can affect the HbA1c levels
3. Subjects with underlying medical disorders that can affect glucose metabolism
4. Subjects with a neuropsychiatric disorder such as depression or eating disorder
5. Subjects with underlying thyroid disorders and abnormal thyroid function
7 Years
19 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Lee Young Ah
Associate professor
Principal Investigators
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Young Ah Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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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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23081591461
Identifier Type: -
Identifier Source: org_study_id
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