Status:
UNKNOWN
Comparison of CSII and MDI in Pediatric Patients With Type 1 Diabetes
Lead Sponsor:
Seoul National University Hospital
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
2-17 years
Phase:
NA
Brief Summary
Prospective, randomized, open-label, two-sequence crossover study to investigate the effects of continuous subcutaneous insulin injection (CSII, using DIA:CONN G8 insulin pump) in pediatric patients w...
Detailed Description
This trial consists of two crossover periods of 5 weeks each (MDI to CSII or CSII to MDI), followed by an extended period of 12 weeks (MDI or CSII). Each intervention period has wash-out period (5 day...
Eligibility Criteria
Inclusion
- The subject is aged 2-17
- 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
- The subject was diagnosed with type 1 diabetes ≥ 1 year
- The subject is treated with multiple daily insulin injection
- The subject must have available continuous glucose monitoring (CGM) data with a percentage of active CGM time ≥ 70% in the past 4 weeks.
Exclusion
- Subjects who were treated with insulin pump therapy within 12 weeks prior to trial
- Any systemic treatment with drugs known to interfere with glucose metabolism within 12 weeks prior to trial
- Subjects with underlying hematologic disorders that can affect the HbA1c levels
- Subjects with underlying medical disorders that can affect glucose metabolism
- Subjects with a neuropsychiatric disorder such as depression or eating disorder
- Subjects with underlying thyroid disorders and abnormal thyroid function
Key Trial Info
Start Date :
January 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT05201846
Start Date
January 18 2022
End Date
March 31 2023
Last Update
March 3 2022
Active Locations (2)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
2
Seoul National University Hospital
Seoul, South Korea, 03080