Overview
Prospective, non-randomized, single-arm clinical trial to investigate the effects of advanced hybrid close-loop (AHCL) system insulin pump in pediatric patients with type 1 diabetes
Description
This trial consists of baseline phase of 3 weeks sustaining the treatment previously maintained by the patient, followed by study phase of 12 weeks of AHCL system application.
Eligibility
Inclusion Criteria:
- The subject is age 7-19
- 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
- The subject was diagnosed with type 1 diabetes ≥ 1 year
- 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)]
- The subject has been applied with real-time continuous glucose monitoring at least for 8 weeks at the start of the study
Exclusion Criteria:
- Any systemic treatment with drugs known to interfere with glucose metabolism within 8 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