Effects of AHCL Insulin Pump on Glycemic Control and Psychosocial Outcomes in Pediatric Patients With Type 1 Diabetes

Effects of Advanced Hybrid Closed-loop System on Glycemic Control and Psychosocial Outcomes in Pediatric Patients With Type 1 Diabetes

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

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.

Inclusion Criteria:

1. The subject is age 7-19

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:

1. Any systemic treatment with drugs known to interfere with glucose metabolism within 8 weeks prior to trial
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