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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Subjects on insulin infusion by 780G AHCL system
Seoul National University Hospital
Seoul, South Korea
RECRUITINGTime In Range (TIR)
glucose level between 70-180 mg/dL derived from continuous glucose monitoring
Time frame: baseline (3 weeks) and intervention (12 weeks) period
Time Above Range (TAR)
glucose level \>180 mg/dL derived from continuous glucose monitoring
Time frame: baseline (3 weeks) and intervention (12 weeks) period
Time Below Range (TBR)
glucose level \<70 mg/dL derived from continuous glucose monitoring
Time frame: baseline (3 weeks) and intervention (12 weeks) period
mean sensor glucose
mean sensor glucose level derived from continuous glucose monitoring
Time frame: baseline (3 weeks) and intervention (12 weeks) period
Coefficient of variation (CV)
Standard deviation \* 100/ mean (derived from continuous glucose monitoring)
Time frame: baseline (3 weeks) and intervention (12 weeks) period
Glucose management indicator (GMI)
Estimated HbA1c levels derived from continuous glucose monitoring
Time frame: baseline (3 weeks) and intervention (12 weeks) period
HbA1c
Glycated hemoglobin level
Time frame: before and at the end of intervention, which in average lasts 12 weeks
Glycated albumin
Glycated albumin level
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Time frame: before and at the end of intervention, which in average lasts 12 weeks
Quality of life measurements (general) of patients and parents
Measured by PedsQL (Pediatric Quality of Life InventoryTM) Generic Core, Module 4.0 (values: 0\~100, higher score means better outcome)
Time frame: baseline (3 weeks) and intervention (12 weeks) period
Quality of life measurements (diabetes-specific) of patients and parents
Measured by PedsQL (Pediatric Quality of Life InventoryTM) Diabetes Specific, Module 3.0 (values: 0\~100, higher score means better outcome)
Time frame: baseline (3 weeks) and intervention (12 weeks) period
Children's Depression Inventory(CDI) (age 7-17) or Beck Depression Inventory (BDI) (age 18-19) of patients
Measured by Korean Children's Depression Inventory, 2nd Edition (values: 0\~100, higher score means worse outcome) or Korean Beck Depression Inventory, 2nd Edition (higher score means worse outcome)
Time frame: baseline (3 weeks) and intervention (12 weeks) period