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 with type 1 diabetes using multiple daily insulin (MDI) injection
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 days) excluded from the outcome measurements.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Subjects on continuous subcutaneous insulin infusion system with CGM
Subjects on multiple daily insulin injection with CGM
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
NOT_YET_RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGTime in range
glucose level between 70-180 mg/dL derived from continuous glucose monitoring
Time frame: 30 days
Time above range
glucose level \> 180 mg/dL derived from continuous glucose monitoring
Time frame: 30 days
Time below range
glucose level \< 70 mg/dL derived from continuous glucose monitoring
Time frame: 30 days
Mean sensor glucose
mean sensor glucose level derived from continuous glucose monitoring
Time frame: 30 days
Coefficient of variation
Standard deviation \* 100 / mean (derived from continuous glucose monitoring)
Time frame: 30 days
Glucose management indicator
estimated HbA1c levels derived from continuous glucose monitoring
Time frame: 30 days
Glycated albumin
Glycated albumin level
Time frame: Changes from baseline to after 30 days of intervention
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: At the end of intervention (30 days)
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Quality of life measurements (diabetes-specific) of patients and parents
Measured by PedsQL (Pediatric Quality of Life InventoryTM) Diabetes Module 3.0 (values: 0\~100, higher score means better outcome)
Time frame: At the end of intervention (30 days)
Children's Depression inventory of patients
Measured by Korean Children's Depression Inventory, 2nd Edition (values: 0\~100, higher score means worse outcome)
Time frame: At the end of intervention (30 days)
Perceived stress scale of parents
Perceived stress scale (values: 0\~56, higher score means worse outcome)
Time frame: At the end of intervention (30 days)