Comparison of CSII and MDI in Pediatric Patients With Type 1 Diabetes

Effect of Continuous Subcutaneous Insulin Injection in Pediatric Patients With Type 1 Diabetes Using Multiple Daily Insulin Injections

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.

Inclusion Criteria:

1. The subject is aged 2-17

2. 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

3. The subject was diagnosed with type 1 diabetes ≥ 1 year

4. The subject is treated with multiple daily insulin injection

5. The subject must have available continuous glucose monitoring (CGM) data with a percentage of active CGM time ≥ 70% in the past 4 weeks.

Exclusion Criteria:

1. Subjects who were treated with insulin pump therapy within 12 weeks prior to trial
2. Any systemic treatment with drugs known to interfere with glucose metabolism within 12 weeks prior to trial
3. Subjects with underlying hematologic disorders that can affect the HbA1c levels
4. Subjects with underlying medical disorders that can affect glucose metabolism
5. Subjects with a neuropsychiatric disorder such as depression or eating disorder
6. Subjects with underlying thyroid disorders and abnormal thyroid function