NCT05201846

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	DIA:CONN G8 insulin pump	Subjects on continuous subcutaneous insulin infusion system with CGM
OTHER	Multiple daily insulin injection	Subjects on multiple daily insulin injection with CGM

Timeline

• Start date: 2022-01-18
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2022-01-21
• Last updated: 2022-03-03

Locations

2 sites across 1 country: South Korea