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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 19
Healthy Volunteers: f
View:

• The subject is age 7-19

• 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

• The subject was diagnosed with type 1 diabetes ≥ 1 year

• 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 \[insulin multi-injection (MDII), general insulin pump (CSII), sensor-linked insulin pump (SAP), or 770G insulin pump (HCL system)\]

• The subject has been applied with real-time continuous glucose monitoring at least for 8 weeks at the start of the study

Locations
Other Locations
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Young Ah Lee, MD, PhD
nina337@snu.ac.kr
82-2-2072-2308
Backup
Yun Jeong Lee, MD
yjlee103@snuh.org
82-2-2072-2811
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 30
Treatments
Experimental: AHCL system application
insulin infusion using AHCL system insulin pump (Medtronic 780G) with continous glucose monitoring (guardian G4)
Related Therapeutic Areas
Sponsors
Collaborators: Medtronic
Leads: Seoul National University Hospital

This content was sourced from clinicaltrials.gov

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