Effects of AHCL Insulin Pump on Glycemic Control and Psychosocial Outcomes in Pediatric Patients With Type 1 Diabetes

Not Applicable

Recruiting

• Conditions: Type 1 Diabetes
• Interventions: Device: Medtronic 780G insulin pump

• Registration Number: NCT06414564
• Lead Sponsor: Seoul National University Hospital

Brief 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

Detailed Description

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 Timeline

• Study First Submitted: 2024-01-30
• Study Start: 2024-02-01
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-09
• Last Update Submitted: 2024-05-09
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. The subject is age 7-19

2. 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

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

4. 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)]

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

Exclusion Criteria

1. Any systemic treatment with drugs known to interfere with glucose metabolism within 8 weeks prior to trial
2. Subjects with underlying hematologic disorders that can affect the HbA1c levels
3. Subjects with underlying medical disorders that can affect glucose metabolism
4. Subjects with a neuropsychiatric disorder such as depression or eating disorder
5. Subjects with underlying thyroid disorders and abnormal thyroid function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
AHCL system application	Medtronic 780G insulin pump	insulin infusion using AHCL system insulin pump (Medtronic 780G) with continous glucose monitoring (guardian G4)

Primary Outcome Measures

Name	Time	Method
Time In Range (TIR)	baseline (3 weeks) and intervention (12 weeks) period	glucose level between 70-180 mg/dL derived from continuous glucose monitoring

Secondary Outcome Measures

Name	Time	Method
Coefficient of variation (CV)	baseline (3 weeks) and intervention (12 weeks) period	Standard deviation \* 100/ mean (derived from continuous glucose monitoring)
Time Above Range (TAR)	baseline (3 weeks) and intervention (12 weeks) period	glucose level \>180 mg/dL derived from continuous glucose monitoring
Glycated albumin	before and at the end of intervention, which in average lasts 12 weeks	Glycated albumin level
HbA1c	before and at the end of intervention, which in average lasts 12 weeks	Glycated hemoglobin level
Time Below Range (TBR)	baseline (3 weeks) and intervention (12 weeks) period	glucose level \<70 mg/dL derived from continuous glucose monitoring
mean sensor glucose	baseline (3 weeks) and intervention (12 weeks) period	mean sensor glucose level derived from continuous glucose monitoring
Quality of life measurements (general) of patients and parents	baseline (3 weeks) and intervention (12 weeks) period	Measured by PedsQL (Pediatric Quality of Life InventoryTM) Generic Core, Module 4.0 (values: 0\~100, higher score means better outcome)
Children's Depression Inventory(CDI) (age 7-17) or Beck Depression Inventory (BDI) (age 18-19) of patients	baseline (3 weeks) and intervention (12 weeks) period	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)
Glucose management indicator (GMI)	baseline (3 weeks) and intervention (12 weeks) period	Estimated HbA1c levels derived from continuous glucose monitoring
Quality of life measurements (diabetes-specific) of patients and parents	baseline (3 weeks) and intervention (12 weeks) period	Measured by PedsQL (Pediatric Quality of Life InventoryTM) Diabetes Specific, Module 3.0 (values: 0\~100, higher score means better outcome)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of