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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06414564
• Other study ID #: 23081591461
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Seoul National University Hospital
• Contact: Young Ah Lee, MD, PhD
• Phone: 82-2-2072-2308
• Email: nina337[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Medtronic 780G insulin pump
Subjects on insulin infusion by 780G AHCL system

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Medtronic

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleep enter and end time	Measured in time, derived from Fitbit data	baseline (3 weeks) and intervention (12 weeks) period
Other	Sleep duration	Measured in hours and minutes, derived from Fitbit data	baseline (3 weeks) and intervention (12 weeks) period
Other	Sleep efficiency	Derived from Fitbit data	baseline (3 weeks) and intervention (12 weeks) period
Other	Wake after sleep onset	Derived from Fitbit data	baseline (3 weeks) and intervention (12 weeks) period
Primary	Time In Range (TIR)	glucose level between 70-180 mg/dL derived from continuous glucose monitoring	baseline (3 weeks) and intervention (12 weeks) period
Secondary	Time Above Range (TAR)	glucose level >180 mg/dL derived from continuous glucose monitoring	baseline (3 weeks) and intervention (12 weeks) period
Secondary	Time Below Range (TBR)	glucose level <70 mg/dL derived from continuous glucose monitoring	baseline (3 weeks) and intervention (12 weeks) period
Secondary	mean sensor glucose	mean sensor glucose level derived from continuous glucose monitoring	baseline (3 weeks) and intervention (12 weeks) period
Secondary	Coefficient of variation (CV)	Standard deviation * 100/ mean (derived from continuous glucose monitoring)	baseline (3 weeks) and intervention (12 weeks) period
Secondary	Glucose management indicator (GMI)	Estimated HbA1c levels derived from continuous glucose monitoring	baseline (3 weeks) and intervention (12 weeks) period
Secondary	HbA1c	Glycated hemoglobin level	before and at the end of intervention, which in average lasts 12 weeks
Secondary	Glycated albumin	Glycated albumin level	before and at the end of intervention, which in average lasts 12 weeks
Secondary	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)	baseline (3 weeks) and intervention (12 weeks) period
Secondary	Quality of life measurements (diabetes-specific) of patients and parents	Measured by PedsQL (Pediatric Quality of Life InventoryTM) Diabetes Specific, Module 3.0 (values: 0~100, higher score means better outcome)	baseline (3 weeks) and intervention (12 weeks) period
Secondary	Children's Depression Inventory(CDI) (age 7-17) or Beck Depression Inventory (BDI) (age 18-19) of patients	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)	baseline (3 weeks) and intervention (12 weeks) period