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

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

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

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Medtronic 780G insulin pump

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Young Ah Lee, MD, PhD; Phone Number: 82-2-2072-2308; Email: nina337@snu.ac.kr
• Study Contact Backup: Name: Yun Jeong Lee, MD; Phone Number: 82-2-2072-2811; Email: yjlee103@snuh.org

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Young Ah Lee, MD, PhD; Phone Number: 82-2-2072-2308; Email: nina337@snu.ac.kr
    • Contact: Yun Jeong Lee, MD; Phone Number: 82-2-2072-2811; Email: yjlee103@snuh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AHCL system application; insulin infusion using AHCL system insulin pump (Medtronic 780G) with continous glucose monitoring (guardian G4)	Device: Medtronic 780G insulin pump; Subjects on insulin infusion by 780G AHCL system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Above Range (TAR)	glucose level >180 mg/dL derived from continuous glucose monitoring	baseline (3 weeks) and intervention (12 weeks) period
Time Below Range (TBR)	glucose level <70 mg/dL derived from continuous glucose monitoring	baseline (3 weeks) and intervention (12 weeks) period
mean sensor glucose	mean sensor glucose level derived from continuous glucose monitoring	baseline (3 weeks) and intervention (12 weeks) period
Coefficient of variation (CV)	Standard deviation * 100/ mean (derived from continuous glucose monitoring)	baseline (3 weeks) and intervention (12 weeks) period
Glucose management indicator (GMI)	Estimated HbA1c levels derived from continuous glucose monitoring	baseline (3 weeks) and intervention (12 weeks) period
HbA1c	Glycated hemoglobin level	before and at the end of intervention, which in average lasts 12 weeks
Glycated albumin	Glycated albumin level	before and at the end of intervention, which in average lasts 12 weeks
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep enter and end time	Measured in time, derived from Fitbit data	baseline (3 weeks) and intervention (12 weeks) period
Sleep duration	Measured in hours and minutes, derived from Fitbit data	baseline (3 weeks) and intervention (12 weeks) period
Sleep efficiency	Derived from Fitbit data	baseline (3 weeks) and intervention (12 weeks) period
Wake after sleep onset	Derived from Fitbit data	baseline (3 weeks) and intervention (12 weeks) period

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Medtronic
• Investigators: Principal Investigator: Young Ah Lee, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: May 9, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 23081591461

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No