NCT06414564

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

1.4 years

First QC Date

January 30, 2024

Last Update Submit

May 9, 2024

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Time Above Range (TAR)

    baseline (3 weeks) and intervention (12 weeks) period

  • Time Below Range (TBR)

    baseline (3 weeks) and intervention (12 weeks) period

  • mean sensor glucose

    baseline (3 weeks) and intervention (12 weeks) period

  • Coefficient of variation (CV)

    baseline (3 weeks) and intervention (12 weeks) period

  • Glucose management indicator (GMI)

    baseline (3 weeks) and intervention (12 weeks) period

  • +5 more secondary outcomes

Other Outcomes (4)

  • Sleep enter and end time

    baseline (3 weeks) and intervention (12 weeks) period

  • Sleep duration

    baseline (3 weeks) and intervention (12 weeks) period

  • Sleep efficiency

    baseline (3 weeks) and intervention (12 weeks) period

  • +1 more other outcomes

Study Arms (1)

AHCL system application

EXPERIMENTAL

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

Device: Medtronic 780G insulin pump

Interventions

Medtronic 780G insulin pumpDEVICE

Subjects on insulin infusion by 780G AHCL system

AHCL system application

Eligibility Criteria

Age7 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Young Ah Lee, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Young Ah Lee, MD, PhD

CONTACT

82-2-2072-2308nina337@snu.ac.kr

Yun Jeong Lee, MD

CONTACT

82-2-2072-2811yjlee103@snuh.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 30, 2024

First Posted

May 16, 2024

Study Start

February 1, 2024

Primary Completion

June 30, 2025

Study Completion

December 31, 2025

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations

KR(1)