Actively Recruiting

Phase Not Applicable
Age: 7Years - 19Years
All Genders
NCT06414564

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

Led by Seoul National University Hospital · Updated on 2024-05-16

30

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

Sponsors

S

Seoul National University Hospital

Lead Sponsor

M

Medtronic

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 7Years - 19Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 7 and 19 years
  • Diagnosis of type 1 diabetes for at least 1 year
  • Presence of one or more of the following: serum c-peptide ≤ 0.6 ng/mL at diagnosis, positive glutamic acid decarboxylase (GAD) antibody, positive islet cell antibody, positive anti-Insulin antibody, or positive anti-islet Antigen-2 (IA-2) antibody
  • Continuous insulin treatment for at least 8 weeks before the study using multi-injection, general insulin pump, sensor-linked insulin pump, or 770G insulin pump
  • Use of real-time continuous glucose monitoring for at least 8 weeks before the study
Not Eligible

You will not qualify if you...

  • Use of any systemic drugs affecting glucose metabolism within 8 weeks prior to the trial
  • Presence of hematologic disorders affecting HbA1c levels
  • Presence of medical disorders affecting glucose metabolism
  • Diagnosis of neuropsychiatric disorders such as depression or eating disorders
  • Presence of thyroid disorders with abnormal thyroid function

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Seoul National University Hospital

Seoul, South Korea, 03080

Actively Recruiting

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Research Team

Y

Young Ah Lee, MD, PhD

CONTACT

Y

Yun Jeong Lee, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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