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

Last updated: May 9, 2024
Sponsor: Seoul National University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Diabetes And Hypertension

Diabetes Mellitus Types I And Ii

Treatment

Medtronic 780G insulin pump

Clinical Study ID

NCT06414564
23081591461
  • Ages 7-19
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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

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

  2. The subject has been continuously treated at least for 8 weeks at the start of thestudy, by one of the existing insulin treatment methods [insulin multi-injection (MDII), general insulin pump (CSII), sensor-linked insulin pump (SAP), or 770Ginsulin pump (HCL system)]

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

Exclusion

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

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Medtronic 780G insulin pump
Phase:
Study Start date:
February 01, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

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