Using an advanced insulin pump to improve diabetes control in children
Effects of Advanced Hybrid Closed-loop System on Glycemic Control and Psychosocial Outcomes in Pediatric Patients With Type 1 Diabetes
This study is testing whether an advanced insulin pump can help children and teens with type 1 diabetes manage their blood sugar better and improve their overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 7 Years to 19 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06414564 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of an advanced hybrid closed-loop (AHCL) insulin pump on glycemic control and psychosocial outcomes in pediatric patients aged 7-19 with type 1 diabetes. The study consists of a baseline phase lasting 3 weeks, where participants maintain their current treatment, followed by a 12-week phase where they use the AHCL system. The goal is to assess how this technology can enhance diabetes management in children and adolescents.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 7-19 who have been diagnosed with type 1 diabetes for at least one year and have been using insulin treatment and continuous glucose monitoring.
Not a fit: Patients who have recently undergone systemic treatments that interfere with glucose metabolism or have underlying hematologic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved blood sugar control and better quality of life for children with type 1 diabetes.
How similar studies have performed: Other studies have shown promising results with similar advanced insulin pump technologies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Young Ah Lee, MD, PhD — Seoul National University Hospital
- Study coordinator: Young Ah Lee, MD, PhD
- Email: nina337@snu.ac.kr
- Phone: 82-2-2072-2308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.