Clinical trial NCT06414564: Effects of AHCL Insulin Pump on Glycemic Control and Psychosocial Outcomes in Pediatric Patients With Type 1 Diabetes
Official title: Effects of Advanced Hybrid Closed-loop System on Glycemic Control and Psychosocial Outcomes in Pediatric Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2024-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Time In Range (TIR)
timeFrame: baseline (3 weeks) and intervention (12 weeks) period
Secondary outcomes:
measure: Time Above Range (TAR)
timeFrame: baseline (3 weeks) and intervention (12 weeks) period
measure: Time Below Range (TBR)
timeFrame: baseline (3 weeks) and intervention (12 weeks) period
measure: mean sensor glucose
timeFrame: baseline (3 weeks) and intervention (12 weeks) period
measure: Coefficient of variation (CV)
timeFrame: baseline (3 weeks) and intervention (12 weeks) period
measure: Glucose management indicator (GMI)
timeFrame: baseline (3 weeks) and intervention (12 weeks) period
measure: HbA1c
timeFrame: before and at the end of intervention, which in average lasts 12 weeks
measure: Glycated albumin
timeFrame: before and at the end of intervention, which in average lasts 12 weeks
measure: Quality of life measurements (general) of patients and parents
timeFrame: baseline (3 weeks) and intervention (12 weeks) period
measure: Quality of life measurements (diabetes-specific) of patients and parents
timeFrame: baseline (3 weeks) and intervention (12 weeks) period
measure: Children's Depression Inventory(CDI) (age 7-17) or Beck Depression Inventory (BDI) (age 18-19) of patients
timeFrame: baseline (3 weeks) and intervention (12 weeks) period
Other outcomes:
measure: Sleep enter and end time
timeFrame: baseline (3 weeks) and intervention (12 weeks) period
measure: Sleep duration
timeFrame: baseline (3 weeks) and intervention (12 weeks) period
measure: Sleep efficiency
timeFrame: baseline (3 weeks) and intervention (12 weeks) period
measure: Wake after sleep onset
timeFrame: baseline (3 weeks) and intervention (12 weeks) period
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Young Ah Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: