Clinical trial NCT05201846: Comparison of CSII and MDI in Pediatric Patients With Type 1 Diabetes
Official title: Effect of Continuous Subcutaneous Insulin Injection in Pediatric Patients With Type 1 Diabetes Using Multiple Daily Insulin Injections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 66
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Prospective, randomized, open-label, two-sequence crossover study to investigate the effects of continuous subcutaneous insulin injection (CSII, using DIA:CONN G8 insulin pump) in pediatric patients with type 1 diabetes using multiple daily insulin (MDI) injection

Detailed description: This trial consists of two crossover periods of 5 weeks each (MDI to CSII or CSII to MDI), followed by an extended period of 12 weeks (MDI or CSII). Each intervention period has wash-out period (5 days) excluded from the outcome measurements.

Eligibility criteria: Inclusion Criteria:

1. The subject is aged 2-17
2. The subject with one or more of the below at diagnosis

   * serum c-peptide \< 0.6 ng/mL
   * 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 is treated with multiple daily insulin injection
5. The subject must have available continuous glucose monitoring (CGM) data with a percentage of active CGM time ≥ 70% in the past 4 weeks.

Exclusion Criteria:

1. Subjects who were treated with insulin pump therapy within 12 weeks prior to trial
2. Any systemic treatment with drugs known to interfere with glucose metabolism within 12 weeks prior to trial
3. Subjects with underlying hematologic disorders that can affect the HbA1c levels
4. Subjects with underlying medical disorders that can affect glucose metabolism
5. Subjects with a neuropsychiatric disorder such as depression or eating disorder
6. Subjects with underlying thyroid disorders and abnormal thyroid function

Primary outcomes:
measure: Time in range
timeFrame: 30 days
Secondary outcomes:
measure: Time above range
timeFrame: 30 days
measure: Time below range
timeFrame: 30 days
measure: Mean sensor glucose
timeFrame: 30 days
measure: Coefficient of variation
timeFrame: 30 days
measure: Glucose management indicator
timeFrame: 30 days
measure: Glycated albumin
timeFrame: Changes from baseline to after 30 days of intervention
measure: Quality of life measurements (general) of patients and parents
timeFrame: At the end of intervention (30 days)
measure: Quality of life measurements (diabetes-specific) of patients and parents
timeFrame: At the end of intervention (30 days)
measure: Children's Depression inventory of patients
timeFrame: At the end of intervention (30 days)
measure: Perceived stress scale of parents
timeFrame: At the end of intervention (30 days)
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Choong Ho Shin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: