Comparison of CSII and MDI in Pediatric Patients With Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Continuous Subcutaneous Insulin Injection in Pediatric Patients With Type 1 Diabetes Using Multiple Daily Insulin Injections

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: DIA:CONN G8 insulin pump
* Other: Multiple daily insulin injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is aged 2-17 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 The subject was diagnosed with type 1 diabetes ≥ 1 year The subject is treated with multiple daily insulin injection 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: Subjects who were treated with insulin pump therapy within 12 weeks prior to trial Any systemic treatment with drugs known to interfere with glucose metabolism within 12 weeks prior to trial Subjects with underlying hematologic disorders that can affect the HbA1c levels Subjects with underlying medical disorders that can affect glucose metabolism Subjects with a neuropsychiatric disorder such as depression or eating disorder Subjects with underlying thyroid disorders and abnormal thyroid function

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous subcutaneous insulin infusion<br>Continuous subcutaneous insulin infusion using insulin pump (DIA:CONN G8) with continuous glucose monitoring | Device: DIA:CONN G8 insulin pump<br>* Subjects on continuous subcutaneous insulin infusion system with CGM<br>|
| Active Comparator: Multiple daily insulin injection<br>Multiple daily insulin injection with continuous glucose monitoring | Other: Multiple daily insulin injection<br>* Subjects on multiple daily insulin injection with CGM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in range | glucose level between 70-180 mg/dL derived from continuous glucose monitoring | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time above range | glucose level > 180 mg/dL derived from continuous glucose monitoring | 30 days | 
| Time below range | glucose level < 70 mg/dL derived from continuous glucose monitoring | 30 days | 
| Mean sensor glucose | mean sensor glucose level derived from continuous glucose monitoring | 30 days | 
| Coefficient of variation | Standard deviation * 100 / mean (derived from continuous glucose monitoring) | 30 days | 
| Glucose management indicator | estimated HbA1c levels derived from continuous glucose monitoring | 30 days | 
| Glycated albumin | Glycated albumin level | Changes from baseline to after 30 days of intervention | 
| Quality of life measurements (general) of patients and parents | Measured by PedsQL (Pediatric Quality of Life InventoryTM) Generic Core Module 4.0 (values: 0 100, higher score means better outcome) | At the end of intervention (30 days) | 
| Quality of life measurements (diabetes-specific) of patients and parents | Measured by PedsQL (Pediatric Quality of Life InventoryTM) Diabetes Module 3.0 (values: 0 100, higher score means better outcome) | At the end of intervention (30 days) | 
| Children's Depression inventory of patients | Measured by Korean Children's Depression Inventory, 2nd Edition (values: 0 100, higher score means worse outcome) | At the end of intervention (30 days) | 
| Perceived stress scale of parents | Perceived stress scale (values: 0 56, higher score means worse outcome) | At the end of intervention (30 days) |