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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous subcutaneous insulin infusion | Experimental | Continuous subcutaneous insulin infusion using insulin pump (DIA:CONN G8) with continuous glucose monitoring |
|
| Multiple daily insulin injection | Active Comparator | Multiple daily insulin injection with continuous glucose monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DIA:CONN G8 insulin pump | Device | Subjects on continuous subcutaneous insulin infusion system with CGM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time in range | glucose level between 70-180 mg/dL derived from continuous glucose monitoring | 30 days |
| 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 |
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Inclusion Criteria:
The subject is aged 2-17
The subject with one or more of the below at diagnosis
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young Ah Lee, MD, PhD | Contact | 82-2-2072-2308 | nina337@snu.ac.kr | |
| Yun Jeong Lee, MD | Contact | 82-2-2072-2811 | yjlee103@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Choong Ho Shin, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Not yet recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Multiple daily insulin injection | Other | Subjects on multiple daily insulin injection with CGM |
|
| 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) |
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |