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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AHCL system application | Experimental | insulin infusion using AHCL system insulin pump (Medtronic 780G) with continous glucose monitoring (guardian G4) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic 780G insulin pump | Device | Subjects on insulin infusion by 780G AHCL system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time In Range (TIR) | glucose level between 70-180 mg/dL derived from continuous glucose monitoring | baseline (3 weeks) and intervention (12 weeks) period |
| Measure | Description | Time Frame |
|---|---|---|
| Time Above Range (TAR) | glucose level >180 mg/dL derived from continuous glucose monitoring | baseline (3 weeks) and intervention (12 weeks) period |
| Time Below Range (TBR) | glucose level <70 mg/dL derived from continuous glucose monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep enter and end time | Measured in time, derived from Fitbit data | baseline (3 weeks) and intervention (12 weeks) period |
| Sleep duration | Measured in hours and minutes, derived from Fitbit data |
Inclusion Criteria:
The subject is age 7-19
The subject with one or more of the below
The subject was diagnosed with type 1 diabetes ≥ 1 year
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)]
The subject has been applied with real-time continuous glucose monitoring at least for 8 weeks at the start of the study
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@snuh.org |
| Name | Affiliation | Role |
|---|---|---|
| Young Ah Lee, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | 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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| baseline (3 weeks) and intervention (12 weeks) period |
| mean sensor glucose | mean sensor glucose level derived from continuous glucose monitoring | baseline (3 weeks) and intervention (12 weeks) period |
| Coefficient of variation (CV) | Standard deviation * 100/ mean (derived from continuous glucose monitoring) | baseline (3 weeks) and intervention (12 weeks) period |
| Glucose management indicator (GMI) | Estimated HbA1c levels derived from continuous glucose monitoring | baseline (3 weeks) and intervention (12 weeks) period |
| HbA1c | Glycated hemoglobin level | before and at the end of intervention, which in average lasts 12 weeks |
| Glycated albumin | Glycated albumin level | before and at the end of intervention, which in average lasts 12 weeks |
| 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) | baseline (3 weeks) and intervention (12 weeks) period |
| Quality of life measurements (diabetes-specific) of patients and parents | Measured by PedsQL (Pediatric Quality of Life InventoryTM) Diabetes Specific, Module 3.0 (values: 0~100, higher score means better outcome) | baseline (3 weeks) and intervention (12 weeks) period |
| Children's Depression Inventory(CDI) (age 7-17) or Beck Depression Inventory (BDI) (age 18-19) of patients | Measured by Korean Children's Depression Inventory, 2nd Edition (values: 0~100, higher score means worse outcome) or Korean Beck Depression Inventory, 2nd Edition (higher score means worse outcome) | baseline (3 weeks) and intervention (12 weeks) period |
| baseline (3 weeks) and intervention (12 weeks) period |
| Sleep efficiency | Derived from Fitbit data | baseline (3 weeks) and intervention (12 weeks) period |
| Wake after sleep onset | Derived from Fitbit data | baseline (3 weeks) and intervention (12 weeks) period |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |