Type 1 Diabetes
Conditions
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.
Interventions
DEVICEMedtronic 780G insulin pump
Subjects on insulin infusion by 780G AHCL system
Sponsors
Medtronic
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 19 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time In Range (TIR) | baseline (3 weeks) and intervention (12 weeks) period | glucose level between 70-180 mg/dL derived from continuous glucose monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coefficient of variation (CV) | baseline (3 weeks) and intervention (12 weeks) period | Standard deviation \* 100/ mean (derived from continuous glucose monitoring) |
| Glycated albumin | before and at the end of intervention, which in average lasts 12 weeks | Glycated albumin level |
| Quality of life measurements (general) of patients and parents | baseline (3 weeks) and intervention (12 weeks) period | Measured by PedsQL (Pediatric Quality of Life InventoryTM) Generic Core, Module 4.0 (values: 0\ 100, higher score means better outcome) |
| Quality of life measurements (diabetes-specific) of patients and parents | baseline (3 weeks) and intervention (12 weeks) period | Measured by PedsQL (Pediatric Quality of Life InventoryTM) Diabetes Specific, Module 3.0 (values: 0\ 100, higher score means better outcome) |
| Children's Depression Inventory(CDI) (age 7-17) or Beck Depression Inventory (BDI) (age 18-19) of patients | baseline (3 weeks) and intervention (12 weeks) period | 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) |
| Time Above Range (TAR) | baseline (3 weeks) and intervention (12 weeks) period | glucose level \>180 mg/dL derived from continuous glucose monitoring |
| Time Below Range (TBR) | baseline (3 weeks) and intervention (12 weeks) period | glucose level \<70 mg/dL derived from continuous glucose monitoring |
| mean sensor glucose | baseline (3 weeks) and intervention (12 weeks) period | mean sensor glucose level derived from continuous glucose monitoring |
| Glucose management indicator (GMI) | baseline (3 weeks) and intervention (12 weeks) period | Estimated HbA1c levels derived from continuous glucose monitoring |
| HbA1c | before and at the end of intervention, which in average lasts 12 weeks | Glycated hemoglobin level |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sleep efficiency | baseline (3 weeks) and intervention (12 weeks) period | Derived from Fitbit data |
| Wake after sleep onset | baseline (3 weeks) and intervention (12 weeks) period | Derived from Fitbit data |
| Sleep duration | baseline (3 weeks) and intervention (12 weeks) period | Measured in hours and minutes, derived from Fitbit data |
| Sleep enter and end time | baseline (3 weeks) and intervention (12 weeks) period | Measured in time, derived from Fitbit data |
Countries
South Korea
Contacts
Primary ContactYoung Ah Lee, MD, PhD
Backup ContactYun Jeong Lee, MD
Outcome results
None listed