Type 1 Diabetes
Conditions
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.
Interventions
DEVICEDIA:CONN G8 insulin pump
Subjects on continuous subcutaneous insulin infusion system with CGM
Subjects on multiple daily insulin injection with CGM
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in range | 30 days | glucose level between 70-180 mg/dL derived from continuous glucose monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time above range | 30 days | glucose level \> 180 mg/dL derived from continuous glucose monitoring |
| Time below range | 30 days | glucose level \< 70 mg/dL derived from continuous glucose monitoring |
| Mean sensor glucose | 30 days | mean sensor glucose level derived from continuous glucose monitoring |
| Coefficient of variation | 30 days | Standard deviation \* 100 / mean (derived from continuous glucose monitoring) |
| Glucose management indicator | 30 days | estimated HbA1c levels derived from continuous glucose monitoring |
| Glycated albumin | Changes from baseline to after 30 days of intervention | Glycated albumin level |
| Quality of life measurements (general) of patients and parents | At the end of intervention (30 days) | 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 | At the end of intervention (30 days) | Measured by PedsQL (Pediatric Quality of Life InventoryTM) Diabetes Module 3.0 (values: 0\ 100, higher score means better outcome) |
| Children's Depression inventory of patients | At the end of intervention (30 days) | Measured by Korean Children's Depression Inventory, 2nd Edition (values: 0\ 100, higher score means worse outcome) |
| Perceived stress scale of parents | At the end of intervention (30 days) | Perceived stress scale (values: 0\ 56, higher score means worse outcome) |
Countries
South Korea
Contacts
Primary ContactYoung Ah Lee, MD, PhD
Backup ContactYun Jeong Lee, MD
Outcome results
None listed