Comparison of CSII and MDI in Pediatric Patients With Type 1 Diabetes
Effect of Continuous Subcutaneous Insulin Injection in Pediatric Patients With Type 1 Diabetes Using Multiple Daily Insulin Injections
1 other identifier
interventional
66
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2021
CompletedStudy Start
First participant enrolled
January 18, 2022
CompletedFirst Posted
Study publicly available on registry
January 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedMarch 3, 2022
February 1, 2022
1.2 years
December 17, 2021
February 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Time in range
glucose level between 70-180 mg/dL derived from continuous glucose monitoring
30 days
Secondary Outcomes (10)
Time above range
30 days
Time below range
30 days
Mean sensor glucose
30 days
Coefficient of variation
30 days
Glucose management indicator
30 days
- +5 more secondary outcomes
Study Arms (2)
Continuous subcutaneous insulin infusion
EXPERIMENTALContinuous subcutaneous insulin infusion using insulin pump (DIA:CONN G8) with continuous glucose monitoring
Multiple daily insulin injection
ACTIVE COMPARATORMultiple daily insulin injection with continuous glucose monitoring
Interventions
Subjects on continuous subcutaneous insulin infusion system with CGM
Subjects on multiple daily insulin injection with CGM
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Choong Ho Shin, MD, PhD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 17, 2021
First Posted
January 21, 2022
Study Start
January 18, 2022
Primary Completion
March 31, 2023
Study Completion
March 31, 2023
Last Updated
March 3, 2022
Record last verified: 2022-02