Comparison of CSII and MDI in Pediatric Patients With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Effect of Continuous Subcutaneous Insulin Injection in Pediatric Patients With Type 1 Diabetes Using Multiple Daily Insulin Injections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05201846
• Other study ID #: 21111431275
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: February 2022
• Source: Seoul National University Hospital
• Contact: Young Ah Lee, MD, PhD
• Phone: 82-2-2072-2308
• Email: nina337[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• DIA:CONN G8 insulin pump
Subjects on continuous subcutaneous insulin infusion system with CGM

Other:
• Multiple daily insulin injection
Subjects on multiple daily insulin injection with CGM

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in range	glucose level between 70-180 mg/dL derived from continuous glucose monitoring	30 days
Secondary	Time above range	glucose level > 180 mg/dL derived from continuous glucose monitoring	30 days
Secondary	Time below range	glucose level < 70 mg/dL derived from continuous glucose monitoring	30 days
Secondary	Mean sensor glucose	mean sensor glucose level derived from continuous glucose monitoring	30 days
Secondary	Coefficient of variation	Standard deviation * 100 / mean (derived from continuous glucose monitoring)	30 days
Secondary	Glucose management indicator	estimated HbA1c levels derived from continuous glucose monitoring	30 days
Secondary	Glycated albumin	Glycated albumin level	Changes from baseline to after 30 days of intervention
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Perceived stress scale of parents	Perceived stress scale (values: 0~56, higher score means worse outcome)	At the end of intervention (30 days)