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

Not Applicable

• Conditions: Type 1 Diabetes
• Interventions: Other: Multiple daily insulin injection

• Registration Number: NCT05201846
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2021-12-17
• Study First Submitted QC: 2022-01-08
• Study Start: 2022-01-18
• Study First Posted: 2022-01-21
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-03-03
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Multiple daily insulin injection	Multiple daily insulin injection	Multiple daily insulin injection with continuous glucose monitoring

Primary Outcome Measures

Name	Time	Method
Time in range	30 days	glucose level between 70-180 mg/dL derived from continuous glucose monitoring

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of