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

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

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: DIA:CONN G8 insulin pump; Other: Multiple daily insulin 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 Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Young Ah Lee, MD, PhD; Phone Number: 82-2-2072-2308; Email: nina337@snu.ac.kr
• Study Contact Backup: Name: Yun Jeong Lee, MD; Phone Number: 82-2-2072-2811; Email: yjlee103@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Young Ah Lee, MD, PhD; Phone Number: 82-2-2072-2308; Email: nina337@snu.ac.kr
    • Contact: Yun Jeong Lee, MD; Phone Number: 82-2-2072-2811; Email: yjlee103@snu.ac.kr
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Not yet recruiting
      • Seoul National University Bundang Hospital
      • Contact: Jae Hyun Kim, MD, PhD; Phone Number: 82-31-787-7287; Email: joyminer@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous subcutaneous insulin infusion; Continuous subcutaneous insulin infusion using insulin pump (DIA:CONN G8) with continuous glucose monitoring	Device: DIA:CONN G8 insulin pump; Subjects on continuous subcutaneous insulin infusion system with CGM
Active Comparator: Multiple daily insulin injection; Multiple daily insulin injection with continuous glucose monitoring	Other: Multiple daily insulin injection; Subjects on multiple daily insulin injection with CGM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in range	glucose level between 70-180 mg/dL derived from continuous glucose monitoring	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Choong Ho Shin, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: January 8, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: 21111431275

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No