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

Primary Purpose

Type 1 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DIA:CONN G8 insulin pump
Multiple daily insulin injection
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital
  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Continuous subcutaneous insulin infusion

Multiple daily insulin injection

Arm Description

Continuous subcutaneous insulin infusion using insulin pump (DIA:CONN G8) with continuous glucose monitoring

Multiple daily insulin injection with continuous glucose monitoring

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time above range
glucose level > 180 mg/dL derived from continuous glucose monitoring
Time below range
glucose level < 70 mg/dL derived from continuous glucose monitoring
Mean sensor glucose
mean sensor glucose level derived from continuous glucose monitoring
Coefficient of variation
Standard deviation * 100 / mean (derived from continuous glucose monitoring)
Glucose management indicator
estimated HbA1c levels derived from continuous glucose monitoring
Glycated albumin
Glycated albumin level
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)
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)
Children's Depression inventory of patients
Measured by Korean Children's Depression Inventory, 2nd Edition (values: 0~100, higher score means worse outcome)
Perceived stress scale of parents
Perceived stress scale (values: 0~56, higher score means worse outcome)

Full Information

First Posted
December 17, 2021
Last Updated
February 15, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05201846
Brief Title
Comparison of CSII and MDI in Pediatric Patients With Type 1 Diabetes
Official Title
Effect of Continuous Subcutaneous Insulin Injection in Pediatric Patients With Type 1 Diabetes Using Multiple Daily Insulin Injections
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous subcutaneous insulin infusion
Arm Type
Experimental
Arm Description
Continuous subcutaneous insulin infusion using insulin pump (DIA:CONN G8) with continuous glucose monitoring
Arm Title
Multiple daily insulin injection
Arm Type
Active Comparator
Arm Description
Multiple daily insulin injection with continuous glucose monitoring
Intervention Type
Device
Intervention Name(s)
DIA:CONN G8 insulin pump
Intervention Description
Subjects on continuous subcutaneous insulin infusion system with CGM
Intervention Type
Other
Intervention Name(s)
Multiple daily insulin injection
Intervention Description
Subjects on multiple daily insulin injection with CGM
Primary Outcome Measure Information:
Title
Time in range
Description
glucose level between 70-180 mg/dL derived from continuous glucose monitoring
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Time above range
Description
glucose level > 180 mg/dL derived from continuous glucose monitoring
Time Frame
30 days
Title
Time below range
Description
glucose level < 70 mg/dL derived from continuous glucose monitoring
Time Frame
30 days
Title
Mean sensor glucose
Description
mean sensor glucose level derived from continuous glucose monitoring
Time Frame
30 days
Title
Coefficient of variation
Description
Standard deviation * 100 / mean (derived from continuous glucose monitoring)
Time Frame
30 days
Title
Glucose management indicator
Description
estimated HbA1c levels derived from continuous glucose monitoring
Time Frame
30 days
Title
Glycated albumin
Description
Glycated albumin level
Time Frame
Changes from baseline to after 30 days of intervention
Title
Quality of life measurements (general) of patients and parents
Description
Measured by PedsQL (Pediatric Quality of Life InventoryTM) Generic Core Module 4.0 (values: 0~100, higher score means better outcome)
Time Frame
At the end of intervention (30 days)
Title
Quality of life measurements (diabetes-specific) of patients and parents
Description
Measured by PedsQL (Pediatric Quality of Life InventoryTM) Diabetes Module 3.0 (values: 0~100, higher score means better outcome)
Time Frame
At the end of intervention (30 days)
Title
Children's Depression inventory of patients
Description
Measured by Korean Children's Depression Inventory, 2nd Edition (values: 0~100, higher score means worse outcome)
Time Frame
At the end of intervention (30 days)
Title
Perceived stress scale of parents
Description
Perceived stress scale (values: 0~56, higher score means worse outcome)
Time Frame
At the end of intervention (30 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Young Ah Lee, MD, PhD
Phone
82-2-2072-2308
Email
nina337@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Yun Jeong Lee, MD
Phone
82-2-2072-2811
Email
yjlee103@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Choong Ho Shin, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Hyun Kim, MD, PhD
Phone
82-31-787-7287
Email
joyminer@gmail.com
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Ah Lee, MD, PhD
Phone
82-2-2072-2308
Email
nina337@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Yun Jeong Lee, MD
Phone
82-2-2072-2811
Email
yjlee103@snu.ac.kr

12. IPD Sharing Statement

Learn more about this trial

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

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