Type 1 DiabetesNCT05201846
Comparison of CSII and MDI in Pediatric Patients With Type 1 Diabetes
A study testing DIA:CONN G8 insulin pump and Multiple daily insulin injection in people with Type 1 Diabetes, run by Seoul National University Hospital at 2 sites in South Korea.
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 Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- DIA:CONN G8 insulin pump and Multiple daily insulin injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 18 Jan 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Not yet recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Jae Hyun Kim, MD, PhD, 82-31-787-7287, joyminer@gmail.com
- Recruiting
Seoul National University Hospital
Seoul, 03080
Young Ah Lee, MD, PhD, 82-2-2072-2308, nina337@snu.ac.kr
Yun Jeong Lee, MD, 82-2-2072-2811, yjlee103@snu.ac.kr
About this study
Official title: 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
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- DIA:CONN G8 insulin pump, Multiple daily insulin injection
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIA:CONN G8 insulin pumpDevice
Subjects on continuous subcutaneous insulin infusion system with CGM
Multiple daily insulin injectionOther
Subjects on multiple daily insulin injection with CGM
| Study group | Role | What they receive |
|---|---|---|
| Continuous subcutaneous insulin infusion | Experimental | Continuous subcutaneous insulin infusion using insulin pump (DIA:CONN G8) with continuous glucose monitoring Receives: Device: DIA:CONN G8 insulin pump |
| Multiple daily insulin injection | Active comparator | Multiple daily insulin injection with continuous glucose monitoring Receives: Other: Multiple daily insulin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range
glucose level between 70-180 mg/dL derived from continuous glucose monitoring
Measured: 30 days
Secondary outcomes (10)
Time above range
glucose level > 180 mg/dL derived from continuous glucose monitoring
Measured: 30 days
Time below range
glucose level < 70 mg/dL derived from continuous glucose monitoring
Measured: 30 days
Mean sensor glucose
mean sensor glucose level derived from continuous glucose monitoring
Measured: 30 days
Coefficient of variation
Standard deviation * 100 / mean (derived from continuous glucose monitoring)
Measured: 30 days
Glucose management indicator
estimated HbA1c levels derived from continuous glucose monitoring
Measured: 30 days
Glycated albumin
Glycated albumin level
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At the end of intervention (30 days)
Perceived stress scale of parents
Perceived stress scale (values: 0~56, higher score means worse outcome)
Measured: At the end of intervention (30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start18 Jan 2022
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Choong Ho Shin, Seoul National University Hospital
- Investigators
- Choong Ho Shin, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201846
- Sponsor's protocol ID
- 21111431275
- Status last verified
- Feb 2022
- First submitted
- 17 Dec 2021
- Last updated
- 3 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Subcutaneous Insulin Injection in Pediatric Patients With Type 1 Diabetes Using Multiple Daily Insulin Injections
- ClinicalTrials.gov ID
- NCT05201846
- Acronym / sponsor ID
- 21111431275
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous subcutaneous insulin infusion | Experimental | Device: DIA:CONN G8 insulin pumpContinuous subcutaneous insulin infusion using insulin pump (DIA:CONN G8) with continuous glucose monitoring |
| Multiple daily insulin injection | Active comparator | Other: Multiple daily insulin injectionMultiple daily insulin injection with continuous glucose monitoring |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- The subject is aged 2-17
- The subject with one or more of the below at diagnosis
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIA:CONN G8 insulin pumpSubjects on continuous subcutaneous insulin infusion system with CGM | Device | Continuous subcutaneous insulin infusion |
| Multiple daily insulin injectionSubjects on multiple daily insulin injection with CGM | Other | Multiple daily insulin injection |
Primary outcome
Time in range
Time frame: 30 days
glucose level between 70-180 mg/dL derived from continuous glucose monitoring
10 secondary outcomes
Time above range
Time frame: 30 days
Time below range
Time frame: 30 days
Mean sensor glucose
Time frame: 30 days
Coefficient of variation
Time frame: 30 days
Glucose management indicator
Time frame: 30 days
Glycated albumin
Time frame: Changes from baseline to after 30 days of intervention
Quality of life measurements (general) of patients and parents
Time frame: At the end of intervention (30 days)
Quality of life measurements (diabetes-specific) of patients and parents
Time frame: At the end of intervention (30 days)
Children's Depression inventory of patients
Time frame: At the end of intervention (30 days)
Perceived stress scale of parents
Time frame: At the end of intervention (30 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Choong Ho Shin, MD, PhD principal investigator
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIA:CONN G8 insulin pump and Multiple daily insulin injection in people with Type 1 Diabetes, run by Seoul National University Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Young Ah Lee, MD, PhD (82-2-2072-2308, nina337@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.