Type 1 DiabetesNCT06414564
Effects of AHCL Insulin Pump on Glycemic Control and Psychosocial Outcomes in Pediatric Patients With Type 1 Diabetes
A study testing Medtronic 780G insulin pump in people with Type 1 Diabetes, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Prospective, non-randomized, single-arm clinical trial to investigate the effects of advanced hybrid close-loop (AHCL) system insulin pump in pediatric patients with type 1 diabetes Read more about this study
- Who is it for?
- Ages 7 to 19 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Medtronic 780G insulin pump
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2024to 31 Dec 2025
- 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 7 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The subject is age 7-19
- The subject with one or more of the below
- serum c-peptide ≤ 0.6 ng/mL at diagnosis
- 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 has been continuously treated at least for 8 weeks at the start of the study, by one of the existing insulin treatment methods [insulin multi-injection (MDII), general insulin pump (CSII), sensor-linked insulin pump (SAP), or 770G insulin pump (HCL system)]
- The subject has been applied with real-time continuous glucose monitoring at least for 8 weeks at the start of the study
Who cannot join
- Any systemic treatment with drugs known to interfere with glucose metabolism within 8 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
1 site in 1 country.
South Korea1 site, 1 recruiting
- 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@snuh.org
About this study
Official title: Effects of Advanced Hybrid Closed-loop System on Glycemic Control and Psychosocial Outcomes in Pediatric Patients With Type 1 Diabetes
Prospective, non-randomized, single-arm clinical trial to investigate the effects of advanced hybrid close-loop (AHCL) system insulin pump in pediatric patients with type 1 diabetes
Read the detailed description
This trial consists of baseline phase of 3 weeks sustaining the treatment previously maintained by the patient, followed by study phase of 12 weeks of AHCL system application.
- Conditions
- Type 1 Diabetes
- Being tested
- Medtronic 780G insulin pump
- 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.
Medtronic 780G insulin pumpDevice
Subjects on insulin infusion by 780G AHCL system
| Study group | Role | What they receive |
|---|---|---|
| AHCL system application | Experimental | insulin infusion using AHCL system insulin pump (Medtronic 780G) with continous glucose monitoring (guardian G4) Receives: Device: Medtronic 780G insulin pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time In Range (TIR)
glucose level between 70-180 mg/dL derived from continuous glucose monitoring
Measured: baseline (3 weeks) and intervention (12 weeks) period
Secondary outcomes (10)
Time Above Range (TAR)
glucose level >180 mg/dL derived from continuous glucose monitoring
Measured: baseline (3 weeks) and intervention (12 weeks) period
Time Below Range (TBR)
glucose level <70 mg/dL derived from continuous glucose monitoring
Measured: baseline (3 weeks) and intervention (12 weeks) period
mean sensor glucose
mean sensor glucose level derived from continuous glucose monitoring
Measured: baseline (3 weeks) and intervention (12 weeks) period
Coefficient of variation (CV)
Standard deviation * 100/ mean (derived from continuous glucose monitoring)
Measured: baseline (3 weeks) and intervention (12 weeks) period
Glucose management indicator (GMI)
Estimated HbA1c levels derived from continuous glucose monitoring
Measured: baseline (3 weeks) and intervention (12 weeks) period
HbA1c
Glycated hemoglobin level
Measured: before and at the end of intervention, which in average lasts 12 weeks
Glycated albumin
Glycated albumin level
Measured: before and at the end of intervention, which in average lasts 12 weeks
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: baseline (3 weeks) and intervention (12 weeks) period
Quality of life measurements (diabetes-specific) of patients and parents
Measured by PedsQL (Pediatric Quality of Life InventoryTM) Diabetes Specific, Module 3.0 (values: 0~100, higher score means better outcome)
Measured: baseline (3 weeks) and intervention (12 weeks) period
Children's Depression Inventory(CDI) (age 7-17) or Beck Depression Inventory (BDI) (age 18-19) of patients
Measured by Korean Children's Depression Inventory, 2nd Edition (values: 0~100, higher score means worse outcome) or Korean Beck Depression Inventory, 2nd Edition (higher score means worse outcome)
Measured: baseline (3 weeks) and intervention (12 weeks) period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Feb 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Lee Young Ah, Seoul National University Hospital
- Investigators
- Young Ah Lee, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414564
- Sponsor's protocol ID
- 23081591461
- Status last verified
- May 2024
- First submitted
- 30 Jan 2024
- Last updated
- 16 May 2024
- 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 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Advanced Hybrid Closed-loop System on Glycemic Control and Psychosocial Outcomes in Pediatric Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06414564
- Acronym / sponsor ID
- 23081591461
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 May 2024 (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, non-randomized, single-arm clinical trial to investigate the effects of advanced hybrid close-loop (AHCL) system insulin pump in pediatric patients with type 1 diabetes
Detailed description
This trial consists of baseline phase of 3 weeks sustaining the treatment previously maintained by the patient, followed by study phase of 12 weeks of AHCL system application.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AHCL system application | Experimental | Device: Medtronic 780G insulin pumpinsulin infusion using AHCL system insulin pump (Medtronic 780G) with continous glucose monitoring (guardian G4) |
Who may qualify
- Ages
- 7 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- The subject is age 7-19
- The subject with one or more of the below
- The subject was diagnosed with type 1 diabetes ≥ 1 year
- The subject has been continuously treated at least for 8 weeks at the start of the study, by one of the existing insulin treatment methods [insulin multi-injection (MDII), general insulin pump (CSII), sensor-linked insulin pump (SAP), or 770G insulin pump (HCL system)]
- The subject has been applied with real-time continuous glucose monitoring at least for 8 weeks at the start of the study
Key exclusion criteria (5 listed)
- Any systemic treatment with drugs known to interfere with glucose metabolism within 8 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
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 |
|---|---|---|
| Medtronic 780G insulin pumpSubjects on insulin infusion by 780G AHCL system | Device | AHCL system application |
Primary outcome
Time In Range (TIR)
Time frame: baseline (3 weeks) and intervention (12 weeks) period
glucose level between 70-180 mg/dL derived from continuous glucose monitoring
10 secondary outcomes
Time Above Range (TAR)
Time frame: baseline (3 weeks) and intervention (12 weeks) period
Time Below Range (TBR)
Time frame: baseline (3 weeks) and intervention (12 weeks) period
mean sensor glucose
Time frame: baseline (3 weeks) and intervention (12 weeks) period
Coefficient of variation (CV)
Time frame: baseline (3 weeks) and intervention (12 weeks) period
Glucose management indicator (GMI)
Time frame: baseline (3 weeks) and intervention (12 weeks) period
HbA1c
Time frame: before and at the end of intervention, which in average lasts 12 weeks
Glycated albumin
Time frame: before and at the end of intervention, which in average lasts 12 weeks
Quality of life measurements (general) of patients and parents
Time frame: baseline (3 weeks) and intervention (12 weeks) period
Quality of life measurements (diabetes-specific) of patients and parents
Time frame: baseline (3 weeks) and intervention (12 weeks) period
Children's Depression Inventory(CDI) (age 7-17) or Beck Depression Inventory (BDI) (age 18-19) of patients
Time frame: baseline (3 weeks) and intervention (12 weeks) period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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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.
Young Ah Lee, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic 780G insulin pump in people with Type 1 Diabetes, run by Seoul National University Hospital at 1 site 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 5 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 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (TIR) (time frame: baseline (3 weeks) and intervention (12 weeks) period). 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 16 May 2024.