## Protocol Section
### Identification Module
**NCT ID:** NCT06414564

**Brief Title:** Effects of AHCL Insulin Pump on Glycemic Control and Psychosocial Outcomes in Pediatric Patients With Type 1 Diabetes

**Official Title:** Effects of Advanced Hybrid Closed-loop System on Glycemic Control and Psychosocial Outcomes in Pediatric Patients With Type 1 Diabetes

#### Organization Study ID Info
**ID:** 23081591461
#### Organization
**Class:** OTHER
**Full Name:** Seoul National University Hospital
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-30
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Medtronic

#### Lead Sponsor

**Class:** OTHER

**Name:** Seoul National University Hospital

#### Responsible Party

**Investigator Affiliation:** Seoul National University Hospital

**Investigator Full Name:** Lee Young Ah

**Investigator Title:** Associate professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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

**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 Module

**Conditions:**

- Type 1 Diabetes

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SEQUENTIAL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** insulin infusion using AHCL system insulin pump (Medtronic 780G) with continous glucose monitoring (guardian G4)

**Intervention Names:**

- Device: Medtronic 780G insulin pump

**Label:** AHCL system application

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- AHCL system application

**Description:** Subjects on insulin infusion by 780G AHCL system

**Name:** Medtronic 780G insulin pump

**Type:** DEVICE

### Outcomes Module

#### Other Outcomes

**Description:** Measured in time, derived from Fitbit data

**Measure:** Sleep enter and end time

**Time Frame:** baseline (3 weeks) and intervention (12 weeks) period

**Description:** Measured in hours and minutes, derived from Fitbit data

**Measure:** Sleep duration

**Time Frame:** baseline (3 weeks) and intervention (12 weeks) period

**Description:** Derived from Fitbit data

**Measure:** Sleep efficiency

**Time Frame:** baseline (3 weeks) and intervention (12 weeks) period

**Description:** Derived from Fitbit data

**Measure:** Wake after sleep onset

**Time Frame:** baseline (3 weeks) and intervention (12 weeks) period

#### Primary Outcomes

**Description:** glucose level between 70-180 mg/dL derived from continuous glucose monitoring

**Measure:** Time In Range (TIR)

**Time Frame:** baseline (3 weeks) and intervention (12 weeks) period

#### Secondary Outcomes

**Description:** glucose level \>180 mg/dL derived from continuous glucose monitoring

**Measure:** Time Above Range (TAR)

**Time Frame:** baseline (3 weeks) and intervention (12 weeks) period

**Description:** glucose level \<70 mg/dL derived from continuous glucose monitoring

**Measure:** Time Below Range (TBR)

**Time Frame:** baseline (3 weeks) and intervention (12 weeks) period

**Description:** mean sensor glucose level derived from continuous glucose monitoring

**Measure:** mean sensor glucose

**Time Frame:** baseline (3 weeks) and intervention (12 weeks) period

**Description:** Standard deviation \* 100/ mean (derived from continuous glucose monitoring)

**Measure:** Coefficient of variation (CV)

**Time Frame:** baseline (3 weeks) and intervention (12 weeks) period

**Description:** Estimated HbA1c levels derived from continuous glucose monitoring

**Measure:** Glucose management indicator (GMI)

**Time Frame:** baseline (3 weeks) and intervention (12 weeks) period

**Description:** Glycated hemoglobin level

**Measure:** HbA1c

**Time Frame:** before and at the end of intervention, which in average lasts 12 weeks

**Description:** Glycated albumin level

**Measure:** Glycated albumin

**Time Frame:** before and at the end of intervention, which in average lasts 12 weeks

**Description:** Measured by PedsQL (Pediatric Quality of Life InventoryTM) Generic Core, Module 4.0 (values: 0\~100, higher score means better outcome)

**Measure:** Quality of life measurements (general) of patients and parents

**Time Frame:** baseline (3 weeks) and intervention (12 weeks) period

**Description:** Measured by PedsQL (Pediatric Quality of Life InventoryTM) Diabetes Specific, Module 3.0 (values: 0\~100, higher score means better outcome)

**Measure:** Quality of life measurements (diabetes-specific) of patients and parents

**Time Frame:** baseline (3 weeks) and intervention (12 weeks) period

**Description:** 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)

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. The subject is age 7-19
2. 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
   * positive anti-islet Antigen-2 (IA-2) antibody
3. The subject was diagnosed with type 1 diabetes ≥ 1 year
4. 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 \[insulin multi-injection (MDII), general insulin pump (CSII), sensor-linked insulin pump (SAP), or 770G insulin pump (HCL system)\]
5. The subject has been applied with real-time continuous glucose monitoring at least for 8 weeks at the start of the study

Exclusion Criteria:

1. Any systemic treatment with drugs known to interfere with glucose metabolism within 8 weeks prior to trial
2. Subjects with underlying hematologic disorders that can affect the HbA1c levels
3. Subjects with underlying medical disorders that can affect glucose metabolism
4. Subjects with a neuropsychiatric disorder such as depression or eating disorder
5. Subjects with underlying thyroid disorders and abnormal thyroid function

**Maximum Age:** 19 Years

**Minimum Age:** 7 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** nina337@snu.ac.kr

**Name:** Young Ah Lee, MD, PhD

**Phone:** 82-2-2072-2308

**Role:** CONTACT

**Contact 2:**

**Email:** yjlee103@snuh.org

**Name:** Yun Jeong Lee, MD

**Phone:** 82-2-2072-2811

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seoul

**Contacts:**

***Contact 1:***

- **Email:** nina337@snu.ac.kr

- **Name:** Young Ah Lee, MD, PhD

- **Phone:** 82-2-2072-2308

- **Role:** CONTACT

***Contact 2:***

- **Email:** yjlee103@snuh.org

- **Name:** Yun Jeong Lee, MD

- **Phone:** 82-2-2072-2811

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** Seoul National University Hospital

**Status:** RECRUITING

**Zip:** 03080

#### Overall Officials

**Official 1:**

**Affiliation:** Seoul National University Hospital

**Name:** Young Ah Lee, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes

- ID: M7117

- Name: Diabetes Mellitus, Type 1

- Relevance: HIGH

- As Found: Type 1 Diabetes

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003922

- Term: Diabetes Mellitus, Type 1

### Intervention Browse Module - Ancestors

- ID: D000007004

- Term: Hypoglycemic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10365

- Name: Insulin

- Relevance: HIGH

- As Found: Day 1

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: LOW

- As Found: Unknown

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000007328

- Term: Insulin

### Misc Info Module

- Version Holder: 2024-05-31
