## Protocol Section
### Identification Module
**NCT ID:** NCT06434623

**Brief Title:** Federal Learning Algorithm for an Intelligent Insulin Decision System for Dynamic Glucose Control in Type 2 Diabetic Patients

**Official Title:** A Multicenter Federal Learning Algorithm to Build an Intelligent Insulin Decision System for Dynamic Glucose Control in Type 2 Diabetic Patients

#### Organization Study ID Info
**ID:** 20240324025304420
#### Organization
**Class:** OTHER
**Full Name:** Shanghai Zhongshan Hospital
### Status Module
#### Completion Date
**Date:** 2026-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Shanghai Zhongshan Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Constructing an intelligent insulin decision-making system for dynamic glucose control in type 2 diabetes mellitus via a multicentre federated learning algorithm, comparing the performance of the federated learning model, the local model and the initial model, and evaluating their feasibility and safety.

**Detailed Description:** Constructing an intelligent insulin decision-making system for dynamic glucose control in type 2 diabetes mellitus via a multicentre federated learning algorithm, comparing the performance of the federated learning model, the local model and the initial model, and evaluating their feasibility and safety.

### Conditions Module

**Conditions:**

- Diabetes

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** OTHER

#### Enrollment Info

**Count:** 30100

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: patient record

**Label:** patients record

### Interventions

#### Intervention 1

**Arm Group Labels:**

- patients record

**Description:** using patient record to construct AI models

**Name:** patient record

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** the accuracy of AI models

**Time Frame:** up to 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* type 2 diabetes inpatients receiving insulin therapy

Exclusion Criteria:

* use of insulin pumps or glucocorticoids during hospitalisation
* less than two days of insulin therapy

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** type 2 diabetes who

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** li.xiaoying@zs-hospital.sh.cn

**Name:** Xiaoying Li, PhD.

**Phone:** 02164041990

**Role:** CONTACT

**Contact 2:**

**Email:** chen.ying4@zs-hospital.sh.cn

**Name:** Ying Chen

**Phone:** 13482

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Fudan University

**Name:** Xiaoying Li, Professor

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### 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

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

### 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: LOW

- As Found: Unknown

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
