## Protocol Section
### Identification Module
**NCT ID:** NCT06434584

**Brief Title:** Explainable Insulin Decision-making System to Assist Physicians in Diabetes Management

**Official Title:** Explainable Insulin Decision-making System to Assist Physicians in Diabetes Management

#### Organization Study ID Info
**ID:** 20240218043800077
#### Organization
**Class:** OTHER
**Full Name:** Shanghai Zhongshan Hospital
### Status Module
#### Completion Date
**Date:** 2023-06-10

**Type:** ACTUAL

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

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-03-20

**Type:** ACTUAL

#### Start Date
**Date:** 2022-12-10

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-23
### 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:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The investigators plan to conduct a multi-case, multi-reader observational study with the primary objective of exploring the effects of an interpretable insulin-assisted decision-making system on physicians' (1) decision accuracy and (2) decision confidence.

### Conditions Module

**Conditions:**

- Diabetes

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** OTHER

#### Enrollment Info

**Count:** 48

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: without AI assistance

- Other: with AI dosage assistance

- Other: with explainable AI assistance

- Other: with faulty explainable AI assistance

**Label:** senior doctor group

#### Arm Group 2

**Intervention Names:**

- Other: without AI assistance

- Other: with AI dosage assistance

- Other: with explainable AI assistance

- Other: with faulty explainable AI assistance

**Label:** junior doctor group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- junior doctor group

- senior doctor group

**Description:** provide insulin dosage and confidence score without AI assistance

**Name:** without AI assistance

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- junior doctor group

- senior doctor group

**Description:** provide insulin dosage and confidence score with AI dosage assistance

**Name:** with AI dosage assistance

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- junior doctor group

- senior doctor group

**Description:** provide insulin dosage and confidence score with explainable AI assistance

**Name:** with explainable AI assistance

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- junior doctor group

- senior doctor group

**Description:** provide insulin dosage and confidence score with faulty explainable AI assistance

**Name:** with faulty explainable AI assistance

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The investigators used MAE and clinical agreement to quantitatively assess the accuracy of clinician-recommended insulin doses.

1. Mean Absolute Error (MAE) represents the error between the clinician-recommended value and the expert-recommended value (gold standard).
2. Clinical agreement: Clinical agreement is calculated as the proportion of clinically consistent insulin doses (clinician-given adjustments in the same direction as the expert's protocol and within 20% of the dose difference) to the total insulin dose.

**Measure:** Doctors' decision-making accuracy

**Time Frame:** up to 2 months

**Description:** Clinicians' confidence in decision-making was assessed using a 10-point Likert scale from 1 (not at all confident) to 10 (completely confident).

**Measure:** Doctors' decision-making confidence

**Time Frame:** up to 2 months

### Eligibility Module

**Eligibility Criteria:** Case:

Inclusion Criteria:

* Patients with T2DM who were admitted to Zhongshan Hospital of Fudan University from 2022.12 to 2023.3.
* Insulin regimen is one of the following: a. Basal regimen: once a day subcutaneous injection of long-acting or ultra-long-acting insulin; b. Premixed regimen: two/three times a day subcutaneous injection of premixed insulin; c. Basal mealtime regimen: three times a day before meals subcutaneous injection of short-acting or rapid-acting insulin, plus once a day injection of long-acting or ultra-long-acting insulin.

Exclusion Criteria:

- Cases will be excluded if there is insufficient information for a valid assessment (missing data on insulin or blood glucose \>40%).

Doctor

Inclusion Criteria:

licensed medical practitioner.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** include 40 patient cases and 8 doctors (4 senior and 4 junior)

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Shanghai

**Country:** China

**Facility:** Xiaoying Li

**State:** Shanghai

**Zip:** 200032

#### Overall Officials

**Official 1:**

**Affiliation:** Fudan University

**Name:** Xiaoying Li, Professor

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine 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

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: 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

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

### 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
