Explainable Insulin Decision-making System to Assist Physicians in Diabetes Management

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Other: without AI assistance; Other: with AI dosage assistance; Other: with explainable AI assistance; Other: with faulty explainable AI assistance

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Xiaoying Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

include 40 patient cases and 8 doctors (4 senior and 4 junior)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
senior doctor group	Other: without AI assistance; provide insulin dosage and confidence score without AI assistance; Other: with AI dosage assistance; provide insulin dosage and confidence score with AI dosage assistance; Other: with explainable AI assistance; provide insulin dosage and confidence score with explainable AI assistance; Other: with faulty explainable AI assistance; provide insulin dosage and confidence score with faulty explainable AI assistance
junior doctor group	Other: without AI assistance; provide insulin dosage and confidence score without AI assistance; Other: with AI dosage assistance; provide insulin dosage and confidence score with AI dosage assistance; Other: with explainable AI assistance; provide insulin dosage and confidence score with explainable AI assistance; Other: with faulty explainable AI assistance; provide insulin dosage and confidence score with faulty explainable AI assistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Doctors' decision-making accuracy	The investigators used MAE and clinical agreement to quantitatively assess the accuracy of clinician-recommended insulin doses.; Mean Absolute Error (MAE) represents the error between the clinician-recommended value and the expert-recommended value (gold standard).; 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.	up to 2 months
Doctors' decision-making confidence	Clinicians' confidence in decision-making was assessed using a 10-point Likert scale from 1 (not at all confident) to 10 (completely confident).	up to 2 months

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Chair: Xiaoying Li, Professor, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2022
• Primary Completion (Actual): March 20, 2023
• Study Completion (Actual): June 10, 2023

Study Registration Dates

• First Submitted: May 9, 2024
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 20240218043800077

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No