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

May 23, 2024 updated by: Shanghai Zhongshan Hospital
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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: up to 2 months

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.
up to 2 months
Doctors' decision-making confidence
Time Frame: up to 2 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Study Chair: Xiaoying Li, Professor, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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