Explainable Insulin Decision-making System to Assist Physicians in Diabetes Management
1 other identifier
observational
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2023
CompletedFirst Submitted
Initial submission to the registry
May 9, 2024
CompletedFirst Posted
Study publicly available on registry
May 30, 2024
CompletedMay 30, 2024
May 1, 2024
3 months
May 9, 2024
May 23, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Doctors' decision-making accuracy
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
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
Study Arms (2)
senior doctor group
junior doctor group
Interventions
provide insulin dosage and confidence score without AI assistance
provide insulin dosage and confidence score with AI dosage assistance
provide insulin dosage and confidence score with explainable AI assistance
provide insulin dosage and confidence score with faulty explainable AI assistance
Eligibility Criteria
include 40 patient cases and 8 doctors (4 senior and 4 junior)
You may qualify if:
- 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.
You may not qualify if:
- \- Cases will be excluded if there is insufficient information for a valid assessment (missing data on insulin or blood glucose \>40%).
- Doctor
- licensed medical practitioner.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xiaoying Li
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xiaoying Li, Professor
Fudan University
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2024
First Posted
May 30, 2024
Study Start
December 10, 2022
Primary Completion
March 20, 2023
Study Completion
June 10, 2023
Last Updated
May 30, 2024
Record last verified: 2024-05