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

NCT ID: NCT06434584

Last Updated: 2024-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-10

Study Completion Date

2023-06-10

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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senior doctor group

without AI assistance

Intervention Type OTHER

provide insulin dosage and confidence score without AI assistance

with AI dosage assistance

Intervention Type OTHER

provide insulin dosage and confidence score with AI dosage assistance

with explainable AI assistance

Intervention Type OTHER

provide insulin dosage and confidence score with explainable AI assistance

with faulty explainable AI assistance

Intervention Type OTHER

provide insulin dosage and confidence score with faulty explainable AI assistance

junior doctor group

without AI assistance

Intervention Type OTHER

provide insulin dosage and confidence score without AI assistance

with AI dosage assistance

Intervention Type OTHER

provide insulin dosage and confidence score with AI dosage assistance

with explainable AI assistance

Intervention Type OTHER

provide insulin dosage and confidence score with explainable AI assistance

with faulty explainable AI assistance

Intervention Type OTHER

provide insulin dosage and confidence score with faulty explainable AI assistance

Interventions

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without AI assistance

provide insulin dosage and confidence score without AI assistance

Intervention Type OTHER

with AI dosage assistance

provide insulin dosage and confidence score with AI dosage assistance

Intervention Type OTHER

with explainable AI assistance

provide insulin dosage and confidence score with explainable AI assistance

Intervention Type OTHER

with faulty explainable AI assistance

provide insulin dosage and confidence score with faulty explainable AI assistance

Intervention Type OTHER

Eligibility Criteria

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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.


licensed medical practitioner.

Exclusion Criteria

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

Doctor
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaoying Li, Professor

Role: STUDY_CHAIR

Fudan University

Locations

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Xiaoying Li

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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20240218043800077

Identifier Type: -

Identifier Source: org_study_id

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