Skip to main content
OpenTrials
Completed

NCT Number: NCT06434584

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xiaoying Li

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

without AI assistance

Other

provide insulin dosage and confidence score without AI assistance

with AI dosage assistance

Other

provide insulin dosage and confidence score with AI dosage assistance

with explainable AI assistance

Other

provide insulin dosage and confidence score with explainable AI assistance

with faulty explainable AI assistance

Other

provide insulin dosage and confidence score with faulty explainable AI assistance

Primary outcomes

  1. 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.

    • 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 30, 2024
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.