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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06434584
• Other study ID #: 20240218043800077
• Status: Completed
• Start date: December 10, 2022
• Est. completion date: June 10, 2023

Study information

• Verified date: May 2024
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 10, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Other:
• without AI assistance
provide insulin dosage and confidence score without AI assistance
• with AI dosage assistance
provide insulin dosage and confidence score with AI dosage assistance
• with explainable AI assistance
provide insulin dosage and confidence score with explainable AI assistance
• with faulty explainable AI assistance
provide insulin dosage and confidence score with faulty explainable AI assistance

Locations

Country	Name	City	State
China	Xiaoying Li	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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