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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06434584
Enrollment
48
Registered
2024-05-30
Start date
2022-12-10
Completion date
2023-06-10
Last updated
2024-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

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.

Interventions

OTHERwithout AI assistance

provide insulin dosage and confidence score without AI assistance

OTHERwith AI dosage assistance

provide insulin dosage and confidence score with AI dosage assistance

OTHERwith explainable AI assistance

provide insulin dosage and confidence score with explainable AI assistance

OTHERwith faulty explainable AI assistance

provide insulin dosage and confidence score with faulty explainable AI assistance

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Doctors' decision-making accuracyup to 2 monthsThe 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.
Doctors' decision-making confidenceup to 2 monthsClinicians' confidence in decision-making was assessed using a 10-point Likert scale from 1 (not at all confident) to 10 (completely confident).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026