NCT06434623

Brief Summary

Constructing an intelligent insulin decision-making system for dynamic glucose control in type 2 diabetes mellitus via a multicentre federated learning algorithm, comparing the performance of the federated learning model, the local model and the initial model, and evaluating their feasibility and safety.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,100

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Sep 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Sep 2024Jun 2026

First Submitted

Initial submission to the registry

May 23, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

July 16, 2024

Status Verified

May 1, 2024

Enrollment Period

1.7 years

First QC Date

May 23, 2024

Last Update Submit

July 14, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • the accuracy of AI models

    up to 2 years

Study Arms (1)

patients record

Other: patient record

Interventions

using patient record to construct AI models

patients record

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

type 2 diabetes who

You may qualify if:

  • type 2 diabetes inpatients receiving insulin therapy

You may not qualify if:

  • use of insulin pumps or glucocorticoids during hospitalisation
  • less than two days of insulin therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Medical Records

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

RecordsData CollectionEpidemiologic MethodsInvestigative TechniquesOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Xiaoying Li, Professor

    Fudan University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2024

First Posted

May 30, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

July 16, 2024

Record last verified: 2024-05