NCT06319300

Brief Summary

Our study was a single-blind, randomised, controlled, multicentre study. The study was planned to enrol 142 patients with T2DM admitted to general wards who required subcutaneous insulin therapy. Participants were randomly divided into two groups in the ratio of 1:1, one group with an artificial intelligence-assisted insulin decision system to adjust insulin doses for blood glucose control, and the other group received clinician-instituted insulin dose adjustments for blood glucose control. The effectiveness and safety of the system was confirmed by comparing the glycaemic control and risk of adverse events between the two groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 19, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2025

Completed
Last Updated

June 23, 2026

Status Verified

December 1, 2025

Enrollment Period

1.4 years

First QC Date

March 13, 2024

Last Update Submit

June 18, 2026

Conditions

Diabetes Type 2

Keywords

diabetesinsulin

Outcome Measures

Primary Outcomes (1)

  • time in target range (3.9-10.0 mmol/L )

    Proportion of time in the target glucose range (TIR; 3.9-10.0 mmol/L) measured by CGM during the intervention period.

    ≥3 days

Secondary Outcomes (8)

  • sensor glucose

    ≥3 days

  • capillary blood glucose

    ≥3 days

  • hypoglycaemic event

    ≥3 days

  • hyperglycaemic event

    ≥3 days

  • insulin dosage

    ≥3 days

  • +3 more secondary outcomes

Study Arms (2)

AI group

EXPERIMENTAL

AI-assisted insulin dosage adjustment

Device: AI-assisted insulin dose adjustment model

Doctor group

ACTIVE COMPARATOR

doctor adjust insulin

Other: doctor's insulin dose adjustment

Interventions

AI-assisted insulin dose adjustment modelDEVICE

We use an artificial intelligence-assisted insulin dose adjustment system to adjust insulin doses in hospitalised patients

Also known as: the Artificial Intelligence-assisted Insulin Dose Adjustment System
AI group
doctor's insulin dose adjustmentOTHER

participants' insulin doses are adjusted by doctors

Doctor group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of type 2 diabetes mellitus \> 3 months
  • Age≥18 years old
  • Receiving glucose-lowering management for at least 90 days
  • Blood glucose:7.8-22.2 mmol/L
  • Length of proposed hospitalisation ≥5 days.

You may not qualify if:

  • Type 1 diabetes mellitus, other special types of diabetes mellitus
  • BG\>22.2 mmol/L, or acute complications of diabetes, such as diabetic ketoacidosis, diabetic hyperosmolar state
  • History of severe or repeated hypoglycaemia
  • BMI≥45 kg/m2
  • Pregnant and lactating women
  • Clinically relevant liver disease (established cirrhosis and portal hypertension)
  • Presence of severe renal disease (serum creatinine ≥3.0 mg/dL or estimated glomerular filtration rate \<30 ml/min/1.73 m2)
  • Severe cardiac insufficiency
  • Patients undergoing corticosteroid therapy (equivalent to a prednisone dose \>5 mg/day)
  • Psychiatric abnormalities or impaired cognitive function
  • Patients with severe oedema, infection, or peripheral blood circulation disorder
  • Patients with severe illness or patients to be transferred to ICU for treatment
  • Surgery of the heart or abdomen that may have a significant impact on the test is planned during hospitalisation
  • Expected to be NPO for an extended period
  • Any medical or psychological conditions, or medications that, in the doctor's judgment, could interfere with the results
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2024

First Posted

March 20, 2024

Study Start

April 19, 2024

Primary Completion

September 20, 2025

Study Completion

September 20, 2025

Last Updated

June 23, 2026

Record last verified: 2025-12

Locations

CN(1)