Artificial Intelligence-assisted Insulin System in Type 2 Diabetes in General Wards

NCT ID: NCT06319300

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-19

Study Completion Date

2026-05-20

Brief Summary

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Our study was a single-blind, randomised, controlled, multicentre study. The study was planned to include 140 patients admitted to the general ward for subcutaneous insulin therapy, who were randomly divided into two groups in the ratio of 1:1, one group with an artificial intelligence assisted insulin dosimetry system to adjust the insulin dose to control their blood glucose, and the other group with a physician instituted insulin dosimetry adjustments to control their blood glucose. The effectiveness and safety of the system was confirmed by comparing the glycaemic control and risk of adverse events between the two groups.

Detailed Description

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Our study was a single-blind, randomised, controlled, multicentre study. The study was planned to include 140 patients admitted to the general ward for subcutaneous insulin therapy, who were randomly divided into two groups in the ratio of 1:1, one group with an artificial intelligence assisted insulin dosimetry system to adjust the insulin dose to control their blood glucose, and the other group with a physician instituted insulin dosimetry adjustments to control their blood glucose. The effectiveness and safety of the system was confirmed by comparing the glycaemic control and risk of adverse events between the two groups.

Conditions

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Diabetes Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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AI group

AI-assisted insulin dosage adjustment

Group Type EXPERIMENTAL

AI-assisted insulin dose adjustment model

Intervention Type DEVICE

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

Doctor group

doctor adjust insulin

Group Type ACTIVE_COMPARATOR

doctor's insulin dose adjustment

Intervention Type OTHER

participants' insulin doses are adjusted by doctors

Interventions

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AI-assisted insulin dose adjustment model

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

Intervention Type DEVICE

doctor's insulin dose adjustment

participants' insulin doses are adjusted by doctors

Intervention Type OTHER

Other Intervention Names

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the Artificial Intelligence-assisted Insulin Dose Adjustment System

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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 on cortisol-based hormone 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Fifth People's Hospital

UNKNOWN

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Xiaoying Li

Role: primary

+862164041990

Other Identifiers

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20240115023245436

Identifier Type: -

Identifier Source: org_study_id

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