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

Fudan University

Status: Enrolling

Conditions: Diabetes Type 2

Treatments: Other: doctor's insulin dose adjustment; Device: AI-assisted insulin dose adjustment model

Study type: Interventional

Funder types: Other

Identifiers

NCT06319300

20240115023245436

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

AI group

Experimental group

Description:

AI-assisted insulin dosage adjustment

Treatment:

Device: AI-assisted insulin dose adjustment model

Doctor group

Active Comparator group

Description:

doctor adjust insulin

Treatment:

Other: doctor's insulin dose adjustment