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

Not Applicable

Recruiting

• Conditions: Diabetes Type 2
• Interventions: Device: AI-assisted insulin dose adjustment model; Other: doctor's insulin dose adjustment

• Registration Number: NCT06319300
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-20
• Status Verified: 2024-04
• Study Start: 2024-04-19
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22
• Primary Completion: 2026-03-20
• Study Completion: 2026-05-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AI group	AI-assisted insulin dose adjustment model	AI-assisted insulin dosage adjustment
Doctor group	doctor's insulin dose adjustment	doctor adjust insulin

Primary Outcome Measures

Name	Time	Method
time in target range (3.9-10.0 mmol/L )	≥3 days	Percentage of total time with sensor blood glucose levels in the 3.9-10 mmol/L range

Secondary Outcome Measures

Name	Time	Method
capillary blood sugar	≥3 days	pre-breakfast, pre-lunch, pre-dinner, pre-bedtime
hypoglycaemic event	≥3 days	capillary blood sugar\<3.0 mmol/L
sensor glucose	≥3 days	Percentage of total time with sensor blood glucose levels in the range (5.6-10.0mmol/L,10-13.9mmol/L, \>13.9mmol/L,\<3.0mmol/L, 3.0-3.8mmol/L)
Other/Serious Adverse Events	≥3 days	Itchy skin, admission to ICU, death, etc.
hyperglycaemic event	≥3 days	capillary blood sugar\>20.0 mmol/L
insulin dosage	≥3 days	insulin dosage
satisfaction score of doctors	after intervention	evaluated by questionnaire.
Length of hospitalisation	≥3 days	Length of hospitalisation

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China