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

Diabetes Type 2 Clinical Trial

Official title:

Efficacy and Safety of the Artificial Intelligence-assisted Insulin Dose Adjustment System for Glycaemic Control in Patients With Type 2 Diabetes Mellitus in General Wards: a Multicentre, Single-blind, Randomised Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06319300
• Other study ID #: 20240115023245436
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2024
• Est. completion date: May 20, 2026

Study information

• Verified date: April 2024
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: May 20, 2026
• Est. primary completion date: March 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

Device:
• AI-assisted insulin dose adjustment model
We use an artificial intelligence-assisted insulin dose adjustment system to adjust insulin doses in hospitalised patients

Other:
• doctor's insulin dose adjustment
participants' insulin doses are adjusted by doctors

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Shanghai Fifth People's Hospital,Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time in target range (3.9-10.0 mmol/L )	Percentage of total time with sensor blood glucose levels in the 3.9-10 mmol/L range	=3 days
Secondary	sensor glucose	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)	=3 days
Secondary	capillary blood sugar	pre-breakfast, pre-lunch, pre-dinner, pre-bedtime	=3 days
Secondary	hypoglycaemic event	capillary blood sugar<3.0 mmol/L	=3 days
Secondary	hyperglycaemic event	capillary blood sugar>20.0 mmol/L	=3 days
Secondary	insulin dosage	insulin dosage	=3 days
Secondary	satisfaction score of doctors	evaluated by questionnaire.	after intervention
Secondary	Length of hospitalisation	Length of hospitalisation	=3 days
Secondary	Other/Serious Adverse Events	Itchy skin, admission to ICU, death, etc.	=3 days