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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Type 2
• Intervention / Treatment: Device: AI-assisted insulin dose adjustment model; Other: doctor's insulin dose adjustment

Detailed Description

Our study was a single-blind, randomised, controlled, multicentre study. The study was planned to enrol 142 patients with T2DM admitted to the general ward 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.

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Zhongshan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

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 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
• Subjects who cannot comply with the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI group; AI-assisted insulin dosage adjustment	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 Names: the Artificial Intelligence-assisted Insulin Dose Adjustment System
Active Comparator: Doctor group; doctor adjust insulin	Other: doctor's insulin dose adjustment; participants' insulin doses are adjusted by doctors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
insulin dosage	insulin dosage	≥3 days
satisfaction score of doctors	evaluated by questionnaire.	after intervention
Length of hospitalisation	Length of hospitalisation	≥3 days
Other/Serious Adverse Events	Itchy skin, admission to ICU, death, etc.	≥3 days
sensor glucose	Proportion of time during which sensor glucose levels are within the ranges (5.6-10.0mmol/L,10.1-13.9mmol/L, >13.9mmol/L,<3.0mmol/L, 3.0-3.8mmol/L), as measured by CGM during the intervention period	≥3 days
capillary blood glucose	pre-breakfast, pre-lunch, pre-dinner, pre-bedtime	≥3 days
hypoglycaemic event	capillary blood glucose<3.9 mmol/L, <3.0 mmol/L, < 2.2 mmol/L or an episode that requires of assistance of another person	≥3 days
hyperglycaemic event	capillary blood glucose>20.0 mmol/L, and/or ketoacidosis, and/or hyperosmotic status.	≥3 days

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Shanghai Fifth People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2024
• Primary Completion (Actual): September 20, 2025
• Study Completion (Actual): September 20, 2025

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: diabetes; insulin
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Hyperinsulinism; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus; Insulin Resistance; Physiological Effects of Drugs; Hypoglycemic Agents; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: 20240115023245436

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No