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 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 Overview

• Status: Recruiting
• 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 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 Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Xiaoying Li; Phone Number: +862164041990; Email: li.xiaoying@zs-hospital.sh.cn

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 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 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 )	Percentage of total time with sensor blood glucose levels in the 3.9-10 mmol/L range	≥3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
capillary blood sugar	pre-breakfast, pre-lunch, pre-dinner, pre-bedtime	≥3 days
hypoglycaemic event	capillary blood sugar<3.0 mmol/L	≥3 days
hyperglycaemic event	capillary blood sugar>20.0 mmol/L	≥3 days
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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Shanghai Fifth People's Hospital,Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2024
• Primary Completion (Estimated): March 20, 2026
• Study Completion (Estimated): May 20, 2026

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): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: diabetes; insulin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; 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