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

NCT06319300 | Recruiting

• 1 other identifier: 20240115023245436
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Type 2

Keywords

diabetes; insulin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• sensor glucose

  ≥3 days

• capillary blood sugar

  ≥3 days

• hypoglycaemic event

  ≥3 days

• hyperglycaemic event

  ≥3 days

• insulin dosage

  ≥3 days

Study Arms (2)

AI group

EXPERIMENTAL

AI-assisted insulin dosage adjustment

Device: AI-assisted insulin dose adjustment model

Doctor group

ACTIVE COMPARATOR

doctor adjust insulin

Other: doctor's insulin dose adjustment

Interventions

AI-assisted insulin dose adjustment model DEVICE

We use an artificial intelligence-assisted insulin dose adjustment system to adjust insulin doses in hospitalised patients

Also known as: the Artificial Intelligence-assisted Insulin Dose Adjustment System

AI group

doctor's insulin dose adjustment OTHER

participants' insulin doses are adjusted by doctors

Doctor group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Shanghai Fifth People's Hospital: collaborator

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: April 19, 2024
• Primary Completion: March 20, 2026
• Study Completion: May 20, 2026
• Last Updated: August 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)