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

N/ARecruitingNCT06319300

Shanghai Zhongshan Hospital140 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

140

Conditions

Diabetes Type 2

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: ≥3 days

Secondary Outcomes

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)

Time frame: ≥3 days

capillary blood sugar

pre-breakfast, pre-lunch, pre-dinner, pre-bedtime

Time frame: ≥3 days

hypoglycaemic event

capillary blood sugar\<3.0 mmol/L

Time frame: ≥3 days

hyperglycaemic event

capillary blood sugar\>20.0 mmol/L

Time frame: ≥3 days

insulin dosage

Time frame: ≥3 days

satisfaction score of doctors

evaluated by questionnaire.

Time frame: after intervention

Length of hospitalisation

Time frame: ≥3 days

Other/Serious Adverse Events

Itchy skin, admission to ICU, death, etc.

Time frame: ≥3 days

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes