Clinical trial NCT06319300: Artificial Intelligence-assisted Insulin System in Type 2 Diabetes in General Wards
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Type 2
Keywords: diabetes
insulin
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Fudan University
First posted: 2024-03-20
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: time in target range (3.9-10.0 mmol/L )
timeFrame: ≥3 days
Secondary outcomes:
measure: sensor glucose
timeFrame: ≥3 days
measure: capillary blood sugar
timeFrame: ≥3 days
measure: hypoglycaemic event
timeFrame: ≥3 days
measure: hyperglycaemic event
timeFrame: ≥3 days
measure: insulin dosage
timeFrame: ≥3 days
measure: satisfaction score of doctors
timeFrame: after intervention
measure: Length of hospitalisation
timeFrame: ≥3 days
measure: Other/Serious Adverse Events
timeFrame: ≥3 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
References: