Diabetes Type 2 Clinical Trial
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
Verified date | April 2024 |
Source | Shanghai Zhongshan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | May 20, 2026 |
Est. primary completion date | March 20, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Zhongshan Hospital, Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital | Shanghai Fifth People's Hospital,Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | capillary blood sugar | pre-breakfast, pre-lunch, pre-dinner, pre-bedtime | =3 days | |
Secondary | hypoglycaemic event | capillary blood sugar<3.0 mmol/L | =3 days | |
Secondary | hyperglycaemic event | capillary blood sugar>20.0 mmol/L | =3 days | |
Secondary | insulin dosage | insulin dosage | =3 days | |
Secondary | satisfaction score of doctors | evaluated by questionnaire. | after intervention | |
Secondary | Length of hospitalisation | Length of hospitalisation | =3 days | |
Secondary | Other/Serious Adverse Events | Itchy skin, admission to ICU, death, etc. | =3 days |
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