Diabetes Type 2
Conditions
Keywords
diabetes, insulin
Brief summary
Our study was a single-blind, randomised, controlled, multicentre study. The study was planned to enrol 142 patients with T2DM admitted to general wards who required subcutaneous insulin therapy. Participants were randomly divided into two groups in the ratio of 1:1, one group with an artificial intelligence-assisted insulin decision system to adjust insulin doses for blood glucose control, and the other group received clinician-instituted insulin dose adjustments for blood glucose control. 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 enrol 142 patients with T2DM admitted to the general ward who required subcutaneous insulin therapy. Participants were randomly divided into two groups in the ratio of 1:1, one group with an artificial intelligence-assisted insulin decision system to adjust insulin doses for blood glucose control, and the other group received clinician-instituted insulin dose adjustments for blood glucose control. The effectiveness and safety of the system was confirmed by comparing the glycaemic control and risk of adverse events between the two groups.
Interventions
DEVICEAI-assisted insulin dose adjustment model
We use an artificial intelligence-assisted insulin dose adjustment system to adjust insulin doses in hospitalised patients
OTHERdoctor's insulin dose adjustment
participants' insulin doses are adjusted by doctors
Sponsors
Shanghai Zhongshan Hospital
Shanghai Fifth People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of type 2 diabetes mellitus \> 3 months * Age≥18 years old * Receiving glucose-lowering management 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 undergoing corticosteroid 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 * Expected to be NPO for an extended period * Any medical or psychological conditions, or medications that, in the doctor's judgment, could interfere with the results * Subjects who cannot comply with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time in target range (3.9-10.0 mmol/L ) | ≥3 days | Proportion of time in the target glucose range (TIR; 3.9-10.0 mmol/L) measured by CGM during the intervention period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sensor glucose | ≥3 days | Proportion of time during which sensor glucose levels are within the ranges (5.6-10.0mmol/L,10.1-13.9mmol/L, \>13.9mmol/L,\<3.0mmol/L, 3.0-3.8mmol/L), as measured by CGM during the intervention period |
| capillary blood glucose | ≥3 days | pre-breakfast, pre-lunch, pre-dinner, pre-bedtime |
| hypoglycaemic event | ≥3 days | capillary blood glucose\<3.9 mmol/L, \<3.0 mmol/L, \< 2.2 mmol/L or an episode that requires of assistance of another person |
| hyperglycaemic event | ≥3 days | capillary blood glucose\>20.0 mmol/L, and/or ketoacidosis, and/or hyperosmotic status. |
| insulin dosage | ≥3 days | insulin dosage |
| satisfaction score of doctors | after intervention | evaluated by questionnaire. |
| Length of hospitalisation | ≥3 days | Length of hospitalisation |
| Other/Serious Adverse Events | ≥3 days | Itchy skin, admission to ICU, death, etc. |
Countries
China
Outcome results
None listed