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| Name | Class |
|---|---|
| Shanghai Fifth People's Hospital | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI group | Experimental | AI-assisted insulin dosage adjustment |
|
| Doctor group | Active Comparator | doctor adjust insulin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-assisted insulin dose adjustment model | Device | We use an artificial intelligence-assisted insulin dose adjustment system to adjust insulin doses in hospitalised patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| time in target range (3.9-10.0 mmol/L ) | Proportion of time in the target glucose range (TIR; 3.9-10.0 mmol/L) measured by CGM during the intervention period. | ≥3 days |
| Measure | Description | Time Frame |
|---|---|---|
| sensor glucose | 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 | ≥3 days |
| capillary blood glucose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| doctor's insulin dose adjustment | Other | participants' insulin doses are adjusted by doctors |
|
pre-breakfast, pre-lunch, pre-dinner, pre-bedtime
| ≥3 days |
| hypoglycaemic event | 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 | ≥3 days |
| hyperglycaemic event | capillary blood glucose>20.0 mmol/L, and/or ketoacidosis, and/or hyperosmotic status. | ≥3 days |
| insulin dosage | insulin dosage | ≥3 days |
| satisfaction score of doctors | evaluated by questionnaire. | after intervention |
| Length of hospitalisation | Length of hospitalisation | ≥3 days |
| Other/Serious Adverse Events | Itchy skin, admission to ICU, death, etc. | ≥3 days |
| D006946 | Hyperinsulinism |