Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-labeled, one-arm intervention trial to access the effect and safety of the Insulin Titration System Based on Deep Learning in patients with Type 2 Diabetes Mellitus.
The study enrolls 13 patients with Type 2 Diabetes in Zhongshan Hospital who are on treatment with insulin. After screening for the inclusion and exclusion criteria, eligible patients will receive insulin dosage titration set by the Insulin Titration System Based on Deep Learning in the intervention trial. The goal of insulin therapy was to achieve preprandial capillary blood glucose between 5.6-7.8 mmol/L and postprandial capillary glucose less than 10.0mmol/L. All patients are studied for 5 consecutive days or untill hospital discharge. For each patient, capillary glucose concentration was measured at 7 time points of fasting, after breakfast, before and after lunch, before and after dinner, and before bedtime a day using Glucometer (Glupad, Sinomedisite, China). Capillary glucose measurements were performed by the nurse staff according to standard procedures with a point-of-care testing device, which is integrated into the HIS system. And continuous glucose monitoring (CGM) was performed using flash glucose monitoring (Abbott Freestyle Libre, USA) placed on the upper left arm. This study will be conducted in the Department of Endocrinology, Zhongshan Hospital,Fudan University.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI | Experimental | Insulin Titration System Based on Deep Learning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Titration System | Device | A noval insulin titration system, which is based on deep learning |
|
| Measure | Description | Time Frame |
|---|---|---|
| mean daily blood glucose concentration | For each patient, capillary glucose concentration was measured at 7 time points of fasting, after breakfast, before and after lunch, before and after dinner, and before bedtime a day using Glucometer (Glupad, Sinomedisite, China). Capillary glucose measurements were performed by the nurse staff according to standard procedures with a point-of-care testing device, which is integrated into the HIS system. The primary outcome is the difference in glycemia control as measured by mean daily blood glucose concentration during the intervention period. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| glucose concentration in target range (TIR) of 3.9-10.0 mmol/L | TIR measured by CGM and Capillary glucose measurements, respectively | 5 days |
| glucose concentration above range (10.1-13.9 mmol/L or >13.9 mmol/L) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xiaoying Li | Shanghai Zhongshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology, Zhongshan Hospital Fudan University | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37710000 | Derived | Wang G, Liu X, Ying Z, Yang G, Chen Z, Liu Z, Zhang M, Yan H, Lu Y, Gao Y, Xue K, Li X, Chen Y. Optimized glycemic control of type 2 diabetes with reinforcement learning: a proof-of-concept trial. Nat Med. 2023 Oct;29(10):2633-2642. doi: 10.1038/s41591-023-02552-9. Epub 2023 Sep 14. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
TAR measured by CGM and Capillary glucose measurements, respectively
| 5 days |
| glucose concentration below range (3.0-3.8 mmol/L or <3.0 mmol/L) | TBR measured by CGM and Capillary glucose measurements, respectively | 5 days |
| glycemic variability | glycemic variability measured by CGM and Capillary glucose measurements, respectively | 5 days |