Type 2 Diabetes
Conditions
Keywords
iNCDSS, T2D, AI
Brief summary
This is a multi-center, open-labeled, parallel group, randomized controlled trial to access the effect and safety of the Artificial Intelligence Assisted Insulin Titration System (iNCDSS) in patients with Type 2 Diabetes Mellitus.
Detailed description
As one of the most common treatments for diabetes inpatients, insulin regimens often vary due to different physicians. Since 2016, Zhongshan Hospital has set up the Internet-based glucose management system (iGMS) to monitor plasma glucose of diabetes patients, and further set up an Artificial Intelligence Assisted Insulin Titration System (iNCDSS) to recommend insulin regime in 2019. Previous single-center clinical trial (NCT04053959) have demonstrated the efficacy and safety of iNCDSS in glycemic management in patients with type 2 diabetes. This multi-center study enrolls 120 patients with Type 2 Diabetes from 20 wards of Zhongshan Hospital who are on treatment with insulin for at least 3 months. They are randomly allocated into 2 groups at a ratio of 1:1 after screening for the inclusion and exclusion criteria. Patients in the Intervention group (AI group) receive insulin regimen set by iNCDSS and patients in Control group receive insulin regimen recommended by endocrinologists. This study will be conducted in the Department of Endocrinology, Zhongshan Hospital,Fudan University and consist of a 7-day intervention period. Patient allocation will be stratified by HbA1c, BMI and previous total insulin doses. The primary endpoint is the fasting plasma glucose level after the 7-days trial period.
Interventions
Patients of this group will receive the insulin regime set by the AI assisted insulin titration system (iNCDSS).
Patients of this group will receive the insulin regime recommended by professional endocrinologists.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Men or women aged 18-99 years old; * Inpatients who had been diagnosed with type 2 diabetes; * Subjects who are on treatment with insulin for at least 3 months; * HbA1c: 7.0%-10.0%.
Exclusion criteria
* Patients who were diagnosed with T1D, gestational diabetes or other specific types of diabetes. * Subjects with acute complications of diabetes such as ketoacidosis or hyperglycemic hyperosmolar state; * Patients with severe cardiac, hepatic, renal or general diseases; * Subjects that are, in the judgement of the investigator, unlikely to comply with the protocol. * Absence of informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting plasma glucose of T2D patients | After 7-day intervention | Fasting plasma glucose of T2D patients by self-monitoring of bloodglucose (SMBG) in both groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Well-controlled rate of fasting blood glucose | During 7-day intervention | The well-controlled rate of blood glucose is defined as proportion of the time of sensor glucose measurements in targeted range |
| Incidence of hypoglycemia | During 7-day intervention | The hypoglycemia is defined as blood glucose level less than 3.9mmol/L. |
| Total insulin dose | During 7-day intervention | The total insulin dose is defined as daily insulin dose. |
Countries
China
Contacts
Primary ContactHua Bian
Outcome results
None listed