Type 2 Diabetes
Conditions
Keywords
iNCDSS, T2D, AI
Brief summary
This is a multi-center, single-blind, 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 indicated the efficacy and safety of iNCDSS in glycemic management in patients with type 2 diabetes. This multi-center study enrolls 142 patients with Type 2 Diabetes from three sites who are on treatment of diabetes for at least 3 months. They will be randomly allocated into 2 groups at a ratio of 1:1 after screening for the inclusion and exclusion criteria. Patients in the Intervention group (iNCDSS group) receive insulin regimen set by iNCDSS and patients in Regular treatment regime group receive insulin regimen recommended by endocrinologists. This study will be conducted in the Department of Endocrinology in Shanghai Zhongshan Hospital, Shanghai fifth People's Hospital, Shanghai Xuhui Central Hospital, and will consist of a 5-day intervention period. Patient allocation will be stratified by HbA1c and sites. The primary endpoint is the time in target glucose range during the trial period.
Interventions
Patients of this group will receive the insulin regime set by the AI assisted insulin titration system (iNCDSS).
DRUGroutine insulin treatment regime
Patients of this group will receive the insulin regime recommended by professional endocrinologists.
Sponsors
Fudan University
XuHui Central Hospital of Shanghai, Shanghai, China
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
The intervention group will receive iNCDSS assisted recommendation for insulin dose titration. The control group will receive insulin dose titrated by senior attending physicians.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women aged 18 and above years old; * Subjects who had been diagnosed with type 2 diabetes; * Subjects who are on diabetes treatment for at least 3 months; * HbA1c: 7.0%-11.0%.
Exclusion criteria
* Subjects with acute complications of diabetes such as ketoacidosis or hyperglycemic hyperosmolar state; * Subjects who change the insulin regimens during hospitalization; * BMI ≥ 45kg/m2; * Women who are pregnant or nursing; * Subjects with severe cardiac, hepatic, renal or general diseases; * Subjects with psychiatric disorders or impaired cognitive function; * Subjects with severe edema, infections or peripheral circulation disorders; * Patients treated with surgery during hospitalization; * Subjects that are, in the judgement of the investigator, unlikely to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in target glucose range | During 5-day intervention | The well-controlled blood glucose level is defined as the time of sensor glucose measurements in targeted range (3.9-10 mmol/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of time in which the blood glucose level is over 10 mmol/L | During 5-day intervention | The poor control of blood glucose level is defined as greater than 10 mmol/L |
| Proportion of hypoglycemia | During 5-day intervention | The hypoglycemia is defined as blood glucose level less than 3.0mmol/L |
| Daily insulin dose | During 5-day intervention | The daily insulin dose is defined as daily total insulin dose |
Countries
China
Outcome results
None listed