Type 2 Diabetes
Conditions
Brief summary
This is a single-center, open-labeled, parallel group, randomized controlled trial to access the effect and safety of the Artificial Intelligence Assisted Insulin Titration System in patients with Type 2 Diabetes Mellitus.
Detailed description
The study enrolls 44 patients with Type 2 Diabetes in 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 receive insulin regimen set by the AI assisted system and patients in Control group receive insulin regimen set by physicians. 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 percentage of time of sensor glucose measurements in targeted range (3.9-10 mmol/L) during the 7-days trial period.
Interventions
DRUGAI assisted insulin system
The patients receive the insulin regime set by AI assisted insulin titration system
Patients receive the insulin regime recommended by physicians
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The research assistants who collect study outcome data will be masked to participants' intervention assignment. In addition, the adjudicators for end-points will not be aware of study-group assignments.
Intervention model description
A paralle group, randomized, controlled study to assess the effect and safety of artificial intelligence assisted insulin dosage titration system on glucose control in type 2 diabetic patients
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Men or women aged 18-75 years old; * Subjects who had been diagnosed with type 2 diabetes; * Subjects who are on treatment with insulin 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 |
|---|---|---|
| Proportion of time in target range | During 7-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 7-day intervention | The poor control of blood glucose level is defined as greater than 10 mmol/L |
| Proportion of time in which the blood glucose level is below 3.9 mmol/L | During 7-day intervention | The hypoglycemia is defined as blood glucose level less than 3.9mmol/L |
| Total insulin dose | Each day during 7-day intervention | The total insulin dose is defined as daily insulin dose |
Countries
China
Outcome results
None listed