Artificial Intelligence Assisted Insulin Titration System (iNCDSS)

Fudan University

Status and phase

Completed

Phase 4

Conditions

Type 2 Diabetes

Treatments

Drug: Physician based insulin regime

Drug: AI assisted insulin system

Study type

Interventional

Funder types

Other

Identifiers

NCT04053959

ZSE-201902

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.