Study to Assess the Efficacy and Safety of iNCDSS in Type 2 Diabetes Mellitus Patients

• Status: Not yet recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Fifth People's Hospital,Shanghai; Qingpu Central Hospital,Shanghai; Shanghai Fifth People's Hospital; Shanghai Qingpu Central Hospital; Shanghai Xuhui Central Hospital; Xuhui Central Hospital, Shanghai
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

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.